NCT05019339

Brief Summary

Childhood obesity prevention efforts are needed in the United States, especially for families with low income. Educating parents and caregivers on simple lifestyle and affordable home environment changes is an effective strategy to improve health outcomes for the entire family. Therefore, the purpose of this study is to determine whether HomeStyles-2, a nutrition education and childhood obesity prevention program for families with children in middle childhood (ages 6 to 11 years), motivates parents to shape their home environments and weight-related lifestyle practices to be more supportive of optimal health and weight status of their children aged 6-11 years more so than those in the control condition. The study will include the experimental group and an attention control group who will engage in a nutrition education program, Eat Healthy Be Active, that is equal in nonspecific treatment effects but does not overlap on topics covered in HomeStyles-2. This study will be implemented in Florida's Supplemental Nutrition Assistance Program-Education (SNAP-Ed) program, which provides nutrition education and obesity prevention supports for individuals with low income who are receiving or eligible for SNAP benefits. Nutrition Educators will be randomized to the experimental or attention control condition, and will lead participants through virtual, group-based nutrition education series. The following data will be collected: sociodemographic characteristics of the participant and child; child and parent health status; parent weight-related cognitions; weight-related behaviors of the participant and child; and weight-related characteristics of the home environment. Enrollment for this study will begin late-2021.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
247

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2021

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 11, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 24, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

November 19, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2023

Completed
Last Updated

June 1, 2023

Status Verified

May 1, 2023

Enrollment Period

1.4 years

First QC Date

August 11, 2021

Last Update Submit

May 31, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Participant weight-related behaviors

    Participant dietary intake and physical activity behaviors

    Baseline up to follow-up (~4 weeks after post-intervention)

Study Arms (2)

Healthy HomeStyles

EXPERIMENTAL

Six-week virtual, group nutrition education series using the HomeStyles-2 experimental curriculum administered through SNAP-Ed. This curriculum addresses factors affecting school-aged children's health and nutritional status: inadequate intake of fruits and vegetables, infrequent family meals, excessive consumption of sugar-sweetened beverages, large portion sizes, and irregular breakfast consumption.

Behavioral: Healthy HomeStyles

Eat Healthy Be Active

ACTIVE COMPARATOR

Six-week virtual, group nutrition education series using the Eat Healthy Be Active attention control curriculum administered through SNAP-Ed. This curriculum addresses factors affecting overall health and nutritional status: limiting nutrients of concern (saturated fat, sodium, and added sugars), eating healthy while dining out, eating healthy on a budget, losing weight and keeping it off, understanding nutrition facts labels, and being physically active.

Behavioral: Eat Healthy Be Active

Interventions

Comparison of 2 educational interventions

Healthy HomeStyles

Comparison of 2 educational interventions

Eat Healthy Be Active

Eligibility Criteria

Age18 Years - 110 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • SNAP-Ed-eligible (i.e., eligible for or receiving SNAP benefits, household income at or below 200% Federal Poverty Guidelines, or living in communities with significant (50% or greater) low-income population)
  • Parent or caregiver of a least 1 child aged 6 to 11 years
  • Have regular Internet and/or telephone access
  • Can read and comprehend English or Spanish
  • Reside in study catchment area (i.e., Florida)
  • Have not previously participated in nutrition education series using the attention control curriculum

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Florda

Gainesville, Florida, 32610, United States

Location

Related Publications (1)

  • Carman K, O'Neal LJ, Byrd-Bredbenner C, Olfert MD, Shelnutt KP. HomeStyles-2 for SNAP-Ed families with children in middle childhood: Cluster randomized trial protocol. Contemp Clin Trials. 2022 Jun;117:106771. doi: 10.1016/j.cct.2022.106771. Epub 2022 Apr 27.

MeSH Terms

Conditions

Child BehaviorPediatric Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

  • Karla Shelnutt, PhD

    University of Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: experimental group and attention control group
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2021

First Posted

August 24, 2021

Study Start

November 19, 2021

Primary Completion

April 30, 2023

Study Completion

April 30, 2023

Last Updated

June 1, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations