Telehealth Diabetes Prevention Intervention for the Next Generation of African American Youth: Protocol for a Pilot Trial
Authors: Gamble Abigail , Beech Bettina M , Wade Breanna C , Sutton Victor D , Lim Crystal , Sandridge Shanda , Welsch Michael A 
Published: December 2020

Background
In 1999, type 2 diabetes mellitus (T2DM) was identified as an emerging epidemic in youth, and racial and ethnic minority youth were identified with high risk. Two decades later, no gold standard T2DM prevention intervention has been established for this population.

Objective
This study tests the efficacy of a telehealth diabetes prevention intervention for African American (AA) families with children with risk for T2DM. Concurrently, investigators aim to evaluate an implementation strategy for the uptake of the intervention by the University of Mississippi Medical Center’s (UMMC) pediatric weight management clinic.

Methods
This single-arm trial will enroll 20 parents with overweight or obesity of children (8-11 years) with overweight or obesity, both of whom are at risk for T2DM. Parents will meet in small groups (5 parents per group) weekly for 11 weeks and then monthly for 4 monthly maintenance sessions via videoconference using Wi-Fi–enabled iPads with cellular connectivity. The intervention will be adapted from the National Diabetes Prevention Program and Power to Prevent, a diabetes prevention program tailored for AA families. The same lifestyle intervention facilitated by a racially concordant lifestyle coach trained in the Diabetes Prevention Program will be delivered to all groups (n=4). Participants will be recruited in-person during patient encounters at the UMMC’s pediatric weight management clinic. Sessions will consist of dietary and physical activity behavior change strategies facilitated using problem-solving and goal-setting skills. The implementation strategy has 2 targets: the pediatric weight management clinic site and clinical team and parents of children at risk for T2DM engaged in intensive obesity treatment to prevent T2DM. The multifaceted implementation protocol includes 4 discrete strategies: creating a new clinical team, changing the service site, intervening with families, and promoting organizational readiness for change.

Results
Recruitment and enrollment began in December 2020, and the intervention is scheduled to be delivered to the first cohort of parents in March 2021. The results are expected to be submitted for publication beginning in November 2021 through 2022. The primary outcome measure for the pilot trial will include changes from baseline to 12 and 30 weeks in the child BMI z score and parent BMI. The implementation evaluation will include multiple measures of feasibility, acceptability, appropriateness, fidelity, and efficacy. This protocol was approved by the UMMC’s Institutional Review Board (#2020V0249).

Conclusions
The proposed intervention approach is supported by the scientific literature and is scalable given the current and future health care subsidies for telehealth. Findings from this pilot trial will begin to address critical barriers to defining a gold standard lifestyle intervention for AA families with children at risk for T2DM. If effective, the intervention could be feasibly disseminated to treat obesity and prevent T2DM in high-risk AA pediatric populations.

International Registered Report Identifier (IRRID)
PRR1-10.2196/25699