Is MyPlate.Gov Approach to Helping Overweight Patients Lose Weight More Patient-centered?
Phase: NA
Conditions: Obesity
Sponsor: University of California, Los Angeles

Study Protocol and Statistical Analysis Plan 
for Research Project:  
"Is MyPlate.gov approach to helping overweight patients lose 
weight more patient-centered?" 
 
clinicaltrials.gov # NCT02514889 
 
conducted by William J. McCarthy, Ph.D., Lillian Gelberg, MD, MSHS, and 
Melvin Rico, BA 
 
July 31, 2017 

 
Patterned after protocol published online in association with Appel et al. (2011)15 
 
 
MyPlate PCORI Draft Protocol* 
Version 4.0 
June 30, 2017 
Protocol Table of Contents 
1. ABSTRACT  
4 
2. SPECIFIC AIMS  
5 
3. BACKGROUND  
6 
Part A: Impact of Obesity on the Health of Individuals and Populations (Criterion 1) 
6 
Innovation and Potential for Improvement through Research (Criterion 2)  
6 
Summary of Efficacy Trials and Implications for Effectiveness Studies 
11 
Impact on Health Care Performance (Criterion 3) 
11 
Part B: Relevance to Patients (Criterion 4) 
12 
4. STUDY DESIGN  
12 
Qualitative assessment of intervention design features and specific measures 
14 
5. STUDY POPULATION  
17 
6. ELIGIBILITY TO PARTICIPATE IN THE STUDY 
17 
7. RECRUITMENT  
18 
Recruitment Procedures 
19 
Tracking of Recruitment Progress 
20 
8. DATA COLLECTION AND MEASURES 
20 
Data Collection Assessment Periods 
20 
Principal Measures 
22 
9. QUALITY ASSURANCE AND QUALITY CONTROL 
27 
10. RANDOMIZATION AND MASKING 
27 
Randomization 
28 
Masking 
28 
11. INTERVENTIONS  
28 
Overview of the Interventions 
28 
Theoretical Rationale/Model Underlying the Interventions 
29 
Description of Intervention Health Education/ Coaching Sessions 
30 
The Calorie-Counting Approach 
31 
Dietary Goals – Calorie Counting Approach 
32 
Dietary Goals – MyPlate Approach 
32 
Physical Activity Goals for Participants in Both Interventions 
33 
Duration and Format of Intervention Contacts for Both Interventions 
35 
Assessment of Participant Adherence to the Dietary Recommendations of Both 
Interventions 
39 
Outline of the Behavior Change Sessions for Participants in the Calorie Counting 
Condition 
39 
Outline of the Behavior Change Sessions for Participants in the MyPlate Condition 
40 
Standardizing Delivery of the Intervention 
41 
Facilitating Participants' Retention in the Study for Measurement Purposes 
42 
12. SAFETY MONITORING 
43 
Potential Risks 
44 
Alert Values 
45 
Surveillance and Reporting Procedures 
45 
Data Safety and Monitoring Plan 
 
46 
13. STATISTICAL POWER AND SAMPLE SIZE ESTIMATION 
46 

 
Patterned after protocol published online in association with Appel et al. (2011)15 
 
 
14. ANALYSIS PLAN  
47 
Missing and Incomplete Data 
48 
Intent to Treat Analyses 
49 
15. DATA MANAGEMENT  
49 
Data Confidentiality 
49 
Analysis Guide 
50 
Trial Data Release 
50 
16. TRIAL ADMINISTRATION–HOW INVESTIGATORS/ STAFF WILL BE 
ORGANIZED 
50 
17. TIMELINE  
50 
18. DISSEMINATION PLANS 
51 
Determine Ways for Disseminating Lessons Learned 
52 
Implement and Document Dissemination 
52 
19. REFERENCES 
52-62 
 
 
List of Tables 
 
Table 1. Table of Contents 
1 
Table 2.  Chronological Order and Type of Intervention Session 
8 
Table 3. Exlusionary Screening Statements 
19 
Table 4. Data Collection Items and Schedule by Contact 
21-22 
Table 5. Order and Distribution of In-Home Health Education Sessions, 
Telephone Coaching Sessions and Group Education Sessions 
30 
Table 6. Weight Goals and Behavioral Recommendations by Experimental 
Condition 
34-35 
Table 7. Schedule of Lifestyle Change Coaching / Group Education Sessions 
35 
Table 8. Main Topics for Lifestyle Change Coaching/ Group Health Education 
Sessions 
36-38 
Table 9. Alert Values for Signaling Health Safety Officer Notification or Medical 
Attention 
44 
Table 10. Original Timeline for Study 
51 
 
 
LIST OF ABBREVIATIONS / GLOSSARY 
BMI Body Mass Index 
BP Blood Pressure 
CAB Community Advisory Board 
CC Calorie Counting 
CPHHD Center for Population Health and Health Disparities 
CHW Community Health Worker 
CVD Cardiovascular Disease 
DASH Dietary Approaches to Stop Hypertension 
DPP Diabetes Prevention Program 
ESRD End Stage Renal Disease 
F&V Fruits and vegetables 
FFQ Food Frequency Questionnaire 
FU Follow-up 
HDL-C high density lipoprotein cholesterol 
HIPAA Health Insurance Portability and Accountability Act 
IRB Institutional Review Board 

 
Patterned after protocol published online in association with Appel et al. (2011)15 
 
 
ITT Intention-to-treat 
kg Kilogram 
LDL-C low density lipoprotein cholesterol 
MI Multiple Imputation 
MyP MyPlate.gov 
NHLBI National Health of Lung and Blood Institute 
NIH National Institutes of Health 
PCP Primary Care Provider 
PHQ-9 Patient Health Questionnaire to measure depressive symptoms 
QA Quality Assurance 
QC Quality Control 
QoL Quality of Life 
RCT Randomized Controlled Trial 
RE-AIM Reach, Efficacy/Effectiveness, Adoption, Implementation, and Maintenance 
SAE Serious Adverse Events 
SE Standard error 
SF-12 Abbreviated version of the Medical Outcomes, Short Form-36 
TCC The Childrens Clinic of Long Beach, CA 
UCLA University of California, Los Angeles 
WEL-SF Weight Efficacy Lifestyle questionnaire – Short Form 

 
Patterned after protocol published online in association with Appel et al. (2011)15 
 
 
1. ABSTRACT 
BACKGROUND 
Prolonged adult obesity is a consistent predictor of major chronic disease risk, including 
diabetes, heart disease, stroke, and hormone-related cancers. The traditional government-
recommended approach to weight loss for obese patients has been calorie-counting / portion 
control (CC).  In 2011 the government began recommending the MyPlate approach (MyP). The 
CC condition asks overweight patients to reduce their daily calorie intake to less than a 
recommended calorie target.  The MyP approach also limits daily calories but emphasizes 
eating MORE high-satiation/ high-satiety foods by making ½ of daily food choices minimally 
processed fruits and vegetables, and ¼ of daily food choices whole grains.  The relative 
effectiveness of the MyP approach compared to the CC approach has not been clinically tested 
to date in urban, low-income populations. 
 
OBJECTIVES 
We propose a randomized controlled trial comparing the patient-centeredness and efficacy of 
the CC and MyP approaches. MyP uses progressive goal-setting to facilitate a doubling of usual 
fruit and vegetable intake. To facilitate adherence, both approaches also include changes in the 
home environment to make healthier choices easier choices. Both conditions encourage 
patients to do 150 minutes of moderate to vigorous physical activity a week. 
 
Specific Aims 
Aim #1. Use qualitative information from patients and clinicians to revise proposed intervention 
materials and procedures. 
Aim #2. Use results of a pilot test of the intervention conditions to revise intervention materials 
and procedures. 
Aim #3. Conduct a 12-months randomized controlled trial involving two home visits, two group 
education classes, and 7 telephone support/ lifestyle change coaching calls in both conditions. 
Aim #4. Obtain qualitative data from providers and coaches; combine with patient survey data to 
assess intervention feasibility, acceptability and perceived usefulness. 
Aim #5. Disseminate results and recommendations to stakeholder groups. 
 
METHODS 
Study participants are 261 overweight or obese patients with a BMI range of 27.0-40.3, low-
income, mostly Latino and African American adult patients attending community health centers 
in Long Beach, California.  The MyP and CC interventions will be implemented by trained 
community lifestyle change coaches (promotoras) with brief support from clinicians. 
 
Primary hypotheses:  Compared to the CC approach, the MyP approach will yield better 12 
months outcomes in terms of lower levels of everyday hunger, higher meal satisfaction, higher 
patient quality of life, higher patient self-efficacy at adhering to federal nutrition and physical 
activity recommendations, higher patient weight loss self-efficacy,  and higher patient 
satisfaction with the weight loss program.  Secondary hypotheses: Both intervention conditions 
will yield significant and similar declines in body weight and waist circumference; the MyP 
condition will yield greater reduction in systolic blood pressure than the CC condition. 
 
PATIENT OUTCOMES (PROJECTED) 
Patient-centered outcomes include: level of everyday hunger, health-related quality of life, self-
efficacy to eat more fruits and vegetables as recommended on choosemyplate.gov, and patient 
satisfaction with the weight loss program, all of which are expected to favor the MyP condition at 
12 months follow-up relative to the CC condition.  Medical outcomes include changes in body 

 
Patterned after protocol published online in association with Appel et al. (2011)15 
 
 
weight, waist circumference, and blood pressure.  Body composition was expected to improve in 
both conditions but systolic blood pressure reduction was expected only in the MyP condition. 
 
2. SPECIFIC AIMS 
We propose a randomized controlled trial (RCT) comparing the patient-centeredness and 
efficacy of two government-supported lifestyle change approaches to reducing patient obesity 
risk. Study participants are 261 obese, low income, mostly Latino and African American adult 
patients or staff associated with community health centers in Long Beach, California.  The 
interventions will be implemented by trained community lifestyle change coaches (promotoras) 
with brief support from clinicians.   
 
The first weight loss approach is the calorie-counting (CC), portion-cutting approach 
recommended at www.nutrition.gov . The second is the fill-up-sooner-on-fewer-calories 
approach found at www.choosemyplate.gov  (MyP).  The CC condition asks overweight patients 
to reduce their daily calorie intake to less than a recommended calorie target.  The MyP 
approach also limits daily calories but emphasizes eating MORE high-satiation/ high-satiety 
foods by making ½ of daily food choices fruits and vegetables, and ¼ of daily food choices 
whole grains. MyP uses ipsative, progressive goal-setting to facilitate a doubling of usual fruit 
and vegetable intake. To facilitate adherence, the MyP approach also includes home 
environment changes to make healthier choices easier choices. All conditions encourage doing 
at least 150 minutes of moderate to vigorous physical activity a week.   
 
Primary patient-centered outcomes include  levels of everyday hunger, meal satisfaction, 
health-related quality of life, self-efficacy to eat more fruits and vegetables as recommended on 
choosemyplate.gov, and patient satisfaction with the weight loss program, all of which are 
expected to favor the MyP condition at 12 months follow-up relative to the CC condition.  The 
primary medical outcomes are a reduction in body weight and waist circumference 
Specific Aims 
Aim #1.  Use qualitative information from patients and clinical staff to revise intervention 
materials and procedures.   
Aim #2.  Use results of a pilot test of the intervention conditions to revise intervention materials 
and procedures.   
Aim #3.  Conduct a 12-months RCT involving two home visits, two group education classes, and 
seven telephone support/ lifestyle change coaching calls.  
Aim #4.  Obtain qualitative data from providers and coaches; combine with participant data to 
assess intervention feasibility, acceptability and perceived usefulness.  
Aim #5.  Disseminate results and recommendations to community groups and public health 
professionals. 
 
Primary patient-centered hypotheses:  Compared to  the CC approach, the MyP approach will 
yield better 12-months outcomes in terms of reduced everyday hunger, increased meal 
satisfaction, increased participant quality of life, increased participant self-efficacy to eat more 
fruits and vegetables, and participant satisfaction with the weight control program.  Primary 
medical hypotheses: Both government-recommended conditions will yield significant and similar 
12-months declines in body weight. The MyP condition will reduce systolic blood pressure more 
than the CC condition. 

 
Patterned after protocol published online in association with Appel et al. (2011)15 
 
 
3. BACKGROUND 
Part A: Background and Significance 
Impact of the Condition on the Health of Individuals and Populations (PCORI Criterion 1) 
Public Health and Clinical Burden of Obesity, Especially Among Low-Income Urban 
Latinos and African Americans. 
U.S. overweight and obesity prevalence have increased greatly over the past 30 years.1 
Approximately one third of adults are overweight (BMI between 25 and 29.9 kg/m2) and another 
one third are obese (BMI > 30 kg/m2).1 Low-income urban Latinos appear to be at especially 
high risk.2  The lifetime medical cost burden of overweight and obesity is substantial and could 
be reduced through early treatment and prevention.3  Through a variety of mechanisms, obesity 
increases the risk of CVD. These include effects mediated through traditional CVD risk factors 
and effects that are independent of established risk factors. Specifically, in addition to increasing 
BP, excess body weight increases low density lipoprotein cholesterol (LDL-C), triglyceride levels, 
and blood glucose levels and reduces high lipoprotein cholesterol (HDL-C) levels. As reviewed 
by Rashid 4 and as recently documented by Yan,5 overweight and obesity have additional 
impact on CVD outcomes independent of their strong associations with established risk factors.  
The most recent American Heart Association statement recommends weight loss and regular 
physical activity for the prevention and treatment of obesity-related cardiovascular disease.6 
Numerous professional organizations recommend weight loss as an integral component of CVD 
risk factor management, often as first-line therapy prior to the initiation of medications.7-9 
Similarly, overweight and obesity increase the risk of type 2 diabetes, especially in ethnic 
minority groups.10 Lifestyle change efforts promoting weight loss in obese patients through 
increased physical activity and healthier food choices can reduce risk of type 2 diabetes.11  
About 23.6 million people in the United States have diabetes.12 Of those, 17.9 million are 
diagnosed and 5.7 million are undiagnosed. Ninety to 95 percent of people with diabetes have 
type 2 diabetes. Diabetes is the main cause of kidney failure, limb amputation, and new-onset 
blindness in American adults. People with diabetes are more likely than people without diabetes 
to develop and die from diseases of the heart and blood vessels, that is, cardiovascular disease. 
Adults with diabetes have heart disease death rates about two to four times higher than adults 
without diabetes, and the risk for stroke is two to four times higher among people with 
diabetes.12  Latinos and African Americans are particularly at risk of having type 2 diabetes.10 
The decision by the American Medical Association13 to designate obesity as a disease has 
increased interest in practical, effective clinical approaches to reducing patients’ obesity risk 
long before obesity-related biomarkers indicate proximal risk of diabetes or heart disease.  
Innovation and Potential for Improvement through Research (PCORI Criterion 2) 
Two rigorously designed trials of behavioral change weight loss interventions administered to 
patients recruited from community health clinics were reported in the New England Journal of 
Medicine.14,15  Their contrasting findings with respect to the long-term weight control benefits of 
lifestyle change alone were noteworthy and merited further exploring, in part because the 
different approaches may be associated with different patient quality of life outcomes.  Both 
trials included an experimental arm that featured a lifestyle change intervention with no 
adjunctive medical assistance, adjuncts such as meal replacement products or use of 
pharmaceutical products approved for use as weight loss drugs.   One of these lifestyle 
interventions featured a conventional energy restriction approach to weight loss but also 
featured the DASH diet,16-18 a model dietary pattern that all healthy American adults are 
encouraged to consume, regardless of weight status.19  The other lifestyle intervention was 
patterned after the behavioral intervention used in the Diabetes Prevention Program (DPP).11   

 
Patterned after protocol published online in association with Appel et al. (2011)15 
 
 
The DPP lifestyle change approach seeks to create a calorie deficit in overweight patients by 
increasing energy expenditure in daily physical activity and simultaneously limiting daily intake 
of calories.  This approach had yielded 7% weight loss over 2.8 years on average and a 58% 
reduction in risk of diabetes compared to usual care.11  In the present instance, however, the 
DASH-like diet yielded a 5.4 kg weight loss at 1 year whereas the DPP-like intervention yielded 
a 3.4 kg weight loss at 1 year.  This difference mirrored the results of a 1-year trial where a fruit 
and vegetable-supplemented fat-restricted diet yielded better 1-year weight loss than a standard 
fat-restrictive weight loss regimen.20  The satiation/satiety/weight control benefits of encouraging 
obese clinic patients to eat more fruits and vegetables was also corroborated by a clinical trial in 
which Weight Watchers bested a variety of clinic-provided programs.21  The Weight Watchers 
program a decade ago replaced its previous portion-controlled, calorie-counting approach with 
an approach encouraging increased consumption of high-satiation/ high-satiety foods, 
especially fruits and vegetables.22,23  
Although both lifestyle change approaches recommended energy restriction, the DASH-diet 
investigators15  focused more of their lifestyle change efforts on increasing patients’ adherence 
to the DASH dietary pattern.  A defining feature of the DASH dietary pattern is that it 
encourages daily intake of twice the quantity of fruits and vegetables as is typically consumed in 
the usual American diet.  This feature has recently been given more prominence as one of the 
seven dietary recommendations associated with www.MyPlate.gov, the federal initiative 
designed to replace the food pyramid with a food plate as the nation’s leading nutrition 
education icon.(www.MyPlate.gov) The specific recommendation is for Americans to fill half 
their plate with minimally processed fruits and vegetables (fruit juice is highly processed and 
therefore not included).  The naive observer might question the wisdom of Americans doubling 
their consumption of any food groups, given their documentably high prevalence of obesity.  
Counterintuitively, interventions that induce overweight individuals to eat substantially more 
minimally processed fruits and vegetables than usual are consistently (but not always) 
associated with reduced body weight at 6-months,16 12-months 20, 2-years follow-up 24 and 4-
years follow-up.25  One exception was a fruit and vegetable intervention involving breast cancer 
survivors.26  A noteworthy difference between the previous fruit and vegetable interventions and 
this last one, however, is that this last one featured 12 fluid ounces of fruit/vegetable juice a day 
as a replacement for three servings of whole fruit or whole vegetable.  The metabolic 
consequences of consuming carrots in the form of juice are quite different from the metabolic 
consequences of consuming minimally processed, whole carrots.27  In general, calories 
consumed in liquid form have less satiety value than calories consumed in solid form.28 More 
specifically, the conversion of whole fruit to fruit juice usually entails removal of dietary fiber.29 If 
consumed, dietary fiber from fruit can serve as substrate for butyrate-generating or acetate-
generating commensal microbes in the large bowel, which in turn can stimulate satiety-signaling 
via increased expression of the satiety hormones glucagon-like peptide-1 (GLP-1) or peptide 
tyrosine tyrosine (PYY).30  Chronically depriving commensal gut microbes of dietary fiber 
substrate by consuming fruit in the form of juice instead of as whole fruit can contribute to gut 
dysbiosis, inflammation, insulin resistance, reduced satiety-signaling and eventually, obesity.31 
While both the DPP and DASH dietary approaches have been shown to reduce excess body 
weight in the short run, the ability of patients to maintain these approaches for the long-term 
remains to be determined. Several steps were taken to ensure that the intervention effects for 
the MyP condition would be long-lasting. 
Additional steps incorporated in the current proposal to ensure sustainable intervention 
impact.  
We will take several steps to ensure that the intervention effects for the MyP condition would be 
sustainable by the community clinics. One step is to replace the masters or doctoral-level health 

