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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age2+
SponsorUniversity of Michigan

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: Online ProgramExperimental treatment 1 intervention
Group B: Control condition - Informational materials via emailActive comparator 1 intervention

Trial outcomes

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.

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

Secondary outcomes

1

Child sleep duration

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

Time frame
Base line (pre-intervention) and approximately 5 months
2

Child daily screentime

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

Time frame
Base line (pre-intervention) and approximately 5 months
3

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)

Time frame
Base line (pre-intervention) and approximately 5 months
4

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.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Michigan

Lead sponsor

Health Resources and Services Administration (HRSA)

Collaborator