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TELE-GEN
A Telehealth Diabetes Prevention Intervention for the Next Generation of African American Youth (TELE-GEN) Pilot Study
Sponsor study identifier
Secondary identifiers
OTHER_GRANT · Jackson Heart Study Community Engagement Center
interventional
38
1 country
1
Study Start
December 1, 2020
Actual (reported)Primary Completion
December 18, 2021
Actual (reported)Study Completion
December 18, 2021
Actual (reported)The Telehealth Diabetes Prevention Intervention for the Next Generation of African American Youth (TELE-GEN) pilot study will evaluate the implementation and early efficacy of a telehealth diabetes prevention intervention for African American (AA) children (8- to 11-years) and their parents. Power to Prevent is a lifestyle diabetes prevention intervention from the Centers for Disease Control and Prevention that is based on the Diabetes Prevention Program and tailored for AA families. To investigators knowledge, this intervention has not been evaluated in a clinical trial with AA families with children at risk for type 2 diabetes mellitus (T2DM), nor been delivered via telehealth. Employing an effectiveness-implementation hybrid study design, investigators aim to concurrently (1) conduct a single arm pilot trial to assess the early efficacy of Power to Prevent delivered via telehealth to treat overweight/obesity in AA children and their parent, while (2) evaluating an implementation strategy for the uptake of the intervention by the pediatric weight management clinic at the University of Mississippi Medical Center. The primary outcome will be stabilization or reduction in BMI z-score in children (index participant) and reduction in parent BMI (co-participant). Parents (n=20) will receive the same telehealth diabetes prevention intervention, which will be delivered by a racially concordant, trained Lifestyle Coach using small-group videoconferencing (5 parents per group). Sessions will consist of nutrition and physical activity behavior change strategies (20 min), problem solving and decision-making skills to circumvent barriers to behavioral change (20 min), and family goal setting and action planning (20 min). Child and parent measures will be assessed at baseline, 12-weeks (post-intervention), and 30-weeks (follow-up). The implementation strategy has two targets: (1) the pediatric weight management clinical and clinical care team; and (2) overweight/obese pediatric patients and their overweight/obese parents. The multifaceted implementation plan includes four discrete strategies: (1) creating a new clinical team; (2) changing the service site; (3) intervening with families; and (4) assessing organizational readiness. Preliminary findings will provide data to design a full-scale study that will include a powered pilot randomized controlled trial to test the interventions effectiveness for preventing T2DM, while evaluating a refined implementation protocol.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 18, 2021
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 19, 2020
Actual (reported)November 6, 2020
Actual (reported)December 1, 2020
Actual (reported)December 18, 2021
Actual (reported)December 18, 2021
Actual (reported)Child BMI z-score
Standard anthropometric procedures and a calibrated body weight scale (Seca 777 digital scale with stadiometer) will be used to measure participants' weight (0.1kg), stature (0.1 cm); child BMI percentile will be calculated using the statistic equations made available on the Centers for Disease Control and Prevention (CDC) website
Change from baseline child BMI z-score to 12-weeks
Child BMI z-score
Standard anthropometric procedures and a calibrated body weight scale (Seca 777 digital scale with stadiometer) will be used to measure participants' weight (0.1kg), stature (0.1 cm); child BMI percentile will be calculated using the statistic equations made available on the CDC website
Change from baseline child BMI z-score to 30-weeks
Parent BMI
Eligible overweight/obese children and their overweight/obese parent (N=20 families) will receive the same telehealth diabetes prevention intervention based on Power to Prevent and delivered by a trained lifestyle coach. Families will meet weekly for 11-weeks (60-min sessions), and then monthly (60-min sessions) for 4 pilot behavioral reinforcement maintenance sessions (15 sessions total). Participants will meet in their respective groups (n=5 families per group) via videoconference using Wi-Fi-enabled tablets with cellular connectivity for the entire intervention. Sessions will consist of nutrition and physical activity behavior change strategies (20 min), problem solving and decision-making skills to circumvent barriers to behavioral change (20 min), and family goal setting and action planning (20 min). Assessment measures will be collected from the child and parent participants at baseline, 12-weeks (post-intervention), and 30-weeks (follow-up).
Lifestyle diabetes prevention intervention based on the National Diabetes Prevention Program and tailored for African American families. The intervention will be delivered using telehealth and small group videoconferencing.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
Gamble A, Beech BM, Wade BC, Sutton VD, Lim C, Sandridge S, Welsch MA. Telehealth Diabetes Prevention Intervention for the Next Generation of African American Youth: Protocol for a Pilot Trial. JMIR Res Protoc. 2021 Mar 31;10(3):e25699. doi: 10.2196/25699.
Abigail Gamble, PhD, MS
University of Mississippi Medical Center
38 participants (actual enrollment reported by the registry).
First Submitted
October 19, 2020
First Posted
November 6, 2020
Study Start
December 1, 2020
Actual (reported)Standard anthropometric procedures and a calibrated body weight scale will be used to measure participants' weight (0.1kg), stature (0.1 cm); after converting cm to m, BMI = kg/m2
Change from baseline parent BMI to 12-weeks
Parent BMI
Standard anthropometric procedures and a calibrated body weight scale will be used to measure participants' weight (0.1kg), stature (0.1 cm); after converting cm to m, BMI = kg/m2
Change from baseline parent BMI to 30-weeks
Child physical activity
Change from baseline child physical activity to 12-weeks
Child physical activity
Change from baseline child physical activity to 30-weeks
Parent physical activity
Change from baseline parent physical activity to 12-weeks
Parent physical activity
Change from baseline parent physical activity to 30-weeks
Child out-of-school sedentary time
Change from baseline in child out-of-school sedentary time to 12-weeks
Child tanner stage
Change from baseline in child tanner stage to 12-weeks
Child tanner stage
Change from baseline in child tanner stage to 30-weeks
Contact the study team to confirm eligibility.
Primary Completion
December 18, 2021
Actual (reported)Study Completion
December 18, 2021
Actual (reported)Last Updated
August 8, 2022
Record last verified: 2022-08
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Source: ClinicalTrials.gov.
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