- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00186173
Sports to Prevent Obesity: Feasibility and Pilot RCT
연구 개요
상세 설명
After school sports programs may be generalizable, motivating and cost-efficient interventions for long-term weight control among at-risk and overweight children. The infrastructure needed to provide such programs already exists in most communities. In contrast, more traditional, medically- and behaviorally-oriented treatment programs are expensive, generally not very effective, often inconvenient, and not available in most communities. While children involved in team sports tend to be more physically fit than their uninvolved peers, team sports has not yet been tested as a method to increase involvement of at-risk and overweight children in regular physical activity. As an added bonus, these sports programs can displace typical after school television viewing and snacking. Team sports is a potentially innovative and high impact approach for intervening with at-risk and overweight children, as it may provide an opportunity to reduce weight gain while increasing social interaction and self-esteem. If our proposed research finds that team sports are an efficacious intervention for reducing weight gain among low-income at-risk and overweight children, it is an intervention approach that could be rapidly diffused and tested for effectiveness. The policy implications of these findings would be great, encouraging expanded access to team sports programs to a population that has not been previously targeted or included.
We propose a two-phase project in East Palo Alto, California, a low-income, primarily Latino, African-American and Pacific Islander community. The first phase will be a 3-month feasibility trial of an after school team sports program for overweight children to examine several theory-driven approaches to program design and implementation, including assessments of liking and participation and barriers and facilitators of participation. The second phase will be a 6-month randomized controlled pilot trial (RCT) comparing weight changes among overweight children randomized to participate in the after school team sports program versus a traditional weight control/health education program.
연구 유형
등록 (실제)
단계
- 2 단계
- 1단계
참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- In 4th or 5th grade of a participating school at time of enrollment
- BMI greater than or equal to the 85th percentile on the 2000 CDC growth charts
- Medical clearance obtained from primary care provider
Exclusion Criteria:
Our goal is to be inclusive as possible, however, children will not be eligible to participate if they:
- have a condition that limits their participation in physical activity enough that they are not able to participate in Physical Education at school (e.g. significant structural heart disease)
- are pregnant
- have been diagnosed with a chronic illness that affects their growth and/or weight (e.g., type 1 diabetes, hypothyroidism, inflammatory bowel disease)
- have taken systemic steroids (oral, intravenous, or intramuscular) for a period of more than 21 days in the past year
- are taking other medications potentially affecting their growth and/or weight (e.g. methylphenidate HCL)
- are unable to complete the informed consent process
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: After school sports
After school team sports intervention designed specifically for overweight and obese children
|
After school team sports intervention designed specifically for overweight and obese children
|
활성 비교기: After school health education
After school heath and nutrition education program
|
After school health and nutrition education program
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
---|---|
Body mass index
기간: Baseline, 3 and 6 months
|
Baseline, 3 and 6 months
|
2차 결과 측정
결과 측정 |
기간 |
---|---|
Waist circumference
기간: Baseline, 3 and 6 months
|
Baseline, 3 and 6 months
|
Triceps skinfold thickness
기간: baseline, 3 and 6 months
|
baseline, 3 and 6 months
|
Resting heart rate
기간: baseline, 3 and 6 months
|
baseline, 3 and 6 months
|
Physical activity monitoring
기간: baseline, 3 and 6 months
|
baseline, 3 and 6 months
|
Sedentary behaviors
기간: baseline, 3 and 6 months
|
baseline, 3 and 6 months
|
Psychosocial measures
기간: baseline, 3 and 6 months
|
baseline, 3 and 6 months
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Thomas N Robinson, MD, MPH, Stanford University
- 연구 책임자: Dana L Weintraub, MD, Stanford University
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 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 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
After school sports program에 대한 임상 시험
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KK Women's and Children's HospitalDuke University; Duke-NUS Graduate Medical School; Health Promotion Board, Singapore; Sport...완전한