PreDiabetesNCT04822480
Evaluation of a Telehealth DPP With Medicare Patients at the University of Mississippi Medical Center
An observational study of PreDiabetes and Prediabetic State, run by University of Mississippi Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PreDiabetes, Prediabetic State
- What is being tested?
- Diabetes Prevention Program (DPP)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2020to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Mississippi consistently has among the highest rates of diabetes (14.3%) and prediabetes (36.5%) nationally and is the only state where every county (82 counties) are represented in the Diabetes Belt, a geographic region of the U.S. where the prevalence of diagnosed diabetes is highest. Mississippi has the fourth largest rural population (51.2%) and the highest state percent Black (37.8%) population in the U.S., and has persistently high rates of poverty (20.8%).
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Mississippi Medical Center
Jackson, Mississippi, 39216
About this study
Official title: A Telehealth Diabetes Prevention Program in an Academic Medical Center Setting: Hybrid Type III Trial
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.
Read the detailed 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.
- Conditions
- PreDiabetes, Prediabetic State
- Being tested
- Diabetes Prevention Program (DPP)
- Keywords
- diabetes prevention
- Medical subject headings
- Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diabetes Prevention Program (DPP)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| DPP Patients | UMMC Patients with prediabetes or risk for diabetes based on risk parameters referred to and enrolled in the DPP. Receives: Behavioral: Diabetes Prevention Program (DPP) | |
| Non-DPP Patients | Control matched UMMC patients with prediabetes or risk for diabetes based on risk parameters not enrolled in the DPP. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Type 2 diabetes mellitus diagnosis
Diabetes diagnosis extracted via electronic health record; all codes with prefix of 250 and 249
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Change diabetes diagnosis from baseline to 36-months in DPP compared with non-DPP patients
Hemoglobin A1c
Lab values extracted from electronic health record
Measured: Change in HbA1c from baseline to 6-months in DPP compared with non-DPP patients
Hemoglobin A1c
Lab values extracted from electronic health record
Measured: Change in HbA1c from baseline to 12-months in DPP compared with non-DPP patients
Hemoglobin A1c
Lab values extracted from electronic health record
Measured: Change in HbA1c from baseline to 18-months in DPP compared with non-DPP patients
Hemoglobin A1c
Lab values extracted from electronic health record
Measured: Change in HbA1c from baseline to 24-months in DPP compared with non-DPP patients
Hemoglobin A1c
Lab values extracted from electronic health record
Measured: Change in HbA1c from baseline to 30-months in DPP compared with non-DPP patients
Hemoglobin A1c
Lab values extracted from electronic health record
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Number of medical encounters between baseline and 6-months in DPP compared with non-DPP patients
Medical encounters
Extracted from electronic health record
Measured: Number of medical encounters between baseline and 12-months in DPP compared with non-DPP patients
Medical encounters
Extracted from electronic health record
Measured: Number of medical encounters between baseline and 18-months in DPP compared with non-DPP patients
Medical encounters
Extracted from electronic health record
Measured: Number of medical encounters between baseline and 24-months in DPP compared with non-DPP patients
Medical encounters
Extracted from electronic health record
Measured: Number of medical encounters between baseline and 30-months in DPP compared with non-DPP patients
Medical encounters
Extracted from electronic health record
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Medical expenditures from baseline to 36-months in DPP compared with non-DPP patients
Secondary outcomes (104)
Body weight
Total body weight measured using Seca mBCA 554
Measured: Change in body weight from baseline to 6-months
Body weight
Total body weight measured using Seca mBCA 554
Measured: Change in body weight from baseline to 12-months
Body weight
Total body weight measured using Seca mBCA 554
Measured: Change in body weight from baseline to 24-months
Body weight
Total body weight measured using Seca mBCA 554
Measured: Change in body weight from baseline to 36-months
Fat mass
Total body fat mass measured using Seca mBCA 554; bioimpedance analysis
Measured: Change in fat mass from baseline to 6-months
Fat mass
Total body fat mass measured using Seca mBCA 554; bioimpedance analysis
Measured: Change in fat mass from baseline to 12-months
Fat mass
Total body fat mass measured using Seca mBCA 554; bioimpedance analysis
Measured: Change in fat mass from baseline to 24-months
Fat mass
Total body fat mass measured using Seca mBCA 554; bioimpedance analysis
Measured: Change in fat mass from baseline to 36-months
Visceral fat
Visceral fat measured using Seca mBCA 554; bioimpedance analysis
Measured: Change in visceral fat from baseline to 6-months
Visceral fat
Visceral fat measured using Seca mBCA 554; bioimpedance analysis
Measured: Change in visceral fat from baseline to 12-months
Visceral fat
Visceral fat measured using Seca mBCA 554; bioimpedance analysis
Measured: Change in visceral fat from baseline to 24-months
Visceral fat
Visceral fat measured using Seca mBCA 554; bioimpedance analysis
Measured: Change in visceral fat from baseline to 36-months
Skeletal muscle mass
Total body skeletal muscle mass measured using Seca mBCA 554; bioimpedance analysis
Measured: 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
Measured: 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
Measured: 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
Measured: Change in skeletal muscle mass from baseline to 36-months
Waist circumference
Measures using Seca 203 circumference measuring tape
Measured: Change in waist circumference from baseline to 6-months
Waist circumference
Measures using Seca 203 circumference measuring tape
Measured: Change in waist circumference from baseline to 12-months
Waist circumference
Measures using Seca 203 circumference measuring tape
Measured: Change in waist circumference from baseline to 24-months
Waist circumference
Measures using Seca 203 circumference measuring tape
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change in diastolic blood pressure from baseline to 36-months
Resting heart rate
Welch Allyn blood pressure unit.
Measured: Change in resting heart rate from baseline to 6-months
Resting heart rate
Welch Allyn blood pressure unit.
Measured: Change in resting heart rate from baseline to 12-months
Resting heart rate
Welch Allyn blood pressure unit.
Measured: Change in resting heart rate from baseline to 24-months
Resting heart rate
Welch Allyn blood pressure unit.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Change in triglycerides from baseline to 6-months
Triglycerides
PTS Diagnostics CardioChek Plus analyzer; point of care finger stick to obtain 40 μL blood
Measured: Change in triglycerides from baseline to 12-months
Triglycerides
PTS Diagnostics CardioChek Plus analyzer; point of care finger stick to obtain 40 μL blood
Measured: Change in triglycerides from baseline to 24-months
Triglycerides
PTS Diagnostics CardioChek Plus analyzer; point of care finger stick to obtain 40 μL blood
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Change in coping self-efficacy from baseline to 36-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2021
- Study start1 Feb 2020
- Primary completion31 Dec 2023
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PreDiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Mississippi Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- American Medical Association, Mississippi State Department of Health
- Responsible party
- Principal investigator, Abigail Gamble, University of Mississippi Medical Center
- Investigators
- Abigail Gamble, PhD, MS, Principal investigator, University of Mississippi Medical CenterTamkeen Khan, PhD, Principal investigator, American Medical Association
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04822480
- Sponsor's protocol ID
- 2020V0327
- Status last verified
- Apr 2024
- First submitted
- 25 Mar 2021
- Last updated
- 29 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gamble A, Khan T, Hughes A, Guo Y, Vasaitis S, Bidwell J, Christman B. Telehealth Diabetes Prevention Program for Adults With Prediabetes in an Academic Medical Center Setting: Protocol for a Hybrid Type III Trial. JMIR Res Protoc. 2023 Nov 13;12:e50183. doi: 10.2196/50183.
PubMed 37955955
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Telehealth Diabetes Prevention Program in an Academic Medical Center Setting: Hybrid Type III Trial
- ClinicalTrials.gov ID
- NCT04822480
- Acronym / sponsor ID
- 2020V0327
- Conditions
- PreDiabetes, Prediabetic State
- Keywords
- diabetes prevention
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University of Mississippi Medical CenterUniversity, hospital or other
- Collaborators
- American Medical Association, Mississippi State Department of Health
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 30 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DPP Patients | – | Behavioral: Diabetes Prevention Program (DPP)UMMC Patients with prediabetes or risk for diabetes based on risk parameters referred to and enrolled in the DPP. |
| Non-DPP Patients | – | –Control matched UMMC patients with prediabetes or risk for diabetes based on risk parameters not enrolled in the DPP. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Mississippi consistently has among the highest rates of diabetes (14.3%) and prediabetes (36.5%) nationally and is the only state where every county (82 counties) are represented in the Diabetes Belt, a geographic region of the U.S. where the prevalence of diagnosed diabetes is highest. Mississippi has the fourth largest rural population (51.2%) and the highest state percent Black (37.8%) population in the U.S., and has persistently high rates of poverty (20.8%).
Key inclusion criteria (9 listed)
- 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)
- BMI ≥25 (non-Asian) OR
- BMI ≥23 (Asian) AND
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | DPP Patients |
Primary outcome
Type 2 diabetes mellitus diagnosis
Time frame: Change diabetes diagnosis from baseline to 6-months in DPP compared with non-DPP patients
Diabetes diagnosis extracted via electronic health record; all codes with prefix of 250 and 249
Type 2 diabetes mellitus diagnosis
Time frame: Change diabetes diagnosis from baseline to 12-months in DPP compared with non-DPP patients
Diabetes diagnosis extracted via electronic health record; all codes with prefix of 250 and 249
Type 2 diabetes mellitus diagnosis
Time frame: Change diabetes diagnosis from baseline to 18-months in DPP compared with non-DPP patients
Diabetes diagnosis extracted via electronic health record; all codes with prefix of 250 and 249
Type 2 diabetes mellitus diagnosis
Time frame: Change diabetes diagnosis from baseline to 24-months in DPP compared with non-DPP patients
Diabetes diagnosis extracted via electronic health record; all codes with prefix of 250 and 249
Type 2 diabetes mellitus diagnosis
Time frame: Change diabetes diagnosis from baseline to 30-months in DPP compared with non-DPP patients
Diabetes diagnosis extracted via electronic health record; all codes with prefix of 250 and 249
Type 2 diabetes mellitus diagnosis
Time frame: Change diabetes diagnosis from baseline to 36-months in DPP compared with non-DPP patients
Diabetes diagnosis extracted via electronic health record; all codes with prefix of 250 and 249
Hemoglobin A1c
Time frame: Change in HbA1c from baseline to 6-months in DPP compared with non-DPP patients
Lab values extracted from electronic health record
Hemoglobin A1c
Time frame: Change in HbA1c from baseline to 12-months in DPP compared with non-DPP patients
Lab values extracted from electronic health record
Hemoglobin A1c
Time frame: Change in HbA1c from baseline to 18-months in DPP compared with non-DPP patients
Lab values extracted from electronic health record
Hemoglobin A1c
Time frame: Change in HbA1c from baseline to 24-months in DPP compared with non-DPP patients
Lab values extracted from electronic health record
Hemoglobin A1c
Time frame: Change in HbA1c from baseline to 30-months in DPP compared with non-DPP patients
Lab values extracted from electronic health record
Hemoglobin A1c
Time frame: Change in HbA1c from baseline to 36-months in DPP compared with non-DPP patients
Lab values extracted from electronic health record
Fasting plasma glucose
Time frame: Change in fasting plasma glucose from baseline to 6-months in DPP compared with non-DPP patients
Lab values extracted from electronic health record
Fasting plasma glucose
