Families in Balance: Enhancing Household Routines and Reducing Early Childhood Obesity Among Families With Low-income

This study will evaluate the effects of two different approaches to support healthy family mealtime, sleep, and screentime routines: A parent leader-guided online program that promotes parent and child self-regulation as a means to improve healthy family routines versus an asynchronous program that provides parents information about healthy family routines. Families will be randomly assigned to either of these programs and changes in parent and child outcomes will be evaluated.

Study Overview

• Status: Recruiting
• Conditions: Health Behavior
• Intervention / Treatment: Behavioral: Online program; Behavioral: Control Condition

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michelle Clayson; Phone Number: 734-763-2003; Email: mclayson@umich.edu

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Recruiting
      • University of Michigan
      • Contact: Michelle Clayson; Phone Number: 734-763-2003; Email: mclayson@umich.edu
      • Principal Investigator: Kate Bauer, PhD, MS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Parents must be the legal and custodial guardian of a 2 through 5-year-old child
• Parents must report that their child is eligible for public health insurance
• Parents must be able to complete the study activities in English
• Parents must be able to complete study activities at a study location or at home, and online/via Zoom.

Exclusion Criteria:

- Children must not have serious medical problems that affect weight, sleep, activity, or eating.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Online Program; Parents will participate in an online program.	Behavioral: Online program; Families in Balance Online is a 6-week online program that includes 6 weekly group discussions and 3 individual support sessions, all held over Zoom. Program activities will focus on improving parent and child self-regulation as a means to encourage healthy family mealtime, sleep, and screentime routines. Participants will engage in in person and online data collection activities to understand whether the program is impactful.
Active Comparator: Control condition - Informational materials via email; Parents will receive information via email.	Behavioral: Control Condition; Families in Balance is an asynchronous program in which participants will be sent materials weekly over 6 weeks to encourage healthy family mealtime, sleep, and screentime routines. Participants will engage in in person and online data collection activities to understand whether the program is impactful.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Child age and sex-adjusted Body Mass Index (BMI)	Differences in age- and sex-adjusted body mass index (BMI) among children of parents randomized to Families in Balance Online compared to children of parents randomized to Families in Balance at follow-up. Children's weight and height will be used to calculate BMI and measured using standardized protocols at baseline and follow-up.	Base line (pre-intervention) and approximately 5 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Child sleep duration	This will be reported in minutes using data from surveys completed by parents.	Base line (pre-intervention) and approximately 5 months
Child daily screentime	This will be reported in minutes using data from surveys completed by parents.	Base line (pre-intervention) and approximately 5 months
Child intake of key food groups	This will be measured using a parent-completed 25-item dietary screener assessing intake of key foods/food groups (e.g., fruits and vegetables, sugar-sweetened beverages)	Base line (pre-intervention) and approximately 5 months
Child sleep routines	This will be measured through parent completion of the Child Sleep Hygiene Scale which assesses 6 aspects of children's sleep/bedtime routines.	Base line (pre-intervention) and approximately 5 months
Child screentime limits	This will be measured through parent completion of survey items measuring parents' limit setting with respect to screentime.	Base line (pre-intervention) and approximately 5 months
Family meal frequency	This will be measured through parents' completion of survey items assessing the frequency with which families ate meals together.	Base line (pre-intervention) and approximately 5 months

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: Health Resources and Services Administration (HRSA)
• Investigators: Principal Investigator: Katherine Bauer, PhD, University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2025
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: January 21, 2025
• First Submitted That Met QC Criteria: January 21, 2025
• First Posted (Actual): January 28, 2025

Study Record Updates

• Last Update Posted (Actual): April 6, 2026
• Last Update Submitted That Met QC Criteria: April 2, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Sleep; Surveys; Body mass index; Health behaviors; Online program; Informational material; Eating activity
• Additional Relevant MeSH Terms: Behavior; Health Behavior
• Other Study ID Numbers: HUM00263046; 1-R40-MC-53074-01-00 (Other Grant/Funding Number: Department of-Health Resources and Services Administration)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No