 
Patterned after protocol published online in association with Appel et al. (2011)15 
 
 
educators/counselors typically used in behavioral weight loss interventions32 with trained 
community health workers (promotoras). The social modeling of Social Cognitive Theory 33,34 
and experience35 suggest that the predominantly low income Latino immigrant patient 
population comprising the study population can relate to non-college-educated Latino 
community health workers better than they can to bilingual but non-Latino masters or doctoral-
level counselors. 35  African American type 2 diabetes patients as well as Latino patients have 
benefited from use of community health workers as behavior change agents. 36,37  On the other 
hand, community health workers need substantially more training and supervision to carry out 
the intervention according to protocol.  Substantial time is devoted in Year 1 of the present 
proposal to the training of the community health workers.  The Intervention Director’s primary 
responsibility during the active intervention phase is to supervise the community workers in the 
MyP condition weekly, monitor their lifestyle coaching, and provide guidance as needed to 
ensure adherence to the MyPlate.gov messages.  TCC nutritionists will supervise the 
community health workers weekly in the CC condition to ensure good adherence to the CC 
intervention protocol.  The use of coaches with closer community ties to the participants holds 
promise for more sustained lifestyle behavior change benefit.36,38-40 
A second step was to increase the number of coaching sessions so that the maximum number 
of contacts was 11 contacts (2 in-home, 2 group education sessions, 7 telephone coaching 
sessions), to more closely approximate the number of contacts used in previous clinic-originated 
weight loss efforts,14,15,40-44 to allow for more opportunities for participant-coach problem-solving 
and participant trialing of specific lifestyle change strategies, and to capitalize on the 
motivational benefits of continued monitoring by health care professionals.45 For this study, the 
health sessions were delivered in the order give below, in Table 2.  
Table 2. Chronological Order and Type of Intervention Session 
1) In-home health education session #1  
2) Telephone coaching session #1 
3) Group education session #1 
4) Telephone coaching session #2 
5) Telephone coaching session #3 
6) Telephone coaching session #4 
7) In-home health education session #2 
8) Telephone coaching session #5 
9) Group education session #2 
10) Telephone coaching session #6 
11) Telephone coaching session #7 
 
Although patients were encouraged to complete health education sessions in this order, they 
were allowed to complete the lessons in the order that best fit their schedules. In addition, 
patients were encouraged to complete health education sessions within a 3 months period after 
enrollment; however, they were allowed to complete as many lessons as possible before their 6 
months follow-up assessment.  
A third step was to devote more intervention resources to ensuring that the participant’s home 
environment is optimally supportive of healthier lifestyle choices. Two thirds of calories are 
typically consumed in the home.46  There is increasing evidence that, if not addressed, the 
visual cues in the typical home environment can undermine individual efforts to adopt healthier 
lifestyle behaviors and can contribute to relapse despite the strongest behavioral modification 

 
Patterned after protocol published online in association with Appel et al. (2011)15 
 
 
efforts.46 Both physical (e.g., type of food available) and social (e.g., support from family) factors 
in this setting have been associated with weight, dietary habits, and activity patterns.47,48 
Demonstrated links between the physical home environment and behavior include relationships 
between available high-fat foods and fat intake,49 access to home exercise equipment and 
activity levels,50,51 and number of TV sets and amount of television viewing.52  In the most 
ambitious home environment-focused weight loss intervention published to date,46 researchers 
used checklists to get participants to rid the home of high-calorie, high-fat foods and to stock the 
kitchen with healthier fare.  They also provided participants with a treadmill or stationary bicycle 
for home use, and a pedometer for brisk walking outside.  They restricted TV use to one 
communal room of the home, and attached a timer to the TV to limit the daily time spent 
watching TV.  Finally, the investigators gave the participants a digital body weight scale and 
encouraged them to self-weigh daily.  In conjunction with weekly counseling sessions for the 
first 6 months, all participants in the home environment-focused intervention lost significant 
weight at 6 months; the women participants maintained the weight loss at 18 months.  What is 
particularly exciting is that the partners of the study participants all lost and maintained 
significantly more weight loss, male or female, than partners in the more traditional behavioral 
weight loss arm, even though they were not the primary targets of the intervention.46  Most of 
these environmental changes are home environment intervention features in our on-going 
research.53  Several  innovations to the foregoing home environment intervention approach 
need to be noted that will be incorporated in the current intervention design.  One difference is 
that the current proposal features two coaching sessions that actually take place in the home, 
so that the health coach together with the patient can scan food products in the pantry and the 
refrigerator and designate each food product as a red light food (limit to no more than once a 
month), green light food (an everyday food), or yellow light food (nutritiously intermediate food – 
limit to once a week).54  Our community advisory board approved the home visits and our 
community health workers have been warmly welcomed into participants’ homes.  The second 
difference is that our intervention does not seek to ban less healthful choices from the home but 
instead to position the healthier choices so that they are the most conspicuous and the easiest 
choice.  The literature on behavioral economics suggests that changing the “decision 
architecture” around the home will be enough to alter food choices; bans are not necessary. 55,56  
We avoided bans because bans can be seen as taking away legitimate choices and lead to 
pushback by other household members.  We also avoided bans because some low-income 
families have doubled up with other families to share a single apartment and therefore do not 
have the latitude to ban legitimate food choices.   
A third feature is the inclusion of taste-testing as a way to enlarge participants’ repertoire of 
palatable fruits and vegetables.  Persistent efforts by nutrition professionals to induce study 
participants to eat more fruits and vegetables consistently increases participants' liking for and 
consumption of a greater range of fruits and vegetables.25,57-60  Absent the availability of 
consistent access to nutrition professionals, however, a more practical approach is needed to 
engender increased liking for a greater variety of fruits and vegetables.  The taste-testing will 
mimic the “product-demonstration” food sampling techniques that food manufacturers use to 
gain population acceptance of new food products.  The taste-testing to be incorporated in the 
current intervention will consist of fruit and vegetable-rich dishes cooked by a Master’s Level 
nutrition specialist from culturally-tailored recipes contributed by study participants or obtained 
from governmental organizations (Example: Champions for Change, the California Department 
of Public Health). The taste-testing sessions will be offered to participants in the MyPlate arm 
during the group education sessions. The study Intervention Director will conduct nutritional 
analyses of the recipes for each taste-testing and select the 2 recipes to be presented during 
the group education sessions that are richest in minimally processed fruits and vegetables, 
while minimizing sodium.  For this study, the two selected recipes were: 1) Vegetable Ceviche 

 
Patterned after protocol published online in association with Appel et al. (2011)15 
 
 
and 2) Whole-grain vegetable rich tortas. The selected recipes feature fruits and vegetables that 
patients most likely have not tasted before in these dishes. The principle behind taste-testing 
fruit and vegetable dishes that participants have not tasted before is that it can take up to 8-12 
exposures (i.e. “tastings”) for humans to like eating a novel plant-based food.61,62  Participants 
will be encouraged to do their own taste-testing experiments with new plant foods, minimally 
processed, modeling their experiments after the examples prepared for the taste-testing events.  
Once acquired, liking for a new plant food is unlikely to be lost, absent a change in physiology 
occasioned by pregnancy or disease.63,64  Increased liking for plant-based foods, in turn, should 
facilitate adherence to the MyPlate recommendation that one half of the typical meal plate be 
occupied by fruits and vegetables.65 
A fifth innovative feature is to conjoin the MyPlate nutrition messages with the recommendations 
from the Physical Activity Guidelines for Americans, so that increased daily physical activity can 
engender greater appetite for water-bearing and fiber-bearing foods. The most common 
nutritional deficit induced by physical activity is water.66  The most common component of 
minimally processed, fresh fruits and vegetables, by weight, is water.67  Not surprisingly, when 
presented with ad lib consumption of foods varying in water, healthy subjects who just 
completed two hours of aerobic exercise will prefer water-rich foods to calorie-dense foods.68-70  
The most important food component contributor to satiation is water.71,72  But water by itself 
provides little satiation benefit; it must be integrated in foods, typically accompanying fiber, in 
order to promote satiation/ satiety.73  Ironically, given the greater caloric needs of athletes 
relative to sedentary individuals, exercisers who have just completed a bout of exercise prefer 
beverages with less sugar in solution than non-exercisers.68,74  Exercise may affect satiation and 
satiety processes through other pathways as well.75,76  In short, for participants to develop 
increased preference for foods rich in water and for beverages with lower levels of sweetness, it 
would help for participants to engage in “sweat”-related activity every day, even if it is just brisk 
walking.77  By itself increased physical activity seems not to result in sustainable weight loss 78 
but increased physical activity is consistently a predictor of long-term weight loss when coupled 
with a dietary approach to weight loss, perhaps partly because of its effect on preference for 
water-bearing and fiber-bearing foods79-81 and partly because of its effect on the transit time of 
the food remnants through the intestinal tract,82,83 which could affect satiety-signaling in the 
large bowel.76 
The common thread linking these last two steps is the increasing evidence that taste 
preferences are modifiable and can be shaped by conscious participant effort to overcome 
neophobic reactions to new plant tastes and by participants engaging in sweat-inducing daily 
physical activity, to motivate increased intake of high-satiation/ high-satiety foods and 
decreased intake of sugar sweetened beverages. 
 
Efficacy Trials of Weight Loss 
In-Person Interventions. Numerous trials 16,84-87 have demonstrated the efficacy of behavioral 
modification interventions in reducing weight and improving health outcomes in overweight or 
obese adults.  The U.S. Preventive Services Task Force concluded from its review of the 
literature on clinic-based behavioral change approaches to obesity treatment88 that the most 
effective interventions were comprehensive and of high intensity (12 to 26 sessions in a year).  
Effective intervention components included group health education sessions, individual 
coaching sessions, setting weight-loss goals, improving food choices, physical activity sessions, 
addressing barriers to change, active use of self-monitoring, and strategizing how to maintain 
lifestyle changes. 
Telephone Coaching. Personal telephone contacts with a trained lifestyle change 
interventionist have been shown to improve adherence to recommended physical activity89,90 

 
Patterned after protocol published online in association with Appel et al. (2011)15 
 
 
and to promote self-monitoring of food intake and physical activity engagement.89  More 
specifically, results from a study that tested the effects of structured and unstructured telephone 
prompts to increase adherence to a walking program showed a dose-response effect.89  
Participants assigned to receive one telephone call per week had greater adherence to physical 
activity guidelines than those who received one telephone call every 3 weeks. This 
“intermediate” group, in turn, had better adherence than those who received no telephone 
coaching. This is an important finding because adherence to exercise guidelines is a well-
accepted determinant of weight loss outcomes, particularly once weight loss has been 
achieved.91 Another study of telephone lifestyle change coaching found that self-monitoring 
among participants was higher in those who received phone calls and letters compared to those 
receiving no intervention.92 This finding is important because self-monitoring is a consistent 
correlate of success in behavioral weight loss interventions.  
 
Summary of Efficacy Trials and Implications for Effectiveness Studies 
Lifestyle change interventions provided in-person have been well-documented as an evidenced-
based treatment for weight management, particularly when contacts are frequent and treatment 
is of sufficiently long duration.88 Studies suggest that telephone coaching can complement in-
person lifestyle change coaching and can promote behaviors documentably associated with 
successful weight loss (increased physical activity and self-monitoring).  The proposed trial will 
compare two evidence-based approaches to treating patient overweight/obesity using 
modalities of treatment empirically shown to be effective in efficacy studies. Although historically 
experimental trials focused on a single modality to provide the intervention, collective 
consideration of the literature suggests that it is likely that a mix of different channels is optimal 
for generating sustained weight loss over the long-term. 
 
Impact on Health Care Performance (PCORI Criterion 3) 
Effectiveness Studies: Weight Loss in the Health Care Setting 
Results from clinical trials: As previously noted, a rich literature of clinical trials has documented 
the efficacy of behavioral modification interventions  in reducing excess body weight and 
improving health outcomes in overweight or obese adults. In a review that focused on screening 
and treatment of adults in clinical practice, a major limitation was that all but two trials were 
conducted in research settings, not in clinical practice settings.93  
 
Barriers to implementing weight loss interventions in health care settings: 
It has long been a challenge to rely on the primary health care provider to implement weight loss 
interventions in clinical practice; the provider has to be willing and able to deliver the 
intervention. Observational data 94 have consistently shown providers to underdiagnose obesity 
and provide obesity-related counseling to only a minority of eligible patients.95 Qualitative data 
and survey research data collected from primary care providers have identified barriers to 
providing weight loss counseling.  The most common barriers include insufficient confidence, 
knowledge and skills.96  The lack of publicly available, evidence-based weight loss programs 
may be an important reason why health care providers do not proactively recommend lifestyle 
modification to overweight and obese patients.97  It also bears mention that providers may be 
aware that some studies have shown that counseling (with or without drug treatment) to be 
more effective if provided by someone other than the physician or primary health care provider, 
such as a dietitian or clinical psychologist.98,99 
 
Because of these barriers, this study assumed that it would be more effective for primary care 
providers to refer patients to TCC-employed community health workers for intensive behavioral 
coaching using multiple modalities (home health education, group education, telephone 

 
Patterned after protocol published online in association with Appel et al. (2011)15 
 
 
coaching). 93,99 Similar approaches have been used in primary care-based coaching to increase 
physical activity 100,101, to promote a healthy diet 102,103 and to address multiple behavioral risk 
factor interventions.104 For obesity management, the US Preventive Services Task Force stated 
“Some interventions, in particular intense counseling, may be difficult to incorporate into medical 
practice. One option may be referral to programs that offer intense counseling with behavioral 
therapy." This trial will be consistent with the referral option but not referral to an outside agency 
but rather referral to another clinic staff member, a well-trained community worker who knows 
well the community in which the patients live but who also knows well what other clinic 
resources can be called on, if needed. In any event, patients who qualify for the study are 
expected to be encouraged by their primary care provider at the time of enrollment to adhere to 
the federal lifestyle guidelines recommended in this trial. 
 
Part B: Relevance to Patients (PCORI Criterion 4) 
Does the research address one or more of the key questions mentioned in PCORI’s 
definition of patient-centered outcomes research? We seek answers to two PCORI 
questions: 
1. “Given my personal characteristics, conditions and preferences, what should I expect will 
happen to me?”  
2. “What are my options and what are the potential benefits and harms of those options?”  
We surmise that much of the recidivism in weight loss trials reviewed above can be attributed to 
the requirement for dietary restraint and the consequent feeling of deprivation that accompanies 
the calorie counting approach to weight loss.  Because the MyP approach promotes 
consumption of high-satiation/ high-satiety foods, it improves patient-centeredness by reducing 
the feeling of chronic, everyday hunger and reduces the need for dietary restraint because 
patients will stop eating because they feel full, not because they feel they have to.  The results 
of this trial will provide patients with answers to the question of which approach to weight loss 
will result in greater improvement in patient outcomes that matter most to them.  Because most 
of the patients will be low income, issues that matter particularly to low-income patients, such as 
food insecurity, will be assessed and be investigated as potential effect modifiers.  Because 
many of the participants will have low literacy levels, both interventions include in-home visits 
where prescriptive behaviors can be more easily described than in the clinic setting.  Because 
75% of the study participants will be Spanish-speaking, issues that matter particularly to non-
English speaking patients will be studied as additional, potential effect modifiers.   
 
Is the proposed research focused on questions and outcomes of specific interest to 
patients and their caregivers? This application was designed to focus on questions of specific 
interest to patients.  Nearly all (97%) of obese patients and 84% of overweight patients wanted 
to lose their excess weight.105  Less than half of them ever discussed their weight with their 
physicians.  When asked what types of weight management assistance they would want from 
their physicians, they said (1) dietary advice, (2) help with setting realistic weight goals, and (3) 
exercise recommendations.105  Both of the experimental conditions provide dietary advice, help 
with setting realistic weight goals, and the recommendation to exercise at least 30 minutes daily 
most days of the week.  Further, this application focuses on these outcomes of specific interest 
to patients: freedom from hunger, health-related quality of life, weight control self-efficacy, and 
patient satisfaction with the intervention.   
 
4. STUDY DESIGN 
Research Question. Which of two different government-recommended behavioral strategies for 
losing excess weight (MyP vs CC) should clinics feature in their lifestyle change efforts targeted 

 
Patterned after protocol published online in association with Appel et al. (2011)15 
 
 
to obese patients wanting to lose excess weight through lifestyle change? More specifically, do 
patient-centered outcomes at 12-months follow-up favor the traditional energy restriction, 
calorie-counting approach featured in http://win.niddk.nih.gov?  Or do patient-centered 
outcomes favor the newer www.MyPlate.gov  approach, which emphasizes filling up faster on 
fewer calories by greatly increasing the intake of water-rich, fiber-rich foods such as fruits and 
vegetables and other high-satiation/ high-satiety foods (like nuts) in addition to encouraging 
patients to restrict saturated fat and sugar? 
Choice of comparators. Overweight patients are highly interested in receiving advice from 
their primary care physicians about effective lifestyle change approaches to losing excess 
weight. 105   
Calorie Counting Approach.  The traditional government recommendation to clinicians about 
what this advice should be is well-reflected by the information at: 
http://win.niddk.nih.gov/publications/talking.htm#staff or at: 
http://www.healthfinder.gov/prevention/ViewTopic.aspx?topicId=25. This information focuses on 
getting the patient to deliberately adhere to an energy-deficit diet, where energy expenditure 
exceeds energy intake. The behavioral pathways to achieving a daily energy deficit include 
increased physical activity, careful monitoring of energy intake and deliberate reduction of 
portions of foods commonly consumed to ensure adherence to lower-than-usual daily calorie 
intake.  While there is some mention of substituting low-calorie foods such as fruits and 
vegetables for high-calorie foods, the focus is more on reducing the amount of current food 
choices rather than on changing the nature of the foods consumed.  
My Plate Approach.  By contrast, the www.MyPlate.gov  initiative explicitly calls on Americans to 
change the proportion of their plate that is devoted to different food groups, to eat more 
minimally processed fruits and vegetables relative to other food groups, to favor whole grains 
when grains are consumed, to replace high-fat dairy with low-fat or nonfat dairy, to replace 
sugary drinks with water, and to choose lower-sodium alternatives. The behavioral pathways to 
achieving a daily energy deficit using the MyPlate approach include doubling typical intake of 
fruits and vegetables, limiting intake of caloric beverages, engaging in moderate physical activity 
every day, not skipping breakfast, and limiting sodium intake. The message that Americans can 
achieve a healthier weight by eating MORE of some foods is a relatively new message and one 
that would benefit from comparative assessment with the government’s more traditional calorie-
counting, portion-control approach. Differential adherence to these two different approaches 
was not a problem in a clinical trial of overweight adult women20 and is not expected to be a 
problem here.  Protocols for both approaches have been well-detailed in recent clinical trials 
and have been associated with good study retention at 2 year follow-up.14,15 
Choice of study design.  We propose a randomized controlled study involving 300 (later 
reduced to 261)1 low-income obese adults recruited from community clinics located in the Long 
Beach, California metropolitan area. To ensure broad generalizability of results, we will be 
including not only patients with a primary diagnosis of obesity but also patients who are obese 
and also have a primary diagnosis of uncomplicated type 2 diabetes and uncomplicated 
hypertension.  Because of their disproportionate prevalence in the TCC population (76%) and 
because of their disproportionately high risk of obesity, we confidently predict that most of the 
enrollees will be Latinos, half of whom will prefer to speak Spanish.  A  minority (7% according 
to baseline data; 13% according to TCC statistics%) will be African American. We anticipate 
                                                 
1 Accrual took longer than expected.  Planned subgroup analyses by sex and ethnicity requiring the original sample 
size were obviated by the recruitment of fewer men than anticipated (4.6% versus 30% expected) and fewer African 
Americans than expected (7.7% versus 15% expected). Statistical power for remaining planned subgroup analyses 
involving women and Latinos exceeded 80% at the lower sample size of N =261. 

