점진적인 체중 감소와 급속한 체중 감소의 효과 (GoLow)
비만 환자의 1년 체중 감량에 대한 점진적 체중 감량 프로그램과 급속 체중 감량 프로그램(저에너지 다이어트 포함)의 비교 효과 - 무작위, 병렬 그룹, 우월성 시험. (GoLow 연구).
This randomized controlled trial aims to compare the 1-year effectiveness of an initial rapid weight loss (RWL) program and a gradual weight loss (GWL) program.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
A total of at least 286 participants will be randomized to either a 16-week rapid weight loss (RWL) program; [an 8-week low-energy-diet (<1000 kcal/day) - followed by an 8-week gradual increase in energy intake (4 weeks <1300 kcal/day and 4 weeks <1500 kcal/day)], or a 16-week gradual weight loss (GWL) program (controls); [estimated total energy expenditure minus 800-1000 kcal/day]. Thereafter, all participants (both groups) will undergo a 36-week comprehensive weight maintenance program.
연구 유형
연구 유형
등록 (실제)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 장소
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-
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Tønsberg, 노르웨이
- Vestfold Hospital Trust
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
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• Willing and able to give informed consent for participation in the study
- Living in the eastern part of Norway, mainly Oslo, Buskerud, Vestfold and Akershus
- Understanding Norwegian language written and spoken easily
- BMI ≥30.0 kg/m2
- Stable body weight (<5 kg self-reported weight change) during the last 3 months before inclusion
Exclusion Criteria:
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• Pregnancy and breast-feeding mothers
- Suspected non-compliance with regards to visits and/or diet
- Severe chronic disease (endocrine disease, heart disease, neurological disease, lung disease, disease in the gastrointestinal tract, kidney disease, rheumatism or cancer).
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
활성 비교기: Rapid weight loss (RWL) program
16-week rapid weight loss (RWL) program [8-week LED (<1000 kcal/day) - followed by an 8-week gradual increase in energy intake (4 weeks <1300 kcal/day and 4 weeks <1500 kcal/day)] followed by a 36-weight loss maintenance program. |
16-week rapid weight loss (RWL) program (8-week low energy diet (LED) followed by 8-week gradual increased energy intake) and a subsequent 36-week weight-maintenance follow-up |
|
활성 비교기: Gradual weight loss (GWL) program
16-week GWL-program (estimated total energy expenditure minus 800-1000 kcal/day) followed by a 36-weight loss maintenance program. |
16-week gradual weight loss (GWL) program (moderate calorie restriction) and a subsequent 36-week weight-maintenance follow-up |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in body weight from baseline to 12 months
기간: Baseline to 1-year
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Percent total body weight loss (%TBWL) at 12 months follow-up |
Baseline to 1-year
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2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Changes in anthropometric measures
기간: 4-month and 1-year
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Waist and hip circumference (cm) |
4-month and 1-year
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Changes in body composition 1
기간: 4-month and 1-year
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Bioelectrical Impedance Analysis (BIA) |
4-month and 1-year
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Changes in body composition 2
기간: 4-month and 1-year
|
Dual-energy X-ray Absorptiometry (DXA) in selected participants |
4-month and 1-year
|
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Changes in lipids
기간: 4-month and 1-year
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Total-cholesterol, HDL-cholesterol, LDL-cholesterol and triglycerides (mmol/l) |
4-month and 1-year
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Changes in blood pressure
기간: 4-month and 1-year
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Systolic and diastolic blood pressure (mm/Hg) |
4-month and 1-year
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Changes in glucose parameters
기간: 4-month and 1-year
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HbA1c (mmol/mol) |
4-month and 1-year
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Changes in CRP
기간: 4-month and 1-year
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CRP (mg/L) |
4-month and 1-year
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Changes in Health Related Quality of Life 1
기간: 4-month and 1-year
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Generic questionnaire: Short Form-36 Health Survey, SF36. Each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Scores for each of the 8 domains and summary scores for physical and mental health will be calculated |
4-month and 1-year
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Changes in Health Related Quality of Life 2
기간: 4-month and 1-year
|
Obesity specific questionnaire: IWQOL-lite. The IWQOL-Lite is a 31-item measure of weight-related quality of life. There are five domain scores (Physical Function, Self-Esteem, Sexual Life, Public Distress and Work) and a total score. Scores for all domains and total score range from 0-100, with lower scores indicating greater impairment. |
4-month and 1-year
|
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Changes in Health Related Quality of Life 3
기간: 4-month and 1-year
|
Weight-related Symptom Measure (WRSM). The validated obesity specific WRSM measures 20 symptoms commonly related to being overweight or obese, including foot problems, joint pain, sensitivity to cold, shortness of breath, etc. using two different sets of items. The first set assesses whether or not a patient is experiencing specific symptoms, and the second set rates the level of the distress of the symptoms with values from zero ("not at all") to six ("bothers a very great deal"). The first set creates an additive scale summing symptoms from 0-20, while the second forms a symptom distress scale ranging from 0-120. |
4-month and 1-year
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Changes in symptoms of depression and anxiety
기간: 4-month and 1-year
|
Hospital Anxiety and Depression Scale (HADS). The validated generic HADS measures symptoms of anxiety and depression using 14 items scored from 0-3 It is decomposed into two domains measuring depression (HADS-D) and anxiety (HADS-A), both consisting of seven items yielding a score from 0-21. |
4-month and 1-year
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Changes in eating behavior
기간: 4-month and 1-year
|
The Three Factor Eating Questionnaire -R 21 (TFEQ-R21) measures eating behaviour and has been validated for use in individuals with obesity and will be used in the study. It consists of 21 items comprising three domain scores; (1) uncontrolled eating; assessing the tendency to lose control over eating when feeling hungry or when exposed to external stimuli, (2) cognitive restraint; assessing the conscious restriction of food intake to control body weight or body shape, and (3) emotional eating; assessing overeating related to negative mood states. The domain scores were transformed to 0-100 scales to facilitate comparison; a higher score indicates more uncontrolled, restraint, or emotional eating. |
4-month and 1-year
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Change in weight from baseline to 4 months
기간: 4-month
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Percent total body weight loss (%TBWL) at 4 months follow-up |
4-month
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Proportions of participants with a TBWL of ≥ 5%, ≥10% and ≥15% at 52-week
기간: 1-year
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TBWL of ≥ 5%, ≥10% and ≥15% at 52-week follow-up |
1-year
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공동 작업자 및 조사자
수사관
수사관
- 수석 연구원: Jøran Hjelmesæth, Professor, The Hospital of Vestfold
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 (실제)
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
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- GoLow
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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