Eating RePace Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Eating Pace Retraining in Childhood Obesity Prevention

Conditions
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Obesity, Rapid Eating Style

Intervention / Treatment
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* Behavioral: RePace Intervention
* Behavioral: Usual Care Control


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 7 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RePace Intervention Group<br>Re-Pace intervention-five weekly intervention sessions lasting about 1 hour each. Lab Test Meal-2 test meals 6-8 weeks apart. | Behavioral: RePace Intervention<br>* The Re-Pace intervention will provide children and parents/caregivers training in strategies to promote slower eating pace and greater awareness of satiety levels. These skill building strategies can be classified as follows: 1) learning to slow eating rate, 2) awareness-raising activities; 3) role play activities; 4) self-monitoring training; 5) goal setting challenges; and 6) parent training. A core strategy for achieving slower eating pace and improved satiety will be to increase fruit and vegetable intake to meet United States Department of Agriculture (USDA) guidelines (www.myplate.gov). There are 5 intervention visits lasting about 1 to 1.25 hours each. See Section 4.3.1 for more details of the Re-Pace intervention.<br>|
| Active Comparator: Usual Care Control Group<br>One 25 minute education session (week 6) 2 lab test meals 6-8 weeks apart (baseline and week 6) | Behavioral: Usual Care Control<br>* Following the second test meal session, parents and children will receive a brief (25 minute) instruction on healthy eating using materials from www.ChooseMyPlate.gov site, including What's on Your Plate and My Plate for Kids mini-posters.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of eating rate (mouthfuls/min) | 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. We 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. | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of food consumption | Reduce the rate of food consumption (kcal/min) and total kcal intake during the test meals (baseline Lab Meal 1 to Lab Meal 2). We also aim for participants to consume more fruits and vegetables during the test meal (baseline to week 6). | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, Obesity Prevention, Childhood obesity prevention, Rapid Eating Style