漸進的な減量と急速な減量の有効性 (GoLow)
肥満のある被験者の1年間の減量に対する漸進的減量プログラムと急速減量プログラム（低エネルギー食を含む）の比較効果 - 無作為化、並行群、優越性試験。 (GoLow 研究)。
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.
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
-
Tønsberg、ノルウェー
- Vestfold Hospital Trust
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
-
• 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:
-
• 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).
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：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 |
|
アクティブコンパレータ：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 |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in body weight from baseline to 12 months
時間枠：Baseline to 1-year
|
Percent total body weight loss (%TBWL) at 12 months follow-up |
Baseline to 1-year
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Changes in anthropometric measures
時間枠：4-month and 1-year
|
Waist and hip circumference (cm) |
4-month and 1-year
|
|
Changes in body composition 1
時間枠：4-month and 1-year
|
Bioelectrical Impedance Analysis (BIA) |
4-month and 1-year
|
|
Changes in body composition 2
時間枠：4-month and 1-year
|
Dual-energy X-ray Absorptiometry (DXA) in selected participants |
4-month and 1-year
|
|
Changes in lipids
時間枠：4-month and 1-year
|
Total-cholesterol, HDL-cholesterol, LDL-cholesterol and triglycerides (mmol/l) |
4-month and 1-year
|
|
Changes in blood pressure
時間枠：4-month and 1-year
|
Systolic and diastolic blood pressure (mm/Hg) |
4-month and 1-year
|
|
Changes in glucose parameters
時間枠：4-month and 1-year
|
HbA1c (mmol/mol) |
4-month and 1-year
|
|
Changes in CRP
時間枠：4-month and 1-year
|
CRP (mg/L) |
4-month and 1-year
|
|
Changes in Health Related Quality of Life 1
時間枠：4-month and 1-year
|
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
|
|
Changes in Health Related Quality of Life 2
時間枠：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
|
|
Changes in Health Related Quality of Life 3
時間枠：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
|
|
Changes in symptoms of depression and anxiety
時間枠：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
|
|
Changes in eating behavior
時間枠：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
|
|
Change in weight from baseline to 4 months
時間枠：4-month
|
Percent total body weight loss (%TBWL) at 4 months follow-up |
4-month
|
|
Proportions of participants with a TBWL of ≥ 5%, ≥10% and ≥15% at 52-week
時間枠：1-year
|
TBWL of ≥ 5%, ≥10% and ≥15% at 52-week follow-up |
1-year
|
協力者と研究者
スポンサー
協力者
捜査官
- 主任研究者：Jøran Hjelmesæth, Professor、The Hospital of Vestfold
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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