Weight Management in Rural Communities
Phase: NA
Conditions: Weight Loss, Obesity, Body Weight
Sponsor: University of Kansas

Official Title: Weight Management in Rural Communities 
NCT Number: 02932748 
Approval Date: August 5, 2020 
Document: Study Protocol with Statistical Analysis Plan 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
Introduction 
The 2010 Census indicates that 19.3% of the U.S. population, or approximately 60 million 
people, reside in rural areas (1). Obesity prevalence in both children (2-4) and adults is 
significantly higher in rural compared with urban residents (5-8), and approaches 40% in rural 
adults (6, 7). Rural residents are less physically active (5, 6, 8), consume less healthy diets (5, 
9), and have higher rates of obesity associated health problems (10-13), and all-cause mortality 
(6) compared with their urban counterparts. The Rural Healthy People 2020 survey of 1,214 
rural health stakeholders indicated that nutrition and weight status ranked second behind 
access to health care as important rural health priorities (14). 
Barriers to weight management for rural residents include limited availability of  
programs/professionals trained in weight management (6, 15, 16), and travel distance/expense 
to attend on-site programs (17) in areas with limited or non-existent public transportation (18). 
Healthy foods are less available and affordable in rural areas (19-21) requiring travel to urban 
areas where fresh produce, and less expensive foods are available (22, 23). Roads designed 
for higher speed traffic (24, 25), few sidewalks (26, 27) and limited availability of fitness facilities 
or parks (21, 28, 29) make rural areas less conducive to physical activity (PA). 
 
Rural health clinics offer a potential venue for delivery of weight management to rural residents. 
However, traditional, on-site individual or group-based programs (30) require travel to a clinic for 
weekly face-to-face meetings, and are therefore impractical and/or inconvenient for rural 
residents.  Rural clinics are unlikely to employ staff with the requisite expertise to provide 
effective weight management. Thus, weight management in rural clinics is generally limited to 
brief physician counseling and/or referral to a registered dietitian to assist patients with 
complying to an energy reduced diet and increased PA; an approach which is minimally 
effective (30-32). 
Our research team has demonstrated the effectiveness of weight management delivered by 
university-based health educators via group conference (6 mos. =-10.3%, 18 mos. = - 7.4%) 
(33, 34), or individual phone (IP) calls (6 mos. = -10.5%) (35) to both urban and rural adults.  
Weight loss with the group phone (GP) intervention was equivalent to an identical intervention 
delivered in a traditional on-site group meeting format (34). Telephone delivery eliminates the 
need for travel to on-site meetings (17). Group phone delivery allows participant interaction 
which has the potential to increase accountability, social support, and rapport, and has also 
been associated with reduced drop-out (36) and improved weight loss (37, 38). Group-based 
interventions may be especially desirable for rural residents who are often socially isolated (39), 
while the IP approach allows participant anonymity, that some may prefer.   
Thus, effective weight management can be achieved when interventions are delivered by 
university-based health educators using GP or IP approaches.  However, the comparative 
effectiveness of GP and IP interventions, when delivered by rural clinic associated personnel, 
e.g., nurses, nurse practitioners, physician assistants, or community health professionals trained 
by our research team, has not been evaluated, and will be the focus of this trial.  
Methods and Materials 
Study Overview 
Health care providers at five primary care clinics, or community health professionals serving 
individuals in rural Kansas, will be trained to deliver the GP and IP interventions and an 

enhanced version of usual care to compare weight loss (0-6 mos.), weight maintenance (7-18 
mos.), and weight change during a 6 mo. period of no contract (19-24 mos.) between 
interventions. The GP and IP interventions will be identical with the exception of the format 
(group vs. individual) and duration of contact, i.e., GP (~45 min/session) vs. IP (~15 
min/session).  Usual care, which is generally limited to brief counseling (5-7 min.) during a 
routine physician visit and/or referral to a registered dietitian (40), will be enhanced by increased 
contact with the health care providers and provision of information regarding community assets 
for increased PA and improved nutrition. We considered using an established weight 
management intervention such as the Diabetes Prevention Program or Look AHEAD protocols 
(41-43) as a comparison group.  Although efficacious in some settings, the delivery of these 
interventions is expensive and burdensome for both participants and providers, and are unlikely 
to be tolerated by rural clinics. Following considerable discussion, we decided to compare our 
GP and IP interventions to an enhanced version of weight management as currently practiced in 
rural primary care clinics (40), i.e., enhanced usual care (EUC). Two hundred overweight/obese 
adults will be randomized in a 2:2:1 allocation to the GP (n=80), IP (n=80), or EUC (n=40) arms. 
