CHOICES: Family Physicians Treat Overweight Children (CHOICES)
연구 개요
상세 설명
The specific aim of this pilot study was to use the group office visit model to provide an obesity treatment intervention for children 8-11 years of age in gender-specific groups and their parents in a clinic setting. The targeted lifestyle components of the intervention are less TV viewing, less sweetened beverages, smaller food portions, less fast food/better choices away from home and more general physical activity. The psychosocial component was based in Resiliency; the Choices model focused on a non-judgmental approach to empowerment in relation to personal goals and knowledge of the basics of nutrition and physical activity.
Our aim was to recruit 35-40 children (approximately equal boys and girls) ages 8-11 and their parents for a 12 weekly sessions group office visit program. Participants were randomized into 2 groups; one group starting in March 2006 and the lagged intervention control group starting in September 2006. Physical measurements and data collection were at baseline, 4, 8, 12, 16 months from randomization.
We evaluated the acceptability and feasibility of the group office visit model and effect size (body mass index (BMI) and weight-for-age Z-scores). Feasibility and acceptability included ability to recruit within clinics, attendance, completion, follow-up rates, focus groups data and interviews of those who drop out. Evaluation of effect size included the patterns of growth over 15 months from baseline in relation to expected growth patterns and intervention exposure.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Arizona
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Tucson, Arizona, 미국, 85724
- University of Arizona
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Children in the 3rd to 5th grades and above the 85th percentile of BMI for age.
Exclusion Criteria:
- Conditions that would preclude dietary change or physical activity.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Choices
The 3-month twelve-session intervention, "Choices", included topics on nutrition, physical activity, and resiliency.
Parents, boys and girls met separately.
The sessions were developed for delivery by a family physician, two family medicine residents, and a nutritionist, who received training in positive psychology and resilience skills.
All children were measured on the same dates, but children were randomly assigned to two cohorts, beginning 6 months apart, to facilitate statistical analysis by having one group experience "normal growth" on study prior to intervention.
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The 12-week intervention included 1.5 hour classes each week.
Topics included nutrition, physical activity, and psychosocial skills based in Resiliency.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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body mass index age-and-gender specific Z-score
기간: 9 months post intervention baseline
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body mass index is weight over height squared; z-score described the position of that BMI in relation to the reference population in terms of standard deviation units.
It is used to control for growth effects in children.
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9 months post intervention baseline
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2차 결과 측정
결과 측정 |
기간 |
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weight for age-and-gender specific Z-score
기간: 9 months post-intervention baseline
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9 months post-intervention baseline
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공동 작업자 및 조사자
협력자
수사관
- 수석 연구원: Cheryl K Ritenbaugh, PhD, MPH, University of Arizona
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 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. .
Choices에 대한 임상 시험
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University of WashingtonCenters for Disease Control and Prevention완전한
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St. Louis UniversityNational Institute on Drug Abuse (NIDA)모병