Eating RePace Study (REPACE)
Eating Pace Retraining in Childhood Obesity Prevention
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Pennsylvania
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Philadelphia, Pennsylvania, 미국, 19104
- Children's Hospital of Philadelphia
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: RePace Intervention Group
Re-Pace intervention-five weekly intervention sessions lasting about 1 hour each. Lab Test Meal-2 test meals 6-8 weeks apart. |
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.
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활성 비교기: Usual Care Control Group
One 25 minute education session (week 6) 2 lab test meals 6-8 weeks apart (baseline and week 6)
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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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Reduction of eating rate (mouthfuls/min)
기간: 6 weeks
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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.
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6 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Reduction of food consumption
기간: 6 weeks
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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).
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6 weeks
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공동 작업자 및 조사자
수사관
- 수석 연구원: Robert I Berkowitz, MD, Children's Hospital of Philadelphia
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 12-009540
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
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RePace Intervention에 대한 임상 시험
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VA Office of Research and Development모집하지 않고 적극적으로
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Washington University School of MedicineSt. Jude Children's Research Hospital완전한
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University of MichiganNational Institute on Drug Abuse (NIDA)모집하지 않고 적극적으로
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RTI InternationalUniversity of North Carolina, Chapel Hill초대로 등록결절성 경화증 | 다운 증후군 | 뒤시엔 근이영양증 | 프래더-윌리 증후군 | 취약 X 증후군 | 레트 증후군 | 터너 증후군 | 윌리엄스 증후군 | 엔젤만 증후군 | 염색체 22q11.2 결실 증후군 | 클라인펠터 증후군 | 펠란-맥더미드 증후군 | Dup15Q 증후군 | 스미스 마제니스 증후군미국
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University of MichiganNational Institute of Nursing Research (NINR)완전한
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University of MichiganNational Center for Advancing Translational Sciences (NCATS)완전한