Trials / Completed
CompletedNCT02186379
Eating RePace Study
Eating Pace Retraining in Childhood Obesity Prevention
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 28 (actual)
- Sponsor
- Children's Hospital of Philadelphia · Academic / Other
- Sex
- All
- Age
- 4 Years – 7 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | RePace Intervention | 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. |
| BEHAVIORAL | Usual Care Control | 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. |
Timeline
- Start date
- 2012-11-01
- Primary completion
- 2014-10-01
- Completion
- 2014-10-01
- First posted
- 2014-07-10
- Last updated
- 2015-04-24
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02186379. Inclusion in this directory is not an endorsement.