Obesity
Conditions
Brief summary
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.
Detailed description
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.
Interventions
OTHERRapid weight loss (RWL) 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
OTHERGradual weight loss (GWL) program
16-week gradual weight loss (GWL) program (moderate calorie restriction) and a subsequent 36-week weight-maintenance follow-up
Sponsors
Roede AS
The Hospital of Vestfold
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcome assessor was masked
Intervention model description
Randomized controlled study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in body weight from baseline to 12 months | Baseline to 1-year | Percent total body weight loss (%TBWL) at 12 months follow-up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in body composition 1 | 4-month and 1-year | Bioelectrical Impedance Analysis (BIA) |
| Changes in body composition 2 | 4-month and 1-year | Dual-energy X-ray Absorptiometry (DXA) in selected participants |
| Changes in lipids | 4-month and 1-year | Total-cholesterol, HDL-cholesterol, LDL-cholesterol and triglycerides (mmol/l) |
| Changes in blood pressure | 4-month and 1-year | Systolic and diastolic blood pressure (mm/Hg) |
| Changes in glucose parameters | 4-month and 1-year | HbA1c (mmol/mol) |
| Changes in CRP | 4-month and 1-year | CRP (mg/L) |
| Changes in anthropometric measures | 4-month and 1-year | Waist and hip circumference (cm) |
| Changes in Health Related Quality of Life 2 | 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. |
| Changes in Health Related Quality of Life 3 | 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. |
| Changes in symptoms of depression and anxiety | 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. |
| Changes in eating behavior | 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. |
| Change in weight from baseline to 4 months | 4-month | Percent total body weight loss (%TBWL) at 4 months follow-up |
| Proportions of participants with a TBWL of ≥ 5%, ≥10% and ≥15% at 52-week | 1-year | TBWL of ≥ 5%, ≥10% and ≥15% at 52-week follow-up |
| Changes in Health Related Quality of Life 1 | 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 |
Countries
Norway
Outcome results
None listed