Evaluation of a Telehealth DPP With Medicare Patients at the University of Mississippi Medical Center

Study Overview
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Brief Summary
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The National Diabetes Prevention Program (DPP) is an evidence-based, 12-month lifestyle change program to prevent or delay the onset of type 2 diabetes mellitus (herein referred to as 'diabetes') among adults with prediabetes. The Department of Preventive Medicine, University of Mississippi Medical Center (UMMC), in partnership with the American Medical Association, is collaborating to develop and implement the DPP as a clinical service for UMMC patients beginning in September 2020. We aim to recruit 245 patients per year over 3 years. Because this is the first attempt to develop and implement the DPP as a clinical service at the UMMC, we are proposing to conduct a comprehensive process, outcome, impact and return on investment evaluation. An effectiveness-implementation hybrid research design will be used to (1) evaluate a multifaceted implementation strategy and the effectiveness and impact of the DPP delivered using telehealth by UMMC's Department of Preventive Medicine; (2) conduct an analysis on medical expenditures among those who participate in a DPP to measure net savings and return on investment (ROI) relative to non-participants; (3) conduct a longitudinal cohort analysis to assess incidence of diabetes and changes in body composition, biomarkers, and psycho-social behavioral constructs among those who participate in a DPP relative to those who do not. The findings from this comprehensive research evaluation will be used to (1) improve clinical operations and implementation; (2) demonstrate the cost benefit of the DPP as a clinical service for patients with diabetes risk; and (3) provide empirical support for delivering the DPP via different modalities including telehealth to reduce risk and improve health outcomes among patients.

Detailed Description
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The purpose of this research is to: (1) Evaluate a multifaceted implementation strategy for the uptake of a remote DPP by UMMC's Department of Preventive Medicine. (2) Conduct an analysis on medical expenditures among those who participate in a DPP to measure net savings and ROI relative to non-participants. (3) Conduct a longitudinal cohort analysis to assess incidence of diabetes, body composition, biomarkers, and psycho-social behavioral constructs among those who participate in a DPP relative to those who do not. Study methods are described below according to each of three specific aims. Aim 1: Conduct a concurrent implementation and effectiveness evaluation of the DPP in a clinical care setting for patients with prediabetes (n=245). An effectiveness-implementation hybrid type III research design will be used to conduct a non-randomized trial with 245 of patients with prediabetes over a three year recruitment period, while employing an iterative process evaluation to explore the complex processes, dynamic context and organizational influences on implementation. The RE-AIM framework will guide the implementation and effectiveness evaluation including measures of Reach, Effectiveness, Adoption, Implementation and Maintenance. Multiple data sources and data types will be used to assess barriers and facilitators that affect the RE-AIM domains, as well as fidelity, costs, patient satisfaction and physician burnout. Aim 2: Utilize claims and encounters data to measure medical expenditures for patients with prediabetes, and determine spending differentials among DPP participants compared with non-DPP participants. Track trends in per capita medical expenditures for among a panel of case (DPP participant) and control (Non-DPP participant) subjects. To compare variations in spending, the differences in the arithmetic means, compound annual growth rates, and propensity score matching models will be implemented to compare case and control subjects. The study may also look at those with prediabetes that are later diagnosed with diabetes and individuals with prediabetes who are not later diagnosed with the condition. These estimates of spending differentials and evidence of DPP participation and engagement rates will help to further enhance the algorithm to estimate the potential cost savings and ROI if diabetes is prevented or delayed in the at-risk population who participate in the DPP. Aim 3: Assess the longitudinal effect of the DPP on participant changes in cardiovascular disease risk including anthropometric and clinical biomarker and psychosocial health outcomes (N=245). A prospective, repeated measures, experimental cohort design will be used to determine the long-term impact of the DPP on diabetes incidence and cardiovascular disease risk among DPP patient participants.

