Efectividad de la pérdida de peso gradual versus rápida (GoLow)
Efectividad comparativa de un programa de pérdida de peso gradual y un programa de pérdida de peso rápida (que incluye una dieta baja en energía) en la pérdida de peso de 1 año en sujetos con obesidad: un ensayo de superioridad aleatorizado, de grupos paralelos. (El estudio 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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Tønsberg, Noruega
- Vestfold Hospital Trust
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: 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 |
|
Comparador activo: 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 |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in body weight from baseline to 12 months
Periodo de tiempo: Baseline to 1-year
|
Percent total body weight loss (%TBWL) at 12 months follow-up |
Baseline to 1-year
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Changes in anthropometric measures
Periodo de tiempo: 4-month and 1-year
|
Waist and hip circumference (cm) |
4-month and 1-year
|
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Changes in body composition 1
Periodo de tiempo: 4-month and 1-year
|
Bioelectrical Impedance Analysis (BIA) |
4-month and 1-year
|
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Changes in body composition 2
Periodo de tiempo: 4-month and 1-year
|
Dual-energy X-ray Absorptiometry (DXA) in selected participants |
4-month and 1-year
|
|
Changes in lipids
Periodo de tiempo: 4-month and 1-year
|
Total-cholesterol, HDL-cholesterol, LDL-cholesterol and triglycerides (mmol/l) |
4-month and 1-year
|
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Changes in blood pressure
Periodo de tiempo: 4-month and 1-year
|
Systolic and diastolic blood pressure (mm/Hg) |
4-month and 1-year
|
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Changes in glucose parameters
Periodo de tiempo: 4-month and 1-year
|
HbA1c (mmol/mol) |
4-month and 1-year
|
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Changes in CRP
Periodo de tiempo: 4-month and 1-year
|
CRP (mg/L) |
4-month and 1-year
|
|
Changes in Health Related Quality of Life 1
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 1-year
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TBWL of ≥ 5%, ≥10% and ≥15% at 52-week follow-up |
1-year
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Jøran Hjelmesæth, Professor, The Hospital of Vestfold
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- GoLow
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
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