NCT04802291

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
459

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 14, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 17, 2021

Completed
2.2 years until next milestone

Study Start

First participant enrolled

May 15, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 17, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 17, 2024

Completed
Last Updated

March 24, 2026

Status Verified

March 1, 2026

Enrollment Period

1.2 years

First QC Date

March 14, 2021

Last Update Submit

March 20, 2026

Conditions

Keywords

middle childhoodparentlifestylehome environmentobesitySocial Cognitive Theory

Outcome Measures

Primary Outcomes (1)

  • Child Weight-Related behaviors

    Child dietary intake, physical activity, and sleep behaviors

    Pre-intervention (baseline), post-intervention (~8 weeks after baseline), follow-up (~4 weeks after post-intervention)

Secondary Outcomes (3)

  • Parent Weight-Related Cognitions

    Pre-intervention (baseline), post-intervention (~8 weeks after baseline), follow-up (~4 weeks after post-intervention)

  • Supports for Obesity-Preventive Measures

    Pre-intervention (baseline), post-intervention (~8 weeks after baseline), follow-up (~4 weeks after post-intervention)

  • Parent Weight-Related behaviors

    Pre-intervention (baseline), post-intervention (~8 weeks after baseline), follow-up (~4 weeks after post-intervention)

Study Arms (2)

Healthy HomeStyles

EXPERIMENTAL

Online educational intervention addressing salient factors affecting school-age children's health and nutritional status: inadequate intake of fruits and vegetables, infrequent family meals, excessive consumption of sugar-sweetened beverages, large portion sizes, irregular breakfast consumption, limited physical activity, and inadequate sleep as well as children's limited food preparation skills.

Behavioral: HomeStyles-2: Obesity Prevention Program for Families with Children in Middle Childhood

Safe HomeStyles

ACTIVE COMPARATOR

Online educational intervention addressing aspects of home safety issues, such as indoor air quality, mold \& moisture, hazardous household products, carbon monoxide, home safety, foodborne illness, and refrigerator temperatures.

Behavioral: HomeStyles-2: Obesity Prevention Program for Families with Children in Middle Childhood

Interventions

Comparison of 2 educational interventions

Healthy HomeStylesSafe HomeStyles

Eligibility Criteria

Age24 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • parent between the ages of 24 and 50 years with at least 1 child aged 6 to 11 years; primary food gatekeeper in the household (i.e., makes all or most decisions related to family food choices), have regular Internet access, read English and/or Spanish, and reside in the United States

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rutgers University

New Brunswick, New Jersey, 08901, United States

Location

Related Publications (1)

  • Byrd-Bredbenner C, Santiago E, Eck KM, Delaney CL, Quick VM, Pozzoli A, Worobey J, Shelnutt KP, Olfert MD. HomeStyles-2: Randomized controlled trial protocol for a web-based obesity prevention program for families with children in middle childhood. Contemp Clin Trials. 2022 Jan;112:106644. doi: 10.1016/j.cct.2021.106644. Epub 2021 Dec 1.

MeSH Terms

Conditions

Child BehaviorPediatric ObesityObesity

Condition Hierarchy (Ancestors)

BehaviorOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Carol Byrd-Bredbenner, PhD

    Rutgers Universitiy

    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
Model Details: experimental group and an attention control group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Distinguished Professor of Nutrition

Study Record Dates

First Submitted

March 14, 2021

First Posted

March 17, 2021

Study Start

May 15, 2023

Primary Completion

July 17, 2024

Study Completion

July 17, 2024

Last Updated

March 24, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

There is no plan to share IPD.

Locations