HomeStyles-Adults of Chinese Heritage

Part of paid clinical trials in New Brunswick, New Jersey.

Sponsor
Rutgers, The State University of New Jersey
Study ID
NCT06136793
Status
Enrolling By Invitation

Conditions

  • Cardiometabolic Disease
  • Diabetes Mellitus
  • Dietary Habits
  • Gut Microbiota
  • Health Behavior
  • Healthy Lifestyle
  • Home Environment Related Disease
  • Physical Inactivity
  • Self Efficacy
  • Systemic Inflammatory Response

Eligibility Criteria

Sex
ALL
Age
30 Years - 70 Years
Healthy Volunteers
Accepted

Interventions

  • HomeStyles-China — BEHAVIORAL
    2-arm \~10 week educational intervention

Study Details

Individuals of Chinese heritage are the largest and fastest growing segment of the US Asian population. US Chinese have sociodemographic characteristics and culture that differ substantially from other US Asians, and therefore, differ in social determinants of health, health status, and disease risk. US Chinese adults are at increased risk for cardiometabolic disease, related conditions (obesity, type 2 diabetes mellitus, hypertension), and systemic inflammation that promotes disease onset and progression. Immigration to a new country can substantially impact the gut microbiome which may promote systemic inflammation. Pilot interventions indicate a high-fiber diet rich in whole grains reduced inflammation and improved obesity. Additionally, the United States Department of Agriculture (USDA) supported, evidence-based HomeStyles intervention has demonstrated feasibility, acceptability, and efficacy in improving lifestyle behaviors and home environments associated with obesity risk in families. A lack of linguistically, culturally tailored interventions to their specific health needs makes it difficult for US Chinese to implement healthy lifestyle behaviors and reduce health risks. Interventions tailored for US Chinese that could attenuate modifiable cardiometabolic risk factors, understand physiological sequelae, and bridge health equity are not currently available. Thus, the overall goal of this project is to test the efficacy of HomeStyles in improving health outcomes in US Chinese. Project aims are to: A) Culturally adapt the HomeStyles intervention through community-engaged approaches. B) Conduct a 10-week, 2-armed Randomized Controlled Trial (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. C) 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.

Key Dates

Start date
Aug 25, 2024
Status verified
Mar 2026
Primary completion
May 31, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
400 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Experimental: Healthy HomeStyles
    Online educational intervention
  • Active Comparator: Active Comparator: Safe HomeStyles
    Online educational intervention

Primary Outcome Measure

Participant Health-related behaviors: Fruit/Vegetable/Fiber Intake (servings/day) [ Time Frame: Pre-intervention (baseline), post-intervention (~10 weeks after baseline), follow-up (~12 weeks after post-intervention) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Rutgers UniversityNew BrunswickNew Jersey08901-

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Rutgers University· New Brunswick, NJ

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