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HomeStyles-2: Shaping HOME Environments and LifeSTYLES to Prevent Childhood Obesity (HomeStyles-2)

Primary Purpose

Healthy Lifestyle, Home Environment Related Disease, Cognitive Change

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
HomeStyles-2: Obesity Prevention Program for Families with Children in Middle Childhood
Sponsored by
Rutgers, The State University of New Jersey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Healthy Lifestyle focused on measuring middle childhood, parent, lifestyle, home environment, obesity, Social Cognitive Theory

Eligibility Criteria

24 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Does not fit inclusion criteria

Sites / Locations

  • Rutgers UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Healthy HomeStyles

Safe HomeStyles

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Child Weight-Related behaviors
Child dietary intake, physical activity, and sleep behaviors

Secondary Outcome Measures

Parent Weight-Related Cognitions
Parent self-efficacy, outcome expectations, attitudes, modeling
Supports for Obesity-Preventive Measures
Parent weight-related parenting behaviors; home availability of foods; space and supports for physical activity
Parent Weight-Related behaviors
Parent dietary intake, physical activity, and sleep behaviors

Full Information

First Posted
March 14, 2021
Last Updated
July 6, 2023
Sponsor
Rutgers, The State University of New Jersey
Collaborators
United States Department of Agriculture (USDA)
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1. Study Identification

Unique Protocol Identification Number
NCT04802291
Brief Title
HomeStyles-2: Shaping HOME Environments and LifeSTYLES to Prevent Childhood Obesity
Acronym
HomeStyles-2
Official Title
HomeStyles-2: Shaping HOME Environments and LifeSTYLES to Prevent Childhood Obesity
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 15, 2023 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rutgers, The State University of New Jersey
Collaborators
United States Department of Agriculture (USDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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. RCT Design CONSORT guidelines extension for social and psychological intervention trials will be used to generate a participant flow diagram and report RCT enrollment and retention data.113 Interested participants will begin by completing a short eligibility screener survey. Eligible participants who give informed consent will have immediate access to the baseline survey. Those who complete the baseline survey, meet survey plausibility checks (e.g., consistent answers to items measuring the same concept, meet minimal likely completion time, do not answer to all questions on a survey page the same), and complete the registration page (i.e., provide name and contact information) will be enrolled in the RCT. Enrolled participants will be systematically randomized by computer by alternating assignment to the experimental or attention control study condition. Recruitment materials and the bona fide treatment to be delivered to the attention control group are designed to blind participant assignment to study condition. Participants will receive intervention materials starting immediately after registration and at weekly intervals for 8 weeks. In week 9 of the study, participants will be invited to take the post survey to assess intervention effects Approximately 8 to 10 weeks after participants complete the post survey, they will be invited to take the follow-up survey to assess longer-term intervention effects. Each week parents will be encouraged to spend about 15 minutes reviewing intervention materials; think about the changes like those suggested in the materials that could help their families; and implement 1 or 2 easy, quick, low-cost changes in their homes. Intervention materials (described in a subsequent section) provided each week for 8 weeks include an electronic informational guide for parents, tracker to list guide-related goals for the week and monitor progress toward them, 3 to 4 encouraging nudges delivered by SMS and email, and a guide for kids that is available electronically and is mailed to the participant homes along with a reminder magnet. Participant progress through the RCT will be monitored by project staff by observing their visits to the website. Bilingual staff will be trained in customer service strategies and instructed to quickly address any participant queries submitted by email or phone using scripted responses to ensure equitable care across study groups. Participants will receive modest stipends that increase in value after they complete each survey. Experimental Group Intervention The HomeStyles-2 experimental group intervention materials (i.e., "Healthy" HomeStyles-2) were designed to be congruent with White House and IOM recommendations for home-centered obesity prevention interventions and critical elements for effective interventions (e.g., interventions are positive, culturally sensitive, supportive of parent-child interaction and child development; develop realistic, effective plans that empower families). Like HomeStyles for preschoolers, HomeStyles-2 for middle childhood intervention materials provide intensive, interactive, fun, non-judgmental opportunities for parents to shape their home environments and lifestyle practices to protect child health. They also promote positive strategies and changes that adults can control in their environments to reduce risk of excessive weight gain in their middle childhood youth. A positive approach teaches individuals what they can do (eat more fruits) rather than giving prohibitions (cut out fries). Substantial evidence supports parent preference for positive messages and the value of promoting positive vs restrictive behaviors to achieve health goals. Intervention Content. Key factors contributing to childhood obesity that can be suitably addressed in the home environment with middle childhood kids identified for inclusion in the intervention materials were selected using systematic literature reviews and input from experts in childhood obesity prevention. The most salient factors affecting school-age children's health and nutritional status that emerged were 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. An additional factor was children's limited food preparation skills. Attitudes toward engaging in healthy behaviors (i.e., eating fruits and vegetables, having family meals, curtailing intake of sweet beverages, controlling portion sizes, eating breakfast, getting physical exercise and limiting screentime, getting sufficient sleep, and giving children food preparation opportunities), barriers to performing healthy behaviors, strategies for overcoming barriers to healthy behaviors, and confidence in the ability to perform healthy behaviors regularly, as well as determinants of quality of life, were explored via focus groups with parents of middle-childhood youth and children ages 6 to 11 years. Attention Control Intervention The attention control intervention will use bona fide, credible materials that are structurally equivalent to the experimental group. The attention control treatment will be credible in that it focuses on a topic fitting the description of the study recruitment materials (i.e., shaping homes and lifestyles to help kids grow up even happier and healthier) yet providing distinctly different, non-overlapping content (i.e., home safety) devoid of the RCT "active" ingredient (i.e., content related to childhood obesity prevention). The attention control intervention materials include the same components as those used in the experimental group (i.e., parent guides, trackers, children's guides, and reminder magnets) with the content focused on home safety. The Safe HomeStyles parent guides, like the HomeStyles! Guide for the experimental group provided an overview of home safety. The other parent guides, as well as the children's guides, trackers, and reminder magnets, focus on indoor air quality, mold & moisture, hazardous household products, carbon monoxide, home safety, foodborne illness, and refrigerator temperatures. The Safe HomeStyles materials have an appearance and structure similar to those in the experimental group. Instruments The study survey, "Home Obesogenicity Measure of EnvironmentS"-Families with School-age Kids (HOMES-FSAK), will be used to collect baseline, post, and follow-up data in the HomeStyles-2 RCT. The Social Cognitive Theory along with the key concepts addressed in the HomeStyles-2 guides provided the framework for identification of cognitions, behaviors, and aspects of the home environment to be assessed. Online survey collection procedures will be used to collect baseline, post, and follow-up data. The survey 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Lifestyle, Home Environment Related Disease, Cognitive Change, Child Behavior, Child Obesity, Parenting, Parents, Parent-Child Relations
Keywords
middle childhood, parent, lifestyle, home environment, obesity, Social Cognitive Theory

