A Multisite, Randomized Trial Testing a Community-Digital Health Intervention among Black and Latino Adults with Cardiometabolic Conditions: The Roots of Wellness (Raíces del Bienestar) Protocol
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Background
Black and Latino adults in the United States experience a disproportionate burden of cardiometabolic conditions due to interacting behavioral, social, and structural drivers of health. Less is known about the impact of integrating digital health tools into CHW-led interventions to improve cardiometabolic health. This trial evaluates a multilevel community–digital health promotion model delivered by CHWs to improve service utilization, health behaviors and cardiometabolic health among Black and Latino adults.
Methods
This community-partnered trial uses a randomized delayed-control group with a phased recruitment design. Four cohorts (N = 664) are enrolled through three community-based organizations (CBOs). Eligible participants are ≥18 years who self-identify as Black or Latino, and have prediabetes/diabetes, hypertension, or overweight/obesity. Participants are allocated to either (1) a multilevel intervention consisting of CBO and CHW capacity building combined with individualized CHW-led lifestyle coaching and group activities supported by digital tools, or (2) a delayed control group receiving SMS-only cardiometabolic health education. Data collected at baseline, 6, 9, and 18 months include surveys and health metrics. Qualitative data are collected from participants and community partners to assess intervention acceptability, implementation facilitators and barriers, and sustainability.
Results
The primary outcome is health service utilization at 6 and 9 months. Secondary outcomes include health behaviors, health metrics, and social determinants of health. Sustainability of health behaviors and health metrics is assessed at 18 months.
Conclusions
Findings will provide evidence to inform scalable, sustainable community-digital health models for CHW-supported cardiometabolic health interventions in underserved communities.
Trial registration
Prospectively registered at ClinicalTrials.gov ( NCT06607341 ) on May 23, 2025.
Sponsor name and contact
National Institute of Health/National Heart, Lung and Blood Institute 9000 Rockville Pike, Bethesda, Maryland 20892 Phone: (301) 402-9612; Email: kimberly.durkin@nih.gov
