Brighter Bites for Childhood Obesity

Overseen By Emily Adlparvar

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas Health Science Center, Houston

Disqualifiers: Special needs, Physical, Cognitive, Psychological, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

720 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to examine the effects of the (Brighter Bites (BB) intervention compared to a wait-list control group 9 months after the intervention on changes in primary child outcomes (HbA1c, and vegetable intake), on changes in secondary outcomes (household food security status, parent and child dietary behaviors, and home access/availability of fruits and vegetables (FV)), and the mediational influence of changes in food security status, parent outcomes, and home environment measures on changes in child outcomes.

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 Brighter Bites treatment for childhood obesity?

Research shows that successful childhood obesity treatments often involve changes in diet and physical activity, along with family support. Programs that include these elements, like Brighter Bites, can help children develop healthier habits and reduce obesity. ^{1 2 3 4 5}

Is the Brighter Bites program safe for children with obesity?

The existing literature on very low-energy diet programs, which may be similar to Brighter Bites, indicates that while they are effective for weight loss in children and adolescents, there is limited information on their safety. Future studies should include comprehensive monitoring of any adverse events to better understand safety. ^{4 5 6 7 8}

How does the Brighter Bites treatment for childhood obesity differ from other treatments?

The Brighter Bites treatment is unique because it focuses on providing fresh produce and nutrition education to families, aiming to improve eating habits and lifestyle choices, rather than relying on high-intensity, family-based interventions or pharmacological approaches. ^{9 10 11 12 13}

Research Team

Shreela Sharma, PhD

Principal Investigator

The University of Texas Health Science Center, Houston

Eligibility Criteria

This trial is for children and their parents living in areas of persistent poverty, who are facing issues with obesity and cardiometabolic health. The study aims to include families willing to participate in a fruit and vegetable co-op program. Specific medical criteria like HbA1c levels may be considered.

Inclusion Criteria

High proportion of children participating in the free and reduced lunch (FRL) program (>70%)

I am willing to start a school health program.

I am a student in the 1st, 2nd, or 3rd grade.

Exclusion Criteria

Prior participation in BB in the previous school year

I or my child have a condition that makes it hard to participate in certain activities.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive the Brighter Bites intervention, including fruit and vegetable distributions, healthy recipe tastings, and nutrition education

9 months

Regular visits for intervention activities

Post-intervention Assessment

Assessment of primary and secondary outcomes, including child vegetable intake, HbA1c levels, and household food security status

1 month

In-person assessments

Follow-up

Participants are monitored for long-term effects of the intervention on diet, adiposity, and metabolic outcomes

21 months

Treatment Details

Interventions

• Brighter Bites

Trial Overview The 'Brighter Bites' intervention is being tested against a wait-list control group to see if it improves kids' health by increasing vegetable intake, improving household food security, and changing dietary behaviors over nine months.

Participant Groups

Group I: Brighter Bites Experimental Treatment 1 Intervention

This group will receive the Brighter Bites intervention throughout the study implementation. The intervention includes fruit and vegetable distributions of \~20lbs. for teachers and families, healthy recipe tastings, and nutrition education.

Group II: Control group Active Control 1 Intervention

This delayed intervention group will receive the Brighter Bites intervention after concluding their participation in the study.

Brighter Bites is already approved in United States for the following indications:

Approved in United States as Brighter Bites for:

• Improving access to fruits and vegetables among low-income children and families
• Nutrition education

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials

974

Recruited

361,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

Childhood obesity interventions aim to regulate body weight and fat while ensuring proper nutrition for growth, with successful programs leading to healthier eating and exercise behaviors that can persist into adulthood.

While these interventions can lead to positive health outcomes like reduced blood pressure and improved insulin sensitivity, they also carry risks such as the potential development of disordered eating patterns, highlighting the need for careful implementation and monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of pediatric obesity. Epstein, LH., Myers, MD., Raynor, HA., et al.[2007]

Long-term improvements in eating behavior, supported by family involvement and child-friendly organization, can significantly reduce obesity prevalence in children and adolescents.

A structured approach combining a balanced diet (300-400 kcal/day below daily needs), increased physical activity, and parental training is essential for effective weight reduction, especially in high-risk groups that are often underserved.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Dietary interventions and social care for treating obesity in children]. Wiegand, S., Bau, AM., Babitsch, B.[2016]

Current behavioral treatments for childhood and adolescent obesity can achieve long-term weight control in about one-third of participants, highlighting the need for effective strategies.

Successful treatment components include group formats with individualized counseling, parent involvement, frequent sessions, and a focus on creating supportive home environments, but further research is needed to optimize these approaches for sustained weight management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioural treatment of childhood and adolescent obesity. Robinson, TN.[2022]

After 12 months of family-based obesity treatment, 40% of children with severe obesity no longer met the criteria for severe obesity, indicating the efficacy of the intervention.

