Behavioral Intervention for Childhood Obesity

(FOODIE Trial)

Overseen By Zenas Okero

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Pennsylvania

Must not be taking: Weight medications

Disqualifiers: Serious medical, Psychiatric, Food allergies, others

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

Compensation: Varies

Number of Visits: 3

242 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how children's eating behaviors and family influences impact the risk of obesity, especially in those with a genetic predisposition. The focus is on understanding behaviors like eating speed and eating when not hungry, and how these may alter a child's natural inclination toward obesity. This study is particularly suited for healthy children aged 5-7 who are at or above the 5th percentile for BMI and whose biological mothers are their primary caregivers. As an unphased trial, it offers a unique opportunity to contribute to important research that may help shape future obesity prevention strategies for children.

Will I have to stop taking my current medications?

The trial excludes children who are using medications that affect food intake, body weight, physical activity, or sleep, so if your child is on such medications, they would not be eligible to participate.

What prior data suggests that this behavioral intervention is safe for children?

Research shows that the "Heightened Drive to Eat" treatment focuses on eating behaviors, such as eating speed, eating when not hungry, and the enjoyment of food compared to other activities. Specific safety data for this treatment is unavailable because it addresses behavior rather than drugs or medical procedures.

The trial is in a "Not Applicable" phase, indicating no previous clinical testing phase to provide safety data. However, this suggests the study might lack the risks typically associated with drug trials. Participants will likely focus on observing and changing their eating habits, which is generally safe.

The treatment does not involve new medications or surgeries, so the risk of side effects is low. Instead, it examines how certain habits and environments can influence eating behavior and the risk of obesity. This approach is usually well-tolerated because it emphasizes lifestyle changes rather than medical treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the behavioral intervention for childhood obesity because it takes a unique approach by focusing on eating behaviors rather than just diet or exercise. Unlike standard treatments that often emphasize calorie restriction or increased physical activity, this intervention targets the underlying behaviors like eating rate, eating in the absence of hunger, and the relative reinforcing value of food. This approach could lead to more sustainable changes in habits and potentially more effective long-term weight management for children. By addressing the psychological and behavioral aspects of eating, the intervention offers a fresh perspective that could complement existing methods and enhance overall treatment success.

What evidence suggests that this behavioral intervention is effective for childhood obesity?

This trial will focus on a behavioral intervention for childhood obesity, specifically targeting a "Heightened Drive to Eat." Research has shown that changing a child's diet can help lower their Body Mass Index (BMI), a measure of body fat based on height and weight. One study found that children who followed special meal plans experienced a greater drop in BMI than those who received regular healthcare advice. Another study discovered that a 10-week health program for families helped reduce BMI scores, which compare a child's weight to others their age. Using mobile apps to guide parents of overweight children also yielded positive results, highlighting the family's role in addressing childhood obesity. Adding exercise to dietary changes can further aid in weight control. These findings suggest that modifying eating and activity habits can help manage and reduce childhood obesity. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This study is for children aged 5-7 with a BMI at or above the 5th percentile, and their biological mothers who are primary caregivers. Mothers must understand English. Kids can't join if they have conditions or take meds that affect eating, weight, activity, sleep; have developmental/psychiatric issues impacting compliance; food allergies related to study foods; or lactose intolerance.

Inclusion Criteria

Mother must be able to read and understand English

My child's BMI is at or above the 5th percentile.

I am the biological mother and main caregiver of my children.

Exclusion Criteria

Children with food allergies related to study foods or lactose intolerance

My child does not like the foods used in the study.

Children with developmental and/or psychiatric conditions that may impact study compliance

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Initial assessment of genotype, phenotype, and energy balance behaviors

4 weeks

1 visit (in-person)

Intervention

Participants engage in energy balance behavior interventions focusing on diet, physical activity, and sleep

12 months

Monthly visits (in-person or virtual)

Follow-up

Participants are monitored for changes in weight, adiposity, and BMI z-score

1 year

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Heightened Drive to Eat

Trial Overview The trial investigates how genetic risk for obesity and behaviors like diet, physical activity, and sleep interact in kids. It looks at whether these factors can influence changes in weight over a year when considering the child's natural urge to eat and family environment influences.

How Is the Trial Designed?

Group I: Heightened Drive to Eat Experimental Treatment 1 Intervention

* Eating rate * Eating in the absence of hunger * Relative reinforcing value of food

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

Published Research Related to This Trial

A study involving 72 overweight or obese children and their parents showed that both self-directed and prescribed interventions for pediatric obesity were effective in reducing body mass index (BMI) over a 2-year period.

Both intervention methods resulted in similar reductions in child and parent BMI, indicating that the self-directed approach is a viable alternative to the standard prescribed method for treating pediatric obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized clinical trial comparing delivery of behavioral pediatric obesity treatment using standard and enhanced motivational approaches. Saelens, BE., Lozano, P., Scholz, K.[2023]

Involving parents in treatment interventions for childhood obesity is crucial, with effective strategies including goal setting, motivational counseling, and role modeling, which promote shared ownership of health goals between parents and children.

Programs that address family barriers and enhance intrinsic motivation and self-efficacy are associated with positive changes in children's dietary and physical activity behaviors, suggesting these elements should be central in future obesity treatment designs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Family-Based Behavior Change Interventions on Obesity-Related Behavior Change in Children: A Realist Synthesis. Enright, G., Allman-Farinelli, M., Redfern, J.[2020]

A systematic review of 108 studies found that interventions using behavioral insights were effective in improving children's diet-related outcomes in 74% of cases, with the most successful strategies involving incentives, changing defaults, and modifying the physical environment.

However, the review highlighted a lack of evidence regarding the long-term sustainability, cost-effectiveness, and health equity implications of these interventions, which poses challenges for policymakers in implementing effective obesity prevention strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interventions using behavioural insights to influence children's diet-related outcomes: A systematic review. Chambers, T., Segal, A., Sassi, F.[2021]

In a study of 111 children with overweight/obesity, significant correlations were found between certain measures of food cue responsiveness (FCR), indicating some level of agreement among different assessment methods, particularly between eating in the absence of hunger and parent-reported food responsiveness.

However, the overall lack of strong concordance among the various FCR measures raises concerns about their reliability, suggesting a need for clearer definitions and improved assessments to better understand FCR in children and its implications for obesity interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Discordance between assessments of food cue responsiveness: Implications for assessment in youth with overweight/obesity. Manzano, MA., Strong, DR., Rhee, KE., et al.[2023]

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]

In a study involving 84 families with children aged 8-12 years who are obese, adding appetite awareness training (AAT) to standard family-based behavioral treatment (FBT) resulted in significantly lower weights for children in the FBT-AAT group at both one and two years post-treatment.

While both treatment groups showed no significant differences immediately after treatment, the FBT-AAT group continued to improve in weight management over the second year, suggesting that AAT may help maintain treatment effects longer than standard FBT alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incorporating Appetite Awareness Training Within Family-Based Behavioral Treatment of Pediatric Obesity: A Randomized Controlled Pilot Study. Njardvik, U., Gunnarsdottir, T., Olafsdottir, AS., et al.[2019]

A three-week play-based intervention aimed at enhancing self-regulation in preschool children did not significantly reduce overall calorie consumption compared to a control group, but it showed promise in balancing calorie intake between overweight/obese and healthy weight children in the intervention group.

Younger children in the intervention group demonstrated better inhibitory control skills than their peers in the control group, suggesting that such programs may be beneficial for improving self-regulation in younger preschoolers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cluster randomized control trial promoting child self-regulation around energy-dense food. Rhee, KE., Kessl, S., Manzano, MA., et al.[2021]

The study evaluated a culturally adapted obesity prevention intervention for pre-adolescent non-Hispanic Black/African American girls, involving 361 families, but found no significant improvements in diet quality as measured by the Healthy Eating Index 2015 after 6 months.

Despite the lack of significant changes in overall diet quality, the findings suggest that future interventions should consider different behavior change strategies and more engaging dietary assessment methods to effectively promote healthier eating habits among at-risk children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diet Quality among Pre-Adolescent African American Girls in a Randomized Controlled Obesity Prevention Intervention Trial. Thompson, D., Mirabile, Y., Islam, N., et al.[2023]

The Kid's Choice Program (KCP) effectively increased healthy behaviors like eating fruits and vegetables first, choosing low-fat drinks, and exercising among 382 children, leading to a decrease in BMI% for both overweight and average-weight participants during the three-month intervention.

However, while overweight children showed initial weight loss, they tended to regain weight six months after the program ended, highlighting the need for ongoing support and application of the KCP to maintain long-term weight management benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Kid's Choice Program improves weight management behaviors and weight status in school children. Hendy, HM., Williams, KE., Camise, TS.[2021]

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]

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]

Childhood obesity prevention programs often overlook individual differences in children's eating behaviors, which can be influenced by genetic and environmental factors from infancy.

Identifying specific appetitive traits early on may help develop personalized interventions, potentially improving the effectiveness of obesity prevention strategies in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identifying behavioral phenotypes for childhood obesity. Kral, TVE., Moore, RH., Chittams, J., et al.[2020]

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. bmcpublichealth.biomedcentral.com bmcpublichealth.biomedcentral.com/articles/10.1186/s12889-024-21120-5

The effectiveness of a 10-week family-focused e-Health ... Mixed ANOVA confirmed BMI z-score decreased after 10 weeks of the program, irrespective of the Control group undergoing 10 weeks waiting period ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9501985/

Effectiveness of mobile health interventions targeting parents ... Interventions targeting overweight and/or obese children had the most positive results. All studies reported high acceptability and feasibility of interventions ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2589537025000628

Do the effects of interventions aimed at the prevention ... The findings suggested that a range of physical activity interventions, alone or in combination with dietary interventions, can have a modest beneficial effect, ...

5. healthyeatingresearch.org healthyeatingresearch.org/wp-content/uploads/2019/03/her_kenney_brief-3.pdf

The Cost-Effectiveness of Interventions for Reducing ... One caveat with early childhood obesity prevention interventions is that few show healthcare cost savings over the short run – say a ten year time frame. Even ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9857183/

The Effects of Food Environment on Obesity in Children Of the 725 students studied, 24.8% were overweight and 20.7% were obese. The results showed that there were significantly more food venders near ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9831747/

Obesity in children and adolescents: epidemiology, causes ... This Review describes current knowledge on the epidemiology and causes of child and adolescent obesity, considerations for assessment, and current management ...

8. populationmedicine.org populationmedicine.org/news-media/new-study-links-neighborhood-food-access-child-obesity-risk

New Study Links Neighborhood Food Access to Child ... Recent data indicates an increase from 12.5% in 2021 to 17.3% in 2022. At the same time, childhood obesity rates have been steadily rising. This ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S1570677X22000491

Childhood obesity, is fast food exposure a factor? We investigate whether the residential access to fast food increased BMI of adolescents at a time when fast food restaurants started to open in the UK.

10. who.int who.int/europe/news/item/23-05-2024-the-inequality-epidemic--low-income-teens-face-higher-risks-of-obesity--inactivity-and-poor-diet

The inequality epidemic: low-income teens face higher ... New WHO/Europe report finds alarming disparities in diet, exercise and weight among adolescents from different socioeconomic backgrounds.