- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00562263
Barriers to Effective Weight Loss in Overweight Adolescents (TEENS)
Barriers to Effective Weight Loss in Overweight Adolescents Enrolled in an Intensive, Team-based, Family-centered Lifestyle Modification Program
연구 개요
상세 설명
The study will annually enroll 100 - 200 adolescent male and female subjects between 11 and 18 years of age with a BMI > the 85th percentile and one parent. Adolescents enrolled in the study, will participate in a structured exercise program and meet regularly with a dietitian and behavior specialist for nutrition education and review and update of progress and goals. The study is designed for 2 years of participation with data collection points at baseline, 3 months, 6 months, 1 year and 2 years. Data collected from adolescents include demographic information anthropometric information (height, weight, blood pressure, temperature, pulse, percent body fat); assessments of nutritional knowledge, food choices and dietary intake; assessments of activity and fitness level of behavioral status (depression, self-esteem, self-confidence, satisfaction with life, happiness, perspectives on health, exercise and diet, family environment, quality of life, body awareness, teasing, social efficacy, self-perception, coping mechanisms), assessments of sleep time and quality and physiological and medical data (including blood and urine tests)
Parents will accompany their children to the nutrition and behavior support visits, and attend 12 group educational sessions to learn skills and strategies to help their children adopt healthier eating and exercise behaviors. Data collected from parents will include demographic, anthropometric measures (height, weight, blood pressure, temperature, pulse, percent body fat); and assessments of activity level, dietary intake and eating habits, behavioral status, child-feeding practices, and understanding of their child.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Virginia
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Richmond, Virginia, 미국, 23298
- Virginia Commonwealth University
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Age between 11 and 18
- BMI at or above the 85th percentile for age and sex
- At least one adult in the household who is committed to come to the program meetings
Exclusion Criteria:
- Previous enrollment in VCU IRB 3354
- Underlying genetic, neurologic, endocrine, or metabolic conditions that preclude weight loss with conventional diet and exercise programs
- Weight greater than 400 pounds
- Pregnancy in female adolescent subjects
- Inability to understand program instructions due to language barrier or a mental disability
- Primary residence outside a 30 mile radius program facility.
- Primary participating parent, if female, cannot be pregnant during the period corresponding to the parents intervention.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Lifestyle Modification
Parents are randomized to attend 12 educational sessions covering strategies to manage children's health behaviors.
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Dietary modification and regular physical activity
다른 이름들:
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간섭 없음: Control
Teen participates in lifestyle intervention, but parent does not attend parent education sessions
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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changes in BMI Z-score
기간: 3 month, 6 month, 12 months and 24 months
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3 month, 6 month, 12 months and 24 months
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2차 결과 측정
결과 측정 |
기간 |
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Changes in body composition, metabolic and anthropometric measures, fitness measures, dietary intake, and quality of life scores.
기간: 3 month, 6 month, 1 year and 2 years.
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3 month, 6 month, 1 year and 2 years.
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공동 작업자 및 조사자
수사관
- 수석 연구원: Gary L. Francis, M.D., Virginia Commonwealth University
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 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. .
Lifestyle modification에 대한 임상 시험
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Dokuz Eylul UniversityThe Scientific and Technological Research Council of Turkey완전한