CAHPE #1

ClinicalTrials.gov link

Diseases or Conditions Being Studied
Healthy lifestyle, Home environment related disease, cognitive change, child behavior, child obesity, parenting parents, parent-child relations

Communities of Focus
Parents between the ages of 24 and 50 years 

Study Objectives
Determine if the HomeStyles intervention enables and motivates parents to shape their home environments and weight-related lifestyle practices (i.e., diet, exercise, sleep) to be more supportive of optimal health and reduced risk of obesity in their middle childhood youth more than those in the control condition

Intervention or Treatment
Online educational intervention addressing salient factors affecting school-age children's health and nutritional status

Abstract

Parents are children's primary role models, are food and physical activity gatekeepers, and create the structure/lifestyle environment within the home. Thus, parents strongly influence children's weight-related behaviors and have the opportunity to cultivate a "culture of health" within the home. Yet, there continues to be a dearth of evidence-based obesity prevention intervention programs, especially for families with children aged 6 to 11 years, commonly called the middle childhood years. The aim of the HomeStyles-2 online learning mode RCT is to determine whether this novel, age-appropriate, family intervention enables and motivates parents to shape their home environments and weight-related lifestyle practices (i.e., diet, exercise, sleep) to be more supportive of optimal health and reduced risk of obesity in their middle childhood youth more than those in the control condition. The RCT will include the experimental group and an attention control group who will engage in a bona fide concurrent treatment different in subject matter but equal in nonspecific treatment effects. The participants will be families with school-age children who are systematically randomly assigned by computer to study condition. The HomeStyles intervention is predicated on the social cognitive theory and a social ecological framework. The RCT will collect sociodemographic characteristics of the participant, child, and partner/spouse; child and parent health status; parent weight-related cognitions; weight-related behaviors of the parent and child; and weight-related characteristics of the home environment. Enrollment for this study will begin mid-2021.This paper describes these aspects of the HomeStyles-2 intervention: rationale; sample eligibility criteria and recruitment; study design; experimental group intervention theoretical and philosophical underpinnings, structure, content, and development process; attention control intervention; survey instrument development and components; outcome measures; and planned analyses.

Specific Aims

1. Culturally adapt the HomeStyles intervention through community-engaged approaches.

2. Conduct a 10-week, 2-armed RCT to test HomeStyles intervention efficacy on health outcomes (dietary intake, physical activity, self-efficacy, HbA1C, waist circumference, and BMI), hypothesizing that participants randomized to the treatment condition will have greater improvements in health outcomes than control comparators.

3. Examine associations between intervention participation and gut microbiota/systemic inflammation and test hypotheses that a whole-grain rich diet adopted by those in the intervention group will increase anti-inflammatory gut bacteria, reduce inflammatory gut bacteria, and lower systemic inflammation.

This proposal’s aims parallel NIMHD’s specific interests, as well as RFA MD-21-007. This includes interventions, like HomeStyles, that aim to ameliorate health inequities in minority populations and reduce multiple common risk factors (e.g., obesity, poor nutrition, physical inactivity, insufficient sleep, systemic inflammation) for multiple chronic diseases as well as address multi-generational chronic disease risk and protective factors. A culturally adapted HomeStyles intervention holds great potential for improving our knowledge about health disparity in the U.S. Chinese population, understanding translational mechanisms toward comorbidities, informing family and community-oriented interventions through sustainable engagement, and serving as a model for health interventions for this audience.