Bright Bodies Program for Childhood Obesity

Not currently recruiting at 2 trial locations

Overseen By Mahnoosh (Mona) Sharifi, MD, MPH

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Yale University

Disqualifiers: Language barrier, Moving, Purging, Chronic conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how effectively the Bright Bodies program helps children with obesity improve their body mass index (BMI), a measure of body fat based on height and weight. Researchers are also examining the program's implementation and sustainability in various settings, particularly where obesity more significantly affects children. The program suits children aged 7-13 with a BMI at or above the 85th percentile who are not currently participating in similar programs or planning major weight-related medical procedures. As an unphased trial, this study provides a unique opportunity for children to benefit from a specialized program tailored to their needs.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that the Bright Bodies program is safe for children with obesity?

Research has shown that the Bright Bodies program is generally safe for children. A study from 2007 found that children in the program improved their body mass index (BMI) and other health markers. This indicates that the program is effective and easy for kids to follow. Another source highlights that Bright Bodies teaches healthy lifestyle changes, such as understanding food choices and involving family support. The CDC recognizes this approach as a proven method to help children manage their weight. Overall, evidence supports Bright Bodies as a safe choice for kids dealing with obesity. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Bright Bodies program is unique because it focuses on lifestyle changes rather than medication to tackle childhood obesity. Unlike traditional treatments like dietary counseling or medication, Bright Bodies combines nutrition education, behavior modification, and physical activity into a comprehensive program. Researchers are excited about this approach because it empowers children and their families to make sustainable health changes, potentially leading to long-term weight management and improved overall health without relying on medication.

What evidence suggests that the Bright Bodies program is effective for childhood obesity?

Research has shown that the Bright Bodies program, which participants in this trial will receive, helps lower body mass index (BMI) in children with obesity. A 2007 study found that children aged 8-16 who joined the program experienced a lower BMI. In 2017, a report highlighted that Bright Bodies achieved the largest BMI reduction compared to similar programs in the U.S. Long-term data indicate that the program can reduce BMI by an average of 1.67 kg/m² each year. Over an 11-year real-world study, participants consistently saw their BMI percentage decrease each month. These findings suggest that Bright Bodies is a promising approach to tackling childhood obesity. ^{1 2 6 7 8}

Who Is on the Research Team?

Mahnoosh (Mona) Sharifi, MD, MPH

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

This trial is for children aged 8-12 with severe obesity (BMI ≥95th percentile) and their parents. It's not for kids who've had eating disorders, dramatic weight loss, are in another similar study or program, planning bariatric surgery soon, have conditions affecting eating or exercise abilities, cognitive impairments, or language barriers.

Inclusion Criteria

Child-parent dyads enrolled in the Bright Bodies intervention at each site will be eligible for inclusion in the evaluation study

I am a child aged 7-13 with a BMI in the top 15%.

Exclusion Criteria

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 and/or parents who plan to move away from the area within the next 15 months

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants engage in the Bright Bodies program aimed at improving BMI and health behaviors

12 months

Regular visits as part of the Bright Bodies program

Follow-up

Participants are monitored for changes in BMI and health behaviors after the intervention

15 months

What Are the Treatments Tested in This Trial?

Interventions

• Bright Bodies

Trial Overview

The Bright Bodies intervention is being tested to see if it helps reduce BMI in obese children while also checking how well the program works across different settings that serve patients affected by obesity.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

Bright Bodies

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Published Research Related to This Trial

The Bright Bodies Weight Management Program effectively reduced BMI z scores and body fat percentage in obese adolescents over a 1-year period, with sustained improvements observed at the 2-year follow-up.

While a structured diet approach showed better short-term results, the nondiet approach led to greater long-term improvements in BMI z scores, suggesting that a focus on healthy food choices may be more beneficial over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anthropometric and psychosocial changes in obese adolescents enrolled in a Weight Management Program. Savoye, M., Berry, D., Dziura, J., et al.[2008]

The Bright Bodies intervention is projected to reduce BMI by an average of 1.67 kg/m² per year over 10 years for children with obesity, demonstrating its efficacy in managing weight compared to traditional clinical approaches.

