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Clinical Trials/NCT01675713
NCT01675713
Completed
Not Applicable

Intensive Lifestyleintervention for the Treatment of Severe Obesity

Norwegian School of Sport Sciences1 site in 1 country149 target enrollmentSeptember 2009
ConditionsMorbid Obesity

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Morbid Obesity
Sponsor
Norwegian School of Sport Sciences
Enrollment
149
Locations
1
Primary Endpoint
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
Status
Completed
Last Updated
11 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
September 2009
End Date
September 2014
Last Updated
11 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Norwegian School of Sport Sciences
Responsible Party
Principal Investigator
Principal Investigator

Professor Jorunn Sundgot-Borgen

Professor, PhD

Norwegian School of Sport Sciences

Eligibility Criteria

Inclusion Criteria

  • morbidly obese

Exclusion Criteria

  • not able to walk slowly for 20 minutes

Outcomes

Primary Outcomes

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

Time Frame: three years

Secondary Outcomes

  • Physical activity(Week 52)
  • Binge eating(Week 52)
  • Health related quality of life(Week 52)
  • Binge Eating(Week 10-14)
  • Body composition(Week 52)
  • Depression(Week 52)
  • Physical fitness(Week 52)
  • Systolic Blood Pressure(Week 52)
  • Lipids(Week 52)
  • Explore the participants experiences with physical activity prior to, during and after the treatment programme(2-3 years post treatment)
  • Anxiety(Week 10-14)
  • Physical Activity(Week 10-14)
  • Glucose(Week 52)

Study Sites (1)

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