JMIR Publications

ABSTRACT

Background:

In 1999, type 2 diabetes (T2DM) was labeled an emerging epidemic in youth and racial and ethnic minority youth were identified at highest risk. Two decades later, there remains no gold standard T2DM prevention intervention for youth.

Objective:

This research protocol aims to test the efficacy of a telehealth diabetes prevention intervention for African American (AA) families with children at risk for T2DM. Concurrently, investigators aim to evaluate a multifaceted implementation strategy for the uptake of the intervention within the pediatric weight management clinic at the University of Mississippi Medical Center (UMMC).

Methods:

This single arm trial will enroll 20 parents with overweight or obesity of children (8- to 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 tablets 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 pediatric weight management clinic. Sessions will consist of dietary and physical activity behavior change strategies, problem-solving, and goal setting. The implementation strategy has two targets: the pediatric weight management clinic site and clinical team; and parents of children at risk for T2DM engaged in intensive obesity treatment for the prevention of T2DM. The multifacted implementation protocol includes four discrete strategies: creating a new clinical team; changing the service site; intervening with families; and organizational readiness for change.

Results:

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

Conclusions:

The proposed intervention approach is supported by the scientific literature and is scalable given current and future health care subsidies for telehealth. Findings from this pilot study 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. Clinical Trial: ClinicalTrials.gov: https://clinicaltrials.gov/ct2/show/NCT04618458