Official Title
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A Telehealth Diabetes Prevention Program in an Academic Medical Center Setting: Hybrid Type III Trial

Conditions
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PreDiabetes, Prediabetic State

Intervention / Treatment
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* Behavioral: Diabetes Prevention Program (DPP)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: UMMC patient within the previous 3-years (at least one UMMC clinical visit within the previous 3-years) ≥ 18 years AND Clinical diagnosis for prediabetes (R73.03) OR any of the following combinations: BMI ≥25 (non-Asian) OR BMI ≥23 (Asian) AND HbA1c 5.7 - 6.4 percent within the past 12-months OR Fasting plasma glucose 110 - 125 mg/dL within the past 12-months OR 2-hour plasma glucose 140 - 199 mg/dL within the past 12-months Exclusion Criteria: Pregnant or planning to become pregnant within the next 12 months <18 years Primary or secondary diagnosis of diabetes mellitus (all codes with prefix of 250 and 249) and other conditions associated with diabetes (357.2, all codes with prefix 362, 366.41, and all codes with prefix 648). End stage renal disease

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| DPP Patients<br>UMMC Patients with prediabetes or risk for diabetes based on risk parameters referred to and enrolled in the DPP. | Behavioral: Diabetes Prevention Program (DPP)<br>* Individuals with prediabetes can mitigate the risks and costs of diabetes by taking preventative action, such as participation in a National Diabetes Prevention Program (DPP). The DPP began as a multisite randomized controlled trial demonstrating the effectiveness and cost-benefit of a 12-month intensive lifestyle intervention over pharmaceutical treatment for preventing or delaying diabetes among prediabetic participants. In 2010, Congress authorized the Centers for Disease Control and Prevention to lead the dissemination of the DPP as a targeted approach (high risk populations) and population-based strategy to reduce the incidence of diabetes and diabetes-related healthcare costs. The goal is to achieve modest weight loss (7%) by developing and implementing behavior change skills resulting in lifestyle modifications such as physical activity (150 minutes per week) and dietary and nutritional practices.<br>|
| Non-DPP Patients<br>Control matched UMMC patients with prediabetes or risk for diabetes based on risk parameters not enrolled in the DPP. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Type 2 diabetes mellitus diagnosis | Diabetes diagnosis extracted via electronic health record; all codes with prefix of 250 and 249 | Change diabetes diagnosis from baseline to 6-months in DPP compared with non-DPP patients | 
| Type 2 diabetes mellitus diagnosis | Diabetes diagnosis extracted via electronic health record; all codes with prefix of 250 and 249 | Change diabetes diagnosis from baseline to 12-months in DPP compared with non-DPP patients | 
| Type 2 diabetes mellitus diagnosis | Diabetes diagnosis extracted via electronic health record; all codes with prefix of 250 and 249 | Change diabetes diagnosis from baseline to 18-months in DPP compared with non-DPP patients | 
| Type 2 diabetes mellitus diagnosis | Diabetes diagnosis extracted via electronic health record; all codes with prefix of 250 and 249 | Change diabetes diagnosis from baseline to 24-months in DPP compared with non-DPP patients | 
| Type 2 diabetes mellitus diagnosis | Diabetes diagnosis extracted via electronic health record; all codes with prefix of 250 and 249 | Change diabetes diagnosis from baseline to 30-months in DPP compared with non-DPP patients | 
| Type 2 diabetes mellitus diagnosis | Diabetes diagnosis extracted via electronic health record; all codes with prefix of 250 and 249 | Change diabetes diagnosis from baseline to 36-months in DPP compared with non-DPP patients | 
| Hemoglobin A1c | Lab values extracted from electronic health record | Change in HbA1c from baseline to 6-months in DPP compared with non-DPP patients | 
| Hemoglobin A1c | Lab values extracted from electronic health record | Change in HbA1c from baseline to 12-months in DPP compared with non-DPP patients | 
| Hemoglobin A1c | Lab values extracted from electronic health record | Change in HbA1c from baseline to 18-months in DPP compared with non-DPP patients | 
| Hemoglobin A1c | Lab values extracted from electronic health record | Change in HbA1c from baseline to 24-months in DPP compared with non-DPP patients | 
| Hemoglobin A1c | Lab values extracted from electronic health record | Change in HbA1c from baseline to 30-months in DPP compared with non-DPP patients | 
| Hemoglobin A1c | Lab values extracted from electronic health record | Change in HbA1c from baseline to 36-months in DPP compared with non-DPP patients | 
| Fasting plasma glucose | Lab values extracted from electronic health record | Change in fasting plasma glucose from baseline to 6-months in DPP compared with non-DPP patients | 
