Efficacité de la perte de poids progressive ou rapide (GoLow)
Efficacité comparative d'un programme de perte de poids progressive et d'un programme de perte de poids rapide (y compris un régime hypocalorique) sur la perte de poids sur 1 an chez des sujets obèses - Un essai de supériorité randomisé en groupes parallèles. (L'étude GoLow).
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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-
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Tønsberg, Norvège
- Vestfold Hospital Trust
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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).
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: 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 |
|
Comparateur actif: 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 |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in body weight from baseline to 12 months
Délai: Baseline to 1-year
|
Percent total body weight loss (%TBWL) at 12 months follow-up |
Baseline to 1-year
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Changes in anthropometric measures
Délai: 4-month and 1-year
|
Waist and hip circumference (cm) |
4-month and 1-year
|
|
Changes in body composition 1
Délai: 4-month and 1-year
|
Bioelectrical Impedance Analysis (BIA) |
4-month and 1-year
|
|
Changes in body composition 2
Délai: 4-month and 1-year
|
Dual-energy X-ray Absorptiometry (DXA) in selected participants |
4-month and 1-year
|
|
Changes in lipids
Délai: 4-month and 1-year
|
Total-cholesterol, HDL-cholesterol, LDL-cholesterol and triglycerides (mmol/l) |
4-month and 1-year
|
|
Changes in blood pressure
Délai: 4-month and 1-year
|
Systolic and diastolic blood pressure (mm/Hg) |
4-month and 1-year
|
|
Changes in glucose parameters
Délai: 4-month and 1-year
|
HbA1c (mmol/mol) |
4-month and 1-year
|
|
Changes in CRP
Délai: 4-month and 1-year
|
CRP (mg/L) |
4-month and 1-year
|
|
Changes in Health Related Quality of Life 1
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 4-month
|
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
Délai: 1-year
|
TBWL of ≥ 5%, ≥10% and ≥15% at 52-week follow-up |
1-year
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Jøran Hjelmesæth, Professor, The Hospital of Vestfold
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- GoLow
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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