A Text-Messaging Lifestyle Program to Promote Cardiovascular Health in Families: Development and Feasibility Study

About This Grant

PROJECT SUMMARY The proposed K01 award aims to provide Dr. Formagini with training and research experience to achieve her long-term goal of becoming an independent investigator in cardiovascular disease (CVD) prevention. This experience will allow Dr. Formagini to develop, evaluate, and implement health system–based lifestyle change programs for U.S. families who primarily speak Spanish using digital interventions. CVD remains the leading cause of morbidity and mortality in the U.S., driven largely by obesity and diabetes—both highly prevalent among Spanish-speaking families. Evidence-based lifestyle change programs implemented in healthcare and community settings have shown that modest body weight loss (~5%) through physical activity and dietary changes leads to improved cardiovascular health. However, the reach and impact of these programs among Spanish-speaking families remain suboptimal. To improve cardiovascular health, innovative approaches are needed to make these programs more accessible and impactful for Spanish-speaking families in settings where they receive health care. The overall objective of this K01 research is to adapt an existing text- messaging lifestyle change program—originally developed for Spanish-speaking adults—to target family member dyads. This study will evaluate the feasibility, acceptability, and preliminary effects of the adapted program within Kaiser Permanente Southern California (KPSC). The project's specific aims are twofold: In Specific Aim 1, we will adapt our existing 6-month text-messaging library for Spanish-speaking family member dyads, in collaboration with an Expert Advisory Board. Text-messages will align with an evidence-based curriculum, be tailored for Spanish-speaking populations, and be designed to promote joint lifestyle change among dyads. Following the completion of this aim, we will initiate Specific Aim 2 by conducting a 6-month pilot randomized controlled trial among 30 family-member dyads (n=60). Aim 2a will evaluate the intervention’s feasibility and acceptability using a mixed-methods approach. In Aim 2b, we will obtain data on the preliminary 6-month effects of the intervention on key outcomes, including body weight (primary outcome) and physical activity, diet, BMI, blood pressure, A1c, and lipid profile (secondary outcomes). This K01 will provide critical data on the feasibility, acceptability, and preliminary effects of a fully-remote text-messaging lifestyle program in a large health system, and will guide an R01 proposal to test the program’s effectiveness. To accomplish the study aims and attain independence, Dr. Formagini will pursue extensive training in health system–embedded research, digital health interventions focused on text-messaging, and clinical trials. An interdisciplinary mentorship team with expertise in these domains will facilitate her development as an independent investigator. If successful, this project will combine digital accessibility with family engagement to establish a scalable intervention for improving cardiovascular health among Spanish-speaking families, with potential for expansion to other healthcare and community settings.