Clinical trial NCT01675713: Lifestyleintervention for the Treatment of Severe Obesity
Official title: Intensive Lifestyleintervention for the Treatment of Severe Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Morbid Obesity
Keywords: Lifestyle
Physical activity
Lead sponsor: Norwegian School of Sport Sciences
Sponsor class: OTHER
Collaborators: name: Hjelp24
First posted: 2012-08-30
Enrollment: 149
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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

Detailed description: 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

Eligibility criteria: Inclusion Criteria:

* morbidly obese

Exclusion Criteria:

* not able to walk slowly for 20 minutes

Primary outcomes:
measure: 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
timeFrame: three years
Secondary outcomes:
measure: Body composition
timeFrame: Week 10-14
measure: Body composition
timeFrame: Week 26
measure: Body composition
timeFrame: Week 52
measure: Health related quality of life
timeFrame: Week 10-14
measure: Health related quality of life
timeFrame: Week 26
measure: Health related quality of life
timeFrame: Week 52
measure: Binge Eating
timeFrame: Week 10-14
measure: Binge eating
timeFrame: Week 26
measure: Binge eating
timeFrame: Week 52
measure: Anxiety
timeFrame: Week 10-14
measure: Depression
timeFrame: Week 10-14
measure: Depression
timeFrame: Week 26
measure: Depression
timeFrame: Week 52
measure: Physical Activity
timeFrame: Week 10-14
measure: Physical activity
timeFrame: Week 26
measure: Physical activity
timeFrame: Week 52
measure: Physical fitness
timeFrame: Week 10-14
measure: Physical fitness
timeFrame: Week 26
measure: Physical fitness
timeFrame: Week 52
measure: Systolic Blood Pressure
timeFrame: Week 10-14
measure: Systolic Blood Pressure
timeFrame: Week 26
measure: Systolic Blood Pressure
timeFrame: Week 52
measure: Lipids
timeFrame: Week 10-14
measure: Lipids
timeFrame: Week 26
measure: Lipids
timeFrame: Week 52
measure: Glucose
timeFrame: Week 10-14
measure: Glucose
timeFrame: Week 26
measure: Glucose
timeFrame: Week 52
measure: Explore the participants experiences with physical activity prior to, during and after the treatment programme
timeFrame: 2-3 years post treatment
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Norwegian School of Sport Sciences
Study officials:
affiliation: Hjelp24
name: Sverre Mæhlum, MD, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.