Clinical trial NCT04618458: Telehealth Diabetes Prevention Intervention for African American Youth
Official title: A Telehealth Diabetes Prevention Intervention for the Next Generation of African American Youth (TELE-GEN) Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PreDiabetes
Obesity
Obesity, Childhood
Keywords: prediabetic state
telehealth
healthy lifestyle
primary prevention
minority health
Lead sponsor: University of Mississippi Medical Center
Sponsor class: OTHER
First posted: 2020-11-06
Enrollment: 38
Sex: ALL
Minimum age (years): 8
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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-old) 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 (DPP) and tailored specifically for AA families. To the knowledge of the study's investigators, this intervention has not yet been evaluated in a clinical trial with AA families with children at risk for T2DM, nor been delivered via telehealth. Employing an effectiveness-implementation hybrid research design, investigators aim to concurrently: (1) conduct a single arm pilot clinical 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) comprehensively evaluate a multifaceted implementation strategy for the uptake of Power to Prevent delivered via telehealth by UMMC's pediatric weight management clinic. The primary outcome measure will be stabilization or reduction in BMI z-score in children (index participant) and a reduction in parent BMI (co-participant). 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, which will be delivered by a racially concordant Lifestyle Coach trained in the DPP. 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 videoconferencing 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). The implementation strategy has two targets: (1) UMMC's pediatric weight management clinical setting and clinical care team; and (2) overweight/obese pediatric patients and their overweight/obese parents referred to and engaged in intensive obesity treatment for the prevention of T2DM. 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 sufficient data to design a full-scale effectiveness-implementation hybrid study that will include a powered pilot randomized controlled trial (RCT) to test the interventions effectiveness for preventing T2DM, while evaluating a refined implementation protocol. The overall purpose of the TELE-GEN pilot study directly contributes to the goal of the Jackson Heart Study Community Engagement Center by leveraging existing infrastructure and technology to engage AA families in a virtual community to prevent T2DM. The proposed aims and methods also parallel the NHLBI's strategic goal to advance transnational research.

Eligibility criteria: Inclusion Criteria:

* AA parents (biological, grandparent, legal guardian) and their 8- to 11-year-old child residing in the same home.
* One overweight/obese parent (BMI ≥25 kg/m2) and child (≥ 85th% age-/sex-specific BMI).
* Parent at-risk for diabetes (American Diabetes Association risk test) AND HbA1c 5.7% - 6.4%.

Exclusion Criteria:

* child or parent has a history of T2DM or a screening HbA1c \>6.4%;
* is taking glucose-lowering medications;
* is participating in a supervised weight loss program;
* is pregnant or breast feeding;
* has conditions limiting participation;
* has undergone weight loss surgery;
* is moving out-of-state within 6 months.
* If a parent becomes pregnant during the study, we will include only child data (index participant) in analyses

Primary outcomes:
measure: Child BMI z-score
timeFrame: Change from baseline child BMI z-score to 12-weeks
measure: Child BMI z-score
timeFrame: Change from baseline child BMI z-score to 30-weeks
measure: Parent BMI
timeFrame: Change from baseline parent BMI to 12-weeks
measure: Parent BMI
timeFrame: Change from baseline parent BMI to 30-weeks
Secondary outcomes:
measure: Child physical activity
timeFrame: Change from baseline child physical activity to 12-weeks
measure: Child physical activity
timeFrame: Change from baseline child physical activity to 30-weeks
measure: Parent physical activity
timeFrame: Change from baseline parent physical activity to 12-weeks
measure: Parent physical activity
timeFrame: Change from baseline parent physical activity to 30-weeks
measure: Child out-of-school sedentary time
timeFrame: Change from baseline in child out-of-school sedentary time to 12-weeks
measure: Child out-of-school sedentary time
timeFrame: Change from baseline in child out-of-school sedentary time to 30-weeks
measure: Parent sedentary time
timeFrame: Change from baseline in parent sedentary time to 12-weeks
measure: Parent sedentary time
timeFrame: Change from baseline in parent sedentary time to 30-weeks
measure: Child Hemoglobin A1c
timeFrame: Change from baseline child Hemoglobin A1c to 12-weeks
measure: Child Hemoglobin A1c
timeFrame: Change from baseline child Hemoglobin A1c to 30-weeks
measure: Parent Hemoglobin A1c
timeFrame: Change from baseline parent Hemoglobin A1c to 12-weeks
measure: Parent Hemoglobin A1c
timeFrame: Change from baseline parent Hemoglobin A1c to 30-weeks
measure: Child systolic blood pressure
timeFrame: Change from baseline child systolic blood pressure to 12-weeks
measure: Child diastolic blood pressure
timeFrame: Change from baseline child diastolic blood pressure to 12-weeks
measure: Child systolic blood pressure
timeFrame: Change from baseline child systolic blood pressure to 30-weeks
measure: Child diastolic blood pressure
timeFrame: Change from baseline child diastolic blood pressure to 30-weeks
measure: Parent systolic blood pressure
timeFrame: Change from baseline parent systolic blood pressure to 12-weeks
measure: Parent diastolic blood pressure
timeFrame: Change from baseline parent diastolic blood pressure to 12-weeks
measure: Parent systolic blood pressure
timeFrame: Change from baseline in parent systolic blood pressure to 30-weeks
measure: Parent diastolic blood pressure
timeFrame: Change from baseline in parent diastolic blood pressure to 30-weeks
measure: Child resting heart rate
timeFrame: Change from baseline in child resting heart rate to 12-weeks
measure: Child resting heart rate
timeFrame: Change from baseline in child resting heart rate to 30-weeks
measure: Parent resting heart rate
timeFrame: Change from baseline in parent resting heart rate to 12-weeks
measure: Parent resting heart rate
timeFrame: Change from baseline in parent resting heart rate to 30-weeks
measure: Parent readiness to change
timeFrame: Change from baseline in parent readiness to change to 12-weeks
measure: Parent readiness to change
timeFrame: Change from baseline in parent readiness to change to 30-weeks
measure: Parent self-efficacy
timeFrame: Change from baseline in parent self-efficacy to 12-weeks
measure: Parent self-efficacy
timeFrame: Change from baseline in parent self-efficacy to 30-weeks
measure: Child self-efficacy
timeFrame: Change from baseline in child self-efficacy to 12-weeks
measure: Child self-efficacy
timeFrame: Change from baseline in child self-efficacy to 30-weeks
measure: Parent perceived family functioning
timeFrame: Change from baseline in parent perceived family functioning to 12-weeks
measure: Parent perceived family functioning
timeFrame: Change from baseline in parent perceived family functioning to 30-weeks
measure: Home physical activity and food environment
timeFrame: Change from baseline in parent perceived home physical activity and food environment to 12-weeks
measure: Home physical activity and food environment
timeFrame: Change from baseline in parent perceived home physical activity and food environment to 30-weeks
measure: Parent perceived child obesity-related behavior
timeFrame: Change from baseline in parent perceived child health behavior to 12-weeks
measure: Parent perceived child obesity-related behavior
timeFrame: Change from baseline in parent perceived child health behavior to 30-weeks
measure: Child perceived obesity-related behavior
timeFrame: Change from baseline in child health behavior to 12-weeks
measure: Child perceived obesity-related behavior
timeFrame: Change from baseline in child health behavior to 30-weeks
measure: Neighborhood Perception Survey
timeFrame: Change from baseline in parent neighborhood perception to 12-weeks
measure: Neighborhood Perception Survey
timeFrame: Change from baseline in parent neighborhood perception to 30-weeks
measure: Child waist circumference
timeFrame: Change from baseline in child waist circumference to 12-weeks
measure: Child waist circumference
timeFrame: Change from baseline in child and parent waist circumference to 30-weeks
measure: Parent waist circumference
timeFrame: Change from baseline in parent waist circumference to 12-weeks
measure: Parent waist circumference
timeFrame: Change from baseline in parent waist circumference to 30-weeks
measure: Parent stress
timeFrame: Change from baseline in parent stress to 12-weeks
measure: Parent stress
timeFrame: Change from baseline in parent stress to 30-weeks
measure: Child stress
timeFrame: Change from baseline in parent stress to 12-weeks
measure: Child stress
timeFrame: Change from baseline in parent stress to 30-weeks
Other outcomes:
measure: Child tanner stage
timeFrame: Change from baseline in child tanner stage to 12-weeks
measure: Child tanner stage
timeFrame: Change from baseline in child tanner stage to 30-weeks
Locations:
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
Study officials:
affiliation: University of Mississippi Medical Center
name: Abigail Gamble, PhD, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.