Outcomes will be assessed by the research team at baseline (0 mos.), following weight loss (6 
mos.), during weight maintenance (12 and 18 mos.) and after a 6 mo. no-contact period (24 
mos.). The primary aim is to compare weight change at 6 mos. between the 3 interventions 
arms; GP, IP, and EUC, analyzed using intention-to treat principles.  Secondarily, we will 
compare the following across the three interventions groups: 1) weight at 12, 18 and 24 mos. 2) 
metabolic syndrome risk factors (waist circumference, triglycerides, HDL-cholesterol, blood 
pressure, fasting glucose) at 6, 12 and 18 mos.  Cost, cost effectiveness, and contingent 
valuation analysis and extensive process evaluation will also be completed.  Approval for this 
study has been obtained from the Human Subjects Committee at the University of Kansas-
Lawrence. 
Clinic recruitment 
At least five clinics, located in rural areas, and/or serving primarily rural residents, with a census 
of ~4,000 to 8,000 patients will be asked to participate. A universally recognized classification 
scheme or definition for urban/rural areas does not exist (44-46). For this project we will use the 
U.S. Census Bureau definition which states:  ““Rural is defined as all population, housing, and 
territory not included within an urbanized area or urban cluster” (47).  An urbanized area is 
defined as a population of 50,000 or more, and urban clusters are areas with populations of at 
least 2,500, but less than 50,000. Each clinic will be asked to assist with recruitment of 40 
participants, deliver the interventions and provide space for both outcome assessments and 
delivery of the EUC intervention arm.   
Participant eligibility 
To enhance generalizability of the results, individuals with chronic medical conditions, or 
common risk factors such as hypertension, tobacco use, hyperlipidemia, diabetes mellitus, etc., 
who receive clearance from their primary care physician, will be allowed to participate. These 
individuals are representative of those typically seeking weight management, and that have 
participated in our previous trials demonstrating the effectiveness of both the GP and IP 
interventions (34, 48).  Medical conditions and medication use may be considered potential 
confounders; however, randomization should ensure that health status will be similar across 
study groups.  In addition to requiring primary care physical approval, additional inclusion and 
exclusion criteria (Table 1), and a comprehensive medical management plan have been 
developed to protect the participants in this trial.  Weight loss in high risk participants, i.e., those 
with chronic conditions or using prescription medications, will be monitored by both the health 
educators and the study physician. Participants will be asked to report changes in medications 

and/or adverse events to the health educators, via toll-free phone call, fax, or email, as they 
occur.   
 Recruitment/randomization 
In addition to recruitment by rural clinic personnel, we will also recruit using flyers posted in rural 
communities and media advertising including print, radio and Facebook®. We will recruit at least 
50% females and minorities to reflect or exceed minority representation in rural Kansas (16.7%) 
(49). Potential participants will be asked to contact study staff via phone, email or our laboratory 
web site. Interested individuals will be directed to complete a brief web-based screener on our 
laboratory website, or will be interviewed by phone, to assess self-reported height and weight 
(BMI), medication use, presence of chronic disease, smoking habits, previous attempts at 
weight loss, and current level of PA. Those satisfying the initial eligibility criteria will be 
scheduled to attend an in-person meeting with study staff at the participant’s respective clinic.  
At this session staff will describe the project, answer questions, obtain consent, complete 
eligibility screening surveys, and measure height and weight to determine preliminary eligibility 
based on BMI.  Screening surveys including health history, depression, eating behavior and 
binge eating will be administered using web-based software (Research Electronic Data Capture 
software (REDCap), Vanderbilt University, Nashville, TN) (50). These surveys will be completed 
during the in-person meeting or at home, depending on the availability of home internet access.  
Project staff will then send a form (fax/email) to the potential participant’s primary care physician 
describing the study and requesting clearance for participation.  Final eligibility based on BMI 
will be confirmed at baseline testing, using height and fasting weight assessed with participants 
wearing hospital gowns. Participants in each clinic will be randomized, stratified by sex, to one 
of the three study arms. The randomization sequence will be generated by an independent 
statistician, sent to the project coordinator and concealed until intervention groups are assigned.   
Community assessments-Physical activity/healthy eating 
Prior to initiating the intervention we will evaluate environmental facilitators/barriers to both PA 
and healthy eating in the area surrounding each participating clinic. The Rural Active Living 
Assessment tools which include The Street Segment Assessment, Town-wide Assessment, and 
The Town Program and Policy Assessment (51) will be used to assess the built environment, 
town characteristics, community programs, and policies and resources that can influence PA. 
Facilitators/barriers to healthy eating will be based on surveys with both clinic health 
professionals and patients.  Food availability will be assessed using a validated survey 
developed for the Multi-Ethnic Study of Atherosclerosis to measure perceived availability of 
healthy food options and access to food shopping in an individual’s neighborhood (52, 53). 
