Obesity, ChildhoodNCT05595161
Dissemination and Implementation of the Bright Bodies Intervention for Childhood Obesity
A study testing Bright Bodies in people with Obesity, Childhood, run by Yale University at 3 sites in United States.
Trial summary
This study will evaluate the effectiveness of the Bright Bodies intervention in improving body mass index (BMI) among 7-13 year-old children with obesity simultaneously with the impact of the implementation strategy on adoption, reach, fidelity, cost, and maintenance of the intervention in three heterogenous settings… Read more about this study
- Who is it for?
- Ages 7 to 13 years
- Conditions the study is for
- Obesity, Childhood
- What is being tested?
- Bright Bodies
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 3 sitesUnited States
- Study dates
- 11 Oct 2022to 8 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 7 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children ages 7-13 years with BMI ≥85th percentile and their parents;
- Child-parent dyads enrolled in the Bright Bodies intervention at each site will be eligible for inclusion in the evaluation study.
Who cannot join
- Children and/or parents who do not speak the language in which the program will be delivered at each site;
- Children and/or parents who plan to move away from the area within the next 15 months;
- Children with a history of purging and/or dramatic weight loss prior to the trial;
- Children who are currently participating in another high-intensity lifestyle intervention or other similar research study, or are planning to have bariatric surgery within the next six months
- Children whose EHR data cannot be accessed by the study teams;
- Children with chronic medical conditions limiting their ability to take food by mouth (e.g., g-tube fed, total parenteral nutrition), participate in physical activity (e.g., wheelchair bound), or meaningfully participate in group sessions (e.g., cognitive impairment);
- Children with a sibling enrolled in the trial
- Children who join the Bright Bodies program after the 4th week of a session (not including orientation)
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35233-1711
Maine Medical Center
Portland, Maine, 04101
University of California San Francisco
San Francisco, California, 94143
About this study
This study will evaluate the effectiveness of the Bright Bodies intervention in improving body mass index (BMI) among 7-13 year-old children with obesity simultaneously with the impact of the implementation strategy on adoption, reach, fidelity, cost, and maintenance of the intervention in three heterogenous settings serving patients disproportionately affected by obesity.
Read the detailed description
The demonstrated efficacy of Bright Bodies in a well-designed randomized controlled trial (RCT) and a real-world effectiveness study reduce equipoise and challenge the ethics of a prospective RCT of implementing Bright Bodies in other settings. As such, this study is an observational, multiphase mixed methods design to evaluate effectiveness and implementation among three purposively selected heterogeneous sites serving low-income populations with racial and ethnic, rural-urban, and geographic diversity.
Children ages 7-13 years with BMI ≥85th percentile and their parent/caregivers hereafter referred to as parent will be recruited to participate in the evaluation study from among participants in the newly-established Bright Bodies programs at each of the three implementation sites. The aim is for each site to recruit approximately 40 children and their parents (a total of 120 children and 120 parents) to participate in the Bright Bodies program over the study's enrollment period. The primary outcome is change in BMI expressed as a percentage of the 95th percentile (%BMIp95) using EHR data collected as part of routine clinical care up to 36 months before and up to 15 months after enrollment in the intervention. Secondary outcomes include: (a) change in %BMIp95 at three and six months, (b) changes in parent BMI at three and six months, (d) parent-reported changes in health behaviors (sleep, physical activity, screen time, eating behaviors), via surveys at 3, 6 and 12 months, and (e) changes in parent-proxy reported weight-related quality of life, parent stress, and parent talk about weight via surveys at baseline, 6, and 12 months after enrollment. We will also describe implementation outcomes (reach, adoption, fidelity/adaptation, and cost) through qualitative and quantitative data collection from members of our study team throughout the process of implementation.