| Fasting plasma glucose | Lab values extracted from electronic health record | Change in fasting plasma glucose from baseline to 12-months in DPP compared with non-DPP patients | 
| Fasting plasma glucose | Lab values extracted from electronic health record | Change in fasting plasma glucose from baseline to 18-months in DPP compared with non-DPP patients | 
| Fasting plasma glucose | Lab values extracted from electronic health record | Change in fasting plasma glucose from baseline to 24-months in DPP compared with non-DPP patients | 
| Fasting plasma glucose | Lab values extracted from electronic health record | Change in fasting plasma glucose from baseline to 30-months in DPP compared with non-DPP patients | 
| Fasting plasma glucose | Lab values extracted from electronic health record | Change in fasting plasma glucose from baseline to 36-months in DPP compared with non-DPP patients | 
| 2-hour plasma glucose | Lab values extracted from electronic health record | Change in 2-hour plasma glucose from baseline to 6-months in DPP compared with non-DPP patients | 
| 2-hour plasma glucose | Lab values extracted from electronic health record | Change in 2-hour plasma glucose from baseline to 12-months in DPP compared with non-DPP patients | 
| 2-hour plasma glucose | Lab values extracted from electronic health record | Change in 2-hour plasma glucose from baseline to 18-months in DPP compared with non-DPP patients | 
| 2-hour plasma glucose | Lab values extracted from electronic health record | Change in 2-hour plasma glucose from baseline to 24-months in DPP compared with non-DPP patients | 
| 2-hour plasma glucose | Lab values extracted from electronic health record | Change in 2-hour plasma glucose from baseline to 30-months in DPP compared with non-DPP patients | 
| 2-hour plasma glucose | Lab values extracted from electronic health record | Change in 2-hour plasma glucose from baseline to 36-months in DPP compared with non-DPP patients | 
| Medical encounters | Extracted from electronic health record | Number of medical encounters between baseline and 6-months in DPP compared with non-DPP patients | 
| Medical encounters | Extracted from electronic health record | Number of medical encounters between baseline and 12-months in DPP compared with non-DPP patients | 
| Medical encounters | Extracted from electronic health record | Number of medical encounters between baseline and 18-months in DPP compared with non-DPP patients | 
| Medical encounters | Extracted from electronic health record | Number of medical encounters between baseline and 24-months in DPP compared with non-DPP patients | 
| Medical encounters | Extracted from electronic health record | Number of medical encounters between baseline and 30-months in DPP compared with non-DPP patients | 
| Medical encounters | Extracted from electronic health record | Number of medical encounters between baseline and 36-months in DPP compared with non-DPP patients | 
| Medical expenditures | Total dollar amount billed per encounter extracted from electronic health record | Medical expenditures from baseline to 6-months in DPP compared with non-DPP patients | 
| Medical expenditures | Total dollar amount billed per encounter extracted from electronic health record | Medical expenditures from baseline to 12-months in DPP compared with non-DPP patients | 
| Medical expenditures | Total dollar amount billed per encounter extracted from electronic health record | Medical expenditures from baseline to 18-months in DPP compared with non-DPP patients | 
| Medical expenditures | Total dollar amount billed per encounter extracted from electronic health record | Medical expenditures from baseline to 24-months in DPP compared with non-DPP patients | 
| Medical expenditures | Total dollar amount billed per encounter extracted from electronic health record | Medical expenditures from baseline to 30-months in DPP compared with non-DPP patients | 
| Medical expenditures | Total dollar amount billed per encounter extracted from electronic health record | Medical expenditures from baseline to 36-months in DPP compared with non-DPP patients | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body weight | Total body weight measured using Seca mBCA 554 | Change in body weight from baseline to 6-months | 
| Body weight | Total body weight measured using Seca mBCA 554 | Change in body weight from baseline to 12-months | 
| Body weight | Total body weight measured using Seca mBCA 554 | Change in body weight from baseline to 24-months | 
| Body weight | Total body weight measured using Seca mBCA 554 | Change in body weight from baseline to 36-months | 
| Fat mass | Total body fat mass measured using Seca mBCA 554; bioimpedance analysis | Change in fat mass from baseline to 6-months | 
| Fat mass | Total body fat mass measured using Seca mBCA 554; bioimpedance analysis | Change in fat mass from baseline to 12-months | 
| Fat mass | Total body fat mass measured using Seca mBCA 554; bioimpedance analysis | Change in fat mass from baseline to 24-months | 
| Fat mass | Total body fat mass measured using Seca mBCA 554; bioimpedance analysis | Change in fat mass from baseline to 36-months | 