Time frame: Change in fasting plasma glucose from baseline to 12-months in DPP compared with non-DPP patients
Lab values extracted from electronic health record
Fasting plasma glucose
Time frame: Change in fasting plasma glucose from baseline to 18-months in DPP compared with non-DPP patients
Lab values extracted from electronic health record
Fasting plasma glucose
Time frame: Change in fasting plasma glucose from baseline to 24-months in DPP compared with non-DPP patients
Lab values extracted from electronic health record
Fasting plasma glucose
Time frame: Change in fasting plasma glucose from baseline to 30-months in DPP compared with non-DPP patients
Lab values extracted from electronic health record
Fasting plasma glucose
Time frame: Change in fasting plasma glucose from baseline to 36-months in DPP compared with non-DPP patients
Lab values extracted from electronic health record
2-hour plasma glucose
Time frame: Change in 2-hour plasma glucose from baseline to 6-months in DPP compared with non-DPP patients
Lab values extracted from electronic health record
2-hour plasma glucose
Time frame: Change in 2-hour plasma glucose from baseline to 12-months in DPP compared with non-DPP patients
Lab values extracted from electronic health record
2-hour plasma glucose
Time frame: Change in 2-hour plasma glucose from baseline to 18-months in DPP compared with non-DPP patients
Lab values extracted from electronic health record
2-hour plasma glucose
Time frame: Change in 2-hour plasma glucose from baseline to 24-months in DPP compared with non-DPP patients
Lab values extracted from electronic health record
2-hour plasma glucose
Time frame: Change in 2-hour plasma glucose from baseline to 30-months in DPP compared with non-DPP patients
Lab values extracted from electronic health record
2-hour plasma glucose
Time frame: Change in 2-hour plasma glucose from baseline to 36-months in DPP compared with non-DPP patients
Lab values extracted from electronic health record
Medical encounters
Time frame: Number of medical encounters between baseline and 6-months in DPP compared with non-DPP patients
Extracted from electronic health record
Medical encounters
Time frame: Number of medical encounters between baseline and 12-months in DPP compared with non-DPP patients
Extracted from electronic health record
Medical encounters
Time frame: Number of medical encounters between baseline and 18-months in DPP compared with non-DPP patients
Extracted from electronic health record
Medical encounters
Time frame: Number of medical encounters between baseline and 24-months in DPP compared with non-DPP patients
Extracted from electronic health record
Medical encounters
Time frame: Number of medical encounters between baseline and 30-months in DPP compared with non-DPP patients
Extracted from electronic health record
Medical encounters
Time frame: Number of medical encounters between baseline and 36-months in DPP compared with non-DPP patients
Extracted from electronic health record
Medical expenditures
Time frame: Medical expenditures from baseline to 6-months in DPP compared with non-DPP patients
Total dollar amount billed per encounter extracted from electronic health record
Medical expenditures
Time frame: Medical expenditures from baseline to 12-months in DPP compared with non-DPP patients
Total dollar amount billed per encounter extracted from electronic health record
Medical expenditures
Time frame: Medical expenditures from baseline to 18-months in DPP compared with non-DPP patients
Total dollar amount billed per encounter extracted from electronic health record
Medical expenditures
Time frame: Medical expenditures from baseline to 24-months in DPP compared with non-DPP patients
Total dollar amount billed per encounter extracted from electronic health record
Medical expenditures
Time frame: Medical expenditures from baseline to 30-months in DPP compared with non-DPP patients
Total dollar amount billed per encounter extracted from electronic health record
Medical expenditures
Time frame: Medical expenditures from baseline to 36-months in DPP compared with non-DPP patients
Total dollar amount billed per encounter extracted from electronic health record
104 secondary outcomes
Body weight
Time frame: Change in body weight from baseline to 6-months
Body weight
