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[Preprint]. 2023 Sep 12:2023.09.11.23295374.
doi: 10.1101/2023.09.11.23295374.

Glycemic outcomes of a family-focused intervention for adults with type 2 diabetes: Main, mediated, and subgroup effects from the FAMS 2.0 RCT

Lyndsay A Nelson  1   2 , Andrew J Spieker  3 , Robert A Greevy  3 , McKenzie K Roddy  1   2 , Lauren M LeStourgeon  1   2 , Erin M Bergner  1   2 , Merna El-Rifai  1   2 , James E Aikens  4 , Ruth Q Wolever  5   6 , Tom A Elasy  1   2 , Lindsay S Mayberry  1   2   7
Affiliations

Glycemic outcomes of a family-focused intervention for adults with type 2 diabetes: Main, mediated, and subgroup effects from the FAMS 2.0 RCT

Lyndsay A Nelson et al. medRxiv. .

Update in

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.

Keywords: family; mobile health; randomized controlled trial; self-care; social support; type 2 diabetes mellitus.

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Conflict of interest statement

Declaration of competing interests: The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Figures

Figure 1.
Figure 1.
CONSORT flow diagram
Figure 2.
Figure 2.
A heuristic depiction of the mediation model predicting hemoglobin A1c (HbA1c) at 9 months. We repeated the model at both 12 and 15 months. For simplicity, the heuristic only shows two mediators; actual models included eight mediators.
See this image and copyright information in PMC

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