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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how healthy foods can reduce inflammation in the brain's hypothalamus, an area involved in hunger and body weight control, in children. Researchers aim to determine if providing nutritious meals for a week can benefit overweight kids. Some participants will join focus groups to discuss the feasibility of such dietary interventions. Children aged 9 to 11 who are overweight and live in Washington State might be suitable candidates, especially if they are open to trying new foods and providing feedback. As an unphased trial, this study offers a unique opportunity for children to contribute to important research on nutrition and health.

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 prior data suggests that this diet modification is safe for children?

Research has shown that changing a child's diet can help manage weight. In studies, children who adjusted their eating habits reduced their body mass index (BMI) without serious problems. BMI measures body fat using height and weight. One study found that these diet changes are safe and easy for children to handle, with no major side effects. This suggests that dietary changes are generally safe for kids. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a practical approach to tackling childhood obesity through diet modification. Unlike standard treatments that often involve medication or intensive lifestyle counseling, this trial provides children with ready-made meals for a week, simplifying healthy eating. The focus groups and taste tests ensure that the meal plans are both feasible for families and appealing to children, potentially increasing adherence and effectiveness. By directly involving caregivers and children, the trial aims to uncover insights into how structured dietary changes can be seamlessly integrated into family routines, ultimately leading to more sustainable weight management strategies.

What evidence suggests that diet modification might be an effective treatment for childhood obesity?

This trial will explore diet modification as a strategy for managing childhood obesity. Studies have shown that changing a child's diet can lower their body mass index (BMI) in cases of obesity. Children who adopt these dietary changes often experience a greater reduction in BMI compared to those receiving standard healthcare. Research also indicates that combining diet changes with exercise can significantly reduce belly fat. These approaches focus on improving eating habits, which are crucial for managing weight and preventing obesity in children. Overall, changing diet, especially when paired with exercise, effectively helps manage childhood obesity. ^{1 6 7 8 9}

Who Is on the Research Team?

Ellen Schur, MD

Principal Investigator

University of Washington

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8107859/

Effectiveness of dietary interventions on weight outcomes ... The results revealed that children who received dietary interventions had greater reduction in BMI when compared with usual healthcare (WMD: –0.12; 95% CI: – ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2211335525000920

The effectiveness of school-based obesity prevention ... The aim of this study is to synthesise the effects of child obesity prevention programs on diet, physical activity, tobacco smoking and alcohol intake.

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2832548

Interventions for Childhood Central Obesity: A Systematic ... Our findings showed that combining dietary and physical activity interventions was associated with significantly lower central obesity.

4. odphp.health.gov odphp.health.gov/sites/default/files/2019-09/Appendix-E-2.31.pdf

Dietary Patterns and Obesity The studies included in the reviews examined a variety of school-based approaches assessing the effectiveness of childhood obesity prevention interventions.

5. bmjpublichealth.bmj.com bmjpublichealth.bmj.com/content/3/1/e001707

Factors associated with the effectiveness of interventions to ... We aim to identify effective characteristics of behavioural change (physical activity and diet) interventions that prevent obesity in children aged 5 to 18 ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S2667368125000622

Systematic Review of Parental Influence on Pediatric Obesity Parent-focused interventions with booster sessions consistently demonstrated significant reductions in children's body mass index z-scores ...

7. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2820245

Interventions for Weight Management in Children and ... In the short term, weight management interventions led to lower BMI in children and adolescents, with no evidence of serious harm.

8. nyaspubs.onlinelibrary.wiley.com nyaspubs.onlinelibrary.wiley.com/doi/full/10.1111/nyas.15278

Behavior‐change lifestyle interventions for the treatment of ... This scoping review discusses optimal behavior-change lifestyle interventions in the treatment of overweight and obesity in children and adolescents.

9. nature.com nature.com/articles/s41366-022-01198-w

Core outcome set for early intervention trials to prevent ... This study aimed to develop a core outcome set for use in early childhood obesity prevention intervention studies in children from birth to five years of age ( ...