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NCT Number: NCT06795490

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.

Recruiting

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Key information

Conditions

Health Behavior Behavior

Age range

2 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location status: Recruiting

Location contact

Kate Bauer, PhD, MS

PRINCIPAL_INVESTIGATOR

Michelle Clayson

CONTACT

[email protected]

734-763-2003

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Online program

Behavioral

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

Behavioral

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 outcomes

  1. Child age and sex-adjusted Body Mass Index (BMI)

    Time frame: Base line (pre-intervention) and approximately 5 months

    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.

Secondary outcomes

  1. Child sleep duration

    Time frame: Base line (pre-intervention) and approximately 5 months

    This will be reported in minutes using data from surveys completed by parents.

  2. Child daily screentime

    Time frame: Base line (pre-intervention) and approximately 5 months

    This will be reported in minutes using data from surveys completed by parents.

  3. Child intake of key food groups

    Time frame: Base line (pre-intervention) and approximately 5 months

    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)

  4. Child sleep routines

    Time frame: Base line (pre-intervention) and approximately 5 months

    This will be measured through parent completion of the Child Sleep Hygiene Scale which assesses 6 aspects of children's sleep/bedtime routines.

  5. Child screentime limits

    Time frame: Base line (pre-intervention) and approximately 5 months

    This will be measured through parent completion of survey items measuring parents' limit setting with respect to screentime.

  6. Family meal frequency

    Time frame: Base line (pre-intervention) and approximately 5 months

    This will be measured through parents' completion of survey items assessing the frequency with which families ate meals together.

Study contacts

Contact information is provided by the study sponsor or research team.

Michelle Clayson

CONTACT

[email protected]

734-763-2003

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • Health Resources and Services Administration (HRSA)

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jan 28, 2025
Registry last updated
Apr 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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