Health BehaviorNCT06795490
Families in Balance: Enhancing Household Routines and Reducing Early Childhood Obesity Among Families With Low-income
A study testing Online program in people with Health Behavior, run by University of Michigan at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 2 years and olderHealthy volunteers can take part
- Conditions the study is for
- Health Behavior
- What is being tested?
- Online program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Mar 2025to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Children must not have serious medical problems that affect weight, sleep, activity, or eating.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109
Michelle Clayson, 734-763-2003, mclayson@umich.edu
Kate Bauer, PhD, MS
About this study
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.
- Conditions
- Health Behavior
- Being tested
- Online program, Control Condition
- Keywords
- Online program, Informational material, Surveys, Eating activity, Sleep, Health behaviors, Body mass index
- Medical subject headings
- Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online programBehavioural
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 ConditionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Online Program | Experimental | Parents will participate in an online program. Receives: Behavioral: Online program |
| Control condition - Informational materials via email | Active comparator | Parents will receive information via email. Receives: Behavioral: Control Condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Base line (pre-intervention) and approximately 5 months
Secondary outcomes (6)
Child sleep duration
This will be reported in minutes using data from surveys completed by parents.
Measured: Base line (pre-intervention) and approximately 5 months
Child daily screentime
This will be reported in minutes using data from surveys completed by parents.
Measured: Base line (pre-intervention) and approximately 5 months
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)
Measured: Base line (pre-intervention) and approximately 5 months
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.
Measured: Base line (pre-intervention) and approximately 5 months
Child screentime limits
This will be measured through parent completion of survey items measuring parents' limit setting with respect to screentime.
Measured: Base line (pre-intervention) and approximately 5 months
Family meal frequency
This will be measured through parents' completion of survey items assessing the frequency with which families ate meals together.
Measured: Base line (pre-intervention) and approximately 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2025
- Study start31 Mar 2025
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health BehaviorStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- About 150 adults and 150 children will take part in the study
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Health Resources and Services Administration (HRSA)
- Responsible party
- Principal investigator, Katherine Bauer, University of Michigan
- Investigators
- Katherine Bauer, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06795490
- Sponsor's protocol ID
- HUM00263046
- Other IDs
- 1-R40-MC-53074-01-00
- Status last verified
- Apr 2026
- First submitted
- 21 Jan 2025
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Families in Balance: Enhancing Household Routines and Reducing Early Childhood Obesity Among Families With Low-income
- ClinicalTrials.gov ID
- NCT06795490
- Acronym / sponsor ID
- HUM00263046
- Conditions
- Health Behavior
- Keywords
- Online program, Informational material, Surveys, Eating activity, Sleep, Health behaviors, Body mass index
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Health Resources and Services Administration (HRSA)
- Study start
- 31 Mar 2025 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 28 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- About 150 adults and 150 children will take part in the study
| Arm | Type | Receives |
|---|---|---|
| Online Program | Experimental | Behavioral: Online programParents will participate in an online program. |
| Control condition - Informational materials via email | Active comparator | Behavioral: Control ConditionParents will receive information via email. |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Children must not have serious medical problems that affect weight, sleep, activity, or eating.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online programFamilies 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. | Behavioural | Online Program |
| Control ConditionFamilies 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. | Behavioural | Control condition - Informational materials via email |
Primary outcome
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.
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Katherine Bauer, PhD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online program in people with Health Behavior, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michelle Clayson (734-763-2003, mclayson@umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child age and sex-adjusted Body Mass Index (BMI) (time frame: Base line (pre-intervention) and approximately 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2026.