NCT05595161

Brief 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 serving patients disproportionately affected by obesity.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
184

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 11, 2022

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

October 20, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 26, 2022

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 8, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 8, 2026

Completed
Last Updated

May 15, 2026

Status Verified

May 1, 2026

Enrollment Period

3.2 years

First QC Date

October 20, 2022

Last Update Submit

May 12, 2026

Conditions

Obesity, Childhood

Keywords

Implementation scienceIntensive lifestyle interventionPediatric obesityBehavior modificationBody mass index

Outcome Measures

Primary Outcomes (1)

  • Change in %BMIp95

    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 Outcomes (6)

  • Change in parent BMI

    Baseline through 6 months after enrollment

  • Change in weight-related quality of life

    Baseline through 12 months after enrollment

  • Change in weight-related health behaviors.

    Baseline through 12 months after enrollment

  • Change in binge eating behaviors.

    Baseline through 12 months after enrollment

  • Change in parent conversations about weight.

    Baseline through 12 months after enrollment

  • +1 more secondary outcomes

Study Arms (1)

Intervention

EXPERIMENTAL

Bright Bodies

Behavioral: Bright Bodies

Interventions

Bright BodiesBEHAVIORAL

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.

Also known as: SmartMoves TM (name of the curriculum used in the Bright Bodies intervention)
Intervention

Eligibility Criteria

Age7 Years - 13 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children ages 7-13 years with BMI ≥85th percentile and their parents;

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of Alabama at Birmingham

Birmingham, Alabama, 35233-1711, United States

Location

University of California San Francisco

San Francisco, California, 94143, United States

Location

Maine Medical Center

Portland, Maine, 04101, United States

Location

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Mahnoosh (Mona) Sharifi, MD, MPH

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2022

First Posted

October 26, 2022

Study Start

October 11, 2022

Primary Completion

January 8, 2026

Study Completion

January 8, 2026

Last Updated

May 15, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

US(3)