 
Patterned after protocol published online in association with Appel et al. (2011)15 
 
 
enrolling mostly women.  Randomization will occur at the individual level despite the risk of 
patients assigned to different conditions talking to each other in the waiting room and 
discovering that their health coaching messages are different.  Except for brief encounters with 
trained clinical staff about their participation in the lifestyle change coaching program, most of 
the health information transmitted in this program will occur in the home, by phone or in group 
education classes, not in the examination room.  Analyses will take into account the fact that 
patients are nested within clinics and within providers but previous experience with 
randomization at the clinic level convinced us that the study design was stronger, easier to 
administer and easier to analyze when randomization occurred at the level of the individual 
patient instead of at the level of the primary care clinic. 
The Community Advisory Board.  The Community Advisory Board (CAB) is comprised of 
members representing all major stakeholders: UCLA investigators, TCC investigators, TCC 
patient representatives, community public health leaders, thought leaders in lifestyle change 
interventions.  The CAB can be viewed as equivalent to the Board of Directors.  Members' input 
will help shape the design of the proposed research, interpretation of results and the nature of 
the final recommendations, but will generally leave the day-to-day decision-making to the TCC 
and UCLA investigators.  Members with equivalent ability to represent specific stakeholders with 
respect to community approaches to weight control will be selected to replace those who can no 
longer serve on the CAB, with the objective of continuing to represent fairly the full range of 
stakeholders.  Study investigators are part of the CAB because their presence validates the 
stated authority of the CAB to make decisions about study implementation, interpretation of 
results and final recommendations. 
Culturally tailored materials. All print materials and study measures will be translated into 
Spanish, back-translated to ensure accuracy and subjected to cognitive interviews, to ensure 
that they communicate the same constructs as the corresponding English print materials and 
study measures.  Study print materials and measures will be reviewed in focus group 
discussions to ensure community acceptance of the final versions. 
Qualitative assessment of intervention features and specific measures proposed for use in this 
study.  The intervention features and specific measures described below are included in the 
study conditional on their being accepted by participants in focus groups and key stakeholder 
interviews (report of qualitative results due July 31, 2014) and conditional on the results of the 
pilot randomized controlled clinical trial (report of pilot study results due January 30, 2014). The 
Community Advisory Board will also vet the proposed intervention design and study measures. 
Relying on their past experience conducting and publishing qualitative research 106,107 the 
investigators will use well-accepted protocols for preparing the discussion guide, facilitating the 
focus group discussion, identifying common themes from the resulting transcripts and using 
these results to modify draft intervention protocols and proposed measures. These procedures 
were adapted from ones well-described in the 3rd edition of Krueger & Casey (2000).108   
Laying the groundwork: overview of key stakeholder interviews. The initial six key stakeholder 
interviews will be drawn primarily from community members and interested TCC staff who are 
knowledgeable about the challenges typically faced by TCC patients in their obesity control 
efforts and knowledgeable about the obesity control resources and limitations that characterize 
the typical TCC clinic.  Input from some of these key stakeholders would continue to be sought 
throughout the data collection phase and intervention design phase as members of an informal 
“brain trust” and would include the signatories of some of the support letters submitted with the 
application.  Key stakeholders will be paid a nominal incentive worth $20 for spending 30-50 
minutes responding to structured questions about designing the optimal obesity control program 
for TCC patients. 
 

 
Patterned after protocol published online in association with Appel et al. (2011)15 
 
 
The final list of topics discussed with key stakeholders is given below and was established by 
the research partnership comprised of Dr. Chandler, the TCC patient representatives, other 
CAB members and the UCLA investigators.  
Knowledge and attitudes about healthy eating habits 
Federal nutrition guidelines109 currently recommend that Americans make one half of everything 
that they eat per day fruits and vegetables (excluding juices), and that they make another 
quarter of everything that they eat per day grain foods high in fiber and low in salt and unhealthy 
fats.  
 
 
Would these healthy eating habits be easy or hard to follow?  (Why/How?) 
 
What makes these healthy eating habits hard (or easy) to follow when you eat 
meals at home? 
 
What makes these healthy eating habits hard (or easy) to follow when you eat 
meals outside the home? 
 
What makes these healthy eating habits hard (or easy) to follow on special 
occasions (weddings, quinceañeras, church or social gatherings)? 
 
What makes these healthy eating habits hard (or easy) to follow when shopping 
in stores or markets? 
 
Do you have suggestions or ideas how to make it easier for people like you to 
follow these healthy eating habits? 
Knowledge and attitudes about physical activity 
Federal physical activity guidelines110 recommend moderate physical activity of at least 30 
minutes per day, five days per week of at least 10 minutes per bout of exercise.  This may be 
any kind of activity (walking, dancing, going up and down stairs, playing a sport, etc.), and may 
be either 30 minutes at a time, or in three separate periods of ten minutes each.  National 
experts111 also recommend that people spend no more than 2 hours a day watching TV or doing 
computer or video games and instead engage in more physically active pursuits, such as 
walking, gardening or bicycling. 
 
Is this a physically active lifestyle that would be easy or hard to follow?  (Why/How?) 
 
What makes this physically active lifestyle hard (or easy) to follow when you are at 
home? 
 
What makes this physically active lifestyle hard (or easy) to follow when you are outside 
of the home? 
 
Many people find that they can better follow a physically active lifestyle when they do so 
with friends or family members.  What makes this physically active lifestyle hard (or 
easy) for you to do with friends or family members? 
 
Do you have suggestions or ideas how to make it easier for people like you to follow this 
kind of physically active lifestyle? 
 
Are there programs and services that the Long Beach community could provide that 
would make it easier to increase your level of physical activity in the Long Beach area?   
 
Are there programs and services that the Long Beach community could provide that 
would make it easier to improve your eating habits in the Long Beach area?   
 
If you have participated in any healthy-eating programs or physical activity promotion 
programs here in the Long Beach area, could you tell me some of the good (bad) things 
about these programs? 
 
Would it be helpful if you had a form (like a daily chart or diary) to help you keep track of 
progress in your eating habits and physical activity?   

 
Patterned after protocol published online in association with Appel et al. (2011)15 
 
 
 
How helpful would the following components of a possible health promotion program be 
in encouraging better eating and increased daily physical activity? 
o Having a pedometer that could be used to count the daily number of steps that 
you take in the course of the day?   
o A low-impact exercise video emphasizing slow-motion dance moves?   
o A health educator who visits you at home to discuss how your home can be 
made more supportive of healthy eating habits and increasing physical activity? 
o A community health worker who visits you at home to discuss how your home 
can be made more supportive of healthy eating habits and increasing physical 
activity? 
o Taste-testing of different fruit and vegetable-rich dishes that appeal to African 
Americans? 
o Taste-testing of different fruit and vegetable-rich dishes that appeal to Mexican 
Americans? 
o Taste-testing of different fruit and vegetable-rich dishes that appeal to 
Cambodians or Samoans or other Asian communities in Long Beach? 
o Community cooking classes featuring vegetable-rich dishes? 
 
 
The discussion guide will be translated into Spanish, to be used in the focus group of TCC 
patients who voiced a preference to speak in Spanish.  Questions in the Spanish version may 
be modified to capture issues specific to Spanish-speaking Latinas, such as immigration or 
linguistic issues.  Cognitive interviewing strategies, involving two additional key stakeholders, 
will be used to ensure that the final forms (English, Spanish) of the Focus Group Discussion 
Guide include questions that are understood by the participants as the investigators had 
intended for them to be understood (see Tourangeau et al. 2000,112 for a review of cognitive 
interviewing strategies).  Cognitive interviewing is the most common way for the creators of 
survey research to test the practical acceptability of their research questions.  The most 
common technique in cognitive interviewing is a think-a-loud technique which subjects can use 
as they complete the survey items.  Items will be rephrased or replaced if this and other 
cognitive interviewing techniques demonstrate that the questionable items lead to respondent 
confusion or to interpretations at variance with the meaning that the investigators intended for 
the survey item to have. 
Focus group data collection protocol    
The investigators will use focus group data collection procedures that they have used in the past 
to collect high-quality information from men and women living in homeless shelters. 107  These 
procedures are well-described in the 3rd edition of Krueger & Casey (2000).108   
 
Eight (4 English-speakers and 4 Spanish-speakers) participants, including TCC patients and 
TCC staff, will participate in two focus group discussions.  One of these groups will be 
conducted in Spanish and one in English, so that the views of monolingual Spanish speakers 
can be included. 
 
In brief, prior to starting the actual focus group discussion, the facilitator will want to get to know 
each participant by asking a few questions.  The facilitator will query the participant about her / 
his age, ethnicity, favorite fruit, favorite vegetable, number of children living with her / him, and 
current housing status.  The facilitator will also ask the participant to answer up to five questions 
similar to the questions in the Focus Group Discussion Guide.  From past experience the 
investigators know that the facilitator can use prior knowledge of focus group members’ views to 
stimulate discussion.  Experience with conducting focus groups suggests that some of the 

 
Patterned after protocol published online in association with Appel et al. (2011)15 
 
 
inhibitions that naturally constrain conversations between strangers can be overcome if the 
facilitator can engender mini-debates by encouraging participants with differing initial views to 
share each one’s perspective with the group.  The preparatory “get-to-know-you” interview helps 
the facilitator to identify these opposing views prior to the actual focus group discussion. 
Eligibility to participate in the focus group discussions will depend on the willingness of the 
would-be participant to agree to common rules concerning focus group participation.  The rules 
include keeping everything said in the discussion confidential, being respectful of opinions that 
one might disagree with, letting others have a chance to voice their own opinion, and respecting 
the authority of the facilitator to determine who gets to speak and when to end discussion of a 
specific issue.  The data collection protocol will abide by UCLA IRB stipulations, including 
maintaining each participant’s confidentiality (see Human Subjects section for more detail).  
Error checking and data cleaning will take place at UCLA but will often require input from TCC 
investigators for resolution.   
 
5. STUDY POPULATION  
 Study population. This population is primarily working poor families who would have to 
choose between food and medication were it not for TCC’s services. Approximately 98% of 
TCC’s patients are under 200% of the Federal Poverty Level. About 44% of TCC’s patients are 
uninsured, and that number has been increasing. The ethnic composition of TCC’s patient 
population is 76% Latino, 13% African American, 4% Asian, 4% White, 1% American Indian, 
less than 1% Alaskan Native, Native Hawaiian or Pacific Islander, and 2% Other. About 58% 
of patients are female, 42% are male; 66% are children, while 34% are adults.  With nearly 
100,000 patient visits in the last year and 8 clinics, TCC has more than enough obese adult 
patients (N ~2,000) to yield the number that the investigators plan to enroll in the proposed 
intervention trial.  To ensure maximum range of patient participation, recruitment involved two 
clinic sites. These sites are located in Long Beach, California. General information about each 
medical practice and its providers, as well as specific information about weight loss 
management strategies, will be collected at baseline and during follow-up.  The UCLA 
investigators are familiar with strategies for recruiting participants from the clinic waiting room in 
TCC clinics by virtue of having used these strategies as part of a predecessor NIH-funded 
intervention study. 
 
6. ELIGIBILITY TO PARTICIPATE IN THE STUDY.  
To optimize the internal validity of this study and minimize potential risks for individuals for 
whom participation would not be appropriate, the following eligibility criteria were developed: 
 
Table 1 Eligibility Criteria 
Inclusion Criteria 
 
BMI ≥ 27 & BMI <40.4 kg/m2 [had been BMI≥ 30 & BMI <40]2  and weight ≤ 400 lbs. if 
observed 
 
Age ≥ 18 years 
 
Willingness to change diet, physical activity and weight 
 
Willing to accept randomization to each group 
 
Able to give informed consent 
                                                 
2 Knowing that accrual could be challenging, from the outset participants whose BMI fell short of the lower 
limit of 30 were told that there was a chance that they might be eligible later.  When accrual was 
determined to be slower than planned, with IRB approval the range was extended to those with a BMI≥ 27. 

 
Patterned after protocol published online in association with Appel et al. (2011)15 
 
 
 
Persons with the following conditions are eligible with PCP approval: 
i) 
 
Diabetes Mellitus 
ii)  
Prior CVD event > 6 months 
iii)  
Known stable CVD or peripheral vascular disease 
 
Speaks English or Spanish 
 
Exclusion Criteria 
 
MI, Stroke or Atherosclerotic Cardiovascular Disease procedure within 6 months 
 
Serious medical condition likely to hinder accurate measurement of weight, or for which 
weight  loss is contraindicated, or which would cause weight loss (e.g. End Stage Renal 
Disease patient on dialysis, cancer diagnosis or treatment within 2 years) 
 
Prior or planned bariatric surgery 
 
Use of prescription weight loss medication (including off label drugs e.g. topiramate, 
buproprion, byetta) or over-the-counter orlistat within 6 months 
 
Chronic use (at least past 6 months) of medications likely to cause weight gain or 
prevent weight loss (e.g. corticosteroids, lithium, olanzapine, risperidone, clozapine) 
 
Unintentional weight loss within past 6 months (≥ 5% of body weight) 
 
Intentional weight loss within past 6 months (≥ 5% of body weight) 
 
Pregnant or nursing within past 6 months 
 
Plans to become pregnant within 18 months 
 
Plans to relocate from area within 18 months 
 
Another member of household is a study participant or trial staff member 
 
Principal Investigator discretion 
 
Problem alcohol use: Self reported average consumption of > 14 alcoholic drinks per 
week or 5+ drinks on any occasion in past week for males and >7 drinks per week or 4+ 
drinks on any occasion in the past week for females.  Problem use and heavy use of 
alcohol have been associated consistently with poor outcomes in behavioral weight loss 
programs.113  
 
Cigarette smoking or e-cigarette “vaping” any time in the last 6 months 
 
Psychiatric hospitalization in last year 
 
Unstable angina 
 
Blood pressure >160/100 (note: individuals may be rescreened) at discretion of patient's 
primary care provider 
 
7. RECRUITMENT 
Patients Recruited and Screened. Patient participants will be recruited from all eligible adult 
patients in the clinic waiting room at each study site using a Tablet PC for data collection 
starting with a brief (<2 minute) Screener to assess eligibility. Inclusion criteria include 1) age 18 
and older 2) English or Spanish-speaking 4) overweight or obese (27 >= BMI <40.4 3) willing to 
cooperate with data collection (e.g., completing interviews). Exclusion criteria include insulin 
dependent diabetes mellitus with complications, severe physical impairment, conditions 
precluding adherence to the two dietary approaches (Calorie Counting or MyPlate), and end-
stage health conditions. All recruitment materials are in Spanish and English and culturally 
appropriate for Latinos and African Americans.  
Population to be Recruited. This trial will recruit participants from primary care practices of 
The Children’s Clinic (TCC), a federally qualified health center in the Long Beach metropolitan 
area. TCC’s patients come from the most densely populated, diverse, low-income, underserved 
zip codes in greater Long Beach and its surrounding communities. TCC’s critical services target 

 
Patterned after protocol published online in association with Appel et al. (2011)15 
 
 
a diverse population, identified as having significant barriers to affordable and accessible health 
care.  
Recruitment Procedures. UCLA Investigators will identify a recruitment environment that is not 
only likely to be an effective venue for successful recruitment, but also one in which it would be 
easy to be in compliance with IRB regulations. Well-trained and supervised UCLA fieldwork staff 
plan to directly approach potential participants face to face within the waiting rooms of two TCC 
clinic sites. The screening process is designed to be seen as being respectful of the dignity of all 
potentially eligible individuals. Accordingly, research assistants will approach all adult patients, 
regardless of body size, despite the fact that only patients with a BMI exceeding 27 are eligible. 
We will do this to avoid creating the perception that we are approaching patients because of 
their overweight status. In addition, to our direct contact method, IRB approved flyers will be 
posted within each check-in station of the waiting room. Any prospective participants could then 
approach our research staff directly in the waiting room or contact our fieldwork staff by calling 
the toll-free number on the flyer. The fieldwork staff will then schedule a time to meet at the 
clinic to complete the screening process. 
Lastly, potentially eligible patients will also be referred to us by others not associated with the 
project. These referrals included: 1) health care providers recommending patients who could 
potentially benefit from the program to speak to us in the waiting room. 2) participants referring 
other potential participants to visit us in the waiting room or call our recruitment numbers, or 3) 
the result of UCLA fieldwork staff providing IRB-approved flyers to ineligible patients in the 
waiting room to pass along to friends and family members.  
To address the needs of our patient population, bilingual and bicultural UCLA fieldwork staff will 
be trained in the recruitment protocol approved by the UCLA IRB while concurrently maintaining 
PCORI patient centeredness in mind. Research assistants will be certified by the project 
manager and Principal investigator to carry out the recruitment protocol as follows: Research 
assistants will be assigned quadrants of the waiting rooms to observe, systematically approach 
and screen all patients in the waiting rooms. A research assistant (RA) will directly approach 
adult patients and identify themselves and their UCLA affiliation. The research staff will then 
introduce the study to the patient. If the patient provides verbal consent to continue with the 
screening questions, then the RAs will proceed with the screening questions. The RA then 
explains that 18 statements would be read to them. The statements will be read in 4 groups of 2 
to 5 statements each. After each group of statements the patient will be asked to respond yes or 
no to the group of questions as a whole as a strategy to ensure confidentiality even if another 
patient in the waiting room were to eavesdrop. If the patient states that any of the statements 
applies to him or her, then they will be told that they are ineligible to participate in the study, will 
be thanked and exited from the study. The exclusion screening statements are as described 
below in Table 3. 
Table 3. Exclusionary Screening Statements 
GROUP ONE 
1. 
I am younger than 18. 
2. 
I live outside the Long Beach area. 
3. 
I am planning on moving away from the Long Beach area in the next 12 months. 
4. 
Another member of my household is a participant in this weight loss study. 
5. 
In the last week, I had more than [if men: 5; if women or 65+ years old: 4] glasses of 
beer or other alcohol that I drank on one occasion. 
 
GROUP TWO 

 
Patterned after protocol published online in association with Appel et al. (2011)15 
 
 
6. 
I have experienced intentional or unintentional weight loss in the last 6 months [>5% of 
body weight]. 
7. 
I am taking or have taken a weight loss medication/prescription medication likely to 
cause weight gain or weight loss. 
8. 
I am currently taking insulin. 
9. 
I had a heart attack in the last 12 months. 
10. 
I had treatment for cancer. 
 
GROUP THREE 
11. 
I have a condition that limits what I eat and how much I exercise. 
12. 
I had or plan to have bariatric surgery (stomach stapling). 
13. 
I hospitalized for a mental health problem in the past 12 months. 
14. 
I am a new patient receiving health services for the first time at this clinic. 
15. 
I am pregnant or planning to become pregnant in the next year [FOR WOMEN ONLY]. 
16. 
I am currently breast-feeding [FOR WOMEN ONLY]. 
 
GROUP FOUR 
17. 
I am NOT interested in losing unwanted weight at this time. 
18. 
I smoked cigarettes or used e-cigarettes in the last 6 months. 
 
Tracking of Recruitment Progress 
The tracking of recruitment, i.e. defining and counting the number contacted and the number 
interested at each stage and then characterizing enrollees and non-enrollees, is complex. To 
the extent possible, we will describe the recruitment funnel beginning with the number contacted 
(denominator). This is most easily accomplished for targeted mailings and, to a lesser extent, for 
in-person clinic contacts. It cannot be done for those who view a poster, review a notice on a 
clinic website, or talk to clinic staff. Using the TCC administrative database, we will compare 
basic characteristics of enrollees to the general population of individuals seeking medical care 
at the facilities. Using information collected at in-person visits and on the web, we can compare 
characteristics of enrollees to non-enrollees.  
 