Information gathered related to the PA or healthy eating environment will be used to tailor our 
intervention to each participating clinic.   
INTERVENTION 
Health educator selection/training.  Our research team, in collaboration with clinic/health 
system management, will select a staff member with an interest in delivering weight 
management, e.g., nurse, nurse practitioner, physician’s assistant, registered dietician, exercise 
physiologist, or a qualified professional from the local community, e.g. registered dietician, 
certified diabetes or health educator, to serve as health educator. Participating clinics, or 
community professionals will be compensated for time devoted to this project. The selected 
health educator in each clinic will deliver all three interventions, i.e., GP and IP, and EUC, to 
minimize the potential for health educator effects.  Health educators will be provided with a 
detailed intervention notebook which outlines the topics for each session, provides answers to 
common participant questions, and strategies for engaging participants in the intervention.  

Health educators will be trained by our research team during an initial one-day, on-site session 
at each clinic, and four one-hour sessions conducted via FaceTime® prior to initiating the 
intervention. On-site training will provide an overview of the intervention notebook, discuss the 
biologic/medical impacts of weight loss and strategies for effective intervention delivery via GP 
or IP calls, or face-to-face that will be utilized in the EUC arm.  Audio recordings from GP 
sessions from our completed NIH trial which compared GP and face-to-face delivery of weight 
management (34) will be utilized to demonstrate effective leadership and facilitation techniques 
in the GP setting. Strategies for conducting IP and face-to-face interventions will be 
demonstrated by role playing with a member of our research team with the health educator and 
clinic staff as participants.  The four follow-up training sessions will be used to reinforce 
strategies taught during on-site training and to further model teaching strategies used in GP, IP 
and face-to-face sessions. Prior to initiating the intervention all health educators will be required 
to successfully conduct three simulated sessions of each of the three intervention arms, i.e. GP, 
IP, and EUC in which members of the research team will serve as participants. A standardized 
checklist, including the important skills/strategies taught during training, will be used to assure 
all health educators demonstrate mastery of these skills. The research team will be available for 
consultation with health educators to address issues that may arise during the interventions.    
Theoretical model.  The intervention will be grounded in Social Cognitive Theory, a triadic, 
dynamic model that indicates an individual’s behavior is uniquely determined by the reciprocal 
interaction of personal, behavioral, and environmental factors, to effect change in energy intake 
(EI) and PA (54, 55).  We will focus on social cognitive techniques which have been shown to 
be most effective for changing EI and PA including intention formation, goal setting, self-
monitoring (diet, PA, weight), and participant feedback relative to intervention compliance (56). 
These techniques will be enhanced by employing behavior shaping (gradually modifying diet 
and PA), social support, and stimulus control (strategies to decrease cues for less desirable and 
increase cues for more desirable diet and PA behaviors). Additionally, cognitive strategies will 
be used to increase self-efficacy and to deal with social relationships affected by weight, such 
as identifying/confronting self-sabotage attempts, responding to stress with non-food 
techniques, relapse prevention strategies to teach participants to recognize precursors and 
consequences of lapses, and develop plans for addressing high risk situations. The intervention 
is also informed by both social ecologic (57) and social network theories (58) as content will be 
tailored to both the physical and social environment of participants. 
General Description.  All intervention arms will complete weight loss (6 mos.) and weight 
maintenance (12 mos.).  Weight will also be evaluated following a 6 mos. no contact follow-up.  
A comparison of contact format and intervention session frequency and duration between 
intervention arms is shown in Table 2.  The protocols for reducing EI, increasing PA, content 
presented during behavioral sessions, and self-monitoring diet, weight, and PA will be identical 
in the GP and IP arms.  Participants in both the GP and IP arms will receive identical notebooks 
that will include detailed instructions for the weight loss and weight maintenance diets including 
recipes, instructions for PA, self-monitoring diet and PA, and the schedule for behavioral 
sessions. The notebooks will be organized by behavioral session and contain handouts, 
worksheets, and assignments specific to each session.  
Group and individual phone arms.  
Diet-Weight loss (0-6 mos.). Energy intake will be prescribed at 1,200-1,500 kcal/d for women 
and 1,500-1,800 kcal/d for men as recommended by current weight management guidelines 
from the American Heart Association/American College of Cardiology/The Obesity Society (30). 
Participants will be asked to consume a minimum daily total of two portion controlled entrées 
(~200 to 300 kcal each, saturated fat ≤ 3g, sodium ≤ 600 mg), two low calorie shakes (~100 kcal 

each),  at least five one-cup servings of fruits/vegetables, and ad libitum non-caloric beverages 
to achieve their energy reduction goals.  Participants will be asked to purchase entrées from a 
list maintained by the study dietician that satisfies these caloric/fat/sodium requirements, as well 
as fruits/vegetables, and non-caloric beverages.  Two low calorie shakes per day (Profile by 
Sanford Health, Sioux Falls, SD) will be provided to participants during weight loss (0-6 mos.). 
Participants will order shakes, which are available in a variety of flavors, either on-line or by 
telephone. Shakes will be delivered by the United Parcel Service to participant’s residence. The 
study will provide the shakes and shipping during weight loss (0-6 mos.) The list of available 
frozen and shelf stable entrées currently contains over 180 entrées from numerous 
manufacturers, e.g., Healthy ChoiceTM, Smart Ones TM, Michelina’s TM etc.,  which meet the 
caloric, saturated fat and sodium requirements. This list will be updated by the study dietician as 
new products become available.  The recommended entrées are affordable and available at 
most grocery stores at a cost of $2-$4 each, which may be an important consideration for 
individuals in rural areas where household income is often low (6). The Academy of Nutrition 
and Dietetics Evidence Analysis Library indicates strong, consistent, supportive evidence 
(Grade I) that  a portion controlled entrée approach results in significantly greater weight loss 
and maintenance compared with meal plan diets, and are especially useful for individuals who 
have difficulty with food selection and portion control (59). This approach simplifies food 
shopping and preparation, and can be incorporated as part of a long-term dietary plan. The 
nutritional information on the product labels (calories, fat, protein, etc.) simplifies adherence to 
specific energy and nutrient recommendations. The use of portion controlled entrées and 
shakes for weight loss has been criticized for inadequately preparing participants to deal with 
meal planning and portion control required for successful weight loss maintenance. However, 
this approach requires decision making regarding shopping and preparation of fruit/vegetables, 
beverages and also provides participants with an understanding of appropriate portion size. 
Numerous trials by our group (34, 48, 60) and others (61-63) have reported excellent 
maintenance of weight initially lost using portion controlled entrées and low calorie shakes. The 
study dietician will assure that all diets are both energy and nutritionally adequate based on 
current dietary guidelines (64).  Participants for whom additional weight loss would be 
contraindicated, e.g., BMI of ≤ 22 kg/m2 will be placed on a weight maintenance diet at any time 
during the 18 mo. intervention. Those who continue to lose weight will be referred to appropriate 
health professionals/agencies, and may be dismissed from the trial. 
Diet- Weight maintenance and no-contact follow-up (7-24 mos.). Participants will be 
encouraged to consume a diet with an energy level designed to maintain weight loss. 
Recommended EI will be based on the resting metabolic rate (RMR) equation of Mifflin-St Jeor 
(65) adjusted for activities of daily living (RMR x 1.4-1.6) as participants will have a routine PA 
program.  Participants will be encouraged to continue using commercially available portion 
controlled entrées, low calorie shakes, or transition to a meal plan or combination portion 
controlled entrée/meal plan diet.  A meal plan diet, based on the United States Department of 
Agriculture’s MyPlate guidelines (66) will  prescribe  amounts of grains, proteins, fruits, 
vegetables, dairy, and fats to achieve the desired level of EI.  Participants experiencing weight 
gain will be counseled to improve compliance with the diet and PA protocols.   
Physical activity (0- 24 mos.).  We will prescribe a progressive moderate intensity PA 
program, e.g., brisk walking, jogging, biking, etc., as recommended in the “2009 ACSM Position 
Stand on Physical Activity Interventions for Weight Loss and Prevention of Weight Regain in 
Adults” (67). The prescribed activities can be completed in rural communities that frequently 
lack public or commercial exercise facilities.  Prescribed PA will progress from 45 min/wk. during 
week 1 to 225 min/wk. at 4 mos. and remain at 225 min/wk. for the duration of the 18 mo. 
intervention and 6 mo. no contact follow-up.  As the intervention progresses, participants will be 

encouraged to try new activities and/or target an event such as a 5 or 10K race, charity walks, 
etc., to provide variety and motivation.  Pedometers will be provided as a motivational tool and 
to track steps across the 18 mo. active intervention. 
Self-monitoring.  Participants will be ask to self-monitor diet, i.e., the number of portion 
controlled entrées, shakes and servings of fruits and vegetables/day, PA, i.e., pedometer steps, 
self-report minutes of activity, and body weight across the 6 mo. weight loss and 12 mo. weight 
maintenance interventions.  Participants will report this data twice each week using a web-
based form on our laboratory website or by phone calls to health educators for those without 
internet access.  This information will summarized by research staff and made available to clinic 
health educators for use during behavioral counseling sessions.   