| Visceral fat | Visceral fat measured using Seca mBCA 554; bioimpedance analysis | Change in visceral fat from baseline to 6-months | 
| Visceral fat | Visceral fat measured using Seca mBCA 554; bioimpedance analysis | Change in visceral fat from baseline to 12-months | 
| Visceral fat | Visceral fat measured using Seca mBCA 554; bioimpedance analysis | Change in visceral fat from baseline to 24-months | 
| Visceral fat | Visceral fat measured using Seca mBCA 554; bioimpedance analysis | Change in visceral fat from baseline to 36-months | 
| Skeletal muscle mass | Total body skeletal muscle mass measured using Seca mBCA 554; bioimpedance analysis | Change in skeletal muscle mass from baseline to 6-months | 
| Skeletal muscle mass | Total body skeletal muscle mass measured using Seca mBCA 554; bioimpedance analysis | Change in skeletal muscle mass from baseline to 12-months | 
| Skeletal muscle mass | Total body skeletal muscle mass measured using Seca mBCA 554; bioimpedance analysis | Change in skeletal muscle mass from baseline to 24-months | 
| Skeletal muscle mass | Total body skeletal muscle mass measured using Seca mBCA 554; bioimpedance analysis | Change in skeletal muscle mass from baseline to 36-months | 
| Waist circumference | Measures using Seca 203 circumference measuring tape | Change in waist circumference from baseline to 6-months | 
| Waist circumference | Measures using Seca 203 circumference measuring tape | Change in waist circumference from baseline to 12-months | 
| Waist circumference | Measures using Seca 203 circumference measuring tape | Change in waist circumference from baseline to 24-months | 
| Waist circumference | Measures using Seca 203 circumference measuring tape | Change in waist circumference from baseline to 36-months | 
| Systolic blood pressure | Welch Allyn blood pressure unit following the American Heart Association guidelines for adults. | Change in systolic blood pressure from baseline to 6-months | 
| Systolic blood pressure | Welch Allyn blood pressure unit following the American Heart Association guidelines for adults. | Change in systolic blood pressure from baseline to 12-months | 
| Systolic blood pressure | Welch Allyn blood pressure unit following the American Heart Association guidelines for adults. | Change in systolic blood pressure from baseline to 24-months | 
| Systolic blood pressure | Welch Allyn blood pressure unit following the American Heart Association guidelines for adults. | Change in systolic blood pressure from baseline to 36-months | 
| Diastolic blood pressure | Welch Allyn blood pressure unit following the American Heart Association guidelines for adults. | Change in diastolic blood pressure from baseline to 6-months | 
| Diastolic blood pressure | Welch Allyn blood pressure unit following the American Heart Association guidelines for adults. | Change in diastolic blood pressure from baseline to 12-months | 
| Diastolic blood pressure | Welch Allyn blood pressure unit following the American Heart Association guidelines for adults. | Change in diastolic blood pressure from baseline to 24-months | 
| Diastolic blood pressure | Welch Allyn blood pressure unit following the American Heart Association guidelines for adults. | Change in diastolic blood pressure from baseline to 36-months | 
| Resting heart rate | Welch Allyn blood pressure unit. | Change in resting heart rate from baseline to 6-months | 
| Resting heart rate | Welch Allyn blood pressure unit. | Change in resting heart rate from baseline to 12-months | 
| Resting heart rate | Welch Allyn blood pressure unit. | Change in resting heart rate from baseline to 24-months | 
| Resting heart rate | Welch Allyn blood pressure unit. | Change in resting heart rate from baseline to 36-months | 
| Total cholesterol | PTS Diagnostics CardioChek Plus analyzer; point of care finger stick to obtain 40 μL blood | Change in total cholesterol from baseline to 6-months | 
| Total cholesterol | PTS Diagnostics CardioChek Plus analyzer; point of care finger stick to obtain 40 μL blood | Change in total cholesterol from baseline to 12-months | 
| Total cholesterol | PTS Diagnostics CardioChek Plus analyzer; point of care finger stick to obtain 40 μL blood | Change in total cholesterol from baseline to 24-months | 
| Total cholesterol | PTS Diagnostics CardioChek Plus analyzer; point of care finger stick to obtain 40 μL blood | Change in total cholesterol from baseline to 36-months | 
| HDL cholesterol | PTS Diagnostics CardioChek Plus analyzer; point of care finger stick to obtain 40 μL blood | Change in HDL cholesterol from baseline to 6-months | 
| HDL cholesterol | PTS Diagnostics CardioChek Plus analyzer; point of care finger stick to obtain 40 μL blood | Change in HDL cholesterol from baseline to 12-months | 
| HDL cholesterol | PTS Diagnostics CardioChek Plus analyzer; point of care finger stick to obtain 40 μL blood | Change in HDL cholesterol from baseline to 24-months | 
| HDL cholesterol | PTS Diagnostics CardioChek Plus analyzer; point of care finger stick to obtain 40 μL blood | Change in HDL cholesterol from baseline to 36-months | 