Recruitment of women and minorities 
UCLA/TCC investigators have a strong interest and proven track record in recruiting diverse 
populations. We anticipate that at least 60% of participants will be women, at least 70% will be 
Latinos and at least 10% will be African American.  Given the demographic characteristics of 
TCC’s patients, these goals should be achievable without targeted recruitment efforts. 
 
8. DATA COLLECTION AND MEASUREMENTS 
Data Collection Assessment Periods 
Eligibility, baseline and follow-up data will be collected by phone and at in-person visits in the 
home or in the clinic site waiting room. Intervention process data will be collected separately. In-
person data collection visits will be conducted in the waiting rooms of the participating clinics.  
The following contacts describe the primary data collection points for participant level data. 
Prescreen Contacts: During the initial waiting room contact, research staff will provide 
information about the trial and will collect additional data on eligibility. Those who remain 
interested and eligible will be consented to participate in the screening phase and will begin to 
complete screening visit measures. Most patients will complete screening and enrollment 
activities in this initial visit, some will finish the self-report data assessment but many will be 

 
Patterned after protocol published online in association with Appel et al. (2011)15 
 
 
called up for their appointment and therefore will have to leave off completion of the self-report 
data assessment at a later time. The study participant will be scheduled for an in-person 
screening visit and will be provided a number to call if interested in asking additional questions. 
Screening Visit: Interested persons who are unable to complete screening and enrollment 
procedures during their first contact will be schedule at their TCC clinic site from which they 
were recruited, where their blood pressure, waist circumference, height and weight will be 
measured.  If these measures indicate continued eligibility then the participant will be provided 
more detail about the trial.  Written informed consent to participate in the full trial will be 
obtained. After consent has been signed, the patient will be randomized and questionnaire data 
be collected.   
Randomization procedure. If all screening and baseline measures indicate that the patient 
remains eligible, a programmed application in REDCap generates a random assignment to 
experimental condition for the patient at the end of the screening assessment.  The lifestyle 
change coaches can look up in REDCap’s database the study participants assigned to their 
condition.  The coach will then call the patient and arrange for the first coaching session, if 
appropriate.  The research assistants will be kept ignorant of the patient’s assignment to 
experimental condition, to reduce the chance for bias.  Of necessity, the lifestyle change 
coaches will be aware of the patient’s experimental assignment but will be instructed to follow 
the protocol carefully, so as not to introduce any personal bias.   
The REDCap data entry system has also been programmed to generate a randomly determined 
assignment to condition, if the would-be participant met all inclusion criteria and reported no 
exclusion criteria. Hence, at the completion of the screening visit the study participant will be 
informed about the experimental condition that he/she had been assigned to and the name and 
contact number of his/her lifestyle coach.  More information about the randomization process is 
provided below. 
Follow-Up (FU) Visits: Participants will be asked to attend in-person follow-up visits at 6 and 12 
months after randomization.   Most of these data will be collected in-person at the clinic but the 
FFQ may be administered over the phone, depending on the time constraints of the study 
participant.  The target windows used to schedule participants will coincide with a one month 
period around the 6 and 12 months follow-up visits. During follow-ups, e will also ask patients to 
evaluate the trial, including their perceptions of the acceptability and usefulness of the 
intervention and its components (MyPlate or Calorie Counting).   
Measurement intervals. 
Most measures will be assessed at baseline, at 6 months and 12 months follow-up.  The Block 
Food Frequency Questionnaires will be administered only at baseline and 12-months follow-up, 
not at 6-months follow-up, to minimize the burden on study participants. Questionnaires were 
administered in the order described below in Table 4. 
 
Table 4: Data Collection Items and Schedule by Contact 
  
Screening Baseline 
F-up-6 
F-up-12 
Eligibility/Interest 
X 
  
  
  
Informed Consent 
X 
X 
  
  
Weight (self-reported) 
X 
  
  
  
Height (self-reported) 
X 
  
  
  
Weight (measured) 
  
X 
X 
X 
Height (measured) 
  
X 
X  
X  
Waist (measured) 
  
X 
X 
X 
BP (measured) 
  
X 
X 
X 

 
Patterned after protocol published online in association with Appel et al. (2011)15 
 
 
Randomization 
  
X 
  
  
Questionnaire topics (administered in this 
order) 
  
  
  
  
Demographics/Medical 
X 
X 
  
X 
WHO Health and performance questionnaire 
 
X 
X 
X 
Health-Related QoL-SF-12 
 
X 
X 
X 
Mental Health Inventory (MHI-5) 
 
X 
X 
X 
Physical Activity Quest. (IPAQ) 
  
X 
X 
X 
Physical Activity self-efficacy 
  
X 
X 
X 
Outcomes: hunger – fullness - satisfaction 
 
X 
X 
X 
MyPlate adherence 
  
X 
X 
X 
MyPlate self-efficacy 
  
X 
X 
X 
Weight loss history 
 
X 
X 
X 
Weight control self-efficacy (WEL-SF) 
  
X 
X 
X 
Patient sense of autonomy 
  
X 
X 
X 
Patient satisfaction with care 
  
 
X 
X 
Social support and eating habits survey 
 
X 
X 
X 
Social support and exercise survey 
 
X 
X 
X 
TV/Monitor use time 
 
X 
X 
X 
USDA Short-Form Food Security survey 
 
X 
X 
X 
Medical History survey 
 
 
X 
X 
Patient satisfaction with weight loss program 
 
 
X 
X 
Block Food Freq. Quest. 
  
X 
  
X 
    *note.  F-up-6 = follow-up assessment 6 months after randomization; F-up-12 =follow-up   
      assessment 12 months after randomization. 
 
Principal Measures 
The following sections describe the specific measurements to be collected from participants at 
each contact point in the trial. After considering the total burden of data collection procedures 
and measurements, we may drop or modify some items. We may also add questionnaires. For 
example, to improve study procedures and interventions, we will query participants about their 
experiences in the study. 
Choice of outcomes.  The primary patient-centered outcome is level of everyday hunger; the 
primary patient medical outcome is body weight (kg).  Secondary patient-centered outcomes 
include: patient weight control self-efficacy, patient autonomy, patient quality of life, and patient 
satisfaction with obesity treatment efforts by TCC.  Secondary patient medical outcomes 
include: waist circumference, blood pressure and weight.  Most of these measures were used in 
the two clinical weight loss intervention trials whose protocols are the basis for the comparative 
effectiveness study protocol being described here. 14,15  Our primary patient-centered outcome 
measure, however, was not included, and so is described in detail below.  Two additional 
indicators of satiation/satiety were added to the study to optimize capture of the satiation/satiety 
construct, namely meal satisfaction and feeling of fullness after eating.  These additional 
measures are further described below.  
 
Prior to examining patient-centered or medical outcomes, however, we plan to conduct a check 
on the dietary impact of the intervention conditions, by examining weekly fruit and vegetable 
intake.  F&V Intervention checks: 1) Daily fruit and vegetable intake.  Because of its 
importance to intervention success, daily fruit and vegetable intake will be assessed in both the 

 
Patterned after protocol published online in association with Appel et al. (2011)15 
 
 
overall assessment questionnaire and concurrently using the Block Food Frequency 
Questionnaire (FFQ). The Block FFQ has been used in previous community-based intervention 
research to document changes in fruit and vegetable intake.114  The Block FFQ has been 
translated into Spanish and has been demonstrated effective in capturing valid food intake data 
from Mexican American respondents.115  FFQs typically capture 85-90% of the variation in food 
intake as measured by multiple 24-hour dietary recalls116 but are less burdensome to study 
participants and less expensive for investigators to administer.  Because the MyP approach 
features the DASH diet, 16 adherent study participants assigned to the MyP condition are 
expected to report twice the daily intake of fruits and vegetables as study participants assigned 
to the DPP-like dietary prescription.  This measure will be important for sensitivity analyses, to 
gauge whether the magnitude of the quality of life benefits and weight control benefits of the 
MyP condition covary with the degree of participant adherence to the DASH diet, as reflected by 
the Block FFQ measures of fruit and vegetable intake. The corresponding fruit and vegetable 
intake questions on the overall questionnaire were developed specifically to evaluate adherence 
to the www.choosemyplate.gov recommendation117 that Americans fill half their plate with fruits 
and vegetables.   
Primary patient-centered outcome: Level of everyday hunger (Before start of study added 
meal satisfaction and feeling full as additional indicators of satiety 118).  An understudied 
but potent influence on adherence to therapeutic diets is level of everyday hunger.119-121  The 
published intervention trial that comes closest to the study proposed here was a comparison 
between a standard low-fat energy restriction (only) approach compared to a low-fat energy 
restriction approach combined with the goal of increasing intake of water rich foods, particularly 
fruits and vegetables (F&V).20  A key finding in this study was that the F&V intervention yielded 
greater 1-year weight loss but significantly LESS daily feelings of hunger than the more 
conventional low-fat energy restriction approach.20  The particular item used in the Ello-Martin et 
al. trial was this: ““How hungry did you feel today?” The type of scale used was a “Visual 
Analogue Scale (VAS).”  The VAS consists of a 100 mm line anchored from “Not at all hungry” 
to “Extremely hungry.” Participants place a hash mark on the line that represents their level of 
appetite. Each VAS item is scored by measuring the distance from the left end of the line to the 
participant’s hash mark.122,123  The effect of increasing intake of water-rich foods (i.e., minimally 
processed fruits and vegetables) on repeated hunger ratings over one year was significant, with 
a moderate effect size (Cohen’s Effect Size = (53.5 – 46.7)/ 13.2= .52).  Part of the reason for 
this salubrious effect on feelings of hunger was that the water-rich food intervention was 
associated with a 25% increase in the daily weight of the food consumed, even though the daily 
calories consumed were lower in the low-fat + water-rich foods condition than in the low-fat 
(only) condition. When people can fill up faster on fewer calories, risk of passive 
overconsumption of calories is diminished.20 The emerging science of the gut microbiome 
suggests that consumption of polysaccharides in minimally processed fruits and vegetable also 
enhances satiety by providing substrate to large bowel microbes that then generate short chain 
fatty acids that then trigger expression of the satiety-signaling hormones glucagon-like peptide-1 
and peptide tyrosine tyrosine (PYY).124   
Although feeling hunger has face validity as the antithesis of satiation/satiety, two additional 
indicators of satiation/satiety were added to the study, namely meal satisfaction and feeling full 
after a meal.  The same 100mm VAS response scale was used to measure these two additional 
indicators of satiation/satiety as was used for assessing feelings of hunger.  The 100mm VAS 
fullness measure has been used in previous research on satiety/satiation.125,126 
Cognitive testing with Spanish-speaking bilingual patients will be used to ensure that the 
Spanish translation of “How hungry do you feel today” measures the same construct as the 
original question. For low-literacy patients, the question will be administered by a research 

 
Patterned after protocol published online in association with Appel et al. (2011)15 
 
 
assistant instead of being self-administered.  As noted in the PCORI Methodology Report, there 
is no easy way to address the challenge of low literacy.  Fortunately, hunger is a universally 
understood construct with strong face validity and high sensitivity, so we anticipate obtaining 
meaningful data in response to this question from all study participants, regardless of literacy 
level. 
While we are hypothesizing that the MyPlate diet, with its doubling of fruits and vegetables, will 
yield greater satiation/satiety and less daily hunger than the DPP-like diet, a confounding 
contributor to hunger is meal-skipping, both voluntary and involuntary.  The lifestyle change 
coaches will be trained to encourage breakfast-eating in both conditions and to discourage 
meal-skipping.  For patients dependent on government food assistance, there may be periods of 
involuntary hunger.  Questions about food insecurity will be asked of all participants and used 
as covariates to help control for the hunger-generating effects of periodic meal-skipping. 
The 100mm visual analogue scale used to assess the everyday hunger measure is shown 
below: 
 
 
 
 
Primary Patient Medical Outcome: Weight (kg) will be measured at each assessment in the 
clinic setting. Weight in light indoor clothes without shoes will be recorded by trained, certified 
staff using a high-quality digital scale (Tanita). Duplicate measurements will be made to ensure 
accuracy. Weight will be measured in pounds for ease of interpretation by the participants and 
subsequently converted to kilograms for data analysis. Scales will be calibrated weekly using 
standardized weights.  The weight at screening/baseline will be used to determine eligibility 
(27.0 <= BMI <= 40.4). The difference between body weight obtained at screening/baseline and 
12 months follow-up will be the primary patient medical outcome. 
Secondary patient-centered outcomes include: weight control self-efficacy, patient autonomy, 
health-related quality of life, and patient satisfaction. 
Weight control self-efficacy will be assessed using the 8-item short version 127  of the 20-item 
Weight Efficacy Life-style Questionnaire (WEL), a measure judged reliable and valid in obese 
populations.128,129 The WEL-SF provides a total weight self-efficacy score based on the sum of 
the item scores (total range = 0– 80). Higher scores indicate greater self-efficacy. The WEL has 
demonstrated good internal consistency reliability in a general overweight patient population 
(Cronbach’s coefficient alpha = 0.95 for men, 0.93 for women). 129,130  The WEL-SF correlates r 
= .968 (shared variance = .937) with the WEL, despite the 60% reduction in the number of 
items. 127  Because of the high shared variance, the short version was chosen over the long 
version in order to minimize respondent burden. 

 
Patterned after protocol published online in association with Appel et al. (2011)15 
 
 
We also plan to gauge patients’ patient activation sense of autonomy in medical decision-
making occurring during the visit, drawing on recent work 131,132  for measuring both patient 
perception of the actual autonomy that they experienced during the visit and the amount of 
autonomy they wanted to experience. We will explore the use of the stem question – “When 
considering ways to lose weight, please think about who should make the decision, your doctor 
or yourself? Please select which of these statements is most appropriate for you: Considering 
your visit today (or last visit): (1) who made the decisions about your care?” (doctor or patient); 
and (2) “Who should have made the decisions about your care?” (doctor or patient).” 
We plan to administer the SF-12, an abbreviated health-related quality of life instrument, 
based on the SF-36. 133  Test-retest (2-week) correlations of 0.89 and 0.76 were observed for 
the 12-item Physical Component Summary and the 12-item Mental Component Summary, 
respectively, in the general US population (n = 232). 133  A Spanish translation of this instrument 
is available and has similar psychometric properties. 134,135  Our patient satisfaction with their 
weight loss program is adapted from literature evaluating consumer satisfaction with 
consumer products. 136 As part of a set of post-intervention evaluation questions concerning 
patient judgments about intervention components the question was asked: "Would you 
recommend this Program to your family members or friends?"  Answer options included: "Yes, 
definitely," " Maybe," and "No."  In evaluating business products, this single item has been 
unusually effective in discriminating high consumer satisfaction with products from less 
successful products.136 
 We will test the reliability of these scales for our minority clinic populations and evaluate the 
meaning of these items when translated into Spanish, during cognitive testing prior to study 
implementation.   
Secondary patient medical outcomes include: BMI, waist circumference, and blood pressure. 
Height (cm) to the nearest 0.1 cm will be measured once at entry using a calibrated, wall-
mounted stadiometer in the clinic. The participant stands shoeless on a  level surface, with 
his/her head in the horizontal (Frankfort) plane. 
 
Waist Circumference (cm) will be measured by trained staff using an anthropometric 
measuring tape (Gulick anthropometric ), at a horizontal plane around the abdomen just above 
the uppermost lateral border of the right iliac crest (i.e. the top of the hip bone). 137  Obesity 
cutpoints of 88 cm (women) and 102 cm (men) 137 will be used in analyses. Because visceral fat 
expresses inflammatory cytokines that increase cardiovascular risk, 138  waist circumference is 
arguably more predictive of future heart disease than overall obesity.139 
 
For the waist circumference measurement, the subject should be wearing a top and short, 
pants, or skirt, adjusted to obtain access to the waistline.  If it is not possible to access the 
waistline, the measurement can be taken over thin clothing (thin shirt or blouse), and this should 
be noted on the data entry form. The participant should stand with abdomen relaxed, arms at 
sides, and feet close together with weight equally distributed between both legs.  
 
Participant’s preference of Research Assistant’s gender taking waist circumference should be 
taken into consideration prior to taking measurement. In addition Research Assistant (RA) 
should ask patient if they feel more comfortable having the measurement taken under or over 
clothing. RAs will asks patients: 
 
“The next measurement is your waist circumference. This measurement is more accurate if we 
measure it under clothes and directly on top of the skin. Would it be OK if we measure your 
waist circumference under your clothes? Or do you prefer over your clothes?” 

 
Patterned after protocol published online in association with Appel et al. (2011)15 
 
 
 
Analytically, the bias introduced by measurements over clothing instead of against the skin-
which is ideally the way waist circumference should be measured- can be corrected for by 
subtracting the mean increase in waist circumference associated with measuring the waist 
circumference over clothing compared to waist circumference associated with measuring the 
waist circumference over skin.140 
 
BMI will be calculated as the Quetelet index (kg/m2).  Although BMI is collinear with body 
weight, it is included in order to provide comparability with other studies, where BMI was the 
primary outcome.   
 
Blood Pressure (BP) will be determined via automatic blood pressure cuff using Life Source 
UA-767 Plus, A&D Medical digital blood pressure monitor. BP will be obtained by trained data 
collectors according to a standard protocol, adapted from that used in the OmniHeart trial.  The 
cuff size will vary by degree of patient obesity status, with leg cuffs for the most obese. Two 
measurements (each separated by 1 minute seconds) will be obtained at each visit on the left 
arm of participants after they have rested quietly in the seated position for at least 5 minutes. A 
cuff of appropriate size will be identified at the initial visit and used thereafter at all subsequent 
visits. 
 
Questionnaires (self-report survey items that include weight control self-efficacy, patient 
quality of life (SF-12), patient satisfaction and patient sense of autonomy previously 
described) 
The trial will collect questionnaire data from participants. These data will be used for a variety of 
purposes - baseline data to describe participants, outcome data to assess the effects of the trial 
interventions, and mediating variables to assess potential causal pathways. Questionnaires will 
be added or removed depending on scientific and logistic considerations, including burden to 
participants and staff.   
 
Demographic: The demographic questionnaire is a self-report assessment of basic patient 
characteristics. It assesses age, gender, race/ethnicity, health insurance status, employment, 
education level, tobacco use, postmenopausal status, and current health conditions (presence 
of diabetes, hypertension, and cardiovascular disease).  
 
Has a doctor ever diagnosed you with diabetes, heart disease or high blood pressure? 
Get medication use from electronic health record, with participant’s permission. 
 
MyPlate Adherence Questionnaire: Developed for a previous nutrition intervention trial, the 
MyPlate Adherence Questionnaire consists of 5 items assessing awareness of the 7 nutrition 
messages associated with MyPlate  and 5 items that assess adherence to five of the 7 MyPlate 
messages on a typical day (http://www.choosemyplate.gov/print-materials-ordering/selected-
messages.html).  The messages include: 1) Make half your plate fruits and vegetables, 2) Make 
at least half your grains whole grains, 3) Switch to low-fat or non-fat milk, 4) Choose the foods 
with lower sodium, and 5) Drink water instead of sugary drinks. 
 
MyPlate Self-efficacy: Developed for a previous nutrition intervention trial, the MyPlate Self-
efficacy scale consists of 5 items querying the participant about her/his confidence that she/he 
can adhere to the 5 nutrition messages associated with MyPlate 
(http://www.choosemyplate.gov/print-materials-ordering/selected-messages.html)  
 

 
Patterned after protocol published online in association with Appel et al. (2011)15 
 
 
Physical Activity: The short format, self administered version of the International Physical 
Activity Questionnaire (IPAQ: http:ipaq.ki.se) will be used to assess participants’ usual level of 
moderate to vigorous physical activity. The IPAQ is a standardized self-reported measure of 
physical activity that has demonstrated validity and reliability.141  It will be used to estimate 
levels of moderate and vigorous physical activity from the previous week. 
 
