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Morbid ObesityNCT01675713

Lifestyleintervention for the Treatment of Severe Obesity

A study testing Intensive lifestyle intervention in people with Morbid Obesity, run by Norwegian School of Sport Sciences at 1 site in Norway.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Morbid Obesity
What is being tested?
Intensive lifestyle intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
149 participants
Where
1 siteNorway
Study dates
Sep 2009to Sep 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • morbidly obese

Who cannot join

  • not able to walk slowly for 20 minutes

Trial locations and contacts

1 site in 1 country.

Norway1 site

  • Norwegian School of Sport Sciences

    Oslo, 0806

Other trials in Norway

About this study

Official title: 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
Read the 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

Conditions
Morbid Obesity
Being tested
Intensive lifestyle intervention
Keywords
Lifestyle, Physical activity
Medical subject headings
Obesity, Morbid, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intensive lifestyle interventionBehavioural

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

Study groups in NCT01675713
Study groupRoleWhat they receive
Lifestyle interventionExperimental10-14 weeks intensive lifestyle intervention
Receives: Behavioral: Intensive lifestyle intervention
ControlsNo interventionNo treatment, waiting list

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: three years

Secondary outcomes (29)

  1. Body composition

    Change in body composition (body weight, fat mass, fat free mass, visceral fat area) from baseline

    Measured: Week 10-14

  2. Body composition

    Change in body composition (body weight, fat mass, fat free mass, visceral fat area) from baseline

    Measured: Week 26

  3. Body composition

    Change in body composition (body weight, fat mass, fat free mass, visceral fat area) from baseline

    Measured: Week 52

  4. Health related quality of life

    Change in Health related quality of life from baseline

    Measured: Week 10-14

  5. Health related quality of life

    Change in Health related quality of life from baseline

    Measured: Week 26

  6. Health related quality of life

    Change in Health related quality of life from baseline

    Measured: Week 52

  7. Binge Eating

    Change in binge eating from baseline

    Measured: Week 10-14

  8. Binge eating

    Change in binge eating from baseline

    Measured: Week 26

  9. Binge eating

    Change in binge eating from baseline

    Measured: Week 52

  10. Anxiety

    Change in anxiety from baseline

    Measured: Week 10-14

  11. Depression

    Change in depression from baseline

    Measured: Week 10-14

  12. Depression

    Change in depression from baseline

    Measured: Week 26

  13. Depression

    Change in depression from baseline

    Measured: Week 52

  14. Physical Activity

    Change in physical activity from baseline

    Measured: Week 10-14

  15. Physical activity

    Change in physical activity from baseline

    Measured: Week 26

  16. Physical activity

    Change in physical activity from baseline

    Measured: Week 52

  17. Physical fitness

    Change in physical fitness from baseline

    Measured: Week 10-14

  18. Physical fitness

    Change in physical fitness from baseline

    Measured: Week 26

  19. Physical fitness

    Change in physical fitness from baseline

    Measured: Week 52

  20. Systolic Blood Pressure

    Change in Systolic Blood Pressure

    Measured: Week 10-14

  21. Systolic Blood Pressure

    Change in Systolic Blood Pressure

    Measured: Week 26

  22. Systolic Blood Pressure

    Change in Systolic Blood Pressure from baseline

    Measured: Week 52

  23. Lipids

    Change in lipids (Total cholestrol, LDL cholestrol, HDL cholestrol and Triglycerides) from baseline

    Measured: Week 10-14

  24. Lipids

    Change in lipids (Total cholestrol, LDL cholestrol, HDL cholestrol and Triglycerides) from baseline

    Measured: Week 26

  25. Lipids

    Change in lipids (Total cholestrol, LDL cholestrol, HDL cholestrol and Triglycerides) from baseline

    Measured: Week 52

  26. Glucose

    Change in glucose from baseline

    Measured: Week 10-14

  27. Glucose

    Change in glucose from baseline

    Measured: Week 26

  28. Glucose

    Change in glucose from baseline

    Measured: Week 52

  29. Explore the participants experiences with physical activity prior to, during and after the treatment programme

    In depth interviews

    Measured: 2-3 years post treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Aug 2012 (estimated)
  2. Study startSep 2009
  3. Primary completionJul 2013
  4. Study completionSep 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
149 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01675713
Sponsor's protocol ID
KKD1
Status last verified
Apr 2015
First submitted
20 Aug 2012
Last updated
15 Apr 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 20460258

  • 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.

    PubMed 24491067

  • 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.

    PubMed 23710347

Questions about this trial

What is this clinical trial studying?

A study testing Intensive lifestyle intervention in people with Morbid Obesity, run by Norwegian School of Sport Sciences at 1 site in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01675713, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2015.

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