- Conditions
- Obesity, Childhood
- Being tested
- Bright Bodies
- Keywords
- Implementation science, Intensive lifestyle intervention, Pediatric obesity, Behavior modification, Body mass index
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bright BodiesBehavioural
Also called SmartMoves TM (name of the curriculum used in the Bright Bodies intervention)
The Bright Bodies intensive, family-based lifestyle intervention uses group sessions including nutrition education, behavior modification, and exercise to improve weight and weight-related outcomes among children and adolescents with obesity.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Bright Bodies Receives: Behavioral: Bright Bodies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in %BMIp95
Change in %BMIp95, calculated from height and weight. A negative percentage indicates that the participant's BMI has decreased since enrollment.
Measured: Up to 36 months prior to baseline through up to 15 months after enrollment
Secondary outcomes (6)
Change in parent BMI
Change in BMI, calculated from height and weight measured as part of the Bright Bodies program. A negative change in parent BMI indicates that the parent's BMI has decreased since enrollment.
Measured: Baseline through 6 months after enrollment
Change in weight-related quality of life
Sizing Them Up is a validated, parent-proxy reported instrument assessing weight-related quality of life for children aged 5-13 years. Possible score ranges from 1 (never) to 4 (always). Higher score indicates a higher quality of life.
Measured: Baseline through 12 months after enrollment
Change in weight-related health behaviors.
Parent-proxy responses to the Bright Bodies Healthy Lifestyles Questionnaire about vegetable and fruit intake [scores range from 1 (none) to 4 (three or more); Higher score indicates healthier behavior]; sugar-sweetened beverage intake [scores range from 1 (none) to 4 (three or more); Lower score indicates healthy behavior]; intake of sweets/desserts [scores range from 1 (none) to 4 (seven or more); Lower score indicates healthy behavior]; physical activity [scores range from 1 (less than 30 minutes) to 4 (more than 2 hours); higher score indicates healthy behavior.]; screen time [scores range from 1 (more than 4 hours) to 4 (1 hour or less); higher score indicates healthy behavior.]; sleep [scores range from 1 (6 hours or less) to 3 (9 hours or more) for the amount a child sleeps each night and from 1 (no) to 2 (yes) for the question about a regular bedtime; Higher score indicates healthy behavior].
Measured: Baseline through 12 months after enrollment
Change in binge eating behaviors.
Children's Brief Binge-Eating Questionnaire will be parent-proxy reported. Possible score ranges from 1 (definitely false) to 3 (definitely true). Higher scores indicate greater concern for binge eating behavior.
Measured: Baseline through 12 months after enrollment
Change in parent conversations about weight.
Parent conversation about weight is measured with three questions using a parent self-report instrument from the New Moves, a school-based intervention designed to prevent obesity and other weight-related problems. Possible scores range from 1 (never) to 5 (very often). Lower score indicates less weight talk.
Measured: Baseline through 12 months after enrollment
Per patient cost for participation in Bright Bodies
Calculated based on data regarding resource utilization of the Bright Bodies program and participants' use of relevant medical and non-medical resources.
Measured: From enrollment through 12 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2022
- Study start11 Oct 2022
- Primary completion8 Jan 2026
- Study completion8 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, ChildhoodStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 184 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Mahnoosh (Mona) Sharifi, MD, MPH, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05595161
- Sponsor's protocol ID
- 2000032608
- Other IDs
- 5R01HL151603-02
- Status last verified
- May 2026
- First submitted
- 20 Oct 2022
- Last updated
- 15 May 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 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dissemination and Implementation of the Bright Bodies Intervention for Childhood Obesity
- ClinicalTrials.gov ID
- NCT05595161
- Acronym / sponsor ID
- 2000032608
- Conditions
- Obesity, Childhood
- Keywords
- Implementation science, Intensive lifestyle intervention, Pediatric obesity, Behavior modification, Body mass index
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 184 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 11 Oct 2022 (actual)
- Primary completion
- 8 Jan 2026 (actual)
- Study completion
- 8 Jan 2026 (actual)
- First posted
- 26 Oct 2022 (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 effectiveness of the Bright Bodies intervention in improving body mass index (BMI) among 7-13 year-old children with obesity simultaneously with the impact of the implementation strategy on adoption, reach, fidelity, cost, and maintenance of the intervention in three heterogenous settings serving patients disproportionately affected by obesity.