Physical Activity Self-efficacy: A 10-item scale was adapted from the 12-item Exercise Self-
efficacy scale.142 Most of the items asked the respondent to indicate how sure she/he was that 
she/he could stick to the recommended exercise goal despite specific challenges such as when 
the family demands too much time, there is too much other work to do, when you feel 
depressed, etc. The test-retest reliability for the 12-item scale was .68; the Cronbach’s alpha 
measure of internal consistency averaged alpha = .85 across two subscales that made up this 
overall scale. 
 
Depressive Symptoms: The MHI-5 will be used to measure depressive symptoms. The MHI-5 
is a five-item mental health Likert measure derived from the SF-36 that was established in 
1991.133  Each MHI-5 item has six answer options ranging from ‘All of the time’ to 'Most of the 
time' to 'A good bit of the time' to 'Some of the time' to 'A little of the time' to ‘Not at all’, with a 
sum score ranging from 5 to 30.  High scores indicate good mental health.  This measure has 
been found to be a reliable measure of distress/ mental health.143  
 
Health-Related TV viewing time:  The NHANES item used to assess typical respondent time 
spent watching television each day will be used.144 To assess TV-viewing time, participants 
were asked: Over the past 30 days, on average about how many hours per day did you sit and 
watch TV or videos? Possible responses included: <1 hour, 1 hour, 2 hours, 3 hours, 4 hours, 
and > 5 hours.  This item was shown to predict obesity status in both children (girls 12y – 18y) 
and adults (men) 144 and correlated inversely with scores on the Healthy Eating Index. 145 
 
Weight Loss History: Weight loss history will be assessed using questions drawn from the 
NHANES survey. Questions will pertain to weight history, weight loss methods, and frequency 
and outcome of weight loss attempts. 
 
Social support for eating and exercise: Both active interventions are designed to provide 
social support through interactions with staff (both interventions) and participants (MyPlate only-
participant menu exchanges during MyPlate cooking demonstrations). The instruments for 
measuring social support include the “Social Support and Eating Habits Survey” and the “Social 
Support and Exercise Survey.”  These instruments are reliable, have high internal 
consistency,146 and are associated with other measures of physical activity and dietary 
behaviors.146,147 
 
 
9. QUALITY ASSURANCE AND QUALITY CONTROL 
Quality Assurance (QA) pertains to activities that promote collection of high quality data, while 
Quality Control (QC) pertains to activities that detect emerging issues. Our basic approach to 
QA is as follows: 
 
prepare a well-documented fieldwork manual of procedures, 
 
implement a trainer model to train and certify other staff 
 
train and certify all primary data collectors, with special emphasis on procedures related 
to trial outcomes, 
 
establish proficiency requirements before initial certification of data collectors, 

 
Patterned after protocol published online in association with Appel et al. (2011)15 
 
 
 
routinely observe data collectors, 
 
routinely calibrate equipment, including weekly calibration of the weight scales used for 
assessing body weight and regular calibration of the blood pressure equipment 
 
use cognitive testing to ensure that Spanish translations of questionnaires are 
comparable in meaning to the English versions; use cognitive testing to ensure that new 
and other conceptual questions measure what they were intended to measure 
 
pilot test new questionnaires and data collection procedures 
 
maintain logs of certified data collection staff and calibrated equipment. 
 
To identify problems with sufficient time to institute appropriate corrective actions and to quantify 
the quality of data collected during the trial, we will perform the following QC activities: 
 
monitor counts of completed assessments and key data collection items, 
 
monitor distributions of trial outcomes, overall, by data collector, 
 
issue queries about missing data, out of range values, or illogical data relations, 
 
review types and distribution of data entry errors. 
 
10. RANDOMIZATION AND MASKING 
Randomization 
Randomization.  As mentioned above in describing the use of REDCap in recruitment, if 
all measures indicate that the patient remains eligible, a programmed application in REDCap 
will generate a random assignment to experimental condition for the patient at the end of the 
screening assessment.  The lifestyle change coaches can look up in REDCap’s database the 
study participants assigned to their condition.  The coach will then call the patient and arrange 
for the first coaching session, if appropriate.  The research assistants will be kept ignorant of the 
patient’s assignment to experimental condition, to reduce the chance for bias.  Of necessity, the 
behavior change / lifestyle change coaches will be aware of the patient’s experimental 
assignment but will be instructed to follow the protocol carefully, so as not to introduce any 
personal bias.   
 
Masking 
Trial participants will know their intervention assignments, as will the community health worker 
staff that are involved in delivering the interventions. However, UCLA fieldwork staff involved in 
follow-up data collection will be kept masked to participants’ randomization assignments.. At the 
conclusion of the trial, participants will receive a summary of clinically relevant measurements.  . 
 
11. INTERVENTIONS 
Overview of the interventions. The MyP and CC interventions to be tested here are evidence-
based lifestyle counseling programs that have been adapted from those implemented in other 
weight loss trials.14,15  Other trials that have informed the design of our interventions include the 
Diabetes Prevention Program and LookAhead. 86,148  Although not weight loss trials, the DASH 
trials (DASH, DASH-Sodium and OmniHeart) helped to provide the scientific rationale for the 
dietary advice to be offered to achieve and maintain desirable weight loss.17,149-151  Both the MyP 
and CC interventions seek to generate a daily energy deficit as long as the participant has 
excess weight to lose.  Both interventions limit intake of high energy foods and both encourage 
increasing expenditure of energy in daily physical activity.  Both interventions use standard 
cognitive behavioral approaches to behavior modification, including self-monitoring of behavior, 
relapse prevention, and mobilizing social support for sustaining adherence to the recommended 
lifestyle approach.  The MyPlate/DASH-style intervention differs from the CC approach 
principally by its insistence that the form of the food in which calories come can influence 

 
Patterned after protocol published online in association with Appel et al. (2011)15 
 
 
metabolic functioning and appetite and can make a difference to quality of life, to optimal 
nutritional health, and to the sustainability of the weight loss approach for a lifetime.  The CC 
approach, by contrast, asserts that a calorie is a calorie and that it does not matter whether the 
calories come from minimally processed fruits and vegetables or from highly processed juices 
derived from fruits and vegetables.  The DASH-style approach therefore limits intake of juices 
and limits the consumption of highly processed carbohydrate-rich foods including ready to eat 
breakfast cereals, refined wheat breads, pizza, chips, pastries, candies, power bars and fruit 
smoothies.  As previously noted, the DASH-style approach also strongly encourages increasing 
the intake of fresh fruit and vegetables to at least twice the daily intake of the average American 
adult, as well as increased intake of whole grain cereals, legumes, seeds and nuts. 
 
Theoretical Rationale/ Model Underlying the Interventions 
The theoretical framework for the CC and MyP interventions draws largely upon the strengths of 
behavior changes theories, specifically, social cognitive theory, 34,152 Behavioral self-
management and motivational enhancement 153,154 approaches are used as a foundation to 
teach participants strategies including goal setting, self-monitoring, problem solving and 
identification of barriers and strategies for overcoming these barriers. Both interventions are 
designed to promote weight control self-efficacy and to help participants identify and develop 
sources of social support. Both self-efficacy and social support are key components in social 
cognitive theory and have been identified as important determinants of behavior change.34 
These efforts will work in conjunction with behavior change counseling in the primary care 
setting. U.S. Preventive Services Task Force (USPSTF) has recommended this multi channel 
approach to promoting lifestyle change.103,155  One feature that distinguishes the CC and MyP 
theoretically is the emphasis that the MyP approach places on environmental cues to support 
the recommended behavior changes initially achieved through goal-setting, self-management 
and motivational enhancement.  This emphasis on the importance of the physical environment 
is more in keeping with Social Ecological Theory 156 than Social Learning theory. 32  Social 
ecological models of health promotion identify several levels of environmental influence on diet 
and physical activity, ranging from familial to global factors. At the most proximal level, there is 
increasing evidence that the home micro-environment can be obesogenic. Both physical (e.g., 
type of food available) and social (e.g., support from family) factors in this setting have been 
associated with weight, dietary habits, and activity patterns.47,48 Demonstrated links between the 
physical home environment and behavior include relationships between available high-fat foods 
and fat intake,49 access to home exercise equipment and activity levels,50,51 and number of 
televisions and amount of television viewing.52 
 
The utility of the calorie-counting (CC) approach to energy restriction was predicated on the 
assumption that a calorie is a calorie, no matter what its source, and that weight loss could be 
achieved regardless of where the calories were coming from, as long as calorie expenditure 
exceeded calorie intake.  It is a simple matter of physics.  To generate a chronic calorie deficit 
the patient either had to increase energy expenditure, through physical activity usually, or 
restrict their calorie intake to a level below the level of calories expended through daily 
metabolism and physical activity.  The behavioral theory behind the DPP calorie-counting 
approach views participants as active problem solvers who are capable of regulating their affect, 
behavior, and cognition.157 Self-monitoring is used to identify times, places, emotions, people, 
and events associated with eating (or exercising) appropriately or inappropriately. Goal setting 
is facilitated by specifying behaviors to be adapted and when, where, how, and with whom they 
will be performed. Behavior change is reinforced by increased self-efficacy, by the inherent 
rewards in reaching a goal (i.e., weight loss or improved fitness), by social support (including 
encouragement from medical personnel) or by the use of external rewards. The provision of 

 
Patterned after protocol published online in association with Appel et al. (2011)15 
 
 
long-term treatment recognizes that obesity, for most individuals, is a chronic condition that 
requires long-term care.  The delivery of the calorie-counting intervention in primary care 
practice is guided by Wagner’s Chronic Care Model. 158,159  Using a community health worker 
lifestyle coaching approach, obese participants will be provided an evidence-based intervention 
(i.e., the Diabetes Prevention Program) that primary care providers can refer their obese 
patients to for obesity treatment. Community health worker lifestyle change coaches will be 
trained to guide and support participants’ efforts to improve their eating behavior and physical 
activity using the DPP approach. 
The utility of the DASH-style approach to energy restriction in MyP is predicated on helping the 
participant reach satiation / satiety sooner with fewer calories by careful choice of foods to 
consume.151  Feeling full with fewer calories is possible by replacing highly processed, usually 
energy dense and nutrient poor food choices with minimally processed foods of Mother Nature, 
particularly fresh fruits and vegetables.  Canned fruits and vegetables are typically processed 
foods, high in added sodium and often high in added sugar as well, and are therefore to be 
consumed only in limited quantities.  Participants in the MyP condition are particularly 
encouraged to limit most caloric beverages, including:  juices, juice drinks, sugar sweetened 
beverages and alcoholic beverages – because of the high potential for passive 
overconsumption of calories from these sources.160  There are several important but 
addressable challenges to the DASH-style approach that can benefit from systematic tracking 
and encouragement by a lifestyle change coach.  These challenges include: 1) the neophobic 
response of the human palate to the taste of botanically distinct new plant foods,61  2) the 
phenomenon of sensory-specific satiety,161 whereby appetite for a specific food declines with 
every additional bite of the food, 3) the negative impact that fasting has on receptivity to low-
calorie, high-fiber foods, 162 4) the prerequisite importance of physical activity for generating 
optimal appetite for water-rich foods, specifically fruits and vegetables.163  With supportive 
coaching and collaborative coach/participant problem-solving, these challenges can be 
overcome. 
Description of Intervention Health Education / Coaching Sessions. 
For the 3-months pilot study, for both interventions there will be weekly meetings of the CHW 
with the participant throughout, including 2 one-hour group education sessions, 2 thirty-minute 
in-home visits and 8 (later reduced to 7 following stakeholder input) twenty-minute telephone 
coaching sessions. 
For the 12-months full study, for both interventions,patients will be encouraged to complete four 
meetings each month with their CHW so that the intervention can be completed in three months. 
However, if patients are unable to complete the health education lessons within this timeline, 
they will be allowed to complete as many lessons out of the 11 possible before their final follow-
up assessment. The meetings will include 2 group education sessions during months, 2 in-home 
visits during months , and 7 telephone coaching sessions that taper off in frequency during the 
first three months of the 12-months study period. For this study, the health sessions were 
delivered in the following order in as described below in Table 5. 
Table 5.  Order and Distribution of In-Home Health Education Sessions, telephone coaching 
sessions, and group education sessions. 
1) In-home health education session #1  
2) Telephone coaching session #1 
3) Group education session #1 
4) Telephone coaching session #2 
5) Telephone coaching session #3 
6) Telephone coaching session #4 

 
Patterned after protocol published online in association with Appel et al. (2011)15 
 
 
7) In-home health education session #2 
8) Telephone coaching session #5 
9) Group education session #2 
10) Telephone coaching session #6 
11) Telephone coaching session #7 
The TCC community health workers responsible for the lifestyle change coaching sessions will 
be recruited from the local community  and local colleges. They will be trained and supervised 
by the TCC health education department, who has years of experience supervising community 
health workers, including community health workers making home visits.  Both the community 
health workers and the patients will be likely to view the in-home visits as part of routine TCC 
care because of TCC's previous history of community health worker lifestyle change coaching. 
The budget includes the telephone lines for the community health workers, to facilitate their 
telephone and in-home visits with study participants.  The budget also includes the cost of 
mileage incurred while making in-home visits.  Because many patients may be prevented from 
attending the group health education because of the cost of transportation to the group 
education event or the cost of childcare, each participant attending the health education will 
receive $10 towards deferring the transportation cost and the participant’s infant children will be 
provided free child care.  The group education will be open to participation by family members, 
including spouses and children old enough to benefit from the education. 
 
The Calorie-Counting (CC) Lifestyle Coaching Intervention Approach, as adapted by 
Wadden et al. (2011) from the Diabetes Prevention Program (DPP-like) 
CC Behavior Change Goals. The goals of this intervention are to induce a loss of 5% or more 
of initial weight through energy restriction by counting calories, limiting daily intake to prescribed 
amounts and increasing participants’ physical activity to > 150 minutes per week and to 
maintain these improvements over 12 months. These goals will be achieved by providing 
participants a program of lifestyle modification, delivered by a community health worker lifestyle 
coach, with encouragement from the patient’s primary care provider (PCP). 
Description and delivery of the CC intervention. Participants in this group will meet with their 
PCPs on the same schedule as those in the MyP group and receive the same attention for their 
comorbid conditions, as well as the weight management handouts. Participants in this condition 
will receive a program of lifestyle modification based on the curriculum used in the Diabetes 
Prevention Program (DPP). The lifestyle modification program will be delivered to participants 
during regularly scheduled phone calls conducted by community health worker lifestyle change 
coaches. We elected to use the DPP materials because they have been shown to be effective 
across a wide range of participants and provide tailored dietary menus for African Americans 
and other ethnic minorities. The DPP materials have been adapted for delivery in primary care 
practice by community health worker lifestyle change coaches and have obtained a loss of 
approximately 3.8% of initial weight during 6 months of treatment. 14 
Duration, and format of intervention contacts. Each of the 7 health CC education/coaching 
sessions by phone will last 15 to 20 minutes and will begin with participants being asked about 
their progress and their weight and informed of their weight change. At each visit, the participant 
and Lifestyle Coach (i.e., community health worker lifestyle change coach) will review the 
participant’s completion of food and activity records since the previous visit. This will include 
examining an estimate of the number of daily calories consumed and minutes walked each 
week, as well as any other homework assignments assigned during the previous contact. The 
Lifestyle Coach will assist participants with problem solving and will then introduce the lesson 
from the DPP curriculum to be completed for the next visit. Participants will receive enough food 

 
Patterned after protocol published online in association with Appel et al. (2011)15 
 
 
monitoring records and activity records to last until their next visit. Participants will have until 
before their last follow-up assessment to complete all sessions. Visits that cannot be completed 
on-site (because of illness, travel, etc.) may be completed by phone. Group health education 
sessions will last 1 hour for the CC participants but will last 1 ½  hours for the MyP participants 
because the last ½  hour will consist of taste-testing fruit- and vegetable-rich recipes.  Finally, 
the two in-home visits will last 50 minutes and will involve a discussion of strategies for keeping 
calorie intake low (DPP-like condition), for keeping fruit and vegetable intake high (MyP 
condition), and for maintaining a daily regimen of 30 minutes or more of moderate to vigorous 
physical activity (both conditions). 
Dietary goals –CC condition: Participants in the CC condition will be prescribed a daily calorie 
goal based on body weight. Following recommendations from the Diabetes Prevention Program, 
persons who weigh ≤ 114 kg (≤ 250 lb) will be prescribed 1200-1499 kcal/d and those > 114 kg 
(> 250 lb) 1500-1800 kcal/d. All participants will be encouraged to aim for the lower end of their 
range. DPP-like participants will be instructed to consume a diet of conventional table foods with 
< 30% of calories from fat (including < 10% from saturated fat), approximately 15%-20% of 
calories from protein, and the remainder from carbohydrate. This includes a goal of consuming 
5 servings of fruits and vegetables, including juices, each day. Participants in this group will be 
provided a calorie guide (e.g., Calorie King) to use as they wish. In addition, participants will be 
informed of the caloric content of common food and food-products found at their home. 
CC participants, for at least the first few weeks, will be asked to record all foods and beverages 
consumed for at least 3 days (2 weekdays and 1 weekend). This will begin at the first meeting 
with the Lifestyle Coach (at week 1). At the second meeting (Week 2), CC participants will be 
instructed to record their calorie intake with the assistance of the calorie guide provided (e.g., 
Calorie King). Food records will be reviewed at each meeting to determine participants’ success 
in meeting calorie goals, and problem solving will be used to facilitate adherence. Over time, the 
effort required to monitor their daily energy intake is expected to diminish as participants 
automate their monitoring of the times, places, and activities associated with their eating. 
Although originally developed for use by middle class patients, interventions such as the ones 
described here can be adapted and made useful for low-literacy patients with guidance from 
community-savvy lifestyle change coaches.164  The lifestyle change coach will also help 
participants develop an eating plan in which they consume breakfast, lunch, and dinner, with 
snacks as needed. Snacks will include fruits and vegetables to meet the goals described 
previously. Participants also will be provided meal plans (from the DPP) that suggest choices for 
breakfast, lunch, dinner, and snacks. 
CC participants’ calorie goals will be evaluated after the each health education session and 
adjusted appropriately based on an individual’s desire to remain weight stable or lose more 
weight. This reduced schedule recognizes that even the most motivated participants tire of 
keeping daily records after the first 6 months. 
Dietary goals –MyP condition: As was the case for CC participants, MyP participants will be 
encouraged to restrict calories but not through calorie counting but by making sure that half their 
typical plate is devoted to minimally processed fruits and vegetables, and that one quarter of 
their plate be grains, mostly whole grain, and that one quarter of their plate be protein-rich foods 
such as meat, fish, nuts and legumes.  Because not every meal is on a plate, the MyP 
participants will be asked to consider every serving of grains and every serving of protein-rich 
food to be yoked to a prerequisite serving of fruit or a serving of vegetables.  Having a serving of 
pizza is fine as long as it is accompanied by a serving of low-calorie salad or a serving of fruit 
(not juice).  In addition to this recommendation, the participants will be asked to adhere to the 
other non-portion-control messages accompanying the MyPlate icon.165  These messages 
include: “Switch to nonfat or low-fat milk,” “Choose lower sodium foods,”  “Drink water instead of 

