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Lifestyleintervention for the Treatment of Severe Obesity

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ClinicalTrials.gov Identifier: NCT01675713
Recruitment Status : Completed
First Posted : August 30, 2012
Last Update Posted : April 15, 2015
Sponsor:
Collaborator:
Hjelp24
Information provided by (Responsible Party):
Professor Jorunn Sundgot-Borgen, 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

Condition or disease Intervention/treatment Phase
Morbid Obesity Behavioral: Intensive lifestyle intervention Not Applicable

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


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 149 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intensive Lifestyleintervention for the Treatment of Severe Obesity
Study Start Date : September 2009
Actual Primary Completion Date : July 2013
Actual Study Completion Date : September 2014

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



Primary Outcome Measures :
  1. 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 Measures :
  1. Body composition [ Time Frame: Week 10-14 ]
    Change in body composition (body weight, fat mass, fat free mass, visceral fat area) from baseline

  2. Body composition [ Time Frame: Week 26 ]
    Change in body composition (body weight, fat mass, fat free mass, visceral fat area) from baseline

  3. Body composition [ Time Frame: Week 52 ]
    Change in body composition (body weight, fat mass, fat free mass, visceral fat area) from baseline

  4. Health related quality of life [ Time Frame: Week 10-14 ]
    Change in Health related quality of life from baseline

  5. Health related quality of life [ Time Frame: Week 26 ]
    Change in Health related quality of life from baseline

  6. Health related quality of life [ Time Frame: Week 52 ]
    Change in Health related quality of life from baseline

  7. Binge Eating [ Time Frame: Week 10-14 ]
    Change in binge eating from baseline

  8. Binge eating [ Time Frame: Week 26 ]
    Change in binge eating from baseline

  9. Binge eating [ Time Frame: Week 52 ]
    Change in binge eating from baseline

  10. Anxiety [ Time Frame: Week 10-14 ]
    Change in anxiety from baseline

  11. Depression [ Time Frame: Week 10-14 ]
    Change in depression from baseline

  12. Depression [ Time Frame: Week 26 ]
    Change in depression from baseline

  13. Depression [ Time Frame: Week 52 ]
    Change in depression from baseline

  14. Physical Activity [ Time Frame: Week 10-14 ]
    Change in physical activity from baseline

  15. Physical activity [ Time Frame: Week 26 ]
    Change in physical activity from baseline

  16. Physical activity [ Time Frame: Week 52 ]
    Change in physical activity from baseline

  17. Physical fitness [ Time Frame: Week 10-14 ]
    Change in physical fitness from baseline

  18. Physical fitness [ Time Frame: Week 26 ]
    Change in physical fitness from baseline

  19. Physical fitness [ Time Frame: Week 52 ]
    Change in physical fitness from baseline

  20. Systolic Blood Pressure [ Time Frame: Week 10-14 ]
    Change in Systolic Blood Pressure

  21. Systolic Blood Pressure [ Time Frame: Week 26 ]
    Change in Systolic Blood Pressure

  22. Systolic Blood Pressure [ Time Frame: Week 52 ]
    Change in Systolic Blood Pressure from baseline

  23. Lipids [ Time Frame: Week 10-14 ]
    Change in lipids (Total cholestrol, LDL cholestrol, HDL cholestrol and Triglycerides) from baseline

  24. Lipids [ Time Frame: Week 26 ]
    Change in lipids (Total cholestrol, LDL cholestrol, HDL cholestrol and Triglycerides) from baseline

  25. Lipids [ Time Frame: Week 52 ]
    Change in lipids (Total cholestrol, LDL cholestrol, HDL cholestrol and Triglycerides) from baseline

  26. Glucose [ Time Frame: Week 10-14 ]
    Change in glucose from baseline

  27. Glucose [ Time Frame: Week 26 ]
    Change in glucose from baseline

  28. Glucose [ Time Frame: Week 52 ]
    Change in glucose from baseline

  29. 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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • morbidly obese

Exclusion Criteria:

  • not able to walk slowly for 20 minutes

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01675713


Locations
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Norway
Norwegian School of Sport Sciences
Oslo, Norway, 0806
Sponsors and Collaborators
Norwegian School of Sport Sciences
Hjelp24
Investigators
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Study Director: Sverre Mæhlum, MD, PhD Hjelp24

Publications of Results:
Other Publications:
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Responsible Party: Professor Jorunn Sundgot-Borgen, Professor, PhD, Norwegian School of Sport Sciences
ClinicalTrials.gov Identifier: NCT01675713     History of Changes
Other Study ID Numbers: KKD1
First Posted: August 30, 2012    Key Record Dates
Last Update Posted: April 15, 2015
Last Verified: April 2015
Keywords provided by Professor Jorunn Sundgot-Borgen, Norwegian School of Sport Sciences:
Lifestyle
Physical activity
Additional relevant MeSH terms:
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Obesity
Obesity, Morbid
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms