Promoting Health in Healthy Living Centres - a Clinical Study Among Children
Promoting Health in Healthy Living Centres - a Clinical Study Among Famililies With Overweight Children
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
The investigators intend to perform a controlled clinical trial on interventions on a systemic level.
The target group is overweight and obese children between 6 and 10 years old, their parents, community administrators and public health nurses. The overall aim is to evaluate if a familybased intervention, targeting overweight and obese children and their parents, has a long-term positive effect on weight development of the children. The alternative hypothesis to the zero hypothesis is that the children with overweight and obesity who participate with their parents, both at completion of the six months intervention and at long term follow up (2 years) will have reduced their BMI-for-age z-score (Iso-BMI). The behavioral models and educational strategies will be tailored (by age, gender etc.) and include both general information and practical learning sessions. The program will offer guided active play, defined as spontaneous gross locomotor movement in which children engage to amuse and to occupy themselves.
Parents will attend to workshops intending to increase knowledge and awareness of family structure, healthy eating habits and practical suggestions for implementing healthy behaviors into everyday life. Parents will be educated on how to use these strategies at home, to further support their children in improving their behaviors. This community based study is the support by the local leadership and collaboration with locally based sports clubs. The primary outcome variable, child BMI-for-age z-score will be measured at referral, inclusion, after 6 months, and at 1 and 2 years post intervention. Secondary outcome variables, measured at inclusion and at the end of intervention, are child activity pattern, screen viewing time, eating habits, sleeping patterns and body composition as well as parent BMI, body composition, exercise habits, perception of health, experience of parenthood and level of parental stress.
Physical activity level as well as sleep duration and -quality will be recorded using biaxial accellerometers. A validated food diary will be used. The participants will also be asked to complete a questionnaire including questions about screen viewing time, self-perceived healt, sleeping patterns (children) and perceived autonomy support and autonomous regulations (parents).
연구 유형
연구 유형
등록 (실제)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 장소
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Hordaland
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Bergen, Hordaland, 노르웨이, 5018
- University of Bergen
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Vest-Agder
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Kristiansand, Vest-Agder, 노르웨이, 4604
- University of Agder
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Iso-BMI>25,
- able to participate in activity groups
Exclusion Criteria:
- Children being unable to participate in activity groups,
- parents not able to participate in group based and individual counseling
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
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활성 비교기: Intervention group
The intervention groups start the intervention 6 months ahead of the control group.
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Children attend to activity groups weekly during the intervention periode.
Parents attend to four sessions of group based dietary counselling
Parents attend to individual counselling focusing on parental skills and family structure
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간섭 없음: Delayed intervention group
The control groups will start intervention with 6 months delay
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연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Iso-BMI
기간: Change at 6 months, 1 year, 2 years
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Measure change at 6 month controlled study, and at 1 and 2 years to measure long-term effects
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Change at 6 months, 1 year, 2 years
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2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Physical activity level
기간: 6 months, 1 and 2 years
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Measure at the end of the 6 month controlled study, and at 1 and 2 years to measure long-term effects.
We will use SenseWear bi-axial accelerometer to mesa sure physics activity.
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6 months, 1 and 2 years
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Dietary habits
기간: 6 months, 1 and 2 years
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Measure at the end of the 6 month controlled study, and at 1 and 2 years to measure long-term effects.
We will use a specially designed questionnaire to measure dietary habits.
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6 months, 1 and 2 years
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Self-perceived health
기간: 6 months, 1 and 2 years
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Measure at the end of the 6 month controlled study, and at 1 and 2 years to measure long-term effects.
We will use KidScreen 10 questionnaire to measure self-perceived health.
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6 months, 1 and 2 years
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기타 결과 측정
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Autonomous regulation and perceived autonomy support
기간: 6 months, 1 and 2 years
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Measure at the end of the 6 month controlled study, and at 1 and 2 years to measure long-term effects.
We will use Treatment Self-regulation Questionnaire to measure autonomous regulation, and Healt Care Climate Questionnaire to measure autonomy support.
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6 months, 1 and 2 years
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Motor skills
기간: 6 months, 1 and 2 years
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Measure at the end of the 6 month controlled study, and at 1 and 2 years to measure long-term effects.
We will use Kôrper-koordinationstest fur Kinder to measure motor skills.
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6 months, 1 and 2 years
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공동 작업자 및 조사자
협력자
협력자
수사관
수사관
- 수석 연구원: Eivind Meland, MD, PhD, Dept of Glob Publ Health and Primary Care, University of Bergen
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (실제)
기본 완료
연구 완료 (실제)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
기타 연구 ID 번호
- NCT02290171
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
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