 
Patterned after protocol published online in association with Appel et al. (2011)15 
 
 
sugary drinks.”  These messages represent complementary weight control strategies that are 
likely to facilitate desirable weight loss.  Reducing discretionary fat is consistently recommended 
for weight loss20,25 and validated by the success of orlistat, a lipase inhibitor.166,167  While sodium 
is not itself caloric, its level in a food is reflective of how highly processed the food is.  The 
consumption of high-salt, low-nutrient snack foods, in turn, has been associated with obesity 
risk.168,169  There is considerable consensus that sugary drink intake contributes to 
obesity160,170,171 and that replacing sugary intake with water would reduce risk. 172   
Part of the challenge in trying suddenly to eat eight or more servings of F&V/day instead of the 
more usual four servings is that sensory-specific satiety will likely render larger quantities of fruit 
and vegetables increasingly unpalatable midway through a meal unless participants increase 
the variety and range of fruit and vegetable choices.161  Increasing the variety and range of fruit 
and vegetable choices will, in turn, run up against the typical human neophobic response to new 
plant foods.  Part of the lifestyle coach’s challenge is to get the participant in the MyP condition 
to be willing to try a new food 8-14 times, because overcoming (permanently) the neophobic 
response to a specific plant food typically takes 8-14 exposures.62 The lifestyle coach will also 
suggest that a way to engender increased appetite for water-rich foods like fruits and vegetables 
is to exercise before the meal.  In school children,173 in athletes,74,174 and in overweight 
undergraduates 163 exercise before a meal increases appetite for water-rich foods.  Conversely, 
fasting or skipping breakfast before a meal are associated with decreased appetite for 
F&V,162,175 so regularity of meal intake will be encouraged. 
Another strategy for exposing participants to new plant foods in order to expand their repertoire 
of acceptable fruits and vegetables is to have the MyP participants take part in taste-testing 
dishes containing new plant foods.  Vegetable-rich recipes will be solicited from study 
participants and submitted for review by the study Intervention Director.  The recipes will be 
evaluated positively according to the quantity of the following dimensions: fruits and vegetables, 
minimally processed; whole grains; low-fat or non-fat dairy; lean proteins.  The recipes will be 
evaluated negatively according to the quantity of the following: saturated fat; sodium; sugar. A 
score composed of the above dimensions will be used to rank order recipes.  The ranking of 
recipe ingredients will favor selection of those recipes with the highest satiation/ highest satiety 
value for the fewest number of calories, thereby facilitating  a program of weight loss featuring 
less hunger 20 and therefore greater likelihood of maintenance for the long-term. 
Two coaching sessions take place in the home, so that an CHW can scan food products in the 
pantry and the refrigerator and designate each food product as a red light food (limit to no more 
than once a month), green light food (may eat every day), or yellow light food (nutritiously 
intermediate food – limit to no more than once a week).54 The intervention does not seek to ban 
less healthful choices from the home but instead to position the healthier choices so that they 
are the most conspicuous and the easiest choice.56  The literature on behavioral economics 
suggests that changing the “decision architecture” around the home will be enough to alter food 
choices; bans are not necessary.55,56  We deliberately avoided bans because bans can be seen 
as taking away legitimate choices and lead to pushback by other household members.  Hence 
the team dietitian will use adhesive-backed colored dots to indicate for every food product in the 
pantry, in the refrigerator, and on the counter whether a product was a red light, yellow light, or 
green light food.  The household residents would be encouraged to rearrange their food 
products such that the red light foods would be placed out of sight, in the far back recesses of 
the refrigerator and the pantry and off the kitchen counter.  Green light foods, by contrast, 
should be placed up front, so that they are the first choices that household members encounter 
when they open the refrigerator door or the pantry cabinet door.  Research shows that the 
healthier choice can be the more popular choice when it is more conveniently located. 176 

 
Patterned after protocol published online in association with Appel et al. (2011)15 
 
 
Physical Activity Goals for Both CC & MyPlate Participants. Participants in the CC behavior 
change intervention will have the same activity prescription as those in the MyP condition (i.e., 
increasing their activity to > 150 minutes per week during the first 6 months). Participants will be 
instructed to engage in aerobic activity (e.g., walking) for a specific number of minutes each day, 
building to ≥ 30 minutes/day, 5 days a week. Participants will be instructed to exercise at a 
moderate intensity so that they could talk comfortably with a partner while walking. They will 
record daily their type and duration of activity, including only bouts in which they have been 
active for ≥ 10 minutes. Lifestyle change coaches will review physical activity records with 
participants and provide suggestions for improving adherence. 
To facilitate adherence, participants in the MyP and CC conditions will receive a gym-in-the-bag.  
The gym-in-the-bag has been used in our previous health promotion interventions involving 
FQHC patients to good effect, leading to increased physical activity and objectively measured 
physical fitness.  The gym-in-the-bag includes the following equipment: a pedometer, three 
resistance bands of varying thickness, instructions on how to use the pedometer and the 
resistance bands, a plastic tape measure with desirable waist circumferences indicated for men 
and women, portion control recipes for the CC condition, DASH recipes for the MyP condition, 
and self-monitoring forms that the study participant can use to log her/his daily minutes of 
physical activity, by type of physical activity (aerobic / resistance).  The study participants will 
also be given a choice of “Instant Recess” DVDs featuring 10-minute dance/ calisthenics 
routines in a variety of ethnic flavors, including Salsa music, Gospel music, Cumbia, Filipino 
dance, etc.  There is much support in the scientific literature for the cardiovascular benefit of 
engaging in several 10-minute bouts every day.177,178 
Participants’ activity goals will be re-evaluated after each health session. Those who have met 
the 150 minute/week goal will be encouraged to increase to > 200 minutes/week. Problem 
solving will be used to improve adherence in those who have not met the initial goal. 
Participants will be given monthly step targets to help them reach 10,000 steps a day (by month 
12). They will be instructed to keep daily records of their steps (and minutes of activity) for the 
first three months after enrolling. After this time, those who wish may decrease their recording 
(e.g. to 3 days a week, as discussed previously). Participants in this group also will receive the 
handouts that illustrate methods to increase strength/resistance training at home. 
Other behavior modification goals. The CC intervention will include other traditional lifestyle 
modification topics (e.g., challenging negative thoughts, obtaining social support), most of which 
will be accompanied by a homework assignment to be completed before the next visit with the 
Behavior Change Coach. An important behavior will be having participants weigh themselves at 
least once a week and record their weight. Regular self monitoring of weight consistently 
facilitates long-term weight management.179 Participants who do not have access to a scale for 
weekly weigh-ins will be provided an inexpensive bathroom scale.  These participants also will 
receive the home strength training program, consisting of stretch bands and instructions for their 
use. The home strength training program covers activities intended to help participants increase 
muscular strength and endurance and promote weight loss. It is a standalone program that 
requires no further instruction. 
 
Table 6. Weight Goals and Behavioral Recommendations by Condition 
Behavior change 
goals 
CC condition 
MyPlate condition 
Weight loss goal 
Min. 5% weight loss 
Min. 5% weight loss 
Daily calorie 
intake 
Achieved weight 
loss <5% 
no daily calorie limit 
but limit fat  
1200 kcal/d if <= 170 

 
Patterned after protocol published online in association with Appel et al. (2011)15 
 
 
lbs. 
1500 kcal/d if >170 & 
< 220 lbs 
1800 kcal/d if >220 & 
< 270 lbs. 
2200 kcal/d if >270 
lbs. 
Achieved weight 
loss >= 5% 
1500-1900 kcal/d for 
women 
1800-2200 kcal/d for 
men 
Dietary 
pattern 
Aim for healthy weight 
DASH dietary pattern 
7-12 servings/d of 
F&V 
2-3 servings/d of low-
fat dairy 
lower sodium choices 
(target=1500mg) 
< 7% calories from 
saturated fat 
< 25% calories from 
fat 
Physical 
activity 
Build to >= 150 
min./week of mod. to 
vigorous physical 
activity in bouts >= 10 
min.each 
Build to >= 150 
min./week of mod. to 
vigorous physical 
activity in bouts >= 10 
min.each 
 
Table 7.  Schedule of Lifestyle Change Coaching / Group Health Education Sessions 
  
Home visit 
Group 
Telephone 
Total # sessions 
Month 1 
1 
1 
2 
4 
Month 2 
1 
 
3 
4 
Month 3 
 
1 
2 
3 
Month 4 
 
 
 
 
Month 5 
 
 
 
 
Month 6 
 
 
 
 
Study totals 
2 
2 
7 
11 
 
 
For the CC & MyPlate interventions: 
Goals. The goals of this intervention (during the first 3 months) are to induce a loss of 5% or 
more of initial weight and to maintain these improvements at 6 months, by meeting dietary and 
physical activity goals shown in Table 3. 
 

 
Patterned after protocol published online in association with Appel et al. (2011)15 
 
 
Description and delivery of the intervention. Participants in this group will receive a lifestyle 
intervention consisting of: 1) 7 telephone lifestyle change coaching contacts; 2) 2 group 
education contacts; 3) 2 in-home lifestyle change coaching contacts (See Table 4).  After 
enrolling, participants will be given a gym-in-the-bag during their first home visit. The gym-in-
the-bag includes the following equipment: a pedometer, three resistance bands of varying 
thickness, instructions on how to use the pedometer and the resistance bands, a plastic tape 
measure with desirable waist circumferences indicated for men and women, portion control 
recipes for the CC condition, DASH recipes for the MyP condition, and self-monitoring forms 
that the study participant can use to log her/his daily minutes of physical activity, by type of 
physical activity (aerobic / resistance).  The study participants will also be given a choice of 
“Instant Recess” DVDs featuring 10-minute dance/ calisthenics routines in a variety of ethnic 
flavors, including Salsa music, Gospel music, Kumbaya, Filipino dance, etc.  There is much 
support in the scientific literature for the cardiovascular benefit of engaging in several 10-minute 
bouts every day. 177,178 
Duration, and Format of Intervention Contacts for Both CC & MyPlate. Each of the 7 health 
CC & MyP education/coaching sessions by phone will last 15 to 20 minutes and will begin with 
participants being asked about his/her most recent body weight measurement, which the coach 
will then use to calculate the participant's weight change since the last session. At each visit, the 
participant and Lifestyle Coach (i.e., community health worker lifestyle change coach) will 
review the participant’s completion of food and activity records since the previous visit. For the 
CC participant, this will include examining the number of calories consumed and minutes 
walked each week, as well as any other homework assignments. The Behavior Change Coach 
will assist participants with problem solving and will then introduce the lesson from the DPP 
curriculum 180 to be completed for the next visit.   For the MyP participant, the Lifestyle Change 
Coach will review the participant’s food and activity records since the previous visit with the view 
of examining how well the participant adhered to the DASH diet. 181  Participants will receive 
enough food monitoring records and activity records to last until their next visit. Group education 
sessions will last 1 hour or as long as needed to complete the healthy grocery shopping tour.  
One will feature tips on making use of the physical activity equipment in the gym-in-the-bag 
(pedometer, resistance bands, “Instant Recess” DVDs, log sheets). A second will feature tips on 
how to shop for low-calorie foods.  This last one will also feature the importance of community 
resources for sustaining prescribed levels of physical activity and reduced calorie intake.  Finally, 
the two in-home visits will last 1 hour and will involve a discussion of strategies for keeping 
calorie intake low (DPP-like condition), for keeping fruit and vegetable intake high (MyP 
condition), and for maintaining a daily regimen of 30 minutes or more of moderate to vigorous 
physical activity (both conditions).  Participants will have a window of opportunity until their last 
follow up assessment to make up previously missed sessions. Visits that cannot be completed 
on-site (because of illness, travel, etc.) may be completed by phone.  See Table 5 for list of 
main topics to be discussed during each session. 
 
Table 8.  Main Topics for Lifestyle Change Coaching/Group Health Education Sessions 
Health 
Education 
Session 
Calorie Counting Topics 
MyPlate Topics 
Home health 
education 
session #1 
 Introduction to Calorie Counting 
and Portion Control 
 Portion control: What are portion 
sizes? 
 Dietary Guidelines for Americans 
 Importance of measuring your 
 The MyPlate Approach and food 
groups. 
 What are the Dietary Guidelines for 
Americans 
 Importance of reducing and 
measuring your waist 

 
Patterned after protocol published online in association with Appel et al. (2011)15 
 
 
waist circumference. 
 Setting up realistic goals and Self-
monitoring: What should I keep 
track of? 
 Introduction to the Gym-in-the-bag 
& Health Notebook 
 Staying in control of your 
environmental cues. 
 Home Audit Inventory 
 What high caloric foods should I 
eat and what foods should I avoid? 
circumference. 
 Introduction to the Gym-in-a-Bag 
and Health booklet 
 Setting up realistic goals and self-
monitoring: What to keep track of? 
 Redesigning your home and 
lifestyle to improve your health. 
Telephone 
coaching 
session #1 
 
 Calculation of Max number of 
calories to eat. 
 Physical Activity Guidelines 
 Number of Calories burned by 
Common Physical activities. 
 The MyPlate Approach and food 
groups. Review of MyPlate 
Guidelines 
 Health benefits of eating more fruits 
and vegetables.  
 Mother Nature’s gift to us: Fruits 
and vegetables form affects 
function. 
Group education 
session #1 
 
 Why be active? (Burning calories) 
 Physical Activity Guidelines. 
 What is moderate and vigorous 
physical activity? 
 How to use the Gym-in-the-bag. 
 What is BMI and how to measure 
it 
 Why be active? (Regular exercise 
helps appetite for Mother Nature 
foods) 
 Physical Activity Guidelines. 
 What is moderate and vigorous 
physical activity?  
 How to use the Gym-in-the-bag. 
 What is BMI and how to measure it. 
 Healthy Cooking Demonstration* 
Telephone 
coaching 
session #2 
 
 Calculating the Max number of 
calories to eat. 
 Reading nutritional Labels 
 Importance of eating low-calorie 
foods and examples of low calorie 
foods. 
 Reading nutritional Labels 
 Review of MyPlate Guidelines 
 Healthy lifestyles must include both 
diet and exercise.  
 Exercise will make you feel more 
energized. 
Telephone 
coaching 
session #3 
 Calculating the Max number of 
calories to eat. 
 Importance of self-monitoring and 
keeping track of your weight, 
calories, etc. 
 Self-monitoring does not cause 
psychological problems. 
 Avoid lapses from becoming 
relapses. 
 Importance of self-monitoring and 
keeping track of your weight 
 Self-monitoring does not cause 
psychological problems. 
 Overcoming neophobia. 
 Eating more fruits and vegetables 
will help you regulate your weight. 
Telephone 
coaching 
session #4 
 Calculation of Max number of 
calories to eat. 
 Review of patient’s current health 
goals. 
 Creating a behavioral contract. 
 Importance of healthy rewards for 
 Review of patient’s current health 
goals. 
 Creating a behavioral contract. 
 Importance of healthy rewards for 
following your contract (90% 
adherence is worthy of a reward). 

 
Patterned after protocol published online in association with Appel et al. (2011)15 
 
 
following your contract (90% 
adherence is worthy of a reward). 
 TV watching: Limit to less than 2 
hours a day. 
 Three Sisters diet. 
Home health 
education 
session #2 
 Calculation of Max number of 
calories to eat. 
 Tips for making the home more 
supportive of low calorie intake 
(Home Audit Inventory) 
 Buddy System (Social Support). 
 Who is your social support? 
 Signing the Behavioral Contract. 
 Addressing any patient concerns 
or questions. 
 Tips for making the home more 
supportive of MyPlate guidelines 
(Home Audit Inventory) 
 Buddy System (Social Support). 
 Who is your social support? 
 Signing the Behavioral Contract. 
 Connecting patient to community 
resources needed to achieve health 
goals. 
 Addressing any patient concerns or 
questions 
Telephone 
coaching 
session #5 
 Calculation of Max number of 
calories to eat. 
 Review of patient’s progress with 
behavioral contract.  
 Strategies to deal with lapses: 
(Urge Surfing, Road maps, 
Positive Addiction 
 Stress reduction (Yoga, 
meditation, etc.) 
 Review of patient’s progress with 
behavioral contract.  
 Don’t let a lapse become a relapse. 
 Strategies to deal with lapses: 
(Urge Surfing, Road maps, Positive 
Addiction 
 Stress reduction (Yoga, meditation, 
etc.) 
 Eating together as family 
Group education 
session #2 
 Reading Nutrition Labels (focused 
on calories).  
 Super Market Layout – Avoiding 
high caloric foods areas. 
 Smart Shopping tips: shopper 
beware of marketers’ tricks 
 Reading Nutrition Labels (focused 
on sodium content)  
 Super Market Layout – Avoiding 
processed foods areas. 
 Smart Shopping tips: shopper 
beware of marketers’ tricks 
 Healthy Cooking Demonstration* 
Telephone 
coaching 
session #6 
 Calculation of Max number of 
calories to eat. 
 What is Quality of life for you? 
 Losing weight affects your health-
related Quality of Life. 
 Achieving calorie balance through 
exercise and eating. 
 Progressive goal-setting to achieve 
your health goals. 
 What is Quality of life for you? 
 Healthy eating and regular physical 
activity leads to a higher health 
related QOL 
 Lifestyle change is all about 
balance in physical activity and 
health eating. 
 Progressive goal-setting to achieve 
your health goals. 
 The importance of heritage fresh 
foods that are healthy and in 
season. 
Telephone 
coaching 
session #7 
 Review Calorie intake, portion 
control, and Physical activity 
guidelines. 
 Review of lessons learned.  
 Review of tips for making the 
home more supportive of low 
calorie intake. 
 Review MyPlate and Physical 
activity guidelines with patients. 
 Review of lessons learned. 
 Review of Tips for making the 
home more supportive of MyPlate 
guidelines 
 Congratulate patient on 

 
Patterned after protocol published online in association with Appel et al. (2011)15 
 
 
 Congratulate patient on 
achievements. 
 Answering any final patient 
questions. 
 New challenges will arise; you 
have the skills to cope. 
achievements. 
 Answering any final patient 
questions. 
 New challenges will arise; you 
have the skills to cope. 
 
Assessment of Participant Adherence to the Dietary Prescription.  
Adherence of CC participants to the DPP prescription will be assessed principally by tracking 
(i.e., recording) their calorie monitoring and their participation in the 12 planned health coaching 
sessions.  This tracking information will be recorded by the community health workers using 
REDCap-generated questions on their laptop computers.  
CC participants will be informed of the benefits of keeping food and activity records during the 
first few weeks of the study. Adherence to the dietary goals can be broadly assessed during the 
first few weeks by counting the number of days each week that participants complete a food 
record. Records can be scored dichotomously (i.e., 0 or 1) to indicate whether the participant 
completed a record for the day in question. At least two meals must be recorded to receive 
credit for the day. Adherence to physical activity can be assessed during the first few weeks by 
counting the number of minutes of aerobic exercise per week that participants report in their 
activity diaries. Minutes can be summed for all aerobic activities (with equal weightings) to 
obtain a weekly value. Strength training will be counted separately from aerobic activity for 
participants who report it.  
Adherence to the MyPlate prescription will similarly be assessed via food and activity records 
during the 3-months main intervention program.  In the case of dietary adherence, however, the 
information to be recorded will consist of reports of the proportion of fruit and vegetable servings 
relative to the grain and protein-rich food servings in the course of each day.  Label reading will 
be necessary, to limit saturated fat, sodium and sugar but no calorie-counting will be needed.  
As with the CC participants, adherence to physical activity will be assessed for the first few 
weeks by recording the number of minutes of moderate to vigorous physical activity engaged in 
each day at end of each week.  Minutes can be summed for all aerobic activities to obtain a 
weekly value.  Minutes of strength training will be counted separately but will be encouraged as 
a consistent correlate of weight control.182 
Outline of the Content of the Behavior Change Sessions for CC participants:  
For the CC participants, the group health education content will include: 1) Tips on making use 
of the physical activity equipment in the gym-in-the-bag; 2) Tips on how to shop for low-calorie, 
portion-controlled food products (DPP) and discussion of the importance of community 
resources for sustaining prescribed levels of physical activity and reduced calorie intake.   
 
