Morbid Obesity Clinical Trial
Official title:
Intensive Lifestyleintervention for the Treatment of Severe Obesity
Verified date | April 2015 |
Source | Norwegian School of Sport Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | Norway: Regional Ethics Commitee |
Study type | Interventional |
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:
1. The BMI/Weight
2. Body composition (waist circumference, fat mass, fat free mass, skeletal muscle mass
and visceral fat area)
3. Psychosocial factors such as eating behavior, anxiety and depression symptoms and
health-related quality of life
Status | Completed |
Enrollment | 149 |
Est. completion date | September 2014 |
Est. primary completion date | July 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - morbidly obese Exclusion Criteria: - not able to walk slowly for 20 minutes |
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Norway | Norwegian School of Sport Sciences | Oslo |
Lead Sponsor | Collaborator |
---|---|
Norwegian School of Sport Sciences | Hjelp24 |
Norway,
Danielsen KK, Sundgot-Borgen J, Mæhlum S, Svendsen M. Beyond weight reduction: improvements in quality of life after an intensive lifestyle intervention in subjects with severe obesity. Ann Med. 2014 Aug;46(5):273-82. doi: 10.3109/07853890.2013.874660. Ep — View Citation
Danielsen KK, Svendsen M, Mæhlum S, Sundgot-Borgen J. Changes in body composition, cardiovascular disease risk factors, and eating behavior after an intensive lifestyle intervention with high volume of physical activity in severely obese subjects: a prosp — View Citation
Mæhlum S, Danielsen KK, Heggebø LK, Schiøll J. The Hjelp24 NIMI Ringerike obesity clinic: an inpatient programme to address morbid obesity in adults. Br J Sports Med. 2012 Feb;46(2):91-4. doi: 10.1136/bjsm.2010.071894. Epub 2010 May 10. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No | |
Secondary | Body composition | Change in body composition (body weight, fat mass, fat free mass, visceral fat area) from baseline | Week 10-14 | No |
Secondary | Body composition | Change in body composition (body weight, fat mass, fat free mass, visceral fat area) from baseline | Week 26 | No |
Secondary | Body composition | Change in body composition (body weight, fat mass, fat free mass, visceral fat area) from baseline | Week 52 | No |
Secondary | Health related quality of life | Change in Health related quality of life from baseline | Week 10-14 | No |
Secondary | Health related quality of life | Change in Health related quality of life from baseline | Week 26 | No |
Secondary | Health related quality of life | Change in Health related quality of life from baseline | Week 52 | No |
Secondary | Binge Eating | Change in binge eating from baseline | Week 10-14 | No |
Secondary | Binge eating | Change in binge eating from baseline | Week 26 | No |
Secondary | Binge eating | Change in binge eating from baseline | Week 52 | No |
Secondary | Anxiety | Change in anxiety from baseline | Week 10-14 | No |
Secondary | Depression | Change in depression from baseline | Week 10-14 | No |
Secondary | Depression | Change in depression from baseline | Week 26 | No |
Secondary | Depression | Change in depression from baseline | Week 52 | No |
Secondary | Physical Activity | Change in physical activity from baseline | Week 10-14 | No |
Secondary | Physical activity | Change in physical activity from baseline | Week 26 | No |
Secondary | Physical activity | Change in physical activity from baseline | Week 52 | No |
Secondary | Physical fitness | Change in physical fitness from baseline | Week 10-14 | No |
Secondary | Physical fitness | Change in physical fitness from baseline | Week 26 | No |
Secondary | Physical fitness | Change in physical fitness from baseline | Week 52 | No |
Secondary | Systolic Blood Pressure | Change in Systolic Blood Pressure | Week 10-14 | No |
Secondary | Systolic Blood Pressure | Change in Systolic Blood Pressure | Week 26 | No |
Secondary | Systolic Blood Pressure | Change in Systolic Blood Pressure from baseline | Week 52 | No |
Secondary | Lipids | Change in lipids (Total cholestrol, LDL cholestrol, HDL cholestrol and Triglycerides) from baseline | Week 10-14 | No |
Secondary | Lipids | Change in lipids (Total cholestrol, LDL cholestrol, HDL cholestrol and Triglycerides) from baseline | Week 26 | No |
Secondary | Lipids | Change in lipids (Total cholestrol, LDL cholestrol, HDL cholestrol and Triglycerides) from baseline | Week 52 | No |
Secondary | Glucose | Change in glucose from baseline | Week 10-14 | No |
Secondary | Glucose | Change in glucose from baseline | Week 26 | No |
Secondary | Glucose | Change in glucose from baseline | Week 52 | No |
Secondary | Explore the participants experiences with physical activity prior to, during and after the treatment programme | In depth interviews | 2-3 years post treatment | No |
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