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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01675713
Other study ID # KKD1
Secondary ID
Status Completed
Phase N/A
First received August 20, 2012
Last updated April 14, 2015
Start date September 2009
Est. completion date September 2014

Study information

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

Clinical Trial 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


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


Recruitment information / eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
Intensive lifestyle intervention
Lifestyle modification program focusing on increasing physical activity level, adjusting energy intake and learning coping strategies

Locations

Country Name City State
Norway Norwegian School of Sport Sciences Oslo

Sponsors (2)

Lead Sponsor Collaborator
Norwegian School of Sport Sciences Hjelp24

Country where clinical trial is conducted

Norway, 

References & Publications (3)

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

Outcome

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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