Children with severe obesity showed improvements in psychosocial distress similar to those with mild obesity/overweight, suggesting that the treatment not only helps with weight loss but also supports mental well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Children with Severe Obesity in Family-Based Obesity Treatment Compared with Other Participants: Conclusions Depend on Metrics. Hayes, JF., Fowler, LA., Balantekin, KN., et al.[2022]

A systematic review of 125 studies found that various dietary interventions can effectively reduce body mass index (BMI) in children and adolescents with obesity, with very-low energy diets showing the greatest effectiveness, resulting in an average BMI reduction of -4.40 kg/m².

In contrast, dietary interventions without a specified energy target were ineffective, leading to a slight increase in BMI (+0.17 kg/m²), highlighting the importance of clear energy targets in obesity treatment for children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Targeted dietary approaches for the management of obesity and severe obesity in children and adolescents: A systematic review and meta-analysis. Southcombe, F., Lin, F., Krstic, S., et al.[2023]

Very low-energy diet (VLED) programs are effective for weight loss in children and adolescents with obesity, showing a mean weight loss of 10.1 kg after interventions lasting 3 to 20 weeks, based on a meta-analysis of 20 studies.

While VLED programs significantly improve weight-related outcomes, the existing literature lacks sufficient data on safety and adverse events, highlighting the need for future studies to monitor these aspects and provide long-term follow-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of very low-energy diet programs for weight loss: A systematic review with meta-analysis of intervention studies in children and adolescents with obesity. Andela, S., Burrows, TL., Baur, LA., et al.[2020]

About 14% of American preschoolers are obese, and this review highlights modifiable behaviors like sugary drink consumption and screen time that can contribute to obesity in this age group.

Current prevention programs have shown limited success in addressing obesity in preschoolers, but family-based interventions show promise, suggesting a need for optimized research strategies to develop effective treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Obesity in preschoolers: behavioral correlates and directions for treatment. Kuhl, ES., Clifford, LM., Stark, LJ.[2022]

A community-based obesity treatment program for children aged 6-15 years led to significant short-term improvements in weight-related measures, including a decrease in BMI by 0.65 kg/m² and waist circumference by 1.8 cm, among 2,812 participants.

Children who attended at least 75% of the program showed greater benefits in BMI reduction, self-esteem, and healthier dietary choices, highlighting the importance of program adherence for achieving positive outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Translational research: are community-based child obesity treatment programs scalable? Hardy, LL., Mihrshahi, S., Gale, J., et al.[2021]

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]

Family-Based Behavioral Treatment (FBT) is the most effective method for managing child obesity, but it is resource-intensive, involving extensive group sessions and coaching.

The newly developed Guided Self-Help (gshFBT) program offers a more accessible alternative, providing families with a manual and shorter coaching sessions, potentially allowing for broader intervention access for children with obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design of the FRESH-DOSE study: A randomized controlled noninferiority trial evaluating a guided self-help family-based treatment program for children with overweight or obesity. Boutelle, KN., Rhee, KE., Manzano, MA., et al.[2023]

Pediatric obesity is a growing global issue, particularly affecting disadvantaged children, and is linked to serious health risks like type 2 diabetes, hypertension, and sleep apnea, stemming from poor lifestyle choices and environmental factors.

Effective interventions require a coordinated effort from governments, communities, and healthcare providers, including public education, school meal reforms, and personalized support for families, as well as new pharmacological approaches targeting appetite control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An overview of pediatric obesity. Lee, WW.[2007]

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

Treatment of pediatric obesity. [2007]

2. Germany pubmed.ncbi.nlm.nih.gov

[Dietary interventions and social care for treating obesity in children]. [2016]

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

Behavioural treatment of childhood and adolescent obesity. [2022]

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

Children with Severe Obesity in Family-Based Obesity Treatment Compared with Other Participants: Conclusions Depend on Metrics. [2022]

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

Targeted dietary approaches for the management of obesity and severe obesity in children and adolescents: A systematic review and meta-analysis. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Efficacy of very low-energy diet programs for weight loss: A systematic review with meta-analysis of intervention studies in children and adolescents with obesity. [2020]

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

Obesity in preschoolers: behavioral correlates and directions for treatment. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Translational research: are community-based child obesity treatment programs scalable? [2021]

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

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

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

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

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

Design of the FRESH-DOSE study: A randomized controlled noninferiority trial evaluating a guided self-help family-based treatment program for children with overweight or obesity. [2023]

12. Denmark pubmed.ncbi.nlm.nih.gov

An overview of pediatric obesity. [2007]

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

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