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| Name | Class |
|---|---|
| Roede AS | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rapid weight loss (RWL) program | Active Comparator | 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. |
|
| Gradual weight loss (GWL) program | Active Comparator | 16-week GWL-program (estimated total energy expenditure minus 800-1000 kcal/day) followed by a 36-weight loss maintenance program. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rapid weight loss (RWL) program | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in body weight from baseline to 12 months | Percent total body weight loss (%TBWL) at 12 months follow-up | Baseline to 1-year |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in anthropometric measures | Waist and hip circumference (cm) | 4-month and 1-year |
| Changes in body composition 1 | Bioelectrical Impedance Analysis (BIA) |
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Inclusion Criteria:
• Willing and able to give informed consent for participation in the study
Exclusion Criteria:
• Pregnancy and breast-feeding mothers
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| Name | Affiliation | Role |
|---|---|---|
| Jøran Hjelmesæth, Professor | The Hospital of Vestfold | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vestfold Hospital Trust | Tønsberg | Norway |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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Randomized controlled study
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Outcome assessor was masked
| Gradual weight loss (GWL) program | Other | 16-week gradual weight loss (GWL) program (moderate calorie restriction) and a subsequent 36-week weight-maintenance follow-up |
|
| 4-month and 1-year |
| Changes in body composition 2 | Dual-energy X-ray Absorptiometry (DXA) in selected participants | 4-month and 1-year |
| Changes in lipids | Total-cholesterol, HDL-cholesterol, LDL-cholesterol and triglycerides (mmol/l) | 4-month and 1-year |
| Changes in blood pressure | Systolic and diastolic blood pressure (mm/Hg) | 4-month and 1-year |
| Changes in glucose parameters | HbA1c (mmol/mol) | 4-month and 1-year |
| Changes in CRP | CRP (mg/L) | 4-month and 1-year |
| Changes in Health Related Quality of Life 1 | 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 | 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 | 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 | 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 | 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 | 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 | TBWL of ≥ 5%, ≥10% and ≥15% at 52-week follow-up | 1-year |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |