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

PreDiabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04822480
• Other study ID #: 2020V0327
• Status: Active, not recruiting
• Start date: February 1, 2020
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: University of Mississippi Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 500
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• PreDiabetes
• Prediabetic State

Intervention

Behavioral:
• Diabetes Prevention Program (DPP)
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.

Locations

Country	Name	City	State
United States	University of Mississippi Medical Center	Jackson	Mississippi

Sponsors (3)

Lead Sponsor	Collaborator
University of Mississippi Medical Center	American Medical Association, Mississippi State Department of Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Eligible DPP patients (reach)	Proportion of patients eligible for DPP relative to total number of patients in ambulatory setting; electronic health record	Baseline to 3-months
Other	Eligible DPP patients (reach)	Proportion of patients eligible for DPP relative to total number of patients in ambulatory setting; electronic health record	Baseline to 6-months
Other	Eligible DPP patients (reach)	Proportion of patients eligible for DPP relative to total number of patients in ambulatory setting; electronic health record	Baseline to 9-months
Other	Eligible DPP patients (reach)	Proportion of patients eligible for DPP relative to total number of patients in ambulatory setting; electronic health record	Baseline to 12-months
Other	Eligible DPP patients (reach)	Proportion of patients eligible for DPP relative to total number of patients in ambulatory setting; electronic health record	Baseline to 15-months
Other	Eligible DPP patients (reach)	Proportion of patients eligible for DPP relative to total number of patients in ambulatory setting; electronic health record	Baseline to 18-months
Other	Eligible DPP patients (reach)	Proportion of patients eligible for DPP relative to total number of patients in ambulatory setting; electronic health record	Baseline to 21-months
Other	Eligible DPP patients (reach)	Proportion of patients eligible for DPP relative to total number of patients in ambulatory setting; electronic health record	Baseline to 24-months
Other	Eligible DPP patients (reach)	Proportion of patients eligible for DPP relative to total number of patients in ambulatory setting; electronic health record	Baseline to 27-months
Other	Eligible DPP patients (reach)	Proportion of patients eligible for DPP relative to total number of patients in ambulatory setting; electronic health record	Baseline to 30-months
Other	Eligible DPP patients (reach)	Proportion of patients eligible for DPP relative to total number of patients in ambulatory setting; electronic health record	Baseline to 33-months
Other	Patients eligible for DPP (reach)	Total number of patients in the ambulatory setting eligible for DPP; electronic health record	Baseline to 36-months
Other	Patients referred to DPP (reach)	Total number of patients in the ambulatory setting referred to DPP; electronic health record	Baseline to 3-months
Other	Patients referred to DPP (reach)	Total number of patients in the ambulatory setting referred to DPP; electronic health record	Baseline to 6-months
Other	Patients referred to DPP (reach)	Total number of patients in the ambulatory setting referred to DPP; electronic health record	Baseline to 9-months
Other	Patients referred to DPP (reach)	Total number of patients in the ambulatory setting referred to DPP; electronic health record	Baseline to 12-months
Other	Patients referred to DPP (reach)	Total number of patients in the ambulatory setting referred to DPP; electronic health record	Baseline to 15-months
Other	Patients referred to DPP (reach)	Total number of patients in the ambulatory setting referred to DPP; electronic health record	Baseline to 18-months
Other	Patients referred to DPP (reach)	Total number of patients in the ambulatory setting referred to DPP; electronic health record	Baseline to 21-months
Other	Patients referred to DPP (reach)	Total number of patients in the ambulatory setting referred to DPP; electronic health record	Baseline to 24-months
Other	Patients referred to DPP (reach)	Total number of patients in the ambulatory setting referred to DPP; electronic health record	Baseline to 27-months
Other	Patients referred to DPP (reach)	Total number of patients in the ambulatory setting referred to DPP; electronic health record	Baseline to 30-months
Other	Patients referred to DPP (reach)	Total number of patients in the ambulatory setting referred to DPP; electronic health record	Baseline to 33-months
Other	Patients referred to DPP (reach)	Total number of patients in the ambulatory setting referred to DPP; electronic health record	Baseline to 36-months
Other	Patients enrolled in DPP (reach)	Total number of patients in the ambulatory setting enrolled in DPP; electronic health record	Baseline to 3-months
Other	Patients enrolled in DPP (reach)	Total number of patients in the ambulatory setting enrolled in DPP; electronic health record	Baseline to 6-months
Other	Patients enrolled in DPP (reach)	Total number of patients in the ambulatory setting enrolled in DPP; electronic health record	Baseline to 9-months
