Lifestyleintervention for the Treatment of Severe Obesity

Morbid Obesity Clinical Trial

Official title:

Intensive Lifestyleintervention for the Treatment of Severe Obesity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01675713
• Other study ID #: KKD1
• 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

• Morbid Obesity
• Obesity
• Obesity, Morbid

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