| Triglycerides | PTS Diagnostics CardioChek Plus analyzer; point of care finger stick to obtain 40 μL blood | Change in triglycerides from baseline to 6-months | 
| Triglycerides | PTS Diagnostics CardioChek Plus analyzer; point of care finger stick to obtain 40 μL blood | Change in triglycerides from baseline to 12-months | 
| Triglycerides | PTS Diagnostics CardioChek Plus analyzer; point of care finger stick to obtain 40 μL blood | Change in triglycerides from baseline to 24-months | 
| Triglycerides | PTS Diagnostics CardioChek Plus analyzer; point of care finger stick to obtain 40 μL blood | Change in triglycerides from baseline to 36-months | 
| Hemoglobin A1c (point of care) | A1CNOW+ System for reliable point-of-care HbA1c measurement; non-fasting 5 μL blood | Change in HbA1c from baseline to 6-months | 
| Hemoglobin A1c (point of care) | A1CNOW+ System for reliable point-of-care HbA1c measurement; non-fasting 5 μL blood | Change in HbA1c from baseline to 12-months | 
| Hemoglobin A1c (point of care) | A1CNOW+ System for reliable point-of-care HbA1c measurement; non-fasting 5 μL blood | Change in HbA1c from baseline to 24-months | 
| Hemoglobin A1c (point of care) | A1CNOW+ System for reliable point-of-care HbA1c measurement; non-fasting 5 μL blood | Change in HbA1c from baseline to 36-months | 
| Self-efficacy for weight loss and maintenance | Weight self-efficacy lifestyle questionnaire; 20 items using a 10-point Likert scale; higher mean score indicates higher self-efficacy; Clark et al., 1991 | Change in self-efficacy from baseline to 6-months | 
| Self-efficacy for weight loss and maintenance | Weight self-efficacy lifestyle questionnaire; 20 items using a 10-point Likert scale; higher mean score indicates higher self-efficacy; Clark et al., 1991 | Change in self-efficacy from baseline to 12-months | 
| Self-efficacy for weight loss and maintenance | Weight self-efficacy lifestyle questionnaire; 20 items using a 10-point Likert scale; higher mean score indicates higher self-efficacy; Clark et al., 1991 | Change in self-efficacy from baseline to 24-months | 
| Self-efficacy for weight loss and maintenance | Weight self-efficacy lifestyle questionnaire; 20 items using a 10-point Likert scale; higher mean score indicates higher self-efficacy; Clark et al., 1991 | Change in self-efficacy from baseline to 36-months | 
| Readiness to change, stage of change | Stages of Change in Overweight and Obese People questionnaire (S-weight); 1-item with 5 distinct and mutually exclusive responses to measure stage of change; Andres et al., 2009 | Change in stage of change from baseline to 6-months | 
| Readiness to change, stage of change | Stages of Change in Overweight and Obese People questionnaire (S-weight); 1-item with 5 distinct and mutually exclusive responses to measure stage of change; Andres et al., 2009 | Change in stage of change from baseline to 12-months | 
| Readiness to change, stage of change | Stages of Change in Overweight and Obese People questionnaire (S-weight); 1-item with 5 distinct and mutually exclusive responses to measure stage of change; Andres et al., 2009 | Change in stage of change from baseline to 24-months | 
| Readiness to change, stage of change | Stages of Change in Overweight and Obese People questionnaire (S-weight); 1-item with 5 distinct and mutually exclusive responses to measure stage of change; Andres et al., 2009 | Change in stage of change from baseline to 36-months | 
| Readiness to change, processes of change | Processes of Change in Overweight and Obese People questionnaire (P-weight); 34 items; 5-point Likert scale from Strongly Disagree to Strongly Agree where higher mean score indicates higher use of respective process; four processes include emotional re-evaluation, weight consequences evaluation, supporting relationships, and weight management actions across 4 processes of change; Andres et al., 2011 | Change in processes of change from baseline to 6-months | 
| Readiness to change, processes of change | Processes of Change in Overweight and Obese People questionnaire (P-weight); 34 items; 5-point Likert scale from Strongly Disagree to Strongly Agree where higher mean score indicates higher use of respective process; four processes include emotional re-evaluation, weight consequences evaluation, supporting relationships, and weight management actions across 4 processes of change; Andres et al., 2011 | Change in processes of change from baseline to 12-months | 
| Readiness to change, processes of change | Processes of Change in Overweight and Obese People questionnaire (P-weight); 34 items; 5-point Likert scale from Strongly Disagree to Strongly Agree where higher mean score indicates higher use of respective process; four processes include emotional re-evaluation, weight consequences evaluation, supporting relationships, and weight management actions across 4 processes of change; Andres et al., 2011 | Change in processes of change from baseline to 24-months | 