Other	Patients enrolled in DPP (reach)	Total number of patients in the ambulatory setting enrolled in DPP; electronic health record	Baseline to 12-months
Other	Patients enrolled in DPP (reach)	Total number of patients in the ambulatory setting enrolled in DPP; electronic health record	Baseline to 15-months
Other	Patients enrolled in DPP (reach)	Total number of patients in the ambulatory setting enrolled in DPP; electronic health record	Baseline to 18-months
Other	Patients enrolled in DPP (reach)	Total number of patients in the ambulatory setting enrolled in DPP; electronic health record	Baseline to 21-months
Other	Patients enrolled in DPP (reach)	Total number of patients in the ambulatory setting enrolled in DPP; electronic health record	Baseline to 24-months
Other	Patients enrolled in DPP (reach)	Total number of patients in the ambulatory setting enrolled in DPP; electronic health record	Baseline to 27-months
Other	Patients enrolled in DPP (reach)	Total number of patients in the ambulatory setting enrolled in DPP; electronic health record	Baseline to 30-months
Other	Patients enrolled in DPP (reach)	Total number of patients in the ambulatory setting enrolled in DPP; electronic health record	Baseline to 33-months
Other	Patients enrolled in DPP (reach)	Total number of patients in the ambulatory setting enrolled in DPP; electronic health record	Baseline to 36-months
Other	Referring clinical sites (adoption)	Total number of clinical sites referring patients to the DPP, electronic health record	Baseline to 3-months
Other	Referring clinical sites (adoption)	Total number of clinical sites referring patients to the DPP, electronic health record	Baseline to 6-months
Other	Referring clinical sites (adoption)	Total number of clinical sites referring patients to the DPP, electronic health record	Baseline to 9-months
Other	Referring clinical sites (adoption)	Total number of clinical sites referring patients to the DPP, electronic health record	Baseline to 12-months
Other	Referring clinical sites (adoption)	Total number of clinical sites referring patients to the DPP, electronic health record	Baseline to 15-months
Other	Referring clinical sites (adoption)	Total number of clinical sites referring patients to the DPP, electronic health record	Baseline to 18-months
Other	Referring clinical sites (adoption)	Total number of clinical sites referring patients to the DPP, electronic health record	Baseline to 21-months
Other	Referring clinical sites (adoption)	Total number of clinical sites referring patients to the DPP, electronic health record	Baseline to 24-months
Other	Referring clinical sites (adoption)	Total number of clinical sites referring patients to the DPP, electronic health record	Baseline to 27-months
Other	Referring clinical sites (adoption)	Total number of clinical sites referring patients to the DPP, electronic health record	Baseline to 30-months
Other	Referring clinical sites (adoption)	Total number of clinical sites referring patients to the DPP, electronic health record	Baseline to 33-months
Other	Referring clinical sites (adoption)	Total number of clinical sites referring patients to the DPP, electronic health record	Baseline to 36-months
Other	Referring providers (adoption)	Total number of providers referring patients to the DPP; electronic health record	Baseline to 3-months
Other	Referring providers (adoption)	Total number of providers referring patients to the DPP; electronic health record	Baseline to 6-months
Other	Referring providers (adoption)	Total number of providers referring patients to the DPP; electronic health record	Baseline to 9-months
Other	Referring providers (adoption)	Total number of providers referring patients to the DPP; electronic health record	Baseline to 12-months
Other	Referring providers (adoption)	Total number of providers referring patients to the DPP; electronic health record	Baseline to 15-months
Other	Referring providers (adoption)	Total number of providers referring patients to the DPP; electronic health record	Baseline to 18-months
Other	Referring providers (adoption)	Total number of providers referring patients to the DPP; electronic health record	Baseline to 21-months
Other	Referring providers (adoption)	Total number of providers referring patients to the DPP; electronic health record	Baseline to 24-months
Other	Referring providers (adoption)	Total number of providers referring patients to the DPP; electronic health record	Baseline to 27-months
Other	Referring providers (adoption)	Total number of providers referring patients to the DPP; electronic health record	Baseline to 30-months
Other	Referring providers (adoption)	Total number of providers referring patients to the DPP; electronic health record	Baseline to 33-months
Other	Referring providers (adoption)	Total number of providers referring patients to the DPP; electronic health record	Baseline to 36-months
Other	Implementation	Qualitative assessment of implementation processes	Continuous processual evaluation
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Hemoglobin A1c	Lab values extracted from electronic health record	Change in HbA1c from baseline to 6-months in DPP compared with non-DPP patients
