- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00872807
The Activity School in Finnmark for Overweight Children
2014년 12월 11일 업데이트: University Hospital of North Norway
The Activity School in Finnmark for Overweight and Obese Children and Their Families
The purpose of this study is to evaluate the effectiveness of a life style counseling programme designed for overweight and obese children and their parents in groups compared to traditional individual counseling in the pediatric outpatient clinic and the community.
The two interventions are both hospital and community based.
연구 개요
상세 설명
Randomized study design with two parallel groups.Active intervention in two years, last follow-up after 3 years.
연구 유형
중재적
등록 (실제)
97
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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Hammerfest, 노르웨이, 9600
- Childrens departement Finnmark Hospital, Norway
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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
6년 (어린이)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- Overweight or obese.
- BMI > IOTF (International Obesity TaskForce) cut-points 27,5. kg/ m2.
Exclusion Criteria:
- Diseases not compatible with normal physical activity.
- Disorders not compatible with group treatment.
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: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Group intervention
Lifestyle counseling (physical activity and dietary modification) in groups both at the hospital and in their own municipality.
They meet a multidisciplinary team, receive organized physical activity in the municipality and are invited to a 3 days camp after 4-6 months.
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The activity school in Finnmark. Lifestyle counseling (physical activity and dietary modification) in groups both at the hospital and in their own municipality. They meet a multidisciplinary team, receive organized physical activity in the municipality and are invited to a 3 days camp after 4-6 months.
Conventional lifestyle counseling individually by single health professionals, both in hospital and in municipality.
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활성 비교기: Individual intervention
Lifestyle counseling for each separate family practiced by single health professionals both in hospital and municipality.
A more conventional model.
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Conventional lifestyle counseling individually by single health professionals, both in hospital and in municipality.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in Body Mass Index compared to baseline
기간: 3 years
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BMI will be measured at baseline and at 3 months- , 1 year-, 2 year- and 3-year follow-up.
Primary measures at 2 years of continuous lifestyle modification.
Last measurement at 1 year after last counselling and active treatment has stopped, 3 years from baseline.
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3 years
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Change in Systolic Blood Pressure compared to baseline
기간: 3 years
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Measured with an automated blood pressure monitor at baseline, at 3 months- , 1 year-, 2 year- and 3-year follow-up.
Primary measures at the end (2 years) of continuous lifestyle modification.
Last measurement at 1 year after last counseling and active treatment has stopped, 3 years from baseline.
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3 years
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Change in Body fat compared to baseline
기간: 3 years
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Measured with bioelectrical impedance analysis at baseline and at 3 months- , 1 year-, 2 year- and 3-year follow-up.Primary measures at 2 years of continuous lifestyle modification.
Last measurement at 1 year after last counseling and active treatment has stopped, 3 years from baseline.
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3 years
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Change in activity level / Counts per min compared to baseline
기간: 3 years
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Measured with accelerometers at baseline, 1 year-, 2 year- and 3-year follow-up.
Primary measures at 2 years of continuous lifestyle modification.
Last measurement at 1 year after last counseling and active treatment has stopped, 3 years from baseline.
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3 years
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Change in Waist circumference compared to baseline
기간: 3 years
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Measured with measuring tape mid-point between the lowest rib and the top of the iliac crest at baseline, 3 months- , 1 year-, 2 year- and 3-year follow-up.
Primary measures at 2 years of continuous lifestyle modification.
Last measurement at 1 year after last counseling and active treatment stopped, 3 years from baseline.
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3 years
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Change in Homa Score / HOMA IR compared to baseline
기간: 3 years
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Homa score calculated from the cross product of fasting plasma insulin and plasma glucose divided with a factor of 22.5.
Fasting plasma insulin and glucose will be measured at baseline, at 1 year-, 2 year- and 3-year follow-up.
Primary measures at 2 years of continuous lifestyle modification.Last measurement at 1 year after last counseling and active treatment has stopped, 3 years from baseline.
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3 years
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Change in triceps skinfold compared to baseline
기간: 3 years
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Measured with Holtain Tanner /Whitehouse Skinfold Caliper at baseline,3 months- , 1 year-, 2 year- and 3-year follow-up.
Primary measures at 2 years of continuous lifestyle modification.Last measurement at 1 year after last counseling and active treatment has stopped, 3 years from baseline.
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3 years
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Change in self-concept compared to baseline
기간: 3 years
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Measured with SPPC, Self Perception Profile for Children at baseline, at 6 months- , 1 year-, 2 year- and 3-year follow-up.
Primary outcome measured at 2 years of continuous lifestyle modification.
Last measurement at 1 year after last counseling and active treatment has stopped.
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3 years
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Change in psychiatric health compared to baseline
기간: 3 years
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Measured with Strengths and difficulties Questionnaire ( SDQ-S)at baseline, at 6 months- , 1 year-, 2 year- and 3-year follow-up.
Primary measurement at 2 years of continuous lifestyle modification.
Last measurement at 1 year after last counseling and active treatment has stopped.
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3 years
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Change in fitness from baseline
기간: 3 years
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Measured with Andersen's test (shuttle test) at baseline, 1 year-, 2 year- and 3-year follow-up.
Primary measures at 2 years of continuous lifestyle modification.
Last measurement at 1 year after last counseling and active treatment has stopped, 3 years from baseline.
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3 years
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Change in quality of life compared to baseline
기간: 3 years
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Measured with KINDL (Kinder Lebensqualitet Fragebogen) at baseline, 6 months-, 1 year-, 2 year- and 3-year follow-up.
Primary measures at 2 years of continuous lifestyle modification.
Last measurement at 1 year after last counseling and active treatment has stopped, 3 years from baseline.
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3 years
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Change in lipid levels compared to baseline
기간: 3 years
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Measurements of total cholesterol, Triglycerides, HDL and LDL at baseline, 1 year-, 2 year- and 3-year follow-up.
Primary measures at 2 years of continuous lifestyle modification.
Last measurement at 1 year after last counseling and active treatment has stopped, 3 years from baseline
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3 years
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
협력자
수사관
- 연구 의자: Trond Flægstad, Professor, UNorth Norway
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
- Kokkvoll A, Grimsgaard S, Odegaard R, Flaegstad T, Njolstad I. Single versus multiple-family intervention in childhood overweight--Finnmark Activity School: a randomised trial. Arch Dis Child. 2014 Mar;99(3):225-31. doi: 10.1136/archdischild-2012-303571. Epub 2013 Dec 11.
- Kokkvoll A, Grimsgaard S, Steinsbekk S, Flaegstad T, Njolstad I. Health in overweight children: 2-year follow-up of Finnmark Activity School--a randomised trial. Arch Dis Child. 2015 May;100(5):441-8. doi: 10.1136/archdischild-2014-307107. Epub 2014 Nov 20.
- Kokkvoll AS, Grimsgaard S, Flaegstad T, Andersen LB, Ball GDC, Wilsgaard T, Njolstad I. No additional long-term effect of group vs individual family intervention in the treatment of childhood obesity-A randomised trial. Acta Paediatr. 2020 Jan;109(1):183-192. doi: 10.1111/apa.14916. Epub 2019 Jul 30.
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
2009년 4월 1일
기본 완료 (실제)
2012년 12월 1일
연구 완료 (실제)
2013년 12월 1일
연구 등록 날짜
최초 제출
2009년 3월 30일
QC 기준을 충족하는 최초 제출
2009년 3월 30일
처음 게시됨 (추정)
2009년 3월 31일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2014년 12월 12일
QC 기준을 충족하는 마지막 업데이트 제출
2014년 12월 11일
마지막으로 확인됨
2012년 12월 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. .