| Readiness to change, processes of change | Processes of Change in Overweight and Obese People questionnaire (P-weight); 34 items; 5-point Likert scale from Strongly Disagree to Strongly Agree where higher mean score indicates higher use of respective process; four processes include emotional re-evaluation, weight consequences evaluation, supporting relationships, and weight management actions across 4 processes of change; Andres et al., 2011 | Change in processes of change from baseline to 36-months | 
| Decisional balance | Decisional balance inventory; 20 items using 5-point Likert scale to identify cognitive and emotional pros and cons to making intentional changes for weight loss and maintenance (Not Important At All to Extremely Important); higher mean scores for subscales (Pros; Pro-Con) would indicate higher intention; O'Connell and Velicer, 1988 | Change in decisional balance from baseline to 6-months | 
| Decisional balance | Decisional balance inventory; 20 items using 5-point Likert scale to identify cognitive and emotional pros and cons to making intentional changes for weight loss and maintenance (Not Important At All to Extremely Important); higher mean scores for subscales (Pros; Pro-Con) would indicate higher intention; O'Connell and Velicer, 1988 | Change in decisional balance from baseline to 12-months | 
| Decisional balance | Decisional balance inventory; 20 items using 5-point Likert scale to identify cognitive and emotional pros and cons to making intentional changes for weight loss and maintenance (Not Important At All to Extremely Important); higher mean scores for subscales (Pros; Pro-Con) would indicate higher intention; O'Connell and Velicer, 1988 | Change in decisional balance from baseline to 24-months | 
| Decisional balance | Decisional balance inventory; 20 items using 5-point Likert scale to identify cognitive and emotional pros and cons to making intentional changes for weight loss and maintenance (Not Important At All to Extremely Important); higher mean scores for subscales (Pros; Pro-Con) would indicate higher intention; O'Connell and Velicer, 1988 | Change in decisional balance from baseline to 36-months | 
| Self-efficacy for overcoming barriers to physical activity and healthy eating | Self-efficacy for overcoming barriers to physical activity and diet; 10 items using a 4-point Likert scale from Very Uncertain to Very Certain or Not True At All to Exactly True; higher mean score (20 to 80) indicated greater self-efficacy; Huttunen-Lenz et al., 2018 | Change in barrier self-efficacy from baseline to 6-months | 
| Self-efficacy for overcoming barriers to physical activity and healthy eating | Self-efficacy for overcoming barriers to physical activity and diet; 10 items using a 4-point Likert scale from Very Uncertain to Very Certain or Not True At All to Exactly True; higher mean score (20 to 80) indicated greater self-efficacy; Huttunen-Lenz et al., 2018 | Change in barrier self-efficacy from baseline to 12-months | 
| Self-efficacy for overcoming barriers to physical activity and healthy eating | Self-efficacy for overcoming barriers to physical activity and diet; 10 items using a 4-point Likert scale from Very Uncertain to Very Certain or Not True At All to Exactly True; higher mean score (20 to 80) indicated greater self-efficacy; Huttunen-Lenz et al., 2018 | Change in barrier self-efficacy from baseline to 24-months | 
| Self-efficacy for overcoming barriers to physical activity and healthy eating | Self-efficacy for overcoming barriers to physical activity and diet; 10 items using a 4-point Likert scale from Very Uncertain to Very Certain or Not True At All to Exactly True; higher mean score (20 to 80) indicated greater self-efficacy; Huttunen-Lenz et al., 2018 | Change in barrier self-efficacy from baseline to 36-months | 
| Self-regulation of eating behaviors | Self-regulation of Eating Behavior Questionnaire; 5 items using a 5-point Likert scale; mean score <2.8, 2.8 - 3.6, >3.6 correspond to low, medium and high self-regulation, respectively; Kliemann et al., 2016 | Change in self-regulation of eating behaviors from baseline to 6-months | 
| Self-regulation of eating behaviors | Self-regulation of Eating Behavior Questionnaire; 5 items using a 5-point Likert scale; mean score <2.8, 2.8 - 3.6, >3.6 correspond to low, medium and high self-regulation, respectively; Kliemann et al., 2016 | Change in self-regulation of eating behaviors from baseline to 12-months | 
| Self-regulation of eating behaviors | Self-regulation of Eating Behavior Questionnaire; 5 items using a 5-point Likert scale; mean score <2.8, 2.8 - 3.6, >3.6 correspond to low, medium and high self-regulation, respectively; Kliemann et al., 2016 | Change in self-regulation of eating behaviors from baseline to 24-months | 
| Self-regulation of eating behaviors | Self-regulation of Eating Behavior Questionnaire; 5 items using a 5-point Likert scale; mean score <2.8, 2.8 - 3.6, >3.6 correspond to low, medium and high self-regulation, respectively; Kliemann et al., 2016 | Change in self-regulation of eating behaviors from baseline to 36-months | 