For the CC participants, the in-home visits will focus on the importance of portion control and 
closely monitoring daily calorie intake.  At the initial visit much time will be devoted to showing 
the participant how to complete the calorie intake, body weight and physical activity monitoring 
forms. 
 
For the CC participants, the content of the 7 telephone lifestyle coaching sessions will include a 
focus on self-monitoring, portion control, stimulus control, social support, problem solving, and 
cognitive restructuring and to problem solve how these behavioral strategies can best be 
deployed when the participant reports challenges to her/his efforts to adhere to the DPP 
prescription. 

 
Patterned after protocol published online in association with Appel et al. (2011)15 
 
 
 
Self-Monitoring by CC participants. The frequency of self-monitoring depends on the CC 
participant’s weight loss progress. 
During weight loss (i.e. 5% weight loss not achieved), CC participants are advised to: 
1. Daily write down: minutes of moderate intensity exercise in bouts of 10 or more minutes and 
all food and beverages consumed. Look up and record calories of each item consumed on hard 
copy of Tracking Form 3 days per week. Bodyweight need be recorded only once each week. 
2. During first few weeks: Weekly reporting to lifestyle change coach of daily average calories 
consumed, average minutes of moderate to vigorous physical activity expended for the week, 
average body weight for the week, and delivery of food records for the week. 
During weight maintenance (i.e. > 5% weight loss achieved), participants are advised to: 
1. Daily write down: minutes of moderate intensity exercise in bouts of 10 or more minutes and 
body weight. 
2. Write down all foods, beverages and calories consumed 3 days/week. 
3. During first few weeks: Weekly reporting of daily activity to lifestyle change coach. To include: 
average body weight for the week, number of days of food records were kept, total calories 
consumed per day, total minutes of moderate intensity physical activity expended each day. 
 
Format, frequency, and duration of CC participant contact. CC participants receive telephone 
calls from lifestyle change coaches throughout the study to encourage recording of body weight, 
daily calories, food intake, and daily physical activity activity. Except for weeks when group 
health education is offered, calls / home visits will be encourage to be  one session per week for 
months 1-3.  Each call is expected to take 15-20 minutes.  
 
Primary Care Provider role. At the screening visit as well as subsequent routine medical visits, 
these participants will be encouraged by their PCP to engage actively in whatever intervention 
they were assigned to.  
 
Outline of the Content of the Lifestyle Change Sessions for MyPlate Participants:  
For MyPlate participants, the group health education content will include: 1) Tips on making use 
of the physical activity equipment in the gym-in-the-bag; 2) Tips on how to shop for fresh 
produce, low-fat/non-fat dairy, lower sodium food products, whole grains and DASH-type mixed 
dishes.  Also discussion of the importance of community resources for sustaining prescribed 
levels of physical activity and good adherence to DASH-style eating.   
For the MyPlate participants, the in-home visits will focus on the importance of re-engineering 
the home environment to make healthy choices easier choices.  In the most ambitious home 
environment-focused weight loss intervention published to date,46 researchers used checklists 
to get participants to rid the home of high-calorie, high-fat foods and to stock the kitchen with 
healthier fare.  They also provided participants with a treadmill or stationary bicycle for home 
use, and a pedometer for brisk walking outside.  They restricted TV use to one communal room 
of the home, and attached a timer to the TV to limit the daily time spent watching TV.  Finally, 
the investigators gave the participants a digital body weight scale and encouraged them to self-
weigh daily.46  We don’t have the resources to provide a treadmill or stationary bicycle to the 
participants but we will provide a digital weighing scale for them to use if they don’t have one.  
Moreover we will not ban high-calorie, high-fat foods for fear of inciting a rebellion by other 
household members not wishing to change their food choices.  Instead, at the initial home visit 
the CHW and the patient will examine food products in the pantry, in the refrigerator, and on the 
kitchen counter and designate each food product as a red light food (limit to no more than once 
a month), green light food (may eat every day), or yellow light food (nutritiously intermediate 
food – limit to no more than once a week).54  The intervention team will recommend that the 

 
Patterned after protocol published online in association with Appel et al. (2011)15 
 
 
study participant position the healthier choices so that they are the most conspicuous and the 
easiest choice.  If the household member opens the pantry or refrigerator door and is visually 
confronted by a selection of green light foods, they are more likely to choose them over the red 
light foods that are hidden in the back.  The literature on behavioral economics confirms that 
changing the “decision architecture” around the home will be enough to alter food choices; bans 
on problem foods are not necessary. 55,56   
 
For the MyPlate participants, the content of the 7 telephone lifestyle coaching sessions will 
include a focus on self-monitoring, stimulus control, social support, problem solving, and 
cognitive restructuring and to problem solve how these behavioral strategies can best deployed 
when the participant reports challenges to her/his efforts to adhere to the MyPlate prescription.  
In addition, at each session the lifestyle change counselor will also ask how the participant can 
further improve the supportiveness of the home environment for facilitating participant 
adherence to the MyPlate prescription. 
 
Self-Monitoring by MyPlate participants. The frequency of self-monitoring depends on the 
MyPlate participant’s weight loss progress. 
During weight loss (i.e. 5% weight loss not achieved), MyPlate participants are advised to: 
1. For the first few weeks, write down each day their estimate of the proportion of their plate that 
was filled with fruits and vegetables, with whole grains, and with high-protein sources over the 
course of the day. Bodyweight need be recorded only once each week. 
2. During months 1-3: Weekly reporting to lifestyle change coach of average minutes of 
moderate to vigorous physical activity expended for the week and average body weight for the 
week. 
 
During weight maintenance (i.e. > 5% weight loss achieved), participants are advised to: 
1. Daily write down: minutes of moderate intensity exercise in bouts of 10 or more minutes and 
body weight. 
2. Write down all foods and beverages consumed 3 days/week. 
3. During months 1-3: Weekly reporting of daily activity to lifestyle change coach. To include: 
average body weight for the week, number of days of food records were kept, and total minutes 
of moderate intensity physical activity expended each day. 
 
Format, frequency, and duration of MyPlate participant contact. MyPlate participants receive 
telephone calls from lifestyle change coaches throughout the study to encourage recording of 
body weight, food intake, and daily physical activity and to problem solve challenges to 
adherence to the MyPlate prescription. Except for weeks when group health education is offered, 
calls / home visits will be weekly for months 1-3.  . Each call will be 15-20 minutes long.  
 
Primary Care Provider role for MyPlate participants. At routine medical visits, MyPlate 
participants will be encouraged by their PCP to actively engage in the intervention. Research 
staff will provide PCP with a report of their patient’s progress and that provides key behavioral 
recommendations for the PCP to reinforce.  
 
Standardizing Delivery of the Intervention. 
The function of the Intervention Director is to monitor the delivery of the intervention on a weekly 
basis, provide corrective feedback if and when the community workers / lifestyle change 
coaches diverge from the intervention protocol, and learn from the coaches' weekly debriefings 
which solutions to lifestyle change challenges are effective.  The lifestyle change coaches will 
meet weekly with the Intervention Director as part of a weekly "Learning Community" to problem 

 
Patterned after protocol published online in association with Appel et al. (2011)15 
 
 
solve how to get patients to adhere better to both the dietary and the physical activity 
prescriptions in the CC and MyPlate conditions.  The coaches will be well-trained in what should 
be covered in each of the 7 phone sessions as well as what should be covered in the two in-
home visits. 
 
All intervention print materials and study measures will be translated into Spanish, back-
translated to ensure accuracy and subjected to cognitive interviews, to ensure that they 
communicate the same constructs as the corresponding English print materials and study 
measures.  Drafts of intervention print materials and study measures will be reviewed in focus 
group discussions to ensure community acceptance of the final versions. 
 
Interventionists/Delivery Systems 
The CC and MyPlate lifestyle interventions are designed to be delivered by community health 
workers (aka “lifestyle change coaches” or “promotoras”) recruited the local community  and 
local colleges and given extensive training and who have had previous experience with 
behavioral strategies for improving patient adherence to disease management protocols.  The 
lifestyle change coaches will provide behavior change coaching to participants by being 
supportive, encouraging, empathetic, respectful, personable, informative and professionally 
competent in general nutrition, behavior-change and physical activity. They will undergo training 
and retraining to reinforce skills and techniques, including motivational interviewing, that 
facilitate behavior change. They will undergo periodic evaluation as part of routine quality 
control efforts. Specifically, a sample of their participant contacts (individual in-home sessions 
and telephone contacts) will be periodically reviewed. These expectations will be periodically 
reinforced throughout the trial. 
 
All PCPs at the participating clinic sites will be invited to participate in the trial. They will receive 
30 minutes brief training, follow the study protocol, and document contact with study participants. 
The study clinicians will also provide information and training related to the study, particularly 
the eligibility requirements and safety monitoring procedures.   At the end of the study, there will 
be additional training of all clinical staff in light of lessons learned from the study.  Budget has 
been set aside to permit training for clinicians and training for clinical staff to share the results of 
the study.    
 
Use of Intervention Protocols 
Leader guides will be developed to provide a standardized framework for flow and format of 
each type of contact.  For telephone calls, a REDCap computer-based system will drive the flow 
and content of the call. 
 
Training Interventionists/Delivery System Personnel: 
Prior to delivery of the intervention, study investigators, the Intervention Director and the TCC 
MPH nutritionist will train the CC and MyPlate lifestyle change coaches and will certify that they 
are prepared to deliver the intervention. Retraining should occur periodically throughout the 
study to enhance the skills of the lifestyle change coaches. 
 
Assessment of Interventionists’/Delivery System’s Fidelity to Protocol 
The Intervention director will implement quality control procedures that include: 1) direct 
observation of contacts to ensure adherence to study protocol and leader’s guides, 2) weekly 
case management to discuss clinical issues related to participants, and 3) regular quality control 
reports to assess completion of contacts as per protocol. 
 

 
Patterned after protocol published online in association with Appel et al. (2011)15 
 
 
FACILITATING PARTICIPANTS’ RETENTION IN THE STUDY FOR MEASUREMENT 
PURPOSES 
Facilitating Participants' Retention in the Study for Measurement Purposes 
From prior research we know that maintaining regular contact with study participants optimizes 
retention.  The nature of the two interventions being compared here – namely 11 contacts over 
3 months – provides a sufficient frequency of contact that retention is likely to be high.  To 
ensure good participation at the baseline, 6-months and 12-months assessments, we are also 
providing $20, $30 and $50 incentives, respectively.  Incentives have been shown to be 
effective in increasing retention.46   
 
Response to Missed Visits or Suboptimal Use of Intervention 
As noted above, a variety of aspects of adherence to the intervention will be assessed and 
monitored for participants in the CC and MyPlate interventions. These aspects include 
completion of scheduled contacts (phone contacts, group health education and in-home visits 
for both the CC and MyPlate participants), completion of weekly food intake, physical activity, 
and body weight reports, and for CC participants, daily calorie intake reports.  Suboptimal 
compliance with these intervention requirements will lead to explicit problem-solving between 
the lifestyle change coach and the participant with respect to the barriers preventing compliance 
with the self-monitoring protocol.  Participants will get encouragement for getting back on track 
and praise for aspects of the intervention where the participant is doing well. If personal phone 
calls from lifestyle change coaches are not enough, the participant will be referred for “case 
management” (i.e. consultation with the Intervention Director supervising the intervention). 
 
Techniques to Facilitate Participant Retention in the Intervention and Continued 
Adherence to the Intervention Protocol 
We will employ a number of strategies to facilitate retention. First, a prime criterion for selecting 
intervention staff will be the individual’s ability to engage participants. Experience from previous 
long-term trials makes it clear that participant retention is maximized when they bond closely 
with staff. Second, all communication with participants will be designed to maximize the 
participant’s sense that the study understands the challenges involved in efforts to lose weight, 
and that the staff is committed to make dealing with these challenges as easy as possible. Third, 
the interventions themselves are designed to help participants succeed in their efforts to lose 
weight, thus providing substantial reinforcement for staying in the study. In addition, the regular 
monitoring reports study participants will receive are also designed to highlight the positive 
changes participants have made. Fourth, the logistic barriers to participation in the study will be 
minimized. For both interventions, sessions will be held in the evenings and weekends. Finally, 
PCPs will serve as intervention ‘cheerleaders’, encouraging participants to stay in the study and 
to maintain their weight loss efforts. Towards the end of the trial, a debriefing of PCPs will occur 
in order to assess their contributions to the MyPlate and CC intervention and identify strategies 
that might improve the effectiveness of the interventions. 
 
12. SAFETY MONITORING 
The study will monitor participant safety. One aspect of safety monitoring is to evaluate potential 
study participants at screening to determine whether it is safe for them to participate in the 
interventions. This will be done in collaboration with the participant’s PCP, who will have 
received information and training about the trial, particularly its eligibility criteria, interventions, 
and safety monitoring procedures. In this trial, primary care will be provided by the participant's 
PCP, not by study personnel. A second aspect is monitoring the safety of enrolled participants. 
If a participant develops a medical problem, the safety of continuing or resuming the intervention 
will be ascertained by the participant’s PCP in collaboration with a study clinician. The 

 
Patterned after protocol published online in association with Appel et al. (2011)15 
 
 
investigators met weekly during the active intervention phase with the community health 
workers/ change agents to discuss, among other things, evidence of adverse events.  
Surveillance for serious adverse events and other relevant clinical events occurred as needed. 
Third, if we became aware of medical problems from abnormal physical measurements, such as 
blood pressure assessment, we referred the patient to her primary care physician and follow-up 
to make sure that she completed the referral. Results of routine physical measures obtained as 
part of study visits will be provided to the participant’s PCP with patient’s consent. In addition, 
the staff were prepared to address immediately items meeting the criteria for ‘Alert Values’ listed 
in the table below. A designated study clinician with appropriate expertise will be designated as 
the ‘Health Safety Officer’ and will review medical eligibility criteria and clinical measures as 
needed. The Safety Officer will also be responsible for reviewing and reporting SAEs for the site, 
as detailed elsewhere. This person or persons will have appropriate back-up during vacations or 
other absences to provide 24/7 medical safety coverage for the duration of the study. 
 
Potential Risks 
The following sections describe potential risks associated with the study along with procedures 
to minimize risk. 
 
Physical Activity 
We recognize the need to minimize the potential risks of physical activity in previously sedentary 
individuals with CVD risk factors. During the screening process, we will exclude persons with a 
CVD event within the past 6 months. In screenees with a prior CVD event (over 6 months ago), 
diabetes, peripheral vascular disease, or a positive Rose Angina Questionnaire, PCP approval 
is required specific to the patient’s CVD risk. In order to protect the participants' safety, we will 
continuously reinforce our recommendation to engage in moderate-intensity physical activity. 
We will also recommend a safety evaluation by their PCP for those participants who wish to 
progress to vigorous physical activity. Still, it is important to acknowledge the participant’s 
autonomy. We can recommend that participants follow safety advice but cannot force them to 
do so. 
 
Nutrient Intake 
Calorie restriction can theoretically lead to inadequate nutrition or excessive, rapid weight loss. 
To minimize these risks, participants are encouraged to eat a variety of foods from all food 
groups and to maintain an adequate calorie level. 6 month follow-up to check that patients are 
not suffering excessive weight loss.  Participants will be advised that marked and sustained 
caloric restriction can have serious health risks, e.g. gallstones and/or cholecystitis. 
 
Hypoglycemia Related to Exercise and Lifestyle Interventions 
For patients who may be susceptible to hypoglycemia due to use of anti-diabetic medications, 
weight loss interventions have the potential to increase the risk of hypoglycemia, especially 
during the time when diet and/or physical activity interventions are implemented. To minimize 
the risk of hypoglycemia, we will require PCP approval prior to enrolling individuals with 
diabetes. PCPs are provided with relevant information, prepared by the study clinicians. In 
addition, participants are educated about symptoms of hypoglycemia. They are urged to contact 
their PCP if they have symptoms or blood glucose values suggestive of hypoglycemia. Changes 
in diabetic regimens and overall management of diabetes remain under the control of the 
participant’s PCP. 
 
Symptomatic Hypotension Related to Exercise and Lifestyle Interventions 

  Patterned after protocol published online in association with Appel et al. (2011)15 
 
 
For patients who may be susceptible to hypotension because they are using medications that 
lower blood pressure, weight loss interventions have the potential to increase the risk of 
hypotension. Participants are educated about symptoms of hypotension and urged to contact 
their PCP if they have symptoms suggestive of hypotension. In addition, staff contact will notify 
PCP of participants who develop symptomatic hypotension while on anti-hypertensive 
medications. Changes in blood pressure regimens and overall management of hypertension 
remain under the control of the participant’s PCP. 
 
 
 
Cardiovascular Events 
All participants with cardiovascular disease (CVD) require approval from their PCP prior to 
enrolling. PCPs are provided with information about safety guidelines for physical activity for 
people with CVD. In addition, participants are educated about CVD symptoms and urged to 
contact their PCP if they have a change in their CVD symptoms. Overall CVD management 
remains under the control of the participant’s PCP. Cardiovascular events are also assessed 
using a standardized questionnaire at regular, pre-specified intervals. When a staff member 
learns that a cardiovascular event (including a procedure) has occurred, the physical activity 
component of the intervention is suspended. The intervention may be resumed after approval 
from the participant’s PCP. 
 
Alert Values 
Table 8 lists the alert values and subsequent actions that will occur. In general, the participant, 
safety officer, and PCP will be notified. 
 
Table 9. Alert Values and Actions 
Measure  
Alert Value  
Notify participant 
Blood 
pressure 
(avg.) 
Level 1                      
SBP >= 180mm/Hg OR    
DBP >= 110mm/Hg 
In clinic. Advise to follow-up 
with PCP within 1 week 
Level 2                       
SBP >= 
140mm/Hg OR                 
DBP >= 90mm/Hg 
In clinic. Advise to follow-up 
with PCP within 1 month. 
Level 3                      
SBP <= 70mm/Hg OR      
DBP <= 50mm/Hg 
In clinic. Advise to follow-up 
with PCP within 2 months. 
PHQ-9 
(Depression 
questionnaire) 
Total score >=16 & <21 
In clinic. Advise to follow-up 
with PCP or mental health 
care provider within 1 month. 
   
Total score >= 21 
In clinic. Advise to follow-up 
with PCP or mental health 
care provider within 1 week 
 
Surveillance and Reporting Procedures 
Serious Adverse Events (SAE) 
As defined by the Food and Drug Administration, serious adverse events include the following: 
  death, 
  a life-threatening experience, 

  Patterned after protocol published online in association with Appel et al. (2011)15 
 
 
  
inpatient hospitalization or prolongation of existing hospitalization, 
  
a persistent or significant disability/incapacity, or 
  
a congenital anomaly/birth defect. 
 
Important medical events that do not result in death or require hospitalization may be 
considered serious adverse events if they jeopardize the participant’s health or require medical 
or surgical intervention to prevent one of the outcomes in the definition.  Surveillance for serious 
adverse events and other relevant clinical events that may be associated with study 
participation will occur at in-person visits scheduled at 6 months and 12 months after 
randomization. This is done using a standardized questionnaire. In addition to the fixed time 
points, participants may report events in other settings, e.g. phone and intervention contacts. 
These events will be referred to unmasked staff that will gather relevant information and 
complete the standardized questionnaire. A study clinician will review the completed forms, will 
classify the event according to several dimensions (expectedness, relatedness, and type), and 
will take appropriate action. Safety-related events will be reported in a timely fashion as required 
by the Safety officer, the IRB, and PCORI. 
 
Expected Events 
Over the duration of the trial, which could last up to six months, a number of medical events 
may be expected to occur in obese adults, including routine surgeries and procedures, the 
development of cancer or other chronic conditions, increased symptoms from a chronic 
condition, musculoskeletal problems, motor vehicle accidents, and other types of accidents (e.g. 
falls, acts of violence). 
 
