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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
Online program
BehavioralFamilies 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
BehavioralFamilies 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
Trial outcomes
Primary outcomes
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.
Secondary outcomes
Child sleep duration
This will be reported in minutes using data from surveys completed by parents.
Child daily screentime
This will be reported in minutes using data from surveys completed by parents.
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)
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.
Sponsors and contacts
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University of Michigan
Lead sponsor
Health Resources and Services Administration (HRSA)
Collaborator