| Self-regulation of physical activity - goals | Exercise goal-setting scale; 10 items using 5-point Likert scale from Does Not Describe Me (0) to Describes Me Completely (4); higher mean score reflects greater self-regulation Rovniak et al., 2002 | Change in self-regulation of physical activity goals from baseline to 6-months | 
| Self-regulation of physical activity - goals | Exercise goal-setting scale; 10 items using 5-point Likert scale from Does Not Describe Me (0) to Describes Me Completely (4); higher mean score reflects greater self-regulation Rovniak et al., 2002 | Change in self-regulation of physical activity goals from baseline to 12-months | 
| Self-regulation of physical activity - goals | Exercise goal-setting scale; 10 items using 5-point Likert scale from Does Not Describe Me (0) to Describes Me Completely (4); higher mean score reflects greater self-regulation Rovniak et al., 2002 | Change in self-regulation of physical activity goals from baseline to 24-months | 
| Self-regulation of physical activity - goals | Exercise goal-setting scale; 10 items using 5-point Likert scale from Does Not Exercise goal-setting scale; 10 items using 5-point Likert scale from Does Not Describe Me (0) to Describes Me Completely (4); higher mean score reflects greater self-regulation Rovniak et al., 2002 | Change in self-regulation of physical activity goals from baseline to 36-months | 
| Self-regulation of physical activity - planning | Exercise planning and scheduling scale; 10 items using 5-point Likert scale from Does Not Describe Me (0) to Describes Me Completely (4); higher mean score reflects greater self-regulation Rovniak et al., 2002 | Change in self-regulation of physical activity planning from baseline to 6-months | 
| Self-regulation of physical activity - planning | Exercise planning and scheduling scale; 10 items using 5-point Likert scale from Does Not Describe Me (0) to Describes Me Completely (4); higher mean score reflects greater self-regulation Rovniak et al., 2002 | Change in self-regulation of physical activity planning from baseline to 12-months | 
| Self-regulation of physical activity - planning | Exercise planning and scheduling scale; 10 items using 5-point Likert scale from Does Not Describe Me (0) to Describes Me Completely (4); higher mean score reflects greater self-regulation Rovniak et al., 2002 | Change in self-regulation of physical activity planning from baseline to 24-months | 
| Self-regulation of physical activity - planning | Exercise planning and scheduling scale; 10 items using 5-point Likert scale from Does Not Describe Me (0) to Describes Me Completely (4); higher mean score reflects greater self-regulation Rovniak et al., 2002 | Change in self-regulation of physical activity planning from baseline to 36-months | 
| Social support from friends - eating | Friend social support for healthy eating scale; 10 items using a 5-point Likert scale from None of the Time (1) to All of the Time (5) where a higher mean score indicated greater social support; Sallis et al., 1987 | Change in social support from baseline to 6-months | 
| Social support from friends - eating | Friend social support for healthy eating scale; 10 items using a 5-point Likert scale from None of the Time (1) to All of the Time (5) where a higher mean score indicated greater social support; Sallis et al., 1987 | Change in social support from baseline to 12-months | 
| Social support from friends - eating | Friend social support for healthy eating scale; 10 items using a 5-point Likert scale from None of the Time (1) to All of the Time (5) where a higher mean score indicated greater social support; Sallis et al., 1987 | Change in social support from baseline to 24-months | 
| Social support from friends - eating | Friend social support for healthy eating scale; 10 items using a 5-point Likert scale from None of the Time (1) to All of the Time (5) where a higher mean score indicated greater social support; Sallis et al., 1987 | Change in social support from baseline to 36-months | 
| Social support from family - eating | Family social support for healthy eating scale; 13 items using a 5-point Likert scale from None of the Time (1) to All of the Time (5) where a higher mean score indicated greater social support; Sallis et al., 1987 | Change in social support from baseline to 6-months | 
| Social support from family - eating | Family social support for healthy eating scale; 13 items using a 5-point Likert scale from None of the Time (1) to All of the Time (5) where a higher mean score indicated greater social support; Sallis et al., 1987 | Change in social support from baseline to 12-months | 
| Social support from family - eating | Family social support for healthy eating scale; 13 items using a 5-point Likert scale from None of the Time (1) to All of the Time (5) where a higher mean score indicated greater social support; Sallis et al., 1987 | Change in social support from baseline to 24-months | 
| Social support from family - eating | Family social support for healthy eating scale; 13 items using a 5-point Likert scale from None of the Time (1) to All of the Time (5) where a higher mean score indicated greater social support; Sallis et al., 1987 | Change in social support from baseline to 36-months | 
