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Randomized controlled trial evaluating a mHealth intervention to optimize self- and social-regulation for emerging
Cynthia A Berg1, Deborah J Wiebe2, Jessica H Mansfield1
1Department of Psychology, University of Utah, USA.
Background:
Emerging adults (EAs) with type 1 diabetes (T1D) are at high-risk for high distress, high glycated hemoglobin (HbA1c), and inconsistent use of continuous glucose monitors (CGMs). EAs are developing self-regulation skills needed to manage T1D and social-regulation skills needed to get support. The Family/Friend Activation to Motivate Self-Care intervention was adapted for T1D (FAMS-T1D) to support EAs' self- and social-regulation needs.
Methods:
FAMS-T1D involves 1) phone-based coaching to improve diabetes management goal pursuit and manage social relationships, 2) text messaging to facilitate goal attainment and support, and 3) optional text messaging to a support person (SP) to enhance social support. In a multisite randomized controlled trial (RCT), we are testing the efficacy of a 6-month intervention (compared to enhanced treatment as usual who receive educational materials and HbA1c testing) and evaluating sustained effects at 9- and 12-months in a diverse sample of EAs and SPs. We evaluate intervention effects on HbA1c, self-management, and diabetes distress and whether the effects occur through improvements in EAs' self-regulation and social-regulation. Among participants using CGM, we explore the effect of the intervention on time in range and effects of the intervention on characteristics of CGM use.
Results:
Recruitment began April 2023 and ended on time in October 2025 (N = 256 EAs, 185 SPs). We share lessons learned about recruiting EAs for a mHealth intervention RCT.
Discussion:
FAMS-T1D has the potential for high impact and reach to help EAs with T1D develop skills for this high-risk time of development.
Trial Registration:
NCT05820477, NCT05854069.