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Completed

NCT Number: NCT01675713

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

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Key information

Conditions

Morbid Obesity Behavior Body Weight Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Morbid Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Norwegian School of Sport Sciences

Oslo, 0806, Norway

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • morbidly obese

Exclusion criteria

  • not able to walk slowly for 20 minutes

Treatment and study plan

Intensive lifestyle intervention

Behavioral

Lifestyle modification program focusing on increasing physical activity level, adjusting energy intake and learning coping strategies

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Norwegian School of Sport Sciences

Other

Collaborators

  • Hjelp24

Registry information

Official study title

Intensive Lifestyleintervention for the Treatment of Severe Obesity

Important dates

Study start
2009
Primary completion
2013
Study completion
2014
First posted
Aug 30, 2012
Registry last updated
Apr 15, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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