Culturally Competent Behavioral Intervention for Diabetes Risk Reduction
Phase: NA
Conditions: Diabetes, Weight Loss, PreDiabetes, Obesity
Sponsor: Kaiser Permanente

Diabetes De Por Vida Protocol   
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Protocol Revised 11/03/2014 
Overview 
The rise in diabetes and pre-diabetes parallels the increasing rates of obesity among adults 
over the past two decades.15 Overweight and weight gain have been shown to prospectively 
predict the onset of type 2 diabetes (T2D).16,17 Moreover, the risk of developing T2D is 3.9-fold 
and 12.4-fold greater among overweight and obese women, respectively, compared to normal-
weight women.18 This close relationship between obesity and diabetes is not surprising given 
the impairments in glucose removal and insulin resistance seen at obesity onset.19 
Two large behavioral weight loss trials with overweight and obese pre-diabetic patients in the 
US and Finland found that a weight loss of 4 to 7 kg reduced the incidence of diabetes by 50% 
or more over 2 to 3 years.20,21 Participants in the weight-loss interventions had decreases in 
waist circumference, blood pressure, and triglycerides, and a non-significant increase in HDL-
cholesterol.20,22 These studies are highly promising; however, they were carried out in highly 
controlled environments, with strict selection criteria. We do not know how well these 
interventions work in real world settings, under real life conditions, and with more complex or 
non-mainstream patients. Affordable and effective interventions for specific at-risk populations 
remain imperative.  
Obesity and diabetes are major problems in the Hispanic population. 
Prevalence rates of overweight and obesity are significantly higher among Hispanics than non-
Hispanic whites,23 as are rates of pre-diabetes,1 T2D,1,24 and risk for cardiovascular disease.1,24-
26 In the US, while the estimated lifetime risk for developing T2D for non-Hispanic white women 
born in 2000 is approximately 31%, the risk for Hispanic women is conservatively estimated at 
52%.27 In fact, Hispanic women have the highest estimated lifetime risk of developing diabetes 
of all ethnic/gender groups.27 If T2D is diagnosed at age 40, Hispanic women are projected to 
lose 12.4 life-years and 21.5 quality-adjusted life-years.27  
Need for diabetes-risk interventions targeting Hispanic populations 
While there is compelling evidence demonstrating the benefits of weight-loss interventions for 
both diabetic and pre-diabetic individuals, Hispanic participants typically lose less weight than 
non-Hispanic white participants, even in successful trials. Furthermore, most large randomized 
trials have selected only adherent individuals, using strict filtering criteria that screen out 
individuals generally considered poor candidates for retention.46-49 Many of the successful 
interventions tested in clinical trials may be too resource-intensive for implementation in 
community settings40 and often include costly incentives, meal replacement products40 or home 
visits.50  
The current study will be implemented in a federally qualified health center (the Virginia Garcia 
Memorial Health Center, VGMHC) primarily serving low-income Hispanic patients. We will 
compare the efficacy of a culturally competent group intervention targeting Hispanic women with 
impaired glucose regulation (diabetic and prediabetic patients), contrasting it with a usual care 
control condition. The intervention we will be testing  is modeled on an intervention program for 
obese Mexican-American women we previously conducted at KPNW CHR.14  Our study will 
assess the cost of the intervention within the context of the clinical trial, and will assess the 
feasibility and cost of implementation in the absence of research support. 
To ensure that this intervention is viable, sustainable, and able to be disseminated, and not 
merely a one-time research project, the program will be conducted by Virginia Garcia clinic staff, 
with training, supervision and support, and a minimum of “scaffolding” provided by the research 
team. Following the clinical trial, and at the request of VGMHC we will assess the sustainability 
and cost of the intervention as delivered by the interventionists without support from research 
staff.  
 

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Aims 
1.  Assess short (6-month) and long-term (12- and 18-month) changes in body weight and waist 
circumference in women in the intervention group compared to an enhanced usual-care 
control group  
2.  Compare the effects of the intervention vs. enhanced usual-care control on secondary 
outcomes, including short- and long-term changes in diabetes and prediabetes-related 
outcomes of metabolic markers of glycemic control (a) hemoglobin A1c, and (b) fasting 
glucose; cardiovascular disease risk factors: (c) fasting lipid profile; and lifestyle outcomes: 
(d) dietary intake (total energy, simple carbohydrates, saturated fat, number of servings of 
fruits and vegetables, dietary fibers, and whole grains), and physical activity.  
3.   Determine the implementation cost of delivering this weight-loss intervention at a Federally 
Qualified Health Center in the context of a pragmatic clinical trial. 
 