Group phone intervention: Delivery/session content.  The GP intervention will be delivered 
to 12-15 participants during a 45 minute call weekly from 0-6 mos. and biweekly from 7-18 mos. 
using the MaestroConference® software platform (Oakland, CA) that allows group audio 
conferences to be accessed by phone.  Approximately five minutes prior to scheduled meetings, 
typically late afternoon or early evening, participants will call a toll-free line and enter a unique 
code number to join the meeting. Participants will be required to remain on the call for the 
duration of each session to be considered as having attended the session.  Call duration for 
each participant is monitored by the Maestro software.  Each meeting will include a check-in 
question to generate discussion regarding diet and PA, a review of participants self-monitored 
diet, weight and PA data reported since the previous meeting, a lesson on a weight 
management topic, and an experiential learning assignment requiring problem solving, or the 
practice of behavioral strategies, to be completed prior to the next meeting. Sample topics 
include: energy density (increase volume, not calories), obtaining fruits and vegetables in rural 
communities, exercising in rural communities, eating/exercising on the go, etc. Several sessions 
at the end of the weight loss phase (mo. 6) will include discussions regarding complying with a 
conventional diet, i.e., meal planning, food shopping, meal preparation, portion control, etc. 
During weight maintenance (7-18 mos.) group sessions will focus on planning and following a 
meal plan diet with or without incorporation of portion controlled entrées/shakes, and cardinal 
behaviors for successful weight maintenance such as self-monitoring, regular PA, eating on 
weekends/vacations, and controlling EI on special occasions and holidays, etc. 
Individual phone intervention: Delivery/session content.  The IP intervention will be 
delivered via brief, i.e., ~15 min. scheduled phone calls weekly from 0-6 mos. and biweekly from 
7-18 mos..  Prior to each call participants will be asked to read a lesson in the study notebook. 
Lesson topics will parallel those in the GP intervention and focus on weight loss over mos. 0-6 
and weight maintenance during mos. 7-18.  During each call, health educators will highlight the 
major points of the lesson, review self- monitoring data relative to weight, diet and PA, and 
problem solve, if necessary.  Thus, the IP intervention is predominately self-directed with 
minimal education and support from the health educator. In contrast, the GP intervention 
includes health educator directed, 45 min educational/behavioral sessions, and provides both 
health educator and group support. 
Enhanced usual care 
Delivery/session content.  Health educators will conduct individual face-to-face meetings (~45 
min) at the clinic site, four times across 18 mos.  These sessions will be held in conjunction with 
outcome assessments to minimize participant travel. Participants will receive  printed materials 
from public health organizations such as the Weight-Control Information Network (68) and NIH 
Aim for a Healthy Weight (69) that include topics such as healthy eating, portion size, and 
MyPlate recommendations, (i.e.being physically active, self-monitoring, and problem-solving) 
(66). Pedometers and forms to self-monitor weight, diet and PA will also be provided; however, 

self-monitoring will not be required and will be shared with health educators only if desired.  
During each session health educators will discuss participant’s progress towards their weight 
loss goals, review salient points from the written materials, assist participants with developing 
strategies to overcome any compliance barriers they may experience, and answer questions.    
Diet-Weight loss (0-6 mos.). Energy intake will be prescribed at 1,200-1,500 kcal/d for women 
and 1,500-1,800 kcal/d for men using a high volume, lower fat diet (20-30% EI) meal plan diet 
as recommended by the Academy of Nutrition and Dietetics (70) and the USDA’s MyPlate 
approach (66). Participants will be provided examples of meal plans consisting of suggested 
servings of proteins, grains, fruits and vegetables, dairy, and fats based on their energy needs, 
and will be counseled on appropriate portion sizes. 
Diet- Weight maintenance and no-contact follow-up (7-24 mos.).  Participants will be 
encouraged to continue with a meal plan diet with an energy level designed to maintain weight 
loss. Recommended EI will be based on the RMR equation of Mifflin-St Jeor (65) adjusted for 
activities of daily living (RMR x 1.4-1.6) as participants will have a routine PA program.  Meal 
plans with suggested servings of protein, grains, fruits and vegetables, dairy, and fats to achieve 
specific energy requirements will be provided. Similar to the GP and IP arms, a participant for 
whom additional weight loss would be contraindicated, e.g., BMI of ≤ 22 kg/m2 will be placed on 
a weight maintenance diet at any time during the 18 mo. intervention. Those who continue to 
lose weight will be referred to appropriate health professionals/agencies, and may be dismissed 
from the trial. 
