NCT06795490

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
7mo left

Started Mar 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress66%
Mar 2025Feb 2027

First Submitted

Initial submission to the registry

January 21, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 28, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

March 31, 2025

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Last Updated

April 10, 2025

Status Verified

April 1, 2025

Enrollment Period

1.8 years

First QC Date

January 21, 2025

Last Update Submit

April 7, 2025

Conditions

Health Behavior

Keywords

Online programInformational materialSurveysEating activitySleepHealth behaviorsBody mass index

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Child sleep duration

    Base line (pre-intervention) and approximately 5 months

  • Child daily screentime

    Base line (pre-intervention) and approximately 5 months

  • Child intake of key food groups

    Base line (pre-intervention) and approximately 5 months

  • Child sleep routines

    Base line (pre-intervention) and approximately 5 months

  • Child screentime limits

    Base line (pre-intervention) and approximately 5 months

  • +1 more secondary outcomes

Study Arms (2)

Online Program

EXPERIMENTAL

Parents will participate in an online program.

Behavioral: Online program

Control condition - Informational materials via email

ACTIVE COMPARATOR

Parents will receive information via email.

Behavioral: Control Condition

Interventions

Online programBEHAVIORAL

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.

Online Program
Control ConditionBEHAVIORAL

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.

Control condition - Informational materials via email

Eligibility Criteria

Age2 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

MeSH Terms

Conditions

Health Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Katherine Bauer, PhD

    University of Michigan

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Michelle Clayson

CONTACT

734-763-2003mclayson@umich.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: About 150 adults and 150 children will take part in the study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Nutritional Sciences, School of Public Health

Study Record Dates

First Submitted

January 21, 2025

First Posted

January 28, 2025

Study Start

March 31, 2025

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2027

Last Updated

April 10, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)