Research Design 
This will be a randomized clinical trial testing a weight-loss lifestyle intervention for obese 
Hispanic women with prediabetes or T2D. The primary aims of the intervention will be to reduce 
body weight and waist circumference at 6, 12, and 18 months. Secondary aims will be to 
improve levels of HbA1c, markers of glycemic control (fasting glucose in addition to HbA1c) and 
cardiovascular disease risk (serum lipid profile), diet, and physical activity. We will also 
determine the implementation cost for delivering the trial intervention in a federally qualified 
health center. Following the clinical trial, through a 2-cohort phase, we will assess the 
sustainability and cost of delivering the intervention as part of regular patient care at the clinic in 
the absence of research support.   
Trial participants will be randomly assigned to one of two conditions: 1) Enhanced usual care 
control, or 2) a culturally tailored behavioral intervention.  Outcome assessments will be 
conducted at 6, 12, and 18 months. Recruitment will be conducted in seven cohorts of 
approximately 30 randomized participants each. 
Each participant will receive a $25 gift card at the completion of the 6-month visit, $30 at 12-
month  and $35 at 18-month data collection points.  
 
Eligibility 
We will enroll 200 obese Hispanic women in this weight-loss intervention trial.  
Inclusion criteria.   
- 
All participants will be patients who receive their primary medical care at the Virginia 
Garcia Memorial Health Center (VGMHC) 
- 
Self-identified as Spanish-speaking Latina or Hispanic 
- 
Female 
- 
Age 18 and older 
- 
BMI greater than or equal to 27kg/m2 
- 
Classified as diabetic or prediabetic in the electronic medical record by at least one of 
the following: 
o Fasting plasma glucose ≥ 100  
o 2-h post glucose level on the 75-g oral glucose tolerance test ≥ 140-199 mg/dL 
(7.8-11.0 mmol/L)  
o Hemoglobin HBA1c ≥  5.7  
o Diagnosis of diabetes in patient’s medical chart 

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o Diagnosis of prediabetes in patient’s medical chart 
- 
Residing in the Portland metropolitan area, and having no plans to leave the area in the 
next 18 months. 
- 
Willing and able to attend the 26-weekly group meetings and 6 monthly group meetings. 
- 
Willing to accept random assignment to the active intervention or enhanced usual care 
control. 
- 
Clearance by the patient’s VGMHC primary care physician to participate in the 
intervention. 
Exclusion criteria 
- 
Treatment for cancer in the past two years (excluding non-melanoma skin cancers). 
- 
Having conditions that require limitation of physical activity or that would be 
contraindicated for the DASH diet patterns. 
- 
Taking weight-loss medication currently or within the past 6 months. 
- 
Current or recent (< 12 months) pregnancy, breastfeeding, or planning pregnancy in the 
next 18 months. 
 
Recruitment 
After attending an explanatory session as part of the informed consent process, each participant 
will sign the IRB-approved, written, bilingual, study consent prior to being enrolled in the study. 
The consent form will describe the purpose of the study, the requirements for participation, and 
the potential benefits and risks. It will also document that participation is voluntary, that it may 
be terminated by the participant at any time, and that decision to participate will not affect the 
clinical care received at VGMHC.  
Potentially eligible patients from VGMHC will be identified through a review of the electronic 
medical record and through direct physician referral. Potentially eligible patients will be mailed a 
written description of the study and a consent form to review. Recruitment materials will be 
provided in both Spanish and English. Interested women will be invited to call the research 
center for more information, and those who are not interested in participating will be able to 
decline by telephone or by mail. Those who do not respond to the mailing may be called by a 
bilingual project staff member and asked about their interest in the study.  
When contacting potential participants, project staff will use an IRB-approved telephone guide 
for describing the study, and potential participants will be encouraged to ask questions about 
the project.  After doing so, interested participants will be asked for verbal consent to complete a 
brief screening interview to confirm eligibility. Those who appear to be eligible and who state 
their desire to learn more about the study, will be invited to attend an explanatory session at 
VGMHC and will be mailed a detailed description of the study. 
The explanatory session will be conducted in two parts: Upon arrival, Dr. Lindberg will conduct a 
group meeting where she will provide attendees with information about the study and the nature 
of the interventions, and will encourage attendees to ask questions.  Attendees will be advised 
that their decision about study participation in no way will affect their clinical care at VGMHC, 
and that they may withdraw from the study at any time. 
During the second part of the explanatory session, after having an opportunity to ask questions 
in a one-on-one setting, interested women will be asked to sign the study consent form. 
Questions will be answered by Dr. Lindberg and study staff using IRB-approved study 
conversation guides. After signing the consent, the consented volunteers will be measured for 
height and weight to determine BMI.  Women who are BMI-eligible will then be scheduled for a 
baseline telephone interview that will take place during the following 2 weeks. This telephone 

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interview (which will be conducted in Spanish or English, by participant preference) will be 
conducted by the Center for Health Research staff, and will include a food frequency 
questionnaire and a physical activity questionnaire., Questions about acculturation, quality of 
life, and literacy/numeracy will be obtained at the baseline visit.. Following completion of the 
telephone interviews, participants will be scheduled for an individual randomization visit at the 
VGMHC. During this visit, a female bilingual VGMHC staff member will measure weight, waist 
circumference, and will take a fasting blood sample using a point-of-care device. Participants 
will then receive their study materials and treatment assignment from an intervention staff 
member.  Data collection staff will be masked from participant group assignment. 
Participants assigned to the usual care control condition will receive printed materials (in English 
and/or Spanish) developed by the NHLBI on how to improve weight-related behaviors (“Steps to 
Lose Weight,” “ChooseMyPlate,”  “Nutrition and Finding Your Way to a Healthier You”).  We 
recognize that literacy limitations will reduce the usefulness of these materials for some of our 
participants, but providing this type of printed materials is our approximation of the best “usual 
care” practices currently available at VGMHC.   Participants in both the intervention and the 
enhanced usual care control arms will receive a bathroom scale, a set of measuring cups and 
spoons, and a pedometer (with printed instructions and tips for increasing physical activity). 
Follow-up data for all randomized participants will be collected at 6, 12 and 18 months following 
randomization. Physical data collection (height, weight, waist circumference, blood draws) will 
be completed at the VGMHC clinic; all other data collection will be done by telephone interview.  
All data-collection staff will be female and bilingual, and masked to participant treatment 
assignment.   
Explanatory Session and Consent Visit 
Explanatory sessions will be conducted by a bilingual study staff member who will provide a 
thorough overview of the study, including the intervention, design, and requirements for weekly 
group meetings, planned data collection, and duration of follow up. Attendees will be 
encouraged to ask questions. Then, the study consent will be discussed, and women interested 
in enrolling in the study will meet individually with study staff to address additional questions, 
confirm eligibility, and sign the consent form. Those who consent will be measured for height 
and weight, and will be scheduled for baseline bilingual assessment interviews conducted by 
telephone in the next 2 weeks. The telephone baseline assessment will include a food 
frequency questionnaire and physical activity questionnaire.  
Participants may take their consent home to return at a later time but must return to the VGMHC 
with their consent form, to be witnessed and signed, and have their baseline measurements 
taken. 
We have revised the consent to include sharing of participants PHI with Arizona Sate University.  
PhD candidate students in the Department of Nutrition will conduct the follow up SW FFQ 
interviews and, if needed due to literacy issues, conduct the Follow Up visit questionnaire by 
phone.  
 
The change in consent will affect about 90 participants.  Participants in the intervention groups 
will receive their new consent at one of the sessions.  Usual care participants will receive a 
phone call from Dr. Lindberg alerting them to watch for the form in the andif desired discuss  the 
change in the consent. 
Prior to randomization, participants will be required to obtain medical clearance for participation 
from their VGMHC health care provider.  
Baseline Data Collection and Randomization 
After completing the baseline telephone assessments, participants will be scheduled for a 
randomization visit at VGMHC. During this visit we will collect baseline measurement of fasting 
lipids, glucose, and HbA1c as they are done in the course of clinic operations at VGMHC, by 