Primary	Hemoglobin A1c	Lab values extracted from electronic health record	Change in HbA1c from baseline to 12-months in DPP compared with non-DPP patients
Primary	Hemoglobin A1c	Lab values extracted from electronic health record	Change in HbA1c from baseline to 18-months in DPP compared with non-DPP patients
Primary	Hemoglobin A1c	Lab values extracted from electronic health record	Change in HbA1c from baseline to 24-months in DPP compared with non-DPP patients
Primary	Hemoglobin A1c	Lab values extracted from electronic health record	Change in HbA1c from baseline to 30-months in DPP compared with non-DPP patients
Primary	Hemoglobin A1c	Lab values extracted from electronic health record	Change in HbA1c from baseline to 36-months in DPP compared with non-DPP patients
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Medical encounters	Extracted from electronic health record	Number of medical encounters between baseline and 6-months in DPP compared with non-DPP patients
Primary	Medical encounters	Extracted from electronic health record	Number of medical encounters between baseline and 12-months in DPP compared with non-DPP patients
Primary	Medical encounters	Extracted from electronic health record	Number of medical encounters between baseline and 18-months in DPP compared with non-DPP patients
Primary	Medical encounters	Extracted from electronic health record	Number of medical encounters between baseline and 24-months in DPP compared with non-DPP patients
Primary	Medical encounters	Extracted from electronic health record	Number of medical encounters between baseline and 30-months in DPP compared with non-DPP patients
Primary	Medical encounters	Extracted from electronic health record	Number of medical encounters between baseline and 36-months in DPP compared with non-DPP patients
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Body weight	Total body weight measured using Seca mBCA 554	Change in body weight from baseline to 6-months
Secondary	Body weight	Total body weight measured using Seca mBCA 554	Change in body weight from baseline to 12-months
Secondary	Body weight	Total body weight measured using Seca mBCA 554	Change in body weight from baseline to 24-months
Secondary	Body weight	Total body weight measured using Seca mBCA 554	Change in body weight from baseline to 36-months
Secondary	Fat mass	Total body fat mass measured using Seca mBCA 554; bioimpedance analysis	Change in fat mass from baseline to 6-months
Secondary	Fat mass	Total body fat mass measured using Seca mBCA 554; bioimpedance analysis	Change in fat mass from baseline to 12-months
Secondary	Fat mass	Total body fat mass measured using Seca mBCA 554; bioimpedance analysis	Change in fat mass from baseline to 24-months
Secondary	Fat mass	Total body fat mass measured using Seca mBCA 554; bioimpedance analysis	Change in fat mass from baseline to 36-months
Secondary	Visceral fat	Visceral fat measured using Seca mBCA 554; bioimpedance analysis	Change in visceral fat from baseline to 6-months
Secondary	Visceral fat	Visceral fat measured using Seca mBCA 554; bioimpedance analysis	Change in visceral fat from baseline to 12-months
Secondary	Visceral fat	Visceral fat measured using Seca mBCA 554; bioimpedance analysis	Change in visceral fat from baseline to 24-months
Secondary	Visceral fat	Visceral fat measured using Seca mBCA 554; bioimpedance analysis	Change in visceral fat from baseline to 36-months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Waist circumference	Measures using Seca 203 circumference measuring tape	Change in waist circumference from baseline to 6-months
Secondary	Waist circumference	Measures using Seca 203 circumference measuring tape	Change in waist circumference from baseline to 12-months
Secondary	Waist circumference	Measures using Seca 203 circumference measuring tape	Change in waist circumference from baseline to 24-months
Secondary	Waist circumference	Measures using Seca 203 circumference measuring tape	Change in waist circumference from baseline to 36-months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Resting heart rate	Welch Allyn blood pressure unit.	Change in resting heart rate from baseline to 6-months
Secondary	Resting heart rate	Welch Allyn blood pressure unit.	Change in resting heart rate from baseline to 12-months
Secondary	Resting heart rate	Welch Allyn blood pressure unit.	Change in resting heart rate from baseline to 24-months
Secondary	Resting heart rate	Welch Allyn blood pressure unit.	Change in resting heart rate from baseline to 36-months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Triglycerides	PTS Diagnostics CardioChek Plus analyzer; point of care finger stick to obtain 40 µL blood	Change in triglycerides from baseline to 6-months
Secondary	Triglycerides	PTS Diagnostics CardioChek Plus analyzer; point of care finger stick to obtain 40 µL blood	Change in triglycerides from baseline to 12-months
Secondary	Triglycerides	PTS Diagnostics CardioChek Plus analyzer; point of care finger stick to obtain 40 µL blood	Change in triglycerides from baseline to 24-months
Secondary	Triglycerides	PTS Diagnostics CardioChek Plus analyzer; point of care finger stick to obtain 40 µL blood	Change in triglycerides from baseline to 36-months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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