Abstract
Aims Family/friends Activation to Motivate Self-care (FAMS) is a self-care support intervention delivered via mobile phones. We evaluated FAMS effects on hemoglobin A1c (HbA1c) and intervention targets among adults with type 2 diabetes in a 15-month RCT.
Methods Persons with diabetes (PWDs) and their support persons (family/friend, optional) were randomized to FAMS or control. FAMS included monthly phone coaching and text messages for PWDs, and text messages for support persons over a 9-month intervention period.
Results PWDs (N=329) were 52% male, 39% from minoritized racial or ethnic groups, with mean HbA1c 8.6±1.7%. FAMS improved HbA1c among PWDs with a non-cohabitating support person (−0.64%; 95% CI [-1.22%, −0.05%]), but overall effects were not significant. FAMS improved intervention targets including self-efficacy, dietary behavior, and family/friend involvement during the intervention period; these improvements mediated post-intervention HbA1c improvements (total indirect effect −0.27%; 95% CI [-0.49%, −0.09%]) and sustained HbA1c improvements at 12 months (total indirect effect −0.19%; 95% CI [−0.40%, −0.01%]).
Conclusions Despite improvements in most intervention targets, HbA1c improved only among PWDs engaging non-cohabitating support persons suggesting future family interventions should emphasize inclusion of these relationships. Future work should also seek to identify intervention targets that mediate improvements in HbA1c.
Competing Interest Statement
The authors have declared no competing interest.
Clinical Trial
NCT04347291
Clinical Protocols
https://classic.clinicaltrials.gov/ProvidedDocs/91/NCT04347291/Prot_001.pdf
https://doi.org/10.1016/j.cct.2022.106956
Funding Statement
This research was funded by the National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) through R01-DK119282.
Author Declarations
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The details of the IRB/oversight body that provided approval or exemption for the research described are given below:
The Institutional Review Board of Vanderbilt University gave ethnical approval for this work.
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Data Availability
All data produced in the present study are available upon reasonable request to the authors