Pregnancy and Other Exclusions 
If a participant becomes pregnant during study after enrollment she is then excluded. If a 
participant develops cancer, unstable angina, or another condition for which weight loss or 
exercise might be contraindicated, further participation will be determined by the participant’s 
PCP in conjunction with a study clinician. 
 
Data Safety and Monitoring Plan 
The data safety and monitoring plan for this study should be proportional to the degree of risks 
of the trial. We believe that this study has minimal risk based on our prior studies in this area. 
We therefore will not have a data safety and monitoring board for this study. However, based on 
our prior studies, we will conduct regular and thorough monitoring of the data by the PIs, project 
manager and director, and statistician, and lead research assistants. The PIs and study team 
will meet weekly to review recruitment, enrollment, retention, adverse events, and adherence to 
study protocols for data collection, and data storage. Cases will be reviewed for any issues 
related to privacy or confidentiality or potential cases of child abuse, victimization, or 
psychological distress. Patients will be provided with contact information for the project 
manager/director/PIs if questions arise. The IRB and PCORI will be informed if any patient 
experiences a serious adverse event or if the patient has concerns about the study. Staff will be 
fully trained to be able to address serious adverse events. The team will undergo human 
subjects protection training via the CITI modules of “Social & Behavioral Researchers & Staff” 
and HIPPA training. 
 
13. STATISTICAL POWER AND SAMPLE SIZE ESTIMATION 
Hypotheses for the Two-Group Randomized Control Trial Design: The aim is to conduct an 
RCT of the impact of CC versus MyP on patient-centered outcomes in up to eight community 
clinic sites in Long Beach.  Participants will include: 150 patients randomly assigned to receive 

 
Patterned after protocol published online in association with Appel et al. (2011)15 
 
 
CC from trained health coaches, another 150 patients assigned to receive MyP from another 
group of trained health coaches over the course of 12 sessions in six months.   
Intervention check:  Does exposure to MyP versus CC lead to increased patient reports of fruit 
and vegetable intake in MyP?  A preliminary check will be made to confirm that one of the 
defining features of the MyP approach, namely a doubling of F&V intake, was reflected in study 
participants’ daily intake of F&V assessed at follow-up.  If no difference were observed in F&V 
assessed at follow-up then the validity of the experimental contrast would be jeopardized.  
There could still be experimental effects, but the causal mechanisms would be unknown.  
Because numerous studies have succeeded in getting patients to double their intake of F&V for 
up to four years, a negative outcome of this intervention check is unlikely.25    
Question:  Does exposure to MyP versus CC lead to decreased patient 12-months reports of 
daily hunger ratings/ daily meal satisfaction ratings/ daily fullness ratings in MyP during a time 
when patients were trying to lose excess weight (primary)?  Will exposure to MyP versus CC 
lead to increased patient weight control self-efficacy, patient quality of life and patient 
satisfaction with her/his weight control program (primary)? 
Question: Will exposure to MyP versus CC lead to increased weight loss/ reduced waist 
circumference equally for both conditions sustained for 12 months (secondary)?   
Avoidance of bias.  Covariates and effect modifiers.  Standard demographic variables, 
including gender, age, ethnicity, marital status, and educational attainment will be included as 
covariates.  Possible effect modifiers will also be included as covariates, including language 
preference (English / Spanish), last month food security, meal-skipping status, and daily 
physical activity level. 
Sample size.  (3) Statistical power.  We power this proposal for the two-group (MyP vs CC) 
randomized design, setting alpha at 0.025 in order to have an experiment wise type I error rate 
of 0.05 after testing two hypotheses. Test of hypothesis #1 is therefore a test of the effect of 
MyP versus CC on the 12 months report of freedom from hunger measure used in the trial most 
similar to the trial proposed here.183  The intervention effect size reported by Ello-Martin and 
associates is Cohen’s d = .52.  (Cohen’s Effect Size = (53.5 – 46.7)/ 13.2= .52).  The total 
sample sized needed to detect this effect, given a two-tailed critical P = .025, minimum 
statistical power of .80, and rho = .85 the total sample size needed is approximately N = 144.  
The test of the second hypothesis is a test of MyP versus CC on the body weight lost over 12 
months.  We have three sources to draw on for estimating effect size involving weight loss over 
12 months.  The first is Ello-Martin and associates, whose low-fat, high fruit and vegetables 
intervention 20 was similar to but not identical to the DASH diet + (sat. fat & sugar restriction) 
featured in the current proposal.16  Ello-Martin’s DASH-similar + fat restricted diet yielded a 12-
months weight loss of 7.9 kg (SE=0.9, n=35) whereas the fat restriction-only condition yielded a 
12-months weight loss of 6.4 kg (SE = 0.9, n=36).  The total sample size needed to detect a 
similar 12-months weight loss difference at alpha=0.025, power=0.80, rho = .7 is N= 206 (n=103 
per group).  In Appel’s recent clinical trial 15 the in-person DASH-like dietary intervention yielded 
a 5.4 kg (SE=0.7, n=124) weight loss relative to baseline at 12 months follow-up.15 The body 
weight lost in response to Wadden’s DPP-like dietary intervention 14 was 3.4 kg (SE=0.6, n = 
112) at 12 months follow-up 184  By design the protocols followed by Appel et al. (2011) and by 
Wadden et al. (2011) were similar, so comparing means across these two studies is informative.  
The sample size needed to detect this difference at 12 months at alpha = 0.025, power=0.80, 
rho=.7 is N = 270 (n = 135 per group).  Based on the best available sources in the literature for 
information about reasonable estimates of the effect size to be expected and given an expected 
attrition of 20% at 6 month follow-up, the baseline initial sample of 300 (N=300 for 2 groups) 
appears to provide ample statistical power for the two experimental comparison hypotheses 

 
Patterned after protocol published online in association with Appel et al. (2011)15 
 
 
considered primary in this proposal.  For a substudy involving only the 76% of participants who 
are Latino, the sample size (N =228) also yields acceptable statistical power.  All additional 
hypothesis-testing will involve secondary hypotheses. 
 
14. ANALYSIS PLAN 
General.  After the data have been cleaned, we will examine the distribution and dispersion of 
data through descriptive numerical summaries and graphical tools such as scatter plots and box 
plots, probability plots, scatter matrix plots, co-plots, and trellis graphics to assess distributional 
assumptions and relationships among important variables.  Before attempting a longitudinal 
analysis of the change in our outcomes using a linear mixed model, we will use profile plots, 
empirical summary plots and correlograms to guide us in the formulation of our model.185  Some 
data will be subjected to scale transformation (e.g., logarithmic), as needed, to meet statistical 
assumptions.  Box Cox or Yeo-Johnson transformations may also be used for this purpose.   
Because missingness can potentially spoil or invalidate a study, we will spare no effort to 
minimize  incomplete or missing data.  All data will be carefully inspected to identify missing 
items, outliers, or other influential features.  We will strive to form conclusions that are robust to 
different missing-data mechanisms,186 and we will consult with colleagues in the Fielding School 
of Public Health Biostatistics Department regarding the use of incomplete-data analysis 
strategies that make effective use of available information. 
Preliminary analyses will compare treatment groups on descriptive and clinical characteristics at 
baseline to ensure that randomization has succeeded. SAS (PC version 9.3) and Stata 
(Intercooled version 13) comprehensive database management and statistical packages will be 
used for descriptive calculations, group comparisons, and conditional regression modeling.  
Experimental contrasts will be examined a priori using Stata's mixed effects modeling 
procedures, with standard errors corrected for the effects of clustered data.187  It is known that 
even with randomized designs, covariate imbalance between treatment groups can exist and 
threaten the integrity of the design.188  Because the potential bias may result in misleading 
conclusions, we will perform a thorough examination for covariate imbalance. Specifically, we 
will examine the distributions of all important variables at baseline and at the major endpoint (12 
months follow-up), and also at intermediate points if the covariate is time-varying.  Formal 
statistical methods for testing selection bias (systematic baseline imbalances) based on 
response data will be followed.188,189 
 
Missing and incomplete data 
Prevention is far superior to a statistical cure, and every effort will be made to collect outcome 
data on all randomized participants. For example, we will ask medical staff at the clinical 
practices to obtain weight measurements on individuals who have stopped participating in the 
trial. Due to the high longitudinal correlation, missed “interior” visits won’t decrease information 
very much for a linear trend. However, they are needed to assess departures from a linear trend.  
As detailed in Little and Rubin 2002 190 and discussed by Mealli,191 the underlying missing data 
process determines the biasing effects of missing data and structures valid analytic strategies. If 
data are missing completely at random, then there is no induced bias and a complete case 
analysis, while inefficient, is valid. Another approach to dealing with missing 12-months follow-
up weights is to conduct “liberal” and “conservative” analyses. One would assume that on 
average there is neither weight loss nor gain, [W12 – W0 = 0].   
 
Censoring 
In certain analyses, data may be censored. Types of potential censoring include: 

 
Patterned after protocol published online in association with Appel et al. (2011)15 
 
 
1. Medical event censoring – a medical event (e.g. stroke, heart attack, or pregnancy), use of 
certain medications, or death. In this case, a weight may or may not be available. If available, 
the weight may be strongly influenced by the condition (e.g. extreme weight gain from use of 
oral steroids) such that the weight data should not be used subsequent to the event. 
2. Dropouts not associated with a particular event (e.g., a participant refuses to continue). 
For our primary analysis we will use the weight change data for the pre-dropout period. 
Sensitivity analyses will evaluate the consequences of imputing subsequent weights 
using a statistical model, last-observation-carried-forward (equivalent to imputing 0 weight 
change subsequent to the dropout), or imputing a non-zero monthly weight gain subsequent to 
dropout. 
 
 
Intent to Treat Analyses 
Primary analyses will be performed on an intention-to-treat (ITT) basis. However, interpretation 
of weight loss trials is complicated because of drop-out from the intervention group and drop-in 
from the control group.  Particularly common are early drop-outs, i.e. individuals randomized to 
intervention who attend only a few intervention sessions, sometimes none. Such persons are 
included in ITT analyses. In this setting, we will compute “on treatment” comparisons and 
variations on this approach that adjust such an analysis for differential correlates of adherence 
in the treatment groups. 
 
Care is needed in answering such questions, and Bellamy et al, Mealli et al. 191,192 provide a 
useful framework for such analyses. For a basic case, we consider how to handle participants 
who complete at most 2 intervention sessions. They will be included in the primary, as 
randomized, intent to treat analysis. A secondary question is, “how does the treatment groups 
compare for those who adhered to treatment?” A straightforward comparison of treatments 
based only on “compliers” is attractive, but is biased if the compliers differ among the treatment 
groups. A valid comparison depends on adjusting for these differences, being careful not to 
adjust away the treatment effect. Propensity score approaches using information available at 
randomization and up through the first session can adjust for this imbalance. More sophisticated 
approaches using time-varying propensities allow accommodating more complicated patterns of 
non-adherence. 
 
15. DATA MANAGEMENT 
Data will be collected from three main sources: 1) data entered by participants on Dell tablet 
PCs; 2) data entered by lifestyle change coaches during coaching sessions; 3) REDCap data 
entry by trial fieldwork staff of selected data (e.g. randomization date, clinic ID, recruitment data, 
clinical measurements, and attendance). Data entry is accessible via the secured websites. 
Web based data entry systems will include range and cross checks. All hard copy data forms 
will undergo editing/checking by a second Research Assistant. Missing and questionable data 
will be followed-up and corrected. Data clerks will perform data entry as soon as possible after 
receipt of forms. All data entered will pass through an extensive computer editing system with 
imbedded checks for internal consistency and biologic plausibility. All data centrally entered will 
be 100% verified. Daily back-ups of all study data will be done in the secured server and stored 
off-line on tape and/or laserdiscs in a locked area. 
 
Data confidentiality 
The investigative team is keenly aware of the need to protect participant confidentiality, as well 
as corresponding legal requirements, including those mandated by HIPAA (Health Insurance 
Portability and Accountability Act). All data collected and stored electronically will be password 

 
Patterned after protocol published online in association with Appel et al. (2011)15 
 
 
protected and saved in a secured fashion. All study related computers will be under firewall 
protection and will maintain automated virus update mechanisms. Timely notification regarding 
relevant patches will be provide. Hard copy of the data collection forms will be store in locked 
cabinets or areas.  Only authorized personnel will have access to these locked areas. In 
addition, all study staff annually sign a confidentiality statement attesting to their understanding 
of, and willingness to abide by, the staff written policies on research ethics and confidentiality. 
Access to the data entry website is password protected and restricted to personnel trained to 
use the system. 
 
Data analysis 
The data management team conducts all analysis of study data under the direction of the 
principal investigators and the trial statistician. A trial statistician will be assigned to all approved 
papers. Working with the lead investigator, the statistician will develop an appropriate analysis 
plan. Formal written analysis requests are reviewed for clarity before work is begun. This 
procedure minimizes rework and thus makes most efficient use of staff resources. 
 
Analysis guide 
To facilitate data analysis requests, the data management team will create a detailed analysis  
guide for the study investigators. This guide provides detailed, organized documentation of all 
study variables along with a process that allows researchers to request analyses in a clear, 
concise fashion. A summary data set including the most frequently used variables is provided, 
with variables in alphabetical order. Copies of every data form used in the study are also 
provided, each labeled with the specific variable name in the response field. 
 
Trial-wide data release. The data management/analysis team will prepare and distribute a 
limited access dataset to the PCORI project office for public use with the analysis guide. The 
data release documentation provides detailed, organized documentation of study variables and 
clear instructions on how to install and access the data. 
 
16. TRIAL ADMINISTRATION – Organization of investigators and project staff 
The UCLA/TCC study operation will be organized into teams of investigators and staff. The type 
and number of subcommittees, ad hoc working groups, and other units depends on the phase of 
the trial and study needs. The organizational structure will be reviewed periodically and 
amended accordingly. Hence, the organizational structure summarized below, which is 
appropriate for the early implement phase of the trial, will likely change over time.  The primary 
decision-making body is the Oversight Committee, chaired by the PIs and comprised of all 
investigators and senior staff (e.g., Intervention Director). This committee, which convenes 
monthly, reviews the progress of all components and focuses on high level scientific and 
administrative issues. This committee will also guide publications. An administrative 
subcommittee, comprised of the UCLA PI (Dr. McCarthy) and Co-PI (Dr. Gelberg) from UCLA, 
the PI from TCC (Dr. Chandler), and a few senior staff, meets weekly and addresses day-to-day 
operational issues and sets short-term priorities. The following are other working units of the 
trial: 
o 
Field Operations Subcommittee, which focuses on recruitment, retention, 
measurements, quality assurance, quality control, and data collection. 
o 
Intervention Subcommittee, which focuses on the design and implementation of the 
interventions. 
o 
Data Management and Analysis Subcommittee. 
 
17. TIMELINE 

 
Patterned after protocol published online in association with Appel et al. (2011)15 
 
 
The trial consists of three main phases: planning (focus groups, pilot study), implementation 
(recruitment, intervention and data collection), and data analysis/dissemination. Planning for the 
trial will begin April, 2014. Recruitment for the full trial will commence in April 2015 and should 
last approximately six months. Closeout will occur 12 months after randomization. Remaining 
time will be devoted to data analyses, presentation/publication, and dissemination activities. 
 

 
Patterned after protocol published online in association with Appel et al. (2011)15 
 
 
Table 9.  Original Timeline for “Is MyPlate.gov approach to helping overweight patients lose weight more  
patient-centered?" 
 
 
 
18. DISSEMINATION PLANS 
The interventions tested in this trial are designed for implementation in routine medical practice. 
If either the MyPlate or CC intervention is found to be effective, the ultimate public health impact 
will be determined by the ability to disseminate it. Therefore, the dissemination component of 
the study includes identifying patient and practice characteristics that will affect acceptance and 
success of the programs. The RE-AIM (Reach, Efficacy/Effectiveness, Adoption, 
Implementation, and Maintenance) framework provides useful guidance for identifying and 
documenting dissemination issues (see www.re-aim.org).193 In this framework, optimal 
dissemination requires an intervention that has been found effective in a representative group of 
individuals (representative of the community or clinical population served, i.e. individual-level 
impact). The ability to translate the intervention into a usual practice setting (institutional impact) 
derives from the feasibility and cost of the program, the degree and quality of adoption, 
implementation, and sustainability of the program within the setting. 
 
With this in mind, the primary objectives of our dissemination activities will be to: 1) collect 
quantitative and qualitative data related to dissemination issues; 2) determine an appropriate 
approach to disseminating components of the intervention that are found effective; and 3) 
implement and document dissemination activities. Plans for each type of activity are 
summarized below. 
 
Collect quantitative and qualitative data related to potential dissemination issues. 
To estimate the representativeness of study participants compared to the overall clinic site, we 
will use administrative data. We will be unable to collect individual-level information of those 
invited but not enrolled. Potentially available data include age, gender, ethnicity, BMI, insurance 

 
Patterned after protocol published online in association with Appel et al. (2011)15 
 
 
status, and prevalence of co-morbid conditions. To describe clinic site characteristics, we will 
collect data on size (average caseload, average number of encounters per week); number and 
types of providers (i.e., physicians, nurses, medical assistants); use of electronic medical 
record; available weight loss programs and resources; and census tract descriptors of the area 
where the clinic site is located. Quantitative data on clinicians will include number invited; 
number who declined or were excluded by the investigator or the clinic site; reasons for 
declinations or exclusions; demographic information; and physician characteristics (e.g. years at 
site, specialty, type of provider). After the 6 months follow-up data have been collected, focus 
group and key stakeholder information will be obtained from representative staff recruited from 
participating clinic sites and clinicians.  These qualitative data will address feasibility issues, 
unanticipated costs attributed to delivering the intervention, and perceptions of the feasibility, 
logistical and cost issues potentially associated with continuing the program once the study has 
ended. Formal process data (e.g., on attendance, adherence, fidelity in delivery of the protocol) 
will provide insights on quality of the intervention and dose delivered. 
 
Determine Ways for Disseminating Lessons Learned. 
Quantitative and qualitative variables described above will be analyzed in conjunction with the 
effects of the active intervention arms on study outcomes to characterize the dissemination 
potential of the program, including considerations that may apply to effective implementation at 
the individual and clinic site levels. The final program content, requirements, and recommended 
approach for implementation will be packaged for dissemination. 
 
Implement and document dissemination. 
If results warrant, activities will be undertaken to market the program. Our primary focus will be 
health care providers, although activities might also be directed towards patients. These 
activities will be tracked. The success of dissemination, i.e. as characterized in the RE-AIM 
framework, cannot be determined within the time frame of this grant. 
 
Health care providers. 
In addition to publishing study results in peer-reviewed journals, we will send provider-focused 
descriptions of the study and its results to medical trade publications (e.g., American Medical 
News, American Nurse, American College of Physicians Observer). Training workshops and 
symposia will be offered at appropriate professional meetings or through other mechanisms, to 
increase the potential for dissemination. We will also post intervention materials and guidelines 
directly on the websites of relevant professional and scientific organizations (e.g., American 
Medical Association, American Heart Association). The information posted on websites also will 
include a summary of the feasibility issues, clinic site requirements, and ballpark costs of 
offering the program. 
 
We plan to disseminate results of this study widely to other organizations that might implement 
or promote the interventions. Information on effectiveness, feasibility, and ballpark cost of the 
interventions will be provided. The targeted audience includes Long Beach and Los Angeles 
County health services departments and public health departments, directors of managed care 
organizations, health maintenance organizations, state Medicare and Medicaid programs, and 
Disease Management companies.  
 
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