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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06795490
Enrollment
300
Registered
2025-01-28
Start date
2025-03-31
Completion date
2027-02-01
Last updated
2026-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Behavior

Keywords

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

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.

Interventions

BEHAVIORALOnline 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.

BEHAVIORALControl 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.

Sponsors

University of Michigan
Lead SponsorOTHER
Health Resources and Services Administration (HRSA)
CollaboratorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

About 150 adults and 150 children will take part in the study

Eligibility

Sex/Gender
ALL
Age
2 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Child age and sex-adjusted Body Mass Index (BMI)Base line (pre-intervention) and approximately 5 monthsDifferences 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.

Secondary

MeasureTime frameDescription
Child sleep durationBase line (pre-intervention) and approximately 5 monthsThis will be reported in minutes using data from surveys completed by parents.
Child daily screentimeBase line (pre-intervention) and approximately 5 monthsThis will be reported in minutes using data from surveys completed by parents.
Child intake of key food groupsBase line (pre-intervention) and approximately 5 monthsThis 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)
Child sleep routinesBase line (pre-intervention) and approximately 5 monthsThis will be measured through parent completion of the Child Sleep Hygiene Scale which assesses 6 aspects of children's sleep/bedtime routines.
Child screentime limitsBase line (pre-intervention) and approximately 5 monthsThis will be measured through parent completion of survey items measuring parents' limit setting with respect to screentime.
Family meal frequencyBase line (pre-intervention) and approximately 5 monthsThis will be measured through parents' completion of survey items assessing the frequency with which families ate meals together.

Countries

United States

Contacts

CONTACTMichelle Clayson
mclayson@umich.edu734-763-2003
PRINCIPAL_INVESTIGATORKatherine Bauer, PhD

University of Michigan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 7, 2026