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finger-stick using point-of-care devices. Participants will then receive their treatment 
assignments using a computerized block randomization scheme provided by the study 
statistician. Randomization will be stratified by baseline BMI (27-34, 35-39, 40 or more) and age 
(18-45, 46 and above). To ensure equal balance in the two arms, randomization will occur in 
block sizes of 4. Participants will be informed of their randomization assignments by intervention 
staff members. Data collection staff will be masked to treatment assignments. 
Enhanced Usual Care Control  
We considered using a no-treatment control condition, but our community clinic partners 
requested that we provide the same information to participants in both conditions. This strategy 
insures that all participants get something they value as part of their involvement in the study, 
and also provides a comparison of the lifestyle intervention program to a very low-cost and easy 
to deliver information-only program.   
Weight Management Tools for All Trial Participants 
So that all randomized participants receive the same basic information, those assigned to the 
enhanced usual care control condition will receive bilingual printed materials on how to improve 
weight-related behaviors: copies of the NHLBI “Steps to Lose Weight,” “ChooseMyPlate,” and 
“Nutrition and Finding Your Way to a Healthier You.” We recognize that literacy limitations may 
be an issue for some participants, but providing this type of printed material is our approximation 
of the best current “usual care” practice.  In addition to this written material, all participants in 
both arms of the trial will receive: 
Bathroom Scale: As found in other studies, 38 our research experience has been that few 
Hispanic women self-weigh regularly, and most do not own a scale. To aid in self-monitoring, all 
participants will be provided with a digital bathroom scale. 
Pedometer: A pedometer and printed bilingual instructions for its use and tips for increasing PA 
will be provided to help participants monitor daily steps. We will not use pedometers for 
outcome data collection. 
Measuring cups and spoons: Our pilot work has shown that many Hispanic women are 
unfamiliar with Anglo-American food measurements.14 Traditional Latin American cooking 
practices rarely use measuring cups and spoons. To help participants measure their food, all 
participants will be provided with a set of measuring cups and spoons, along with a printed 
equivalence table (Anglo-American measuring units and metric units). 
Retention  
To maximize participant retention, during the screening process will we provide oral and written 
information about study expectations, time commitment, schedule and length of intervention 
group sessions, and potential benefits and risks. To enhance completion of the assessment 
visits, we will use appointment reminders (letters and phone), and schedule visits at times as 
convenient as possible to the participant.  
Weight Loss Intervention 
The initial intervention will consist of weekly meetings for 6 months, as recommended by 
Wadden.93  The meetings will be structured to be very interactive, involve participant input and 
group activities, foster problem solving, support, and program ownership.  We are planning for 
approximately 15 participants per group; groups of similar size have been shown to be quite 
effective in previous weight-loss studies.3,25 
Each session will have a similar structure with 6 main components:  
1. Social support/group sharing 
2. Review of each individual’s progress since the last session 
3. Main content area (e.g., meal patterns, calories) 
4. Behavioral skills training 
5. Goal setting and action plans (in small groups) 
6. Plans of self-monitoring activity 

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After the completion of the first six months of weekly intervention sessions, participants will 
attend monthly group sessions and will also interact with each other weekly by telephone.  The 
monthly group sessions and weekly telephone contacts constitute a weight-maintenance phase 
which will help maintain self-management behaviors started during the initial intervention.  The 
self-management behaviors include setting weekly behavioral goals and developing specific 
action plans to achieve those goals, social disclosure of these goals and plans, and scheduled 
accountability for evaluating the outcomes of these plans.  
The structure of these monthly, one hour and-a-half group sessions of the maintenance phase 
will be similar to the initial weight loss sessions, starting with a weigh-in and reporting to the 
group regarding the outcome of their weight management efforts since the last group session.  
The session leaders will then lead a discussion focused on a selected self-management 
strategy such as environmental modification, stimulus control, or social contracting, with 
illustrations taken from the participants’ experience. There will also be a presentation on a topic 
recommended by participants at previous meetings, emphasizing managing ongoing challenges 
of making appropriate food choices and managing total energy intake, motivation, and 
resistance training. 
Motivation for attending the monthly group sessions are social support from other group 
members, new information on nutrition presented by group leaders, and advice from peers and 
group leaders.  The importance of attending the monthly maintenance meetings will be 
emphasized during the final 4 weekly weight-loss sessions with encouragement for participants 
to make a commitment to the group to return to the monthly meetings. 
Participants will be asked to establish a telephone support net for which each participant will call 
one other participant between group meetings.  This telephone contact, which will be promoted 
as a transition aide and as an essential part of the weight-loss maintenance program, will be 
introduced 2 weeks before the end of the weekly sessions. Participants will be encouraged to 
contact each other according to a mutually agreed upon schedule for brief (5-10 minute) 
supportive telephone conversations.  The network will provide ongoing social support between 
the monthly group sessions. 
Dietary, Exercise and Behavioral Recommendations 
The weight loss program is designed to achieve weight loss through dietary calorie reduction, 
increased energy expenditure through physical activity, and improved self-efficacy through 
behavioral self-management.  
Dietary recommendations: 
1. Consume ~500 fewer calories per day to achieve ½-2 lb weight loss per week. 
2. Eat a healthy dietary pattern (i.e., the DASH eating style and WLM program, a diet rich in 
fruits, vegetables, and low-fat dairy foods, and low in fat). 
3. Limit alcohol consumption to no more than one drink per day.  
Physical activity recommendations: 
4. In addition to normal daily activities, exercise at moderate intensity most days per week. 
5. Progress gradually to 30-60 minutes/day to a weekly target of at least 180 minutes. 
Behavioral recommendations: 
6.  Record daily food intake and physical activity. 
7.  Set short-term goals and create action plans. 
8.  Be an active study participant by attending intervention group sessions. 
Measures 
Weight will be measured with participants in light indoor clothes without shoes, and determined 
to the nearest 0.1 kg by a calibrated digital scale. 

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Height will be measured at enrollment to the nearest 0.1 cm using a calibrated, wall-mounted 
stadiometer. 
Waist circumference will be measured at the midpoint between the lower rib and the iliac crest. 
We will record this to the nearest 0.5 cm. Measurement will be done with a Linen non-stretch 
tape measure with a tension device to provide a constant tension during measurement.  
HbA1c and fasting lipids, and glucose will be collected in the course of patient care, using point-
of-care devices to facilitate data collection by VGMHC staff members. Data will be collected for 
all trial participants at baseline, 6-, 12-, and 18-months post randomization. For participants that 
are unable to come to the clinic for the blood draw, we will do a home outreach and collect the 
sample at their homes. 
Fasting lipids (total cholesterol, HDL-cholesterol, and triglycerides) will be measured 
enzymatically (Lipid Panel Plus Reagent Disc; Henry Schein, Inc, Melville, NY) in whole blood 
using a Piccolo Blood Chemistry Analyzer (Abaxis Inc., Union City, CA). LDL-cholesterol will be 
calculated using the Friedewald equation.96 Fasting  
glucose will be 
measured using a 
OneTouch Ultra 
blood glucose 
monitoring system 
(LifeScan, Inc. 
Milipitas, CA). HbA1c  
will be measured 
from capillary blood 
using an A1cNow+ 
device (Bayer HealthCare LLC,  
Sunnyvale, CA), and FDA-approved and National Glycohemoglobin Standardization Program 
certified instrument that accurately measures HbA1c in point-of-care and home settings. 
Dietary data will be collected using SW Food Frequency Questionnaire at each data collection 
time point.,  
Data will be collected by telephone interview by bilingual interviewers from Center for Health 
Research staff  Physical activity. We will assess physical activity through  National Health 
Survey- General Practice Physical Activity Questionnaire  
Participant and staff satisfaction with the intervention will be assessed with the Client 
Satisfaction Questionnaire (CSQ-8).106 The CSQ-8 is a well-validated, 8-item Likert-type 
questionnaire that has been widely used in studies of physical and mental health107 among 
Spanish-speaking and Hispanic individuals.108  
Quality of life will be assessed with the MOS SF-36 (Medical Outcomes Study Short Form 
Health Survey), available in Spanish and English.109,110 This widely used 36-item instrument 
assesses physical functioning, role functioning-physical, role functioning-emotional, bodily pain, 
general health, social function and psychological wellbeing/mental health, and vitality. The 
Spanish version of this standardized instrument has good internal consistency and concurrent 
validity, with coefficient alpha higher than .7 for all dimensions.110,111 
 
