- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05595161
Dissemination and Implementation of the Bright Bodies Intervention for Childhood Obesity
Study Overview
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Mahnoosh (Mona) Sharifi, MD, MPH
- Phone Number: (203) 785-7821
- Email: mona.sharifi@yale.edu
Study Contact Backup
- Name: Emily B Finn, MPH
- Email: e.finn@yale.edu
Study Locations
-
-
Alabama
-
Birmingham, Alabama, United States, 35233-1711
- Recruiting
- University of Alabama at Birmingham
-
Contact:
- Heather A Austin, PhD
- Email: heatheraustin@uabmc.edu
-
-
California
-
San Francisco, California, United States, 94143
- Recruiting
- University of California San Francisco
-
Contact:
- Amy L Beck, MD, MPH
- Phone Number: 415-476-3368
- Email: amy.beck@ucsf.edu
-
-
Maine
-
Portland, Maine, United States, 04101
- Recruiting
- Maine Medical Center
-
Contact:
- Abby Fleisch, MD, MPH
- Phone Number: 207-661-7602
- Email: Abby.Fleisch@mainehealth.org
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention
Bright Bodies
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Up to 36 months prior to baseline through up to 15 months after enrollment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in parent BMI
Time Frame: Baseline through 6 months after enrollment
|
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.
|
Baseline through 6 months after enrollment
|
Change in weight-related quality of life
Time Frame: Baseline through 12 months after enrollment
|
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.
|
Baseline through 12 months after enrollment
|
Change in weight-related health behaviors.
Time Frame: Baseline through 12 months after enrollment
|
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].
|
Baseline through 12 months after enrollment
|
Change in binge eating behaviors.
Time Frame: Baseline through 12 months after enrollment
|
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.
|
Baseline through 12 months after enrollment
|
Change in parent conversations about weight.
Time Frame: Baseline through 12 months after enrollment
|
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.
|
Baseline through 12 months after enrollment
|
Per patient cost for participation in Bright Bodies
Time Frame: From enrollment through 12 months after enrollment
|
Calculated based on data regarding resource utilization of the Bright Bodies program and participants' use of relevant medical and non-medical resources.
|
From enrollment through 12 months after enrollment
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Mahnoosh (Mona) Sharifi, MD, MPH, Yale University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2000032608
- 5R01HL151603-02 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Obesity, Childhood
-
Universiteit LeidenWageningen University; Nutricia, Inc.; Danone ResearchCompletedChildhood Obesity | Childhood Overweight | Vegetable Acceptance in Early ChildhoodNetherlands
-
Oregon State UniversityCompletedChildhood Obesity Prevention
-
The Miriam HospitalHassenfeld Child Health Innovation InstituteCompletedChildhood Obesity PreventionUnited States
-
Fundacion para la Formacion e Investigacion Sanitarias...UnknownChildhood Obesity PreventionSpain
-
Tampere UniversitySeinajoki Central Hospital; Tampere University Hospital; Foundation for Paediatric... and other collaboratorsCompleted
-
Vanderbilt University Medical CenterActive, not recruitingPediatric Obesity | Childhood Obesity | Childhood Onset ObesityUnited States
-
Tehran University of Medical SciencesUnknownChildhood Obesity PreventionIran, Islamic Republic of
-
Cornell UniversityCompletedChildhood Obesity Prevention
-
Harokopio UniversityCompletedPrevention of Childhood ObesityGreece
-
Universidad Autonoma de San Luis PotosíCompletedChildhood Obesity | Childhood OverweightMexico
Clinical Trials on Bright Bodies
-
Yale UniversityTexas A&M University; University of the West of ScotlandCompleted
-
Yale UniversityNational Institutes of Health (NIH); National Center for Research Resources...CompletedImpaired Glucose ToleranceUnited States
-
Ain Shams UniversityAssiut UniversityCompleted
-
University of ArizonaUniversity of North Texas Health Science CenterRecruitingEffectiveness of BIM in Reducing Disordered Eating Among Student Athletes | Effectiveness of BIM in Reducing Body Image Concerns Among Student Athletes | Effectiveness of BIM Improving Psychological Well-Being Among Student AthletesUnited States
-
Ain Shams UniversityActive, not recruiting
-
Vanderbilt University Medical CenterCompleted
-
NoblewellCompletedSystolic Heart Failure | Peripheral Chemoreceptor HypersensitivityPoland
-
Stanford UniversityNational Institute of Mental Health (NIMH); Washington University School of...CompletedEating DisordersUnited States
-
University of ArizonaU.S. Army Medical Research Acquisition ActivityCompletedConcussion, Mild | Sleep Problems | Post-Concussion SymptomsUnited States
-
Assistance Publique - Hôpitaux de ParisCompletedOsseous Spine MetastasesFrance