Physical activity (0- 24 mos.).  Participants will be asked to complete moderate intensity PA, 
e.g., walking, jogging, biking etc., that will progress gradually from 45 min/wk. at baseline to 150 
min/wk. at mo. 4 and remain at 150 min/wk. for the duration of the 24 mo. trial.  The 150 min/wk. 
is based on the current U.S. Department of Health and Human Services PA guidelines of 150 
min/wk. of moderate-intensity PA for overall health (71). We recognize that this recommendation 
differs from the 225min/wk. recommended for the GP and IP arms.  Based on our observations 
of both rural and urban health clinics, physicians and staff rarely recommend greater than 150 
min/wk. of PA for their patients.  Thus, we chose 150 min/wk. to represent “real world” clinical 
practice. 
Participant retention strategies. 
Participants will complete a "contact form" including basic information, i.e., name, address, 
phone number, email. Participants in the GP or IP arms who miss > three consecutive 
behavioral sessions will be contacted by phone, text or email (maximum of three attempts).  A 
maximum of three attempts will also be made to contact participants in the EUC arm who do not 
attend a scheduled session.   
Outcome assessments. 
Outcomes will be obtained at each participating clinic.  As outlined in Table 3, most outcomes 
will be assessed at 0, 6, 12, and 18 months.  Physical measures, i.e., height, weight, waist 
circumference, and blood pressure, will be obtained between 7-11 a.m., following a minimum 
12-hour fast, by trained research assistants blinded to condition.  Research assistants will 
receive refresher training and complete reliability assessments for physical measures two to 
three times each year.  
Anthropometric measures. Weight will be measured with a digital scale accurate to ± 0.1 kg 
(Befour Inc. #PS6600, Saukville, WI) with participants in a hospital gown. Height will be 
measured with a stadiometer (Model #IP0955, Invicta Plastics Limited, Leicester, UK).  The 
average of two measures within 0.25 cm will be recorded. Body mass index (BMI) will be 

calculated as weight (kg) divided by height (m2).   Waist circumference will be measured with an 
anthropometric tape using the procedures described by Lohman et. al. (72). Three 
measurements will be obtained with the outcome recorded as the average of the closest 2 
measures. 
Blood chemistry/ blood pressure. Fasting blood samples will be obtained by a clinic 
phlebotomist. Analysis of HDL and LDL cholesterol, triglycerides, glucose, and HbA1c 
(diabetics) will be completed by the commercial laboratories that are contracted by each 
participating clinic.  Blood pressure will be obtained in duplicate, with an automated 
sphygmomanometer (DinaMap ProCare 100, General Electric Healthcare, Chicago, IL) using 
the National Health and Nutrition Examination Survey (NHANES) blood pressure protocol (73).  
Compliance with diet recommendations. Energy and macronutrient intake will be assessed 
using the self-administered, web-based VioScreen Graphical Food Frequency System (Viocare 
Technologies, Inc., Princeton, NJ).  Participants will complete the survey at a computer in a 
private room during the clinic assessment visit, or at home on a tablet or personal computer 
within one or two days following the clinic visit. Participants who fail to complete the survey 
within that time frame will receive email and telephone reminders.    Assessment of nutrient 
intake using VioScreen is correlated with assessments obtained from a traditional paper and 
pencil food frequency questionnaire:  total fat = 0.82, saturated fat = 0.84, protein = 0.67, 
carbohydrate = 0.79, alcohol = 0.90 (74).  
Compliance with physical activity recommendations. Participants will wear an ActiGraph 
Model GT3X+ (ActiGraph LLC, Pensacola, FL) portable tri-axial accelerometer on a belt over 
the non-dominant hip, at the anterior axillary line, during waking hours for seven consecutive 
days, with the exception of bathing, swimming and contact sports. The ActiGraph accelerometer 
has been shown to provide valid and reliable assessments of PA in adults (75-77).  A 7-day 
monitoring period provides a reliable estimate of moderate-to-vigorous PA (78-80). ActiGraphs 
will be initialized and downloaded using ActiLife Software version 6.13.3 or higher and set to 
collect in the raw data mode at 60 Hz. ActiGraph data will be processed using the protocol used 
for adults in the 2003-2004 and 2005-2006 cycles of NHANES (81, 82).  Data will be 
aggregated over 60-sec epochs. The following intensity cut-points will be used:  sedentary (< 
1.0 METs; ≤ 100 counts/min), light (1.1-2.99 METs; 101-2019 counts/min.), moderate (3.0-5.99 
METs; 2020-5998 counts/min) and vigorous ≥ 6 METs; ≥ 5999 counts/min) (81, 82). Non-wear 
time will be defined as at least 60 consecutive minutes of zero counts, with allowance for 1-2 
min. of counts between 0 and 100. Counts ≥ 20,000/min will be considered spurious and will be 
deleted (83). We have a custom SAS program to complete these analyses. ActiGraphs, with 
instructions on their use, will be distributed to participants at their scheduled assessment visit 
clinic. Participants will be asked to wear the ActiGraph for seven consecutive days, beginning 
the day following the clinic visit, and return the ActiGraph to the research team using a postage 
pre-paid padded envelope provided.   
