JMIR Publications

ABSTRACT

Background:

Maternal obesity is associated with significant racial disparities, with Black and Latina women at highest risk for related adverse short- and long-term health outcomes (e.g., hypertension in pregnancy, postpartum weight retention). Remote lifestyle interventions delivered during and after pregnancy hold promise for supporting healthy weight outcomes; however, few are tested in Black and Latina groups or address the neighborhood-level and psychosocial factors driving maternal health disparities. Implementing remote lifestyle interventions into community-based programs that serve birthing people may optimize trust and engagement, and promote scalability and sustainability to have a public health impact.

Objective:

The goal of the trial described in this paper is to test the effectiveness of a culturally adapted remote lifestyle intervention (Healthy for Two-Home Visiting; H42-HV) implemented into home visiting compared with usual home visiting services (maintain Health in Pregnancy and Postpartum; mHIPP) on postpartum weight retention among Black and Latina pregnant/postpartum individuals. Facilitators and barriers to implementation of the intervention into home visiting will be examined.

Methods:

We describe the rational and protocol for this hybrid type 1 effectiveness-implementation randomized clinical trial. In this paper we will highlight the community-engaged approach and trial design features that enable its implementation into home visiting and applicability of the intervention to the target population. Participants will be 360 pregnant individuals with overweight or obesity enrolled between 20-33 weeks gestation and randomized 1:1 to H42-HV vs. usual home visiting services. The primary outcome is weight retention at 6 months postpartum, calculated as 6-month postpartum weight minus earliest pregnancy weight (≤ 18 weeks gestation). Measures of implementation include intervention feasibility, acceptability, reach, adoption and fidelity. Throughout the paper we will highlight the community input used to improve intervention effectiveness and study implementation, and as a strategy to promote maternal health equity.

Results:

This study was funded in June 2021 and recruitment began in April 2023. Data collection for the intervention effectiveness is expected to end in June 2026. Implementation evaluation is expected to conclude in December 2026.

Conclusions:

This hybrid type I effectiveness-implementation randomized trial integrates a culturally adapted remote lifestyle intervention into early home visiting services to examine its effectiveness on postpartum weight retention compared to usual home visiting. We anticipate that the study results will enable an understanding of the drivers of successful implementation in a community-based setting to maximize future sustainability and dissemination of a strategy for reducing long-term obesity and other maternal health disparities. Clinical Trial: NCT05619705