- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01378806
Family Partners for Health (WEIGHT)
2012년 7월 12일 업데이트: University of North Carolina, Chapel Hill
Children and Parents Partnering Together to Manage Their Weight
Young children who are overweight or at risk for overweight are at increased risk for becoming obese as young adults and developing type 2 diabetes and cardiovascular disease.
To date, there have been no interdisciplinary interventions that targeted predominantly ethnic minority low-income children and parents and taught them to work together to improve nutrition and exercise.
Using a two-group, repeated measures experimental design, this proposed study will test a 12-week intensive intervention on nutrition, exercise and coping skills (Phase I) and 9 months of continued monthly contact (Phase II) to help overweight 2nd, 3rd, and 4th grade children and their parents improve self-efficacy, health behaviors, weight status, and adiposity.
The study will take this intervention to the community in which children and parents live, working with four schools in Alamance-Burlington County, NC, and four schools in Wilson County in the early evening.
A total of 356 Black, Hispanic, and White children with a BMI >85th percentile and 356 parents with a BMI >25 kg/m2 will be inducted over 3 ½ years and randomized by school to either the experimental or control group.
Data will be collected at Time 1 (Baseline), Time 2 (Post Phase I-Intensive Intervention), Time 3 (Post Phase II-Continued Contact), and Time 4 (6-Month Follow-Up).
Data collected will include scores on the Health Promoting Lifestyle Profile II in the parents; eating self-efficacy in the children (CATCH) and parents (Eating Self-Efficacy Scale) and exercise self-efficacy in the children (CATCH) and parents (Exercise Self-Efficacy); health behaviors in the children and parents (3 Day 24-Hour Food Recall and 4 Day Accelerometry Measurement); weight status in the children (BMI percentile) and parents (BMI); and adiposity in the children and parents (waist circumference and triceps and subscapular skinfolds).
Data analysis will use general linear mixed models to test the hypotheses.
Decreasing overweight in children and parents is urgently needed, and helping children and parents to work together to improve their nutrition and exercise patterns by making small lifestyle pattern changes may decrease future health care costs and decrease morbidity and mortality.
The knowledge to be gained from this study may provide a foundation for extending this intervention to other Black, Hispanic, and White children and parents in other communities to assist them to manage their weight.
연구 개요
연구 유형
중재적
등록 (실제)
718
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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North Carolina
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Chapel Hill, North Carolina, 미국, 27599-7460
- The University of North Carolina at Chapel Hill
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
7년 이상 (어린이, 성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria: Inclusion criteria for children include:
- ability to speak, write, and read in English
- a BMI > 85th percentile for age and gender
- at least one parent or guardian with a BMI >25
- assent and their parent or guardian's consent to their participation
Inclusion criteria for parents or guardians include:
- ability to speak, write, and read in English
- a BMI >25
- a 2nd, 3rd or 4th grade child with a BMI > 85th percentile for age and gender
- reside with the child; and consent to join the study
Exclusion Criteria: Parents and children will be excluded if either has a:
- history of a heart murmur
- congenital heart disease
- family history of sudden death
- history of psychological problems such as claustrophobia that would prevent participation in group classes
- participation in another clinical trial or intervention
- Asians will be excluded since there is a higher level of risk at a lower BMI than for Blacks, Hispanics, and Whites
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Intervention
A 12-week intensive intervention on nutrition and exercise education and coping skills training (Phase I), 9 months of continued monthly contact (Phase II), and then 6 months on their own.
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A 12-week intensive intervention on nutrition and exercise education and coping skills (Phase I), 9 months of continued monthly contact (Phase II), and then 6 months on their own.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in body mass index in adults and body mass index percentile in children.
기간: Baseline to 18 months.
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Height and weight measures will be taken in adults and children to calculate body mass index in adults and body mass index percentile in children.
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Baseline to 18 months.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in adiposity for adults and children as measured by change in waist circumference, triceps, and subscapular skinfold measures.
기간: Baseline to 18 months.
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Waist circumference and triceps and subscapular skinfold measures.
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Baseline to 18 months.
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Change in health behaviors as measured by nutrition and exercise in adults and children.
기간: Baseline to 18 months.
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nutrition and exercise behaviors in adults and children based on questionnaire scores.
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Baseline to 18 months.
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Change in self-efficacy in adults and children as measured by belief that they can improve their eating and exercise behaviors.
기간: Baseline to 18 months.
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eating and exercise self-efficacy in adults and children based on questionnaire scores.
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Baseline to 18 months.
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Diane C Berry, PhD, ANP-BC, University of North Carolina, Chapel Hill
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- Berry DC, McMurray RG, Schwartz TA, Adatorwovor R. Benefits for African American and white low-income 7-10-year-old children and their parents taught together in a community-based weight management program in the rural southeastern United States. BMC Public Health. 2018 Sep 10;18(1):1107. doi: 10.1186/s12889-018-6006-4.
- Berry DC, McMurray RG, Schwartz TA, Hall EG, Neal MN, Adatorwovor R, Adatorwover R. A cluster randomized controlled trial for child and parent weight management: children and parents randomized to the intervention group have correlated changes in adiposity. BMC Obes. 2017 Dec 4;4:39. doi: 10.1186/s40608-017-0175-z. eCollection 2017. Erratum In: BMC Obes. 2018 Jan 26;5:3. Adatorwover R [corrected to Adatorwovor R].
- McMurray RG, Berry DC, Schwartz TA, Hall EG, Neal MN, Li S, Lam D. Relationships of physical activity and sedentary time in obese parent-child dyads: a cross-sectional study. BMC Public Health. 2016 Feb 6;16:124. doi: 10.1186/s12889-016-2795-5.
- Berry DC, McMurray R, Schwartz TA, Skelly A, Sanchez M, Neal M, Hall G. Rationale, design, methodology and sample characteristics for the family partners for health study: a cluster randomized controlled study. BMC Public Health. 2012 Mar 30;12:250. doi: 10.1186/1471-2458-12-250.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2007년 4월 1일
기본 완료 (실제)
2011년 10월 1일
연구 완료 (실제)
2011년 10월 1일
연구 등록 날짜
최초 제출
2011년 6월 2일
QC 기준을 충족하는 최초 제출
2011년 6월 20일
처음 게시됨 (추정)
2011년 6월 22일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2012년 7월 13일
QC 기준을 충족하는 마지막 업데이트 제출
2012년 7월 12일
마지막으로 확인됨
2012년 7월 1일
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. .
Nutrition and exercise education and coping skills training에 대한 임상 시험
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Queens College, The City University of New York완전한