Despite being resource-intensive with an incremental cost of $360 per person, Bright Bodies is expected to save $1126 per person in obesity-related healthcare costs over 10 years, making it a cost-effective option for long-term health management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cost-Effectiveness and Long-Term Savings of the Bright Bodies Intervention for Childhood Obesity. Pryor, S., Savoye, M., Nowicka, P., et al.[2023]

A 2-week residential summer camp for 21 obese children led to significant improvements in various health metrics, including a reduction in body weight by an average of 3.7 kg and a decrease in BMI by 1.60 kg/m².

Participants also experienced enhanced self-esteem and better cardiovascular health, with notable reductions in blood pressure and heart rate, indicating the camp's potential effectiveness in addressing childhood obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An innovative summer camp program improves weight and self-esteem in obese children. Wong, WW., Abrams, SH., Mikhail, C., et al.[2022]

The Bright Bodies program, a family-based pediatric weight management intervention, effectively reduced participants' BMI by an average of 1.63% per month over a 10-week duration, demonstrating sustained efficacy since its initial trial in 2007.

The study involved 396 youth participants, with greater reductions in BMI observed in males, during spring/fall seasons, and among those with higher initial BMI, indicating that certain demographic factors may influence the program's effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-world effectiveness of the Bright Bodies healthy lifestyle intervention for childhood obesity. Samuels, SL., Hu, P., Maciejewski, KR., et al.[2023]

A multidisciplinary pediatric weight management program showed a small but significant decrease in BMI z-score among high-risk children after 9 months, indicating some improvement in weight status.

The program also led to significant improvements in cardiovascular risk factors, such as total cholesterol and triglyceride levels, highlighting its effectiveness in addressing obesity-related health issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pediatric weight management program for high-risk populations: a preliminary analysis. Skelton, JA., DeMattia, LG., Flores, G.[2009]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9780185/

Real-World Effectiveness of the Bright Bodies Healthy ...

A randomized controlled trial (RCT) published in 2007 showed reduced body mass index (BMI) among 8-16 year-old children with obesity randomized to Bright Bodies ...

2.

sciencedirect.com

sciencedirect.com/science/article/pii/S1098301523001043

Cost-Effectiveness and Long-Term Savings of the Bright ...

Among US-based interventions evaluated in the 2017 US Preventive Task Force Report, Bright Bodies yielded the greatest magnitude of reduction in BMI of children ...

3.

valueinhealthjournal.com

valueinhealthjournal.com/article/S1098-3015(23)00104-3/fulltext

Cost-Effectiveness and Long-Term Savings of the Bright ...

Over the 10-year simulation period, Bright Bodies is expected to lead to a reduction in BMI by 1.67 kg/m2 (1.43-1.94) per person-year compared ...

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05595161

Dissemination and Implementation of the Bright Bodies ...

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 ...

5.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/36502287/

Real-world effectiveness of the Bright Bodies healthy lifestyle ...

Across the 11 years, participants' %BMIp95 reduced on average by 1.63% (95% CI: 1.44%-1.82%) per month during their first program (mean duration ...

6.

mainehealth.org

mainehealth.org/lets-go/community-settings/parents-caregivers/bright-bodies-mainehealth-lets-go

Bright Bodies | MaineHealth Let's Go!

It is a healthy lifestyle and family approach for children ages 6-17 who have extra weight or obesity. Children and their families will learn about food intake ...

7.

ebccp.cancercontrol.cancer.gov

ebccp.cancercontrol.cancer.gov/programDetails.do?programId=1896571

Smart Moves / Bright Bodies

The study showed decreases in weight, body mass index (BMI), percent body fat, total estimated body fat mass, total fasting cholesterol, fasting ...

8.

cdc.gov

cdc.gov/family-healthy-weight/php/recognized-programs/index.html

CDC-Recognized Family Healthy Weight Programs

This program was evidence-tested as Bright Bodies at Yale University. Healthy Weight Clinic. For families with children aged 2 to 18 years ...