Bright Bodies Program for Childhood Obesity

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

182 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the Bright Bodies treatment for childhood obesity?

Research shows that programs similar to Bright Bodies, like a summer camp for obese children, can lead to significant improvements in weight and self-esteem. Additionally, multidisciplinary treatments for childhood obesity have been found to improve psychosocial well-being and quality of life. ^{1 2 3 4 5}

Is the Bright Bodies Program for Childhood Obesity safe for children?

The research articles reviewed do not provide specific safety data for the Bright Bodies Program itself, but they discuss the general safety concerns related to pediatric obesity in hospital settings, indicating that obesity can lead to worse outcomes in hospitalized children. ^{6 7 8 9 10}

How is the Bright Bodies treatment for childhood obesity different from other treatments?

The Bright Bodies treatment is unique because it is a high-intensity, family-based lifestyle program that not only focuses on weight management but also improves insulin sensitivity and glucose tolerance in obese children, which can help prevent type 2 diabetes. ^{11 12 13 14 15}

Research Team

Mahnoosh (Mona) Sharifi, MD, MPH

Principal Investigator

Yale University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Subjective evaluation of psychosocial well-being in children and youths with overweight or obesity: the impact of multidisciplinary obesity treatment. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

An innovative summer camp program improves weight and self-esteem in obese children. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Modest treatment effects and high program attrition: The impact of interdisciplinary, individualized care for managing paediatric obesity. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

A pediatric weight management program for high-risk populations: a preliminary analysis. [2009]

5. England pubmed.ncbi.nlm.nih.gov

Reducing obesity and related chronic disease risk in children and youth: a synthesis of evidence with 'best practice' recommendations. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Body Mass Index Category and Adverse Events in Hospitalized Children. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Prevention and treatment of childhood obesity. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Validity of body mass index compared with other body-composition screening indexes for the assessment of body fatness in children and adolescents. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Pediatric obesity and safety in inpatient settings: a systematic literature review. [2018]

10. England pubmed.ncbi.nlm.nih.gov

Effectiveness and safety of interventions to manage childhood overweight and obesity: An Overview of Cochrane systematic reviews. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Real-world effectiveness of the Bright Bodies healthy lifestyle intervention for childhood obesity. [2023]

12. United States pubmed.ncbi.nlm.nih.gov

Cost-Effectiveness and Long-Term Savings of the Bright Bodies Intervention for Childhood Obesity. [2023]

13. United States pubmed.ncbi.nlm.nih.gov

Anthropometric and psychosocial changes in obese adolescents enrolled in a Weight Management Program. [2008]

14. United States pubmed.ncbi.nlm.nih.gov

Effect of a successful intensive lifestyle program on insulin sensitivity and glucose tolerance in obese youth. [2018]

15. United States pubmed.ncbi.nlm.nih.gov

Reversal of early abnormalities in glucose metabolism in obese youth: results of an intensive lifestyle randomized controlled trial. [2021]