Families in Balance: Enhancing Household Routines and Reducing Early Childhood Obesity Among Families With Low-income
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Online program, Control Condition.
- Who it may be relevant to
- Registry conditions: Health Behavior. Basic parameters: from 2 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
- Behavioral Online 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. - Behavioral Control 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.
Primary outcome measures
- Child age and sex-adjusted Body Mass Index (BMI) [Time frame: Base line (pre-intervention) and approximately 5 months]
Secondary outcome measures (6)
- Child sleep duration [Time frame: Base line (pre-intervention) and approximately 5 months]
- Child daily screentime [Time frame: Base line (pre-intervention) and approximately 5 months]
- Child intake of key food groups [Time frame: Base line (pre-intervention) and approximately 5 months]
- Child sleep routines [Time frame: Base line (pre-intervention) and approximately 5 months]
- Child screentime limits [Time frame: Base line (pre-intervention) and approximately 5 months]
- Family meal frequency [Time frame: Base line (pre-intervention) and approximately 5 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of Michigan — Ann Arbor
Identifiers
NCT: NCT06795490 · HUM00263046 · 1-R40-MC-53074-01-00