Lifestyleintervention for the Treatment of Severe Obesity

April 14, 2015 updated by: Professor Jorunn Sundgot-Borgen, Norwegian School of Sport Sciences

Intensive Lifestyleintervention for the Treatment of Severe Obesity

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

149

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway, 0806
        • Norwegian School of Sport Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • morbidly obese

Exclusion Criteria:

  • not able to walk slowly for 20 minutes

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Lifestyle intervention
10-14 weeks intensive lifestyle intervention
Behavioral: Intensive lifestyle intervention
Lifestyle modification program focusing on increasing physical activity level, adjusting energy intake and learning coping strategies
NO_INTERVENTION: Controls
No treatment, waiting list

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
three years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body composition
Time Frame: Week 10-14
Change in body composition (body weight, fat mass, fat free mass, visceral fat area) from baseline
Week 10-14
Body composition
Time Frame: Week 26
Change in body composition (body weight, fat mass, fat free mass, visceral fat area) from baseline
Week 26
Body composition
Time Frame: Week 52
Change in body composition (body weight, fat mass, fat free mass, visceral fat area) from baseline
Week 52
Health related quality of life
Time Frame: Week 10-14
Change in Health related quality of life from baseline
Week 10-14
Health related quality of life
Time Frame: Week 26
Change in Health related quality of life from baseline
Week 26
Health related quality of life
Time Frame: Week 52
Change in Health related quality of life from baseline
Week 52
Binge Eating
Time Frame: Week 10-14
Change in binge eating from baseline
Week 10-14
Binge eating
Time Frame: Week 26
Change in binge eating from baseline
Week 26
Binge eating
Time Frame: Week 52
Change in binge eating from baseline
Week 52
Anxiety
Time Frame: Week 10-14
Change in anxiety from baseline
Week 10-14
Depression
Time Frame: Week 10-14
Change in depression from baseline
Week 10-14
Depression
Time Frame: Week 26
Change in depression from baseline
Week 26
Depression
Time Frame: Week 52
Change in depression from baseline
Week 52
Physical Activity
Time Frame: Week 10-14
Change in physical activity from baseline
Week 10-14
Physical activity
Time Frame: Week 26
Change in physical activity from baseline
Week 26
Physical activity
Time Frame: Week 52
Change in physical activity from baseline
Week 52
Physical fitness
Time Frame: Week 10-14
Change in physical fitness from baseline
Week 10-14
Physical fitness
Time Frame: Week 26
Change in physical fitness from baseline
Week 26
Physical fitness
Time Frame: Week 52
Change in physical fitness from baseline
Week 52
Systolic Blood Pressure
Time Frame: Week 10-14
Change in Systolic Blood Pressure
Week 10-14
Systolic Blood Pressure
Time Frame: Week 26
Change in Systolic Blood Pressure
Week 26
Systolic Blood Pressure
Time Frame: Week 52
Change in Systolic Blood Pressure from baseline
Week 52
Lipids
Time Frame: Week 10-14
Change in lipids (Total cholestrol, LDL cholestrol, HDL cholestrol and Triglycerides) from baseline
Week 10-14
Lipids
Time Frame: Week 26
Change in lipids (Total cholestrol, LDL cholestrol, HDL cholestrol and Triglycerides) from baseline
Week 26
Lipids
Time Frame: Week 52
Change in lipids (Total cholestrol, LDL cholestrol, HDL cholestrol and Triglycerides) from baseline
Week 52
Glucose
Time Frame: Week 10-14
Change in glucose from baseline
Week 10-14
Glucose
Time Frame: Week 26
Change in glucose from baseline
Week 26
Glucose
Time Frame: Week 52
Change in glucose from baseline
Week 52
Explore the participants experiences with physical activity prior to, during and after the treatment programme
Time Frame: 2-3 years post treatment
In depth interviews
2-3 years post treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Norwegian School of Sport Sciences

Collaborators

Hjelp24

Investigators

  • Study Director: Sverre Mæhlum, MD, PhD, Hjelp24

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (ACTUAL)

July 1, 2013

Study Completion (ACTUAL)

September 1, 2014

Study Registration Dates

First Submitted

August 20, 2012

First Submitted That Met QC Criteria

August 27, 2012

First Posted (ESTIMATE)

August 30, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

April 15, 2015

Last Update Submitted That Met QC Criteria

April 14, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KKD1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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