Time frame: Change in body weight from baseline to 12-months
Body weight
Time frame: Change in body weight from baseline to 24-months
Body weight
Time frame: Change in body weight from baseline to 36-months
Fat mass
Time frame: Change in fat mass from baseline to 6-months
Fat mass
Time frame: Change in fat mass from baseline to 12-months
Fat mass
Time frame: Change in fat mass from baseline to 24-months
Fat mass
Time frame: Change in fat mass from baseline to 36-months
Visceral fat
Time frame: Change in visceral fat from baseline to 6-months
Visceral fat
Time frame: Change in visceral fat from baseline to 12-months
Visceral fat
Time frame: Change in visceral fat from baseline to 24-months
Visceral fat
Time frame: Change in visceral fat from baseline to 36-months
Skeletal muscle mass
Time frame: Change in skeletal muscle mass from baseline to 6-months
Skeletal muscle mass
Time frame: Change in skeletal muscle mass from baseline to 12-months
Skeletal muscle mass
Time frame: Change in skeletal muscle mass from baseline to 24-months
Skeletal muscle mass
Time frame: Change in skeletal muscle mass from baseline to 36-months
Waist circumference
Time frame: Change in waist circumference from baseline to 6-months
Waist circumference
Time frame: Change in waist circumference from baseline to 12-months
Waist circumference
Time frame: Change in waist circumference from baseline to 24-months
Waist circumference
Time frame: Change in waist circumference from baseline to 36-months
Systolic blood pressure
Time frame: Change in systolic blood pressure from baseline to 6-months
Systolic blood pressure
Time frame: Change in systolic blood pressure from baseline to 12-months
Systolic blood pressure
Time frame: Change in systolic blood pressure from baseline to 24-months
Systolic blood pressure
Time frame: Change in systolic blood pressure from baseline to 36-months
Diastolic blood pressure
Time frame: Change in diastolic blood pressure from baseline to 6-months
Diastolic blood pressure
Time frame: Change in diastolic blood pressure from baseline to 12-months
Diastolic blood pressure
Time frame: Change in diastolic blood pressure from baseline to 24-months
Diastolic blood pressure
Time frame: Change in diastolic blood pressure from baseline to 36-months
Resting heart rate
Time frame: Change in resting heart rate from baseline to 6-months
Resting heart rate
Time frame: Change in resting heart rate from baseline to 12-months
Resting heart rate
Time frame: Change in resting heart rate from baseline to 24-months
Resting heart rate
Time frame: Change in resting heart rate from baseline to 36-months
Total cholesterol
Time frame: Change in total cholesterol from baseline to 6-months
Total cholesterol
Time frame: Change in total cholesterol from baseline to 12-months
Total cholesterol
Time frame: Change in total cholesterol from baseline to 24-months
Total cholesterol
Time frame: Change in total cholesterol from baseline to 36-months
HDL cholesterol
Time frame: Change in HDL cholesterol from baseline to 6-months
HDL cholesterol
Time frame: Change in HDL cholesterol from baseline to 12-months
HDL cholesterol
Time frame: Change in HDL cholesterol from baseline to 24-months
HDL cholesterol
Time frame: Change in HDL cholesterol from baseline to 36-months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2024.
- Derived from this study: PubMed 37955955Gamble A, Khan T, Hughes A, Guo Y, Vasaitis S, Bidwell J, Christman B. Telehealth Diabetes Prevention Program for Adults With Prediabetes in an Academic Medical Center Setting: Protocol for a Hybrid Type III Trial. JMIR Res Protoc. 2023 Nov 13;12:e50183. doi: 10.2196/50183.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abigail Gamble, PhD, MS principal investigator
University of Mississippi Medical Center
Tamkeen Khan, PhD principal investigator
American Medical Association
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of PreDiabetes and Prediabetic State, run by University of Mississippi Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Type 2 diabetes mellitus diagnosis (time frame: Change diabetes diagnosis from baseline to 6-months in DPP compared with non-DPP patients). The study lists 36 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04822480, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2024.