Participants will receive a  
25 for the 6-month visit, $30 for the 12-month visit, and $35 for the 18-month visit. 
Adverse Event information will be collected at 6, 12 and 18 months 
Data Management 
Assessment data will come from questionnaires (all administered as interviews), staff-generated 
documents, and measured weight and waist circumference. The Kaiser Permanente Center for 
Health Research (CHR) data center staff are trained and certified in data management 
procedures: data entry, data flow, quality control, editing, reporting, and storage. The 
Table 5     Data collection schedule 
 
Baseline 
6 mos 
12 mos 
18 mos 
Weight 
X 
X 
X 
X 
Height 
X 
 
 
 
Waist circumference 
X 
X 
X 
X 
24-hr food recalls 
X 
X 
X 
X 
Glucose, HbA1c and lipid profile 
X 
X 
X 
X 
7-Day Physical Activity Recall 
X 
 
X 
X 
Quality of life MOS SF-36 
X 
X 
X 
X 
Satisfaction questionnaire 
 
X 
X 
X 
Demographics, numeracy, literacy, acculturation 
X 
 
 
 

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department maintains CHR’s data management hardware, software, security, storage, and 
networking resources.  Standard data management procedures include Manuals of Operations, 
logging of forms, and work performance and quality control functions. Data management 
protocols include creation of a detailed plan for each instrument covering design, coding, pre-
testing, preparation, administration, entry, verification, data set cleaning, and basic descriptive 
statistics. Procedures for data editing, entry, verification, and summarization are well-
established at CHR. Dr. Lindberg, the study statistician, and the project manager will work 
closely to establish and monitor the data management procedures for this study. The study 
statistician will perform or directly oversee all data analyses. 
 
Statistical Analysis 
Before any analyses are carried out, the data will be audited for quality, completeness, and 
evaluation of distributions with reference to planned analysis models. The evaluation of 
distributions will include the detection of outliers in quantitative data and checking distributions 
of variables to ensure that they meet the assumptions of planned analyses. Whenever possible 
we will use analytical techniques that allow us to keep the natural distribution of the variables, 
but will consider transformation if necessary. 
The main analysis will be based on intention-to-treat principles. To test the effect of the 
intervention on the short term outcomes at 6 months, we will use a residualized change score to 
determine whether the intervention and control groups differ in change in outcome (e.g., weight 
and HbA1c) from baseline, controlling for baseline values. The analysis uses regression with the 
dependent variable being the change in weight (or HbA1c) at 6 months and the independent 
variables are baseline weight (or HbA1c) and a dummy variable for study arm (intervention 
versus control). To examine the long-term effect of the intervention we will use multilevel 
modeling to examine the trajectory of the outcomes across baseline, 6, 12, and 18 months.  
Weight (or HbA1c) is the dependent variable; time, study arm, and the time by study arm 
interaction are the independent variables. Quadratic models will be fit to the data, as it is 
anticipated that the change over time will not be linear throughout the 18 month period. These 
approaches will also be used for the analysis of the short-term and long-term effects of the 
intervention on other outcomes: waist circumference, fasting glucose, serum lipid profile, dietary 
intake (total energy, simple carbohydrates, saturated fat, number of servings of fruits and 
vegetables, dietary fiber and whole grains), and PA. 
 
Assessment of success in sustainability phase 
To evaluate the success of the implementation of the intervention into clinical practice at 
VGMHC, the average percentage of behavioral strategies, participant objectives, session 
content completed across sessions, average number of participants recruited, average 
participant satisfaction, percent of sessions attended in each phase, and average weight 
change will be reported. These numbers will be compared to the benchmark numbers 
established during the clinical trial phase of the study. 
 
Additional Analyses 
We will also examine health literacy and numeracy and acculturation as potential moderators of 
the impact of the intervention by including interaction terms in the residualized change and 
multilevel models.  Acculturation and health literacy and numeracy will be added to the models 
as main effects along with the interaction of these variables and the study arm.  A significant 
interaction would signify that the effect of the intervention varies by the level of the moderator. 
Since these analyses may not be sufficiently powered, effect sizes as well as statistical 
significance will be of interest.  We will also explore the effect of the intervention on quality of life 
over the 18 month period using the multilevel approach outlined above.