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
experimental group and an attention control group
Masking
Participant
Masking Description
concurrent treatments different in subject matter but equal in nonspecific treatment effects
Allocation
Randomized
Enrollment
269 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Healthy HomeStyles
Arm Type
Experimental
Arm Description
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.
Arm Title
Safe HomeStyles
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
HomeStyles-2: Obesity Prevention Program for Families with Children in Middle Childhood
Intervention Description
Comparison of 2 educational interventions
Primary Outcome Measure Information:
Title
Child Weight-Related behaviors
Description
Child dietary intake, physical activity, and sleep behaviors
Time Frame
Pre-intervention (baseline), post-intervention (~8 weeks after baseline), follow-up (~4 weeks after post-intervention)
Secondary Outcome Measure Information:
Title
Parent Weight-Related Cognitions
Description
Parent self-efficacy, outcome expectations, attitudes, modeling
Time Frame
Pre-intervention (baseline), post-intervention (~8 weeks after baseline), follow-up (~4 weeks after post-intervention)
Title
Supports for Obesity-Preventive Measures
Description
Parent weight-related parenting behaviors; home availability of foods; space and supports for physical activity
Time Frame
Pre-intervention (baseline), post-intervention (~8 weeks after baseline), follow-up (~4 weeks after post-intervention)
Title
Parent Weight-Related behaviors
Description
Parent dietary intake, physical activity, and sleep behaviors
Time Frame
Pre-intervention (baseline), post-intervention (~8 weeks after baseline), follow-up (~4 weeks after post-intervention)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
24 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Does not fit inclusion criteria
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carol Byrd-Bredbenner, PhD
Phone
8489320965
Email
bredbenner@sebs.rutgers.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Virginia Quick, PhD
Phone
8489320965
Email
vquick@njaes.rutgers.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carol Byrd-Bredbenner, PhD
Organizational Affiliation
Rutgers Universitiy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rutgers University
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carol Byrd-Bredbenner, PhD
Phone
848-932-0965
Email
bredbenner@sebs.rutgers.edu
First Name & Middle Initial & Last Name & Degree
Virginia Quick, PhD
Phone
8489320965
Email
vquick@njaes.rutgers.edu

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to share IPD.
Citations:
PubMed Identifier
34861408
Citation
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.
Results Reference
derived

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HomeStyles-2: Shaping HOME Environments and LifeSTYLES to Prevent Childhood Obesity

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