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| Name | Class |
|---|---|
| Hjelp24 | OTHER |
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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 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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lifestyle intervention | Experimental | 10-14 weeks intensive lifestyle intervention |
|
| Controls | No Intervention | No treatment, waiting list |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intensive lifestyle intervention | Behavioral | Lifestyle modification program focusing on increasing physical activity level, adjusting energy intake and learning coping strategies |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sverre Mæhlum, MD, PhD | Hjelp24 | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Norwegian School of Sport Sciences | Oslo | 0806 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20460258 | Background | Maehlum S, Danielsen KK, Heggebo LK, Schioll 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. | |
| 24491067 | Result | Danielsen KK, Sundgot-Borgen J, Maehlum 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. Epub 2014 Feb 4. |
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| ID | Term |
|---|---|
| D009767 | Obesity, Morbid |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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| 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 |
| 23710347 | Result | Danielsen KK, Svendsen M, Maehlum 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 prospective clinical controlled trial. J Obes. 2013;2013:325464. doi: 10.1155/2013/325464. Epub 2013 Apr 22. |
| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |