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Completed

NCT Number: NCT02186379

Eating RePace Study

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.

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Key information

Age range

4 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

RePace Intervention

Behavioral

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.

Usual Care Control

Behavioral

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.

Primary outcomes

  1. Reduction of eating rate (mouthfuls/min)

    Time frame: 6 weeks

    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.

Secondary outcomes

  1. Reduction of food consumption

    Time frame: 6 weeks

    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).

Sponsors and collaborators

Lead sponsor

Children's Hospital of Philadelphia

Other

Registry information

Official study title

Eating Pace Retraining in Childhood Obesity Prevention

Acronym: REPACE

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jul 10, 2014
Registry last updated
Apr 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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