Questionnaires. The following instruments will be used to assess behavioral factors that may 
impact weight management: Health Related Quality of life (HRQOL) will be assessed using the 
Short Form 36 (SF36) (84).  Daily stress associated with eating, i.e., planning/preparing, 
monitoring nutrients, concerns about eating correctly, will be assessed with the Nutrition 
Hassles Questionnaire (85). Finally, the implementation of Social Cognitive Theory will be 
assessed by measuring the “active” ingredient, self-efficacy, using the Weight Efficacy Lifestyle 
Scale (WELS) (86), Barriers Self Efficacy (BARSE) (87), and the Exercise Self-Efficacy Scale 
(EXSE) (88). Acceptable construct validity and internal consistency of these instruments have 
been established (84, 85, 87-90). Questionnaires will be completed online using REDCap 

software during the clinic visit by participants with no home internet access or at home within 
one or two days following the clinic visit for participants with home internet access.    
Process evaluation 
As described below, process evaluation will monitor the fidelity of intervention delivery, the 
extent to which the intervention was implemented and received, and the extent to which 
participants actively engaged in the intervention across time. 
Intervention fidelity.  To assure quality control and standardization of intervention delivery, all 
GP, IP, and EUC sessions will be audio recorded.  Research staff will randomly review one 
session each month in the GP and IP arms, and 25% of sessions in the EUC arm for each 
health educator. Recordings will be compared with a standardized checklist of specific content 
and time scheduled for delivery of that content.  Health educators who fail to deliver at least 
80% of scheduled content for the scheduled duration will be required to receive additional 
training from the research team that will be delivered remotely via FaceTime®.  Health educators 
who fail to satisfy the intervention delivery criteria after receiving additional training will be 
replaced by another clinic staff member or a qualified community professional.  A member of the 
research team will be available to substitute for health educators who are unable to deliver a 
session, or while a new health educator is trained in the event a health educator is dismissed or 
leaves the clinic.  Health educator absences and turnover will be tracked and the effect on 
weight change will be evaluated in the analysis. 
Implementation.  The extent to which the intervention was implemented and received will be 
assessed using records of participant attendance at scheduled sessions that will be maintained 
by health educators.   
Engagement.  In addition to attendance, which will be tracked by health educators in all three 
intervention arms, participant engagement in the GP and IP arms will be estimated by 
participant compliance with the self-monitoring protocol, i.e., the frequency of reporting body 
weight, diet ( portion controlled entrées, low calorie shakes, fruits and vegetables) and PA 
(pedometer steps, activity minutes).  
Structured interviews.  A convenience sample of 20% of participants, stratified by intervention 
arm, and a sample of clinic staff, e.g., health educators, physicians etc., will be invited to 
participate in structured interviews at both 6 and 18 months.  Interviews will be conducted by 
phone and will be designed to gather information that might be useful in improving the 
interventions, and/or implementing the interventions in rural clinics. Topics will include, 
preference for intervention format, length, difficulties in complying with intervention components, 
suggestions for improving the intervention, overall satisfaction with the intervention, including 
the diet and PA recommendations, behavior session frequency, duration and content, and 
health educator performance.  Information regarding resource use associated with participating 
and delivering the intervention for inclusion in the cost analysis will also be collected.   
Cost considerations 
A potential advantage of remote delivery of weight management, e.g., GP or IP calls may be 
lower fixed and variable costs for both participants and providers.  Fixed costs are independent 
of the number of participants while variable costs are directly associated with the number of 
participants enrolled (91).  A process flow chart will be created and validated by consensus of 
the research team to assure a complete accounting of resources used in all intervention groups 
(92).  Cost, cost effectiveness, and contingent valuation analyses will be completed at both 6 
and 18 mos. as these costs may differ between the weight loss and weight maintenance phases 
of the interventions.  The cost perspective for all analyses will be societal which includes the 

value of participant time, as this time cannot be used for work or leisure.  Both provider and 
participant costs will be collected prospectively. 
Provider costs. The cost of space to conduct sessions with participants in the EUC arm, and to 
deliver both the GP and IP arms, will be estimated by multiplying the local market values for 
office per square foot by the amount of space utilized. Monthly billing statements will provide an 
estimate of utility costs including heat, electric, computer and internet services.  The cost of 
provider time, i.e. wages and benefits, will be estimated as the number of hours worked 
obtained from provider maintained logs, multiplied by the provider’s wage.  Cost associated with 
purchase and shipping of the low calorie shakes provided to participants in both the GP and IP 
arms will also be tracked with billing and expense records.  
