Behavioral Intervention for Childhood Obesity

(FOODIE Trial)

Overseen By Sarah Malinchak

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

158 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Heightened Drive to Eat for childhood obesity?

Research shows that incorporating appetite awareness training, which helps children recognize hunger and fullness cues, within family-based behavioral treatments can be effective for managing childhood obesity. Additionally, involving parents in behavior change strategies and creating a supportive environment can lead to positive changes in children's eating and physical activity habits, which are important for reducing obesity. ^{1 2 3 4 5}

Is the behavioral intervention for childhood obesity safe?

Behavioral interventions for childhood obesity, like those focusing on diet and exercise changes, are generally safe but can sometimes lead to negative effects like disordered eating patterns. Positive effects include improvements in blood pressure and cholesterol levels. ^{2 6 7 8 9}

How does the behavioral intervention for childhood obesity differ from other treatments?

This treatment is unique because it focuses on identifying and addressing individual behavioral phenotypes (patterns) related to eating habits, which can help tailor interventions to each child's specific needs. Unlike standard treatments that may not consider these individual differences, this approach aims to prevent obesity by modifying risk factors early on. ^{1 3 10 11 12}

What is the purpose of this trial?

A genetic risk for obesity does not always translate to the development of obesity among children, which points to the presence of risk-modifying factors that likely relate to energy balance behaviors as key behavioral drivers. Using an integrated approach to comprehensively examine the interplay between genotype and phenotype, this study will systematically assess the extent to which energy balance behaviors, alone or in combination, in conjunction with family-level influences can modify behavioral and genetic predispositions to childhood obesity in a high-risk sample of predominantly minority children from low-resource backgrounds. Identifying protective factors that may mitigate the impact of obesity risk on weight and adiposity outcomes is critical for moving the prevention of childhood obesity into a new direction.

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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 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]

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 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]

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]

References

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

Incorporating Appetite Awareness Training Within Family-Based Behavioral Treatment of Pediatric Obesity: A Randomized Controlled Pilot Study. [2019]

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

Treatment of pediatric obesity. [2007]

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

Identifying behavioral phenotypes for childhood obesity. [2020]

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

A randomized clinical trial comparing delivery of behavioral pediatric obesity treatment using standard and enhanced motivational approaches. [2023]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Effectiveness of Family-Based Behavior Change Interventions on Obesity-Related Behavior Change in Children: A Realist Synthesis. [2020]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Diet Quality among Pre-Adolescent African American Girls in a Randomized Controlled Obesity Prevention Intervention Trial. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Interventions using behavioural insights to influence children's diet-related outcomes: A systematic review. [2021]

8. 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]

9. England pubmed.ncbi.nlm.nih.gov

Kid's Choice Program improves weight management behaviors and weight status in school children. [2021]

10. Denmark pubmed.ncbi.nlm.nih.gov

An overview of pediatric obesity. [2007]

11. England pubmed.ncbi.nlm.nih.gov

Discordance between assessments of food cue responsiveness: Implications for assessment in youth with overweight/obesity. [2023]

12. England pubmed.ncbi.nlm.nih.gov

Cluster randomized control trial promoting child self-regulation around energy-dense food. [2021]