| Social support from friend - physical activity | Friend social support for physical activity scale; 9-items using a 5-point Likert scale from None of the Time (1) to All of the Time (5) where a higher mean score indicated greater social support; Sallis et al., 1987 | Change in social support from baseline to 6-months | 
| Social support from friend - physical activity | Friend social support for physical activity scale; 9-items using a 5-point Likert scale from None of the Time (1) to All of the Time (5) where a higher mean score indicated greater social support; Sallis et al., 1987 | Change in social support from baseline to 12-months | 
| Social support from friend - physical activity | Friend social support for physical activity scale; 9-items using a 5-point Likert scale from None of the Time (1) to All of the Time (5) where a higher mean score indicated greater social support; Sallis et al., 1987 | Change in social support from baseline to 24-months | 
| Social support from friend - physical activity | Friend social support for physical activity scale; 9-items using a 5-point Likert scale from None of the Time (1) to All of the Time (5) where a higher mean score indicated greater social support; Sallis et al., 1987 | Change in social support from baseline to 36-months | 
| Social support from family - physical activity | Family social support for physical activity scale; 15 items using a 5-point Likert scale from None of the Time (1) to All of the Time (5) where a higher mean score indicated greater social support; Sallis et al., 1987 | Change in social support from baseline to 6-months | 
| Social support from family - physical activity | Family social support for physical activity scale; 15 items using a 5-point Likert scale from None of the Time (1) to All of the Time (5) where a higher mean score indicated greater social support; Sallis et al., 1987 | Change in social support from baseline to 12-months | 
| Social support from family - physical activity | Family social support for physical activity scale; 15 items using a 5-point Likert scale from None of the Time (1) to All of the Time (5) where a higher mean score indicated greater social support; Sallis et al., 1987 | Change in social support from baseline to 24-months | 
| Social support from family - physical activity | Family social support for physical activity scale; 15 items using a 5-point Likert scale from None of the Time (1) to All of the Time (5) where a higher mean score indicated greater social support; Sallis et al., 1987 | Change in social support from baseline to 36-months | 
| Outcome expectancies | Outcome expectancies of behavior change; 25 items using 4-point Likert scale from Not True At All (1) to Exactly True (4); higher mean score indicating greater outcome expectancy; Huttunen-Lenz et al., 2018 | Change in outcome expectancies from baseline to 6-months | 
| Outcome expectancies | Outcome expectancies of behavior change; 25 items using 4-point Likert scale from Not True At All (1) to Exactly True (4); higher mean score indicating greater outcome expectancy; Huttunen-Lenz et al., 2018 | Change in outcome expectancies from baseline to 12-months | 
| Outcome expectancies | Outcome expectancies of behavior change; 25 items using 4-point Likert scale from Not True At All (1) to Exactly True (4); higher mean score indicating greater outcome expectancy; Huttunen-Lenz et al., 2018 | Change in outcome expectancies from baseline to 24-months | 
| Outcome expectancies | Outcome expectancies of behavior change; 25 items using 4-point Likert scale from Not True At All (1) to Exactly True (4); higher mean score indicating greater outcome expectancy; Huttunen-Lenz et al., 2018 | Change in outcome expectancies from baseline to 36-months | 
| Coping self-efficacy | Coping self-efficacy scale; 14 items using a 4-point Likert scale from Not True At All (1) to Exactly True (4); higher mean score indicates greater self-efficacy for coping; Huttunen-Lenz et al., 2018 | Change in coping self-efficacy from baseline to 6-months | 
| Coping self-efficacy | Coping self-efficacy scale; 14 items using a 4-point Likert scale from Not True At All (1) to Exactly True (4); higher mean score indicates greater self-efficacy for coping; Huttunen-Lenz et al., 2018 | Change in coping self-efficacy from baseline to 12-months | 
| Coping self-efficacy | Coping self-efficacy scale; 14 items using a 4-point Likert scale from Not True At All (1) to Exactly True (4); higher mean score indicates greater self-efficacy for coping; Huttunen-Lenz et al., 2018 | Change in coping self-efficacy from baseline to 24-months | 
| Coping self-efficacy | Coping self-efficacy scale; 14 items using a 4-point Likert scale from Not True At All (1) to Exactly True (4); higher mean score indicates greater self-efficacy for coping; Huttunen-Lenz et al., 2018 | Change in coping self-efficacy from baseline to 36-months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes prevention