Participant costs.  The cost of participant time required to attend GP or IP sessions, or travel 
to and attend in-person sessions required in the EUC arm, will be estimated from self-reports of 
time spent in these activities multiplied by the median wage in the region.  Transportation costs 
will be estimated from self-reported driving mileage multiplied by the federal mileage 
reimbursement rate.  
Cost analysis.  Differences in total costs and cost effectiveness; i.e., cost/kg weight loss 
between intervention arms will be evaluated using a one-way analysis of variance (ANOVA). We 
will also make qualitative comparison between the cost effectiveness of our interventions and 
others reported in the literature, such as the Diabetes Prevention Program (93).  Weight loss 
represents only one potential benefit associated with participation in a weight management 
program. Other potential benefits included improved health, enhanced attractiveness, increased 
vitality and productivity etc.  We will use contingent evaluation analysis where participants 
express preferences for hypothetical programs with different attributes such as costs, time, 
delivery method, and magnitude of weight loss to determine how differences in these affect 
preferences for the GP, IP and enhanced usual weight management strategies.  Contingent 
valuation data will be analyzed using conditional logit analysis, with adjustments for clustering of 
observations within clinics. 
Statistical power and analysis 
Statistical power.  Differences in weight loss at six mos. between participants randomized to 
the IP or EUC, and GP or IP are of primary interest.  We hypothesize that six month weight loss 
will average 2 kg, 8 kg, and 12 kg in the EUC, IP, and GP arms, respectively, with a common 
standard deviation for weight change of 7 kg (34) (35).   Statistical power was determined 
assuming a type 1 error rate of 2.5% for each of our two primary comparisons.  Based on these 
assumptions, randomization of 200 participants with a 2:2:1 allocation; GP (n=80), IP (n=80), 
EUC (n=40) will provide 98% power to detect significantly greater weight loss in IP versus EUC, 
and 91% power to detect significantly greater weight loss in GP versus IP. The global F-test for 
a one-way ANOVA provides greater than 99% power under these assumptions. The primary 
analysis will be intent-to-treat with imputation of missing data using multiple imputation 
techniques.  However, a completers only analysis, with a 20% loss to follow-up, will still provide 
95% power for the IP-EUC, and 83% power for the GP-IP comparisons.   
Analysis plan.  A global one-way ANOVA will be followed with two pairwise t-tests on the two 
comparisons of interest, IP versus EUC, and GP versus IP. Statistical significance for each 
pairwise comparisons will be p ≤ 0.025; however, all other analyses will be conducted at p < 
0.05.  These primary analyses will be intent-to-treat utilizing multiple imputation for missing data 
and to determine corresponding p-values. In addition to the intent-to-treat analysis, a completers 
only analysis will be performed, i.e., participants with weight at 6 months.  Secondarily, we will 
compare weight between the three study arms across 24 months using a mixed linear model, 

assuming an autoregressive correlation structure of weight over time, controlling for baseline 
weight, treatment group and time as covariates. The global comparison across the three arms 
will be followed by two pairwise comparisons of interest, i.e., IP versus EUC, and GP versus IP.  
Independent comparisons of change in each chronic disease risk factor, i.e., waist 
circumference, triglycerides, HDL cholesterol, blood pressure, and fasting glucose at 6, 12, and 
18 mos., across the 3 intervention arms will be completed using a mixed linear model, assuming 
an autoregressive correlations structure.  We will also compare Quality of life (SF-36), daily 
stress associated with eating (Nutrition Hassles Questionnaire), self-efficacy for weight change 
(WELS), self-efficacy for exercise (EXES), and self-efficacy for overcoming barriers to exercise 
(BARSE) among the three intervention arms across 24 months using a using a mixed linear 
model assuming an autoregressive correlation structure both unadjusted and adjusted for 
covariates.  A variety of exploratory analyses, as deemed appropriate by the principal 
investigator and the project biostatistician, e.g., assessment of the impact of health educator 
absences and turnover, community environment for healthy eating and PA etc. on weight loss 
outcomes, will be performed.  Analyses will be completed using SAS version 9.4 or higher. 
Missing data. We will determine if the proportion of participants lost to follow-up differs by 
intervention arm and/or sex, and compare demographic characteristics between those lost to 
follow-up and completers. If there are differences across treatment groups, we will examine 
demographic characteristics, i.e., sex, age, magnitude of weight loss, between completers and 
those lost to follow-up, to determine if there are significant differences (p < 0.05) in those 
characteristics. If missing data are related to intervention group and/or demographic 
characteristics, we will use model based multiple imputation; otherwise, traditional multiple 
imputation will be used. 
 
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