Detailed description
The demonstrated efficacy of Bright Bodies in a well-designed randomized controlled trial (RCT) and a real-world effectiveness study reduce equipoise and challenge the ethics of a prospective RCT of implementing Bright Bodies in other settings. As such, this study is an observational, multiphase mixed methods design to evaluate effectiveness and implementation among three purposively selected heterogeneous sites serving low-income populations with racial and ethnic, rural-urban, and geographic diversity.
Children ages 7-13 years with BMI ≥85th percentile and their parent/caregivers hereafter referred to as parent will be recruited to participate in the evaluation study from among participants in the newly-established Bright Bodies programs at each of the three implementation sites. The aim is for each site to recruit approximately 40 children and their parents (a total of 120 children and 120 parents) to participate in the Bright Bodies program over the study's enrollment period. The primary outcome is change in BMI expressed as a percentage of the 95th percentile (%BMIp95) using EHR data collected as part of routine clinical care up to 36 months before and up to 15 months after enrollment in the intervention. Secondary outcomes include: (a) change in %BMIp95 at three and six months, (b) changes in parent BMI at three and six months, (d) parent-reported changes in health behaviors (sleep, physical activity, screen time, eating behaviors), via surveys at 3, 6 and 12 months, and (e) changes in parent-proxy reported weight-related quality of life, parent stress, and parent talk about weight via surveys at baseline, 6, and 12 months after enrollment. We will also describe implementation outcomes (reach, adoption, fidelity/adaptation, and cost) through qualitative and quantitative data collection from members of our study team throughout the process of implementation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Bright BodiesBright Bodies |
Who may qualify
- Ages
- 7 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children ages 7-13 years with BMI ≥85th percentile and their parents;
- Child-parent dyads enrolled in the Bright Bodies intervention at each site will be eligible for inclusion in the evaluation study.
Key exclusion criteria (8 listed)
- Children and/or parents who do not speak the language in which the program will be delivered at each site;
- Children and/or parents who plan to move away from the area within the next 15 months;
- Children with a history of purging and/or dramatic weight loss prior to the trial;
- Children who are currently participating in another high-intensity lifestyle intervention or other similar research study, or are planning to have bariatric surgery within the next six months
- Children whose EHR data cannot be accessed by the study teams;
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 |
|---|---|---|
| Bright BodiesAlso: SmartMoves TM (name of the curriculum used in the Bright Bodies intervention)The Bright Bodies intensive, family-based lifestyle intervention uses group sessions including nutrition education, behavior modification, and exercise to improve weight and weight-related outcomes among children and adolescents with obesity. | Behavioural | Intervention |
Primary outcome
Change in %BMIp95
Time frame: Up to 36 months prior to baseline through up to 15 months after enrollment
Change in %BMIp95, calculated from height and weight. A negative percentage indicates that the participant's BMI has decreased since enrollment.
6 secondary outcomes
Change in parent BMI
Time frame: Baseline through 6 months after enrollment
Change in weight-related quality of life
Time frame: Baseline through 12 months after enrollment
Change in weight-related health behaviors.
Time frame: Baseline through 12 months after enrollment
Change in binge eating behaviors.
Time frame: Baseline through 12 months after enrollment
Change in parent conversations about weight.
Time frame: Baseline through 12 months after enrollment
Per patient cost for participation in Bright Bodies
Time frame: From enrollment through 12 months after enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 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. This study is not recruiting at the moment.
Mahnoosh (Mona) Sharifi, MD, MPH principal investigator
Yale University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bright Bodies in people with Obesity, Childhood, run by Yale University at 3 sites 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 2 inclusion and 8 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: finished, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in %BMIp95 (time frame: Up to 36 months prior to baseline through up to 15 months after enrollment). 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 15 May 2026.