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

University of Michigan

Status: Enrolling

Conditions: Health Behavior

Treatments: Behavioral: Online program; Behavioral: Control Condition

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT06795490

1-R40-MC-53074-01-00 (Other Grant/Funding Number)

HUM00263046

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 2+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

Online Program

Experimental group

Description:

Parents will participate in an online program.

Treatment:

Behavioral: Online program

Control condition - Informational materials via email

Active Comparator group

Description:

Parents will receive information via email.

Treatment:

Behavioral: Control Condition