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Lifestyleintervention for the Treatment of Severe Obesity

Primary Purpose

Morbid Obesity

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Intensive lifestyle intervention
Sponsored by
Norwegian School of Sport Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Morbid Obesity focused on measuring Lifestyle, Physical activity

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • morbidly obese

Exclusion Criteria:

  • not able to walk slowly for 20 minutes

Sites / Locations

  • Norwegian School of Sport Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Lifestyle intervention

Controls

Arm Description

10-14 weeks intensive lifestyle intervention

No treatment, waiting list

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
August 20, 2012
Last Updated
April 14, 2015
Sponsor
Norwegian School of Sport Sciences
Collaborators
Hjelp24
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1. Study Identification

Unique Protocol Identification Number
NCT01675713
Brief Title
Lifestyleintervention for the Treatment of Severe Obesity
Official Title
Intensive Lifestyleintervention for the Treatment of Severe Obesity
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Norwegian School of Sport Sciences
Collaborators
Hjelp24

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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: The BMI/Weight Body composition (waist circumference, fat mass, fat free mass, skeletal muscle mass and visceral fat area) 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morbid Obesity
Keywords
Lifestyle, Physical activity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
149 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lifestyle intervention
Arm Type
Experimental
Arm Description
10-14 weeks intensive lifestyle intervention
Arm Title
Controls
Arm Type
No Intervention
Arm Description
No treatment, waiting list
Intervention Type
Behavioral
Intervention Name(s)
Intensive lifestyle intervention
Intervention Description
Lifestyle modification program focusing on increasing physical activity level, adjusting energy intake and learning coping strategies
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Body composition
Description
Change in body composition (body weight, fat mass, fat free mass, visceral fat area) from baseline
Time Frame
Week 10-14
Title
Body composition
Description
Change in body composition (body weight, fat mass, fat free mass, visceral fat area) from baseline
Time Frame
Week 26
Title
Body composition
Description
Change in body composition (body weight, fat mass, fat free mass, visceral fat area) from baseline
Time Frame
Week 52
Title
Health related quality of life
Description
Change in Health related quality of life from baseline
Time Frame
Week 10-14
Title
Health related quality of life
Description
Change in Health related quality of life from baseline
Time Frame
Week 26
Title
Health related quality of life
Description
Change in Health related quality of life from baseline
Time Frame
Week 52
Title
Binge Eating
Description
Change in binge eating from baseline
Time Frame
Week 10-14
Title
Binge eating
Description
Change in binge eating from baseline
Time Frame
Week 26
Title
Binge eating
Description
Change in binge eating from baseline
Time Frame
Week 52
Title
Anxiety
Description
Change in anxiety from baseline
Time Frame
Week 10-14
Title
Depression
Description
Change in depression from baseline
Time Frame
Week 10-14
Title
Depression
Description
Change in depression from baseline
Time Frame
Week 26
Title
Depression
Description
Change in depression from baseline
Time Frame
Week 52
Title
Physical Activity
Description
Change in physical activity from baseline
Time Frame
Week 10-14
Title
Physical activity
Description
Change in physical activity from baseline
Time Frame
Week 26
Title
Physical activity
Description
Change in physical activity from baseline
Time Frame
Week 52
Title
Physical fitness
Description
Change in physical fitness from baseline
Time Frame
Week 10-14
Title
Physical fitness
Description
Change in physical fitness from baseline
Time Frame
Week 26
Title
Physical fitness
Description
Change in physical fitness from baseline
Time Frame
Week 52
Title
Systolic Blood Pressure
Description
Change in Systolic Blood Pressure
Time Frame
Week 10-14
Title
Systolic Blood Pressure
Description
Change in Systolic Blood Pressure
Time Frame
Week 26
Title
Systolic Blood Pressure
Description
Change in Systolic Blood Pressure from baseline
Time Frame
Week 52
Title
Lipids
Description
Change in lipids (Total cholestrol, LDL cholestrol, HDL cholestrol and Triglycerides) from baseline
Time Frame
Week 10-14
Title
Lipids
Description
Change in lipids (Total cholestrol, LDL cholestrol, HDL cholestrol and Triglycerides) from baseline
Time Frame
Week 26
Title
Lipids
Description
Change in lipids (Total cholestrol, LDL cholestrol, HDL cholestrol and Triglycerides) from baseline
Time Frame
Week 52
Title
Glucose
Description
Change in glucose from baseline
Time Frame
Week 10-14
Title
Glucose
Description
Change in glucose from baseline
Time Frame
Week 26
Title
Glucose
Description
Change in glucose from baseline
Time Frame
Week 52
Title
Explore the participants experiences with physical activity prior to, during and after the treatment programme
Description
In depth interviews
Time Frame
2-3 years post treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: morbidly obese Exclusion Criteria: not able to walk slowly for 20 minutes
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sverre Mæhlum, MD, PhD
Organizational Affiliation
Hjelp24
Official's Role
Study Director
Facility Information:
Facility Name
Norwegian School of Sport Sciences
City
Oslo
ZIP/Postal Code
0806
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
20460258
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.
Results Reference
background
PubMed Identifier
24491067
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. Erratum In: Ann Med. 2014 Nov;46(7):566.
Results Reference
result
PubMed Identifier
23710347
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.
Results Reference
result

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Lifestyleintervention for the Treatment of Severe Obesity

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