HomeStyles-Adults of Chinese Heritage

NCT06136793 | Enrolling By Invitation

• 2 other identifiers: Pro2020001192aP50MD017356
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

Chinese heritage; Asian; Cardiometabolic disease; China; Chinese; Chronic disease; Health behavior; Dietary intake; physical activity; home environment; inflammation; randomized control trial; body mass index; hypertension; diabetes mellitus; health disparities; family; sleep; self efficacy

Outcome Measures

Primary Outcomes (8)

• Participant Health-related behaviors: Fruit/Vegetable/Fiber Intake (servings/day)

  Dietary intake: Block Fruit/Vegetable/Fiber Screener servings/day; possible range 0 to infinity

  Pre-intervention (baseline), post-intervention (~10 weeks after baseline), follow-up (~12 weeks after post-intervention)

• Participant Health-related behaviors: Sugar-sweetened Beverage Intake (servings/day)

  Dietary intake: HOMES Sugar-sweetened beverage Intake servings/day; possible range 0 to infinity

  Pre-intervention (baseline), post-intervention (~10 weeks after baseline), follow-up (~12 weeks after post-intervention)

• Participant Health-related behaviors: Physical Activity Level

  Physical activity: Streamlined International Physical Activity Questionnaire; possible range 0 to 49; 49 is highest

  Pre-intervention (baseline), post-intervention (~10 weeks after baseline), follow-up (~12 weeks after post-intervention)

• Participant Health-related behaviors: Self-Efficacy for Health Behaviors

  HOMES Self-Efficacy for Engaging in Healthy Cardiometabolic Behaviors; possible score range 1 to 5; 5 is highest

  Pre-intervention (baseline), post-intervention (~10 weeks after baseline), follow-up (~12 weeks after post-intervention)

• Participant Cardiometabolic Disease Markers: Diabetes Risk

  HbA1c; percentage; normal below 5.7%; prediabetes 5.7 to 6.4%; diabetes 6.5% or above

  Pre-intervention (baseline), post-intervention (~10 weeks after baseline), follow-up (~12 weeks after post-intervention)

• Participant Cardiometabolic Disease Markers: Height (for BMI calculation)

  Height (in cm)

  Pre-intervention (baseline), post-intervention (~10 weeks after baseline), follow-up (~12 weeks after post-intervention)

• Participant Cardiometabolic Disease Markers: Weight (for BMI calculation)

  Weight (in kg)

  Pre-intervention (baseline), post-intervention (~10 weeks after baseline), follow-up (~12 weeks after post-intervention)

• Participant Cardiometabolic Disease Markers: Waist circumference

  Waist circumference (in cm) for central adiposity assessment

  Pre-intervention (baseline), post-intervention (~10 weeks after baseline), follow-up (~12 weeks after post-intervention)

Secondary Outcomes (15)

• Participant Health-related Behavior: Sleep duration

  Pre-intervention (baseline), post-intervention (~10 weeks after baseline), follow-up (~12 weeks after post-intervention)

• Participant Cardiometabolic Disease Marker: Lipid

  Pre-intervention (baseline), post-intervention (~10 weeks after baseline), follow-up (~12 weeks after post-intervention)

• Participant Cardiometabolic Disease Marker: Inflammation

  Pre-intervention (baseline), post-intervention (~10 weeks after baseline), follow-up (~12 weeks after post-intervention)

• Other adult living in household with a cardiometabolic condition, if participant does not have cardiometabolic condition: Fruit/Vegetable/Fiber Intake (servings/day)

  Pre-intervention (baseline), post-intervention (~10 weeks after baseline), follow-up (~12 weeks after post-intervention)

• Other adult living in household with a cardiometabolic condition, if participant does not have cardiometabolic condition: Sugar-Sweetened Beverage Intake (servings/day)

  Pre-intervention (baseline), post-intervention (~10 weeks after baseline), follow-up (~12 weeks after post-intervention)

Study Arms (2)

Experimental: Healthy HomeStyles

EXPERIMENTAL

Online educational intervention

Behavioral: HomeStyles-China

Active Comparator: Safe HomeStyles

ACTIVE COMPARATOR

Online educational intervention

Behavioral: HomeStyles-China

Interventions

HomeStyles-China BEHAVIORAL

2-arm \~10 week educational intervention

Active Comparator: Safe HomeStyles; Experimental: Healthy HomeStyles

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adult of Chinese heritage \>30 years with a self-reported cardiometabolic condition or living with an adult (spouse/partner, parent) with a cardiometabolic condition; primary food gatekeeper in the household (i.e., makes all or most decisions related to family food choices); has regular Internet access, read English and/or Chinese, and resides in New York/New Jersey metro area

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

Rutgers University

New Brunswick, New Jersey, 08901, United States

Location

MeSH Terms

Conditions

Health Behavior; Feeding Behavior; Sedentary Behavior; Diabetes Mellitus; Chronic Disease; Motor Activity; Inflammation; Hypertension

Condition Hierarchy (Ancestors)

Behavior; Behavior, Animal; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Carol Byrd-Bredbenner

  Rutgers University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: concurrent treatments different in subject matter but equal in nonspecific treatment effects
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Distinguished Professor of Nutrition

Model Details: RCT

Study Record Dates

• First Submitted: November 8, 2023
• First Posted: November 18, 2023
• Study Start: August 25, 2024
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: At the conclusion of the study after study data are published
• Access Criteria: Request for data access to PI

Locations

US (1)