- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01012206
Overweighed Children´s Health - Studies of the Effect of Lifestyle and Food Habits (SELFH)
The aim is to investigate the development of overweight and obesity from infancy to school age, and to evaluate an intervention to prevent further development of overweight and obesity among children.
A follow-up study will be conducted on 267 children and will allow comparison between children that developed overweight with the ones who did not. Subjects will be requited at 10 years of age from a previous project. These children have been studied when they were 6-18 months old and a follow-up was conducted at 4 years of age. Sixteen percent of the children were overweight at 4 years of age and retrospective data of e.g. food intake, blood lipids and anthropometric measurements exists. In the present follow-up data regarding food and physical activity habits, anthropometric measurements and blood samples of e.g. blood lipids, IGF1 will be collected.
An intervention study will be conducted on 80-120 overweight children that will be randomized into one intervention and one control group. An intervention during two years will encourage long term healthy habits regarding diet and physical activity through group meetings and supervision. Information about food habits will be collected through questionnaires, interviews and diaries. Measurement of physical activity and energy expenditure will be made with Sense Wear and double labeled water, and will be used to validate reported food intake. Further, anthropometric measurements and blood samples will be collected.
연구 개요
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Umeå, 스웨덴, SE-901 87
- Umeå University
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria for SELFH intervention study:
- age and gender adjusted body mass index (BMI) > 25
- born in 1995-1998
- living in or nearby the northern city of Umea, Sweden
Exclusion Criteria for SELFH intervention study:
- no chronic disease that could influence metabolic parameters
- no attention deficit disorders
- no access to internet
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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간섭 없음: Control group
Children in control group obtained no lifestyle counseling (intervention).
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활성 비교기: Intervention group
Children in the intervention group and their parents were given lifestyle counseling and participated in an intervention program regarding food habits and physical activity.
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Children in the intervention group participated in an intervention program regarding food habits and physical activity.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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Body Mass Index
기간: Two years
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Two years
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2차 결과 측정
결과 측정 |
기간 |
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Food intake
기간: Two years
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Two years
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Physical activity
기간: Two years
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Two years
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공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Christel Larsson, PhD, Department of Food and Nutrition, Umeå 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. .