Eating Behavior Assessment for Childhood Obesity

(PACE Trial)

Overseen By Kathleen L Keller, Ph.D.

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Penn State University

Must not be taking: Cold, Allergy, Appetite, others

Disqualifiers: Diabetes, Autism, ADHD, others

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

Compensation: Varies

Number of Visits: 6

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand the relationship between children's eating behaviors, brain activity, and body fat. Researchers focus on the PACE phenotype, which examines how much children eat when given large portions, their eating speed, appetite traits, and self-control around food. The study will track children aged 7 to 9 for one year, using brain scans and meal observations to explore connections to weight gain. Children with a body mass index (BMI) below the 85th percentile or above the 95th percentile, who are not on medications affecting weight or appetite, might be suitable candidates. Results could help identify children at risk for obesity and guide future prevention strategies. As an unphased trial, this study offers a unique opportunity for children to contribute to important research that could shape future obesity prevention efforts.

Will I have to stop taking my current medications?

Children cannot participate if they are taking medications that affect body weight, taste, food intake, behavior, or blood flow. If your child is on such medications, they would need to stop taking them to join the study.

What prior data suggests that this assessment is safe for children?

Research has shown that the PACE eating pattern helps clarify how children's eating habits might lead to weight gain. This study focuses on observing and understanding behaviors, not testing treatments on children. It examines how different eating habits and brain responses relate to body fat over time.

Since this is not a trial for a new drug or medical procedure, participants face no risk of side effects from the study itself. The PACE assessment includes safe activities such as brain scans, observing meal consumption, and completing questionnaires. Researchers have safely used these methods in many other studies to explore eating habits and brain activity.

In summary, this study aims to understand eating behaviors and brain activity, not to test a treatment. It is safe for participants and employs standard research methods. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for childhood obesity that often focus on diet and exercise alone, this trial is exploring the PACE eating phenotype to understand the neurobiological and behavioral factors influencing obesity. Researchers are excited because it aims to uncover how brain responses to food cues and family dynamics contribute to weight gain, potentially leading to more personalized and effective interventions. By examining these underlying mechanisms, the study could pave the way for strategies that go beyond conventional calorie counting, offering hope for long-term success in managing childhood obesity.

What evidence suggests that this assessment is effective for understanding childhood obesity?

Research has shown that the PACE eating pattern can help predict which children are more likely to gain body fat as they grow. In this trial, researchers will assess children in the PACE Phenotype Study to understand the neurobiological and behavioral aspects of the PACE eating phenotype and its relationship to adiposity. The PACE score considers how much and how quickly a child eats, their appetite, and their ability to control eating. Studies suggest that these eating habits can affect body fat levels. Understanding this connection might help identify children at higher risk for obesity and guide prevention efforts. ^{2 4 5 6 7}

Who Is on the Research Team?

Kathleen L Keller, Ph.D.

Principal Investigator

Penn State University

Are You a Good Fit for This Trial?

This trial is for children aged 7 to 9 who may be at risk of obesity due to their eating habits. It aims to understand the PACE eating phenotype, which includes behaviors like eating speed and portion control. The study seeks participants without any major health issues that could affect their eating behavior or brain function.

Inclusion Criteria

My child is between 7 and 9 years old.

My child is generally healthy, obesity being the exception.

Children should have no learning disabilities or developmental delays (e.g., ADHD, Autism, dyslexia)

Exclusion Criteria

Children are red/green colorblind

Children do not speak English fluently

Children's BMI-for-age percentile is between 85-95th

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Initial assessment including brain scans, lab-based meal observations, and questionnaires to study eating patterns and body composition

4 visits

4 visits (in-person)

Follow-up Assessment

Follow-up assessment to measure changes in eating behaviors and body composition after 12 months

12 months

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Assessment of PACE Eating Phenotype and Related Behavioral and Neurobiological Measures

Trial Overview The study is testing how certain eating behaviors in children are linked to brain activity and body fat levels. Over one year, researchers will use brain scans, observe mealtime behavior, and gather questionnaire data to track changes in body fat related to the PACE phenotype.

How Is the Trial Designed?

Group I: Children in PACE Phenotype Study Experimental Treatment 1 Intervention

A total of 210 child-parent dyads (420 participants total) will be followed for 12 months to investigate the neurobiological and behavioral aspects of the PACE eating phenotype and its relationship to adiposity in children. Children will be 7 to 9 years old, with a body mass index (BMI)-for-age percentile either below the 85th or at or above the 95th percentile. The biological mother will have a BMI categorized as either normal weight (18.5-25.0 kg/m²) or obese (≥30.0 kg/m²). The study will assess brain responses to food cues, eating behaviors, and body fat using DXA scans, along with family socioeconomic and feeding factors that may influence weight gain trajectories.

Who Is Running the Clinical Trial?

Penn State University

Lead Sponsor

Trials

380

Recruited

131,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38795747/

PACE: a Novel Eating Behavior Phenotype to Assess Risk for ... PACE represents a cumulative eating behavior risk score that predicts adiposity gain over 1 y in middle childhood.

2. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/oby.22329

Reduced Eating Pace (RePace) Behavioral Intervention for ... Children in RePace compared with DUC showed increased “slowness in eating” (P < 0.001), increased food enjoyment (P = 0.04), and less BMI gain ( ...

3. researchgate.net researchgate.net/publication/380842474_PACE_a_novel_eating_behavior_phenotype_to_assess_risk_for_obesity_in_middle_childhood

PACE: a Novel Eating Behavior Phenotype to Assess Risk ... The majority of the studies showed effective economic outcomes applying primary prevention programs on childhood obesity. It is important to ...

4. publications.aap.org publications.aap.org/pediatrics/article/151/2/e2022060640/190443/Clinical-Practice-Guideline-for-the-Evaluation-and

Clinical Practice Guideline for the Evaluation and ... Childhood obesity results from a multifactorial set of socioecological, environmental, and genetic influences that act on children and families.

5. jmir.org jmir.org/2023/1/e45407/

Exploring the Effect of the Dynamics of Behavioral ... This study aimed to investigate the dynamics of behavioral changes during obesity intervention and identify behavioral phenotypes associated with weight change.

6. sciencedirect.com sciencedirect.com/science/article/pii/S0022316624002967

PACE: a Novel Eating Behavior Phenotype to Assess Risk ... PACE represents a cumulative eating behavior risk score that predicts adiposity gain over 1 y in middle childhood.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT07266506

Development of an Eating Behavior Risk Score (PACE) SES will be analyzed as a moderator of the relationship between PACE scores and child adiposity to explore social determinants of obesity risk.