A three-arm randomized controlled trial using ecological momentary intervention, community health workers, and video feedback at family meals to improve child cardiovascular health: the Family Matters study design.

Background: Numerous observational studies show associations between family meal frequency and markers of child cardiovascular health including healthful diet quality and lower weight status. Some studies also show the "quality" of family meals, including dietary quality of the food served and the interpersonal atmosphere during meals, is associated with markers of child cardiovascular health. Additionally, prior intervention research indicates that immediate feedback on health behaviors (e.g., ecological momentary intervention (EMI), video feedback) increases the likelihood of behavior change. However, limited studies have tested the combination of these components in a rigorous clinical trial. The main aim of this paper is to describe the Family Matters study design, data collection protocols, measures, intervention components, process evaluation, and analysis plan.

Methods/design: The Family Matters intervention utilizes state-of-the-art intervention methods including EMI, video feedback, and home visiting by Community Health Workers (CHWs) to examine whether increasing the quantity (i.e., frequency) and quality of family meals (i.e., diet quality, interpersonal atmosphere) improves child cardiovascular health. Family Matters is an individual randomized controlled trial that tests combinations of the above factors across three study Arms: (1) EMI; (2) EMI + Virtual Home Visiting with CHW + Video Feedback; and (3) EMI + Hybrid Home Visiting with CHW + Video Feedback. The intervention will be carried out across 6 months with children ages 5-10 (n = 525) with increased risk for cardiovascular disease (i.e., BMI ≥ 75%ile) from low income and racially/ethnically diverse households and their families. Data collection will occur at baseline, post-intervention, and 6 months post-intervention. Primary outcomes include child weight, diet quality, and neck circumference.

Discussion: This study will be the first to our knowledge to use multiple innovative methods simultaneously including ecological momentary intervention, video feedback, and home visiting with CHWs within the novel intervention context of family meals to evaluate which combination of intervention components are most effective in improving child cardiovascular health. The Family Matters intervention has high potential public health impact as it aims to change clinical practice by creating a new model of care for child cardiovascular health in primary care.

Trial Registration: This trial is registered in clinicaltrials.gov (Trial ID: NCT02669797). Date recorded 5/02/22.