Lifestyleintervention for the Treatment of Severe Obesity

Not Applicable

Completed

• Conditions: Morbid Obesity
• Interventions: Behavioral: Intensive lifestyle intervention

• Registration Number: NCT01675713
• Lead Sponsor: Norwegian School of Sport Sciences

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

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2012-08-20
• Study First Submitted QC: 2012-08-27
• Study First Posted: 2012-08-30
• Primary Completion: 2013-07
• Study Completion: 2014-09
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-14
• Last Update Posted: 2015-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 149

Inclusion Criteria

• morbidly obese

Exclusion Criteria

• not able to walk slowly for 20 minutes

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lifestyle intervention	Intensive lifestyle intervention	10-14 weeks intensive lifestyle intervention

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Lipids	Week 52	Change in lipids (Total cholestrol, LDL cholestrol, HDL cholestrol and Triglycerides) from baseline
Physical activity	Week 52	Change in physical activity from baseline
Binge eating	Week 52	Change in binge eating from baseline
Health related quality of life	Week 52	Change in Health related quality of life from baseline
Binge Eating	Week 10-14	Change in binge eating from baseline
Body composition	Week 52	Change in body composition (body weight, fat mass, fat free mass, visceral fat area) from baseline
Depression	Week 52	Change in depression from baseline
Physical fitness	Week 52	Change in physical fitness from baseline
Systolic Blood Pressure	Week 52	Change in Systolic Blood Pressure from baseline
Explore the participants experiences with physical activity prior to, during and after the treatment programme	2-3 years post treatment	In depth interviews
Anxiety	Week 10-14	Change in anxiety from baseline
Physical Activity	Week 10-14	Change in physical activity from baseline
Glucose	Week 52	Change in glucose from baseline

Trial Locations

Locations (1)

Norwegian School of Sport Sciences; 🇳🇴 Oslo, Norway