Recruiting

Observational Study

Sponsor:

University of Michigan

Code:

NCT06795490

Conditions

Health Behavior

Eligibility Criteria

Sex: All

Age: 2+

Healthy Volunteers: Accepted

Interventions

Online program

Control Condition

Study Details

Brief summary:

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.

Conditions

Health Behavior

Study ID

NCT06795490

Start date

Mar 31, 2025

Status verified date

Apr, 2026

Completion date

Feb, 2027

Anticipated

Primary completion date

Feb, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 2+

Healthy Volunteers: Accepted

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 Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Online Program

Parents will participate in an online program.

active comparator: Control condition - Informational materials via email

Parents will receive information via email.

Interventions

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.

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.

Primary outcome measure

  • Child age and sex-adjusted Body Mass Index (BMI) [ Time Frame: Base line (pre-intervention) and approximately 5 months ]

Central Contacts and Locations

Central contacts

Michelle Clayson

734-763-2003mclayson@umich.edu

Locations

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Michelle Clayson

734-763-2003mclayson@umich.edu

Principal Investigator:

Kate Bauer, PhD, MS

More Information

Sponsor

University of Michigan

Last update posted

Apr 6, 2026

Last verified

Apr, 2026

Keywords

  • Online program
  • Informational material
  • Surveys
  • Eating activity
  • Sleep
  • Health behaviors
  • Body mass index

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Michigan on 2026-04-06.