Telehealth Diabetes Prevention Intervention for African American Youth
Condition: PreDiabetes; Obesity; Obesity, Childhood
MeSH terms: Obesity; Pediatric Obesity
Study type: Interventional

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.
    

Intervention name(s): Power to Prevent
Intervention type(s): Behavioral
Intervention description(s): 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.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: prediabetic state; telehealth; healthy lifestyle; primary prevention; minority health