Lifestyleintervention for the Treatment of Severe Obesity

Study Overview
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Brief Summary
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The overall purpose of this project is to study the acute, short- (≤ 1 year) and long- (> 1 year) term effects on body composition and psychological health after a 10 to 14-weeks comprehensive lifestyle modification program for the treatment of severe obesity. The aims of the PhD project are to investigate whether an intensive lifestyle intervention leads to acute and short term (< 1 year) changes in: The BMI/Weight Body composition (waist circumference, fat mass, fat free mass, skeletal muscle mass and visceral fat area) Psychosocial factors such as eating behavior, anxiety and depression symptoms and health-related quality of life

Detailed Description
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The study is based on data collected from patients at The Hjelp24 NIMI Ringerike Obesity Clinic, which is an inpatient program to address morbid obesity in adults. The study is a non-randomized clinical trial comparing the acute and long-term effects on physical and psychological health of the 10-14-weeks inpatient comprehensive lifestyle modification program for the treatment of morbidly obese patients. In between the inpatient stay, the patients are followed up either by telephone, occasional mail and/or structured / weekly email. In this project we prospectively follow two groups of patient included in the treatment programme in September 2010 and January 2011, respectively. In addition a control group with waiting-list patients is also included in the study, and they were recruited in October-November 2011

Official Title
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Intensive Lifestyleintervention for the Treatment of Severe Obesity

Conditions
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Morbid Obesity

Intervention / Treatment
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* Behavioral: Intensive lifestyle intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: morbidly obese Exclusion Criteria: not able to walk slowly for 20 minutes

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lifestyle intervention<br>10-14 weeks intensive lifestyle intervention | Behavioral: Intensive lifestyle intervention<br>* Lifestyle modification program focusing on increasing physical activity level, adjusting energy intake and learning coping strategies<br>|
| No Intervention: Controls<br>No treatment, waiting list | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute and short term (12 months) effects of an intensive 10 to 14-weeks inpatient program with lifestyle modification for the treatment of morbidly obese patients on body composition and psychosocial health |  | three years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body composition | Change in body composition (body weight, fat mass, fat free mass, visceral fat area) from baseline | Week 10-14 | 
| Body composition | Change in body composition (body weight, fat mass, fat free mass, visceral fat area) from baseline | Week 26 | 
| Body composition | Change in body composition (body weight, fat mass, fat free mass, visceral fat area) from baseline | Week 52 | 
| Health related quality of life | Change in Health related quality of life from baseline | Week 10-14 | 
| Health related quality of life | Change in Health related quality of life from baseline | Week 26 | 
| Health related quality of life | Change in Health related quality of life from baseline | Week 52 | 
| Binge Eating | Change in binge eating from baseline | Week 10-14 | 
| Binge eating | Change in binge eating from baseline | Week 26 | 
| Binge eating | Change in binge eating from baseline | Week 52 | 
| Anxiety | Change in anxiety from baseline | Week 10-14 | 
| Depression | Change in depression from baseline | Week 10-14 | 
| Depression | Change in depression from baseline | Week 26 | 
| Depression | Change in depression from baseline | Week 52 | 
| Physical Activity | Change in physical activity from baseline | Week 10-14 | 
| Physical activity | Change in physical activity from baseline | Week 26 | 
| Physical activity | Change in physical activity from baseline | Week 52 | 
| Physical fitness | Change in physical fitness from baseline | Week 10-14 | 
| Physical fitness | Change in physical fitness from baseline | Week 26 | 
| Physical fitness | Change in physical fitness from baseline | Week 52 | 
| Systolic Blood Pressure | Change in Systolic Blood Pressure | Week 10-14 | 
| Systolic Blood Pressure | Change in Systolic Blood Pressure | Week 26 | 
| Systolic Blood Pressure | Change in Systolic Blood Pressure from baseline | Week 52 | 
| Lipids | Change in lipids (Total cholestrol, LDL cholestrol, HDL cholestrol and Triglycerides) from baseline | Week 10-14 | 
| Lipids | Change in lipids (Total cholestrol, LDL cholestrol, HDL cholestrol and Triglycerides) from baseline | Week 26 | 
| Lipids | Change in lipids (Total cholestrol, LDL cholestrol, HDL cholestrol and Triglycerides) from baseline | Week 52 | 
| Glucose | Change in glucose from baseline | Week 10-14 | 
| Glucose | Change in glucose from baseline | Week 26 | 
| Glucose | Change in glucose from baseline | Week 52 | 
| Explore the participants experiences with physical activity prior to, during and after the treatment programme | In depth interviews | 2-3 years post treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lifestyle, Physical activity