- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00891943
A Trial of One to One Weight Management in Primary Care
A Randomised Controlled Trial of a One to One Weight Management Intervention in Primary Care
연구 개요
상세 설명
Primary care could make a substantial impact on the increasing prevalence of overweight and obesity and their associated adverse impact on health. The lack of a proven intervention may deter health professionals in primary care from providing support to their overweight patients as few obese people recall receiving weight control advice from a health professional.
In this study we aim to conduct a large scale randomised controlled trial to assess the effectiveness of a longer-term structured lifestyle support programme provided by a research nurse and the provision of pedometers compared to usual care in overweight/ obese adults who wish to lose weight. We will assess the degree of weight loss over a period of 12 months as well as related factors such as changes in waist circumference, quality of life and cost-effectiveness of the interventions.
The research is highly relevant to policy making at both national and local levels.
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 장소
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London, 영국, WC1E 7HT
- London School of Hygiene and Tropical Medicine
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London, 영국
- Several GP practices in the Camden and Westminster area.
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- 18 years or over
- BMI ≥ 25 kg/m2
- GP confirmation
Exclusion Criteria:
- pregnant or lactating women
- patients with renal failure, pacemakers or cancer
- participating in other research affecting weight
- Ability to complete questionnaires
- Ability to give consent
공부 계획
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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다른: Structured lifestyle support
Intervention group-structured lifestyle support.
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The intervention group will meet with a research nurse on 14 occasions over the 1 year research study, for structured lifestyle support, including dietary, physical activity and behavioral advice.
They will also receive a pedometer.
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간섭 없음: Usual care for weight management
This is the control group, and they will receive "usual care" for weight management at their GP practice.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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Changes in weight, waist circumference and percent body fat at 12 months.
기간: 12 months
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12 months
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2차 결과 측정
결과 측정 |
기간 |
|---|---|
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Weight, waist circumference, and percent body fat at 6 months.
기간: 0 and 6 months
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0 and 6 months
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BMI, blood pressure, resting heart rate; obesity and weight related quality of life, Rosenberg measure of self-esteem changes at 12 months.
기간: 0 and 12 months
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0 and 12 months
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공동 작업자 및 조사자
협력자
수사관
- 수석 연구원: Kiran Nanchahal, MSc, London School of Hygiene and Tropical Medicine
간행물 및 유용한 링크
일반 간행물
- Noble LM, Godfrey E, Al-Baba L, Baez G, Thorogood N, Nanchahal K. Treatment fidelity in the Camden Weight Loss (CAMWEL) intervention assessed from recordings of advisor-participant consultations. BMC Obes. 2018 Sep 10;5:24. doi: 10.1186/s40608-018-0203-7. eCollection 2018.
- McCambridge J, Sorhaindo A, Quirk A, Nanchahal K. Patient preferences and performance bias in a weight loss trial with a usual care arm. Patient Educ Couns. 2014 May;95(2):243-7. doi: 10.1016/j.pec.2014.01.003. Epub 2014 Jan 13.
- Nanchahal K, Power T, Holdsworth E, Hession M, Sorhaindo A, Griffiths U, Townsend J, Thorogood N, Haslam D, Kessel A, Ebrahim S, Kenward M, Haines A. A pragmatic randomised controlled trial in primary care of the Camden Weight Loss (CAMWEL) programme. BMJ Open. 2012 May 4;2(3):e000793. doi: 10.1136/bmjopen-2011-000793. Print 2012.
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
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. .