Clinical trial NCT02186379: Eating RePace Study
Official title: Eating Pace Retraining in Childhood Obesity Prevention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Rapid Eating Style
Keywords: Obesity
Obesity Prevention
Childhood obesity prevention
Rapid Eating Style
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
First posted: 2014-07-10
Enrollment: 28
Sex: ALL
Minimum age (years): 4
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aims of this study are to develop a novel family-based behavioral intervention (Re-Pace) to help children at risk for obesity (children who eat rapidly and have an overweight parent/legal guardian) develop a more normal eating rate.

Detailed description: Childhood obesity is one of nation's foremost public health epidemics, for which more potent and enduring prevention interventions are needed. The goal of this program of research is to study novel methods which may help to prevent childhood obesity. The purpose of this randomized, controlled pilot study is to retrain children at risk for obesity (4-7 years of age in the 65th - \<96th BMI percentile for age and sex, who have rapid eating and an obese participating parent/legal guardian \[ N = 15\]) to reduce their rate of eating (mouthfuls/minute) during a laboratory test meal, compared with participants in usual care control condition (UCC),which receives a brief educational intervention to promote healthy eating after the final assessment) (N=15). Between group change scores in mouthfuls/min (baseline Lab meal 1 to Lab meal 2) will be assessed. The investigators hypothesize that the children in the Re-Pace group will have a greater reduction in the rate of eating (mouthfuls of food/min) from baseline to week 6, compared to those in the UCC group.

As the sample size is relatively small, the aim is to develop an "effect size estimation," i.e., to generate an effect size that will be used to power an extramural grant application. Specifically, the investigators will generate Cohen's D as the effect size estimate, which is calculated as the difference in the group means divided by the pooled standard deviation. Cohen's D is an established quantitative measure for effect size estimation and informing power analysis for study design.

In addition, this study's objective is to develop and pilot a novel family-based eating behavior program for a prevention intervention in at risk children.

Eligibility criteria: Inclusion Criteria:

Children:

* Males or females 4 to 7 years of age.
* Participants (the children) have a body mass index (BMI) for age and sex between the 65th-\<96th percentile (thus, the children will not have a BMI at the 97th percentile or more).
* Parental/guardian permission (informed consent).
* Have an overweight or obese participating parent/guardian with a BMI of \> 27 kg/m2
* Increased child eating rate as reported on the questionnaire (Child Eating Behavior Questionnaire) by the parent/guardian

Parents:

* Parent/legal guardian of subject.
* Age 21 years and above.
* Have a BMI of \> 27 kg/m2.

Exclusion Criteria:

Children:

* Children who have any developmental, medical, or psychiatric condition which might affect study compliance, as described by parental (caregiver) report.
* Children who have serious medical conditions or use of medications (e.g., chronic oral steroids, antipsychotic medications) known to affect food intake or body weight, as described by parental report.
* Children who have food allergies which may influence consumption of test foods, as reported by the parent; any child with reported peanut allergy.
* Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.

Parents:

* Parents/guardians who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.

Primary outcomes:
measure: Reduction of eating rate (mouthfuls/min)
timeFrame: 6 weeks
Secondary outcomes:
measure: Reduction of food consumption
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Robert I Berkowitz, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Faith MS, Diewald LK, Crabbe S, Burgess B, Berkowitz RI. Reduced Eating Pace (RePace) Behavioral Intervention for Children Prone to or with Obesity: Does the Turtle Win the Race? Obesity (Silver Spring). 2019 Jan;27(1):121-129. doi: 10.1002/oby.22329. Epub 2018 Dec 4.