Diet Modification for Childhood Obesity

(BRIDGE Trial)

Overseen By BRIDGE Study

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of Washington

Must not be taking: Stimulants

Disqualifiers: Type 2 diabetes, Eating disorder, Cognitive disorder, others

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

Compensation: Varies

Number of Visits: 3

75 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

If you or your child are currently using medications that affect appetite or body weight, you will not be eligible to participate in this trial.

What data supports the effectiveness of the treatment Diet modification for childhood obesity?

Research shows that changing a child's diet, especially when combined with setting achievable goals and increasing physical activity, can effectively help manage and reduce obesity in children. ^{1 2 3 4 5}

Is diet modification safe for children with obesity?

The safety of very low-energy diet programs for children and adolescents with obesity is not well-established, as existing studies have limited details on adverse events. More research is needed to understand the long-term safety of these dietary interventions. ^{1 2 6 7 8}

How does diet modification differ from other treatments for childhood obesity?

Diet modification for childhood obesity is unique because it focuses on changing eating habits and behaviors, often combined with setting short-term goals and increasing physical activity, rather than relying on medication or surgery. This approach emphasizes reducing sugar and ultra-processed foods without strict calorie restrictions, which can be more sustainable and effective for long-term weight management in children. ^{1 3 8 9 10}

What is the purpose of this trial?

The goal of this study is to 1) use magnetic resonance imaging (MRI) to evaluate the effect of nutritious foods on inflammation in the human hypothalamus of children and 2) assess the feasibility and acceptability of nutritious food feeding intervention strategies in children with overweight or obesity.

Research Team

Ellen Schur, MD

Principal Investigator

University of Washington

Eligibility Criteria

This trial is for children with overweight or obesity issues. It aims to study the impact of nutritious foods on brain inflammation and test if kids will accept healthy eating habits. Participants must be willing to undergo MRI scans.

Inclusion Criteria

I am an adult caregiver of a child aged 9-11 and willing to attend a focus group.

I am 9-11 years old with a BMI between the 85th and 95th percentile.

I am a caregiver of a child aged 9-11 who is overweight and qualifies for free or reduced-cost lunch in WA State.

Exclusion Criteria

Study 1 child participants and Study 3 criteria for children of adult participants:

Documented cognitive disorder

Severe food allergies, vegetarian, or vegan (Study 1 only)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Focus Group and Child Taste Test

Adult caregivers participate in a focus group to assess feasibility of a controlled feeding study, and children complete a taste-test of a controlled feeding study menu

1 week

1 visit (in-person)

Study-provided food

Participants are provided all meals for a 7-day period and then asked to consume their usual diet for another 7 days

2 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the intervention

4 weeks

Treatment Details

Interventions

• Diet modification

Trial Overview The intervention being tested is a diet modification plan focused on nutritious foods. The study involves MRI scans to observe changes in brain inflammation, specifically in the hypothalamus, related to dietary changes.

Participant Groups

Group I: Study-provided food (Study 2) Experimental Treatment 1 Intervention

Participants will be provided all meals for a 7-day period. For the other 7-days of their enrollment, they will be asked to consume their usual diet.

Group II: Focus Group and Child Taste Test (Study 1) Active Control 1 Intervention

No intervention is administered. Adult caregivers will participate in a focus group to assess feasibility of a controlled feeding study in children and children will complete a taste-test of a controlled feeding study menu.

Group III: Focus Group (Study 3) Active Control 1 Intervention

No intervention is administered. Adult caregivers of children will participate in a focus group to learn from families about participating in research involving feeding studies in children.

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials

1,858

Recruited

2,023,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Findings from Research

Combining dietary changes with behavioral management techniques, like setting short-term goals, is effective in treating obesity in children.

Increasing physical activity alongside dietary interventions is crucial for achieving weight loss in pediatric patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effective dietary therapies for pediatric obesity treatment. Fitch, A., Bock, J.[2021]

In a study involving 549 Hispanic and black children aged 2-12, both the MEND and Next Steps interventions led to significant improvements in diet quality and reductions in the consumption of unhealthy foods, particularly in younger age groups (2-5 and 6-8 years).

Parenting practices around feeding also improved, with increased monitoring and limit-setting observed in both interventions, indicating a positive shift in how parents manage their children's eating behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavior Modification of Diet and Parent Feeding Practices in a Community- Vs Primary Care-Centered Intervention for Childhood Obesity. Wilson, TA., Liu, Y., Adolph, AL., et al.[2022]

Dietary interventions for obese children can lead to relative weight loss, as indicated by meta-analyses of 37 randomized controlled trials, although the specifics of these dietary treatments are often poorly documented.

The overall effectiveness of dietary treatments for childhood obesity remains unclear due to the lack of high-quality studies and the variability in study designs and outcomes, highlighting the need for better research in this critical area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Measuring effectiveness of dietetic interventions in child obesity: a systematic review of randomized trials. Collins, CE., Warren, J., Neve, M., et al.[2018]

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]

In a study of 96 overweight and obese adults, it was found that many participants had inadequate vitamin intake, with men particularly lacking in vitamin A and women in vitamin B1 and PP, even before starting a low-energy diet.

After 18 weeks on a low-energy diet (about 1000 kcal/day), the average intake of essential vitamins remained below recommended levels, highlighting the need for careful dietary planning to ensure adequate nutrient supply during weight loss efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Changes in vitamins intake in overweight and obese adults after low-energy diets]. Pachocka, L., Kłosiewicz-Latoszek, L.[2014]

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Effective dietary therapies for pediatric obesity treatment. [2021]

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

Behavior Modification of Diet and Parent Feeding Practices in a Community- Vs Primary Care-Centered Intervention for Childhood Obesity. [2022]

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

Impact of weight management nutrition interventions on dietary outcomes in children and adolescents with overweight or obesity: a systematic review with meta-analysis. [2021]

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

Measuring effectiveness of dietetic interventions in child obesity: a systematic review of randomized trials. [2018]

5. Korea (South) pubmed.ncbi.nlm.nih.gov

Evidence-based customized nutritional intervention improves body composition and nutritional factors for highly-adherent children and adolescents with moderate to severe obesity. [2020]

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. Poland pubmed.ncbi.nlm.nih.gov

[Changes in vitamins intake in overweight and obese adults after low-energy diets]. [2014]

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

Impact of dietary macronutrient distribution on BMI and cardiometabolic outcomes in overweight and obese children and adolescents: a systematic review. [2022]

9. China pubmed.ncbi.nlm.nih.gov

Comparative dietary effectiveness of a modified government-recommended diet with avoidance of ultra-processed foods on weight and metabolic management in children and adolescents: An open-label, randomized study. [2022]

10. 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]