Morbid ObesityNCT01336725
Learning and Coping With Chronic Illness
An observational study of Morbid Obesity, run by Oslo University Hospital at 1 site in Norway.
Trial summary
The purpose of this study is to determine whether the participants have improved their scores on health related quality of life (HRQL) 1 year after completing a learning and mastery course and whether sociodemographic variables are associated with HRQL. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Morbid Obesity
- What is being tested?
- Teaching life style changes, Active participation and Teaching
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 150 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2009to Dec 2010
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Learning and mastery centre
Who may be able to join
- diagnosis of morbid obesity
- attending learning and mastery course for the obese
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine whether the participants have improved their scores on health related quality of life (HRQL) 1 year after completing a learning and mastery course and whether sociodemographic variables are associated with HRQL.
Read the detailed description
Persons with chronic illnesses have to adjust to changes in their life-style. In the last 10 years Learning and Mastery Centres have been established in Norwegian hospitals to offer patient education for the chronically ill. It is not known whether these courses impact any changes in HRQL 1 year after course completion.
- Conditions
- Morbid Obesity
- Being tested
- Teaching life style changes, Active participation, Teaching
- Keywords
- Morbid obesity, Patient education
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Teaching life style changesBehavioural
Single group: Teaching, group sessions, physical activity
Active participationOther
Obesity group attend 10 group sessions,are informed about and discuss needed life style changes such as weight loss and participate in physical activity and cooking.
TeachingOther
Morbid obesity group attend 40 hours of group sessions
| Study group | Role | What they receive |
|---|---|---|
| Morbid obesity | All attending learning and mastery courses for persons with morbid obesity Receives: Behavioral: Teaching life style changes; Other: Active participation; Other: Teaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health related quality of life
Measured: 1 year after course completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2011 (estimated)
- Study startJan 2009
- Primary completionSep 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Morbid ObesityStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01336725
- Sponsor's protocol ID
- S-08662c 2008/17575 (REK)
- Status last verified
- Apr 2011
- First submitted
- 14 Apr 2011
- Last updated
- 18 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Lerdal A, Gay CL, Bonsaksen T, Fagermoen MS. Predictors of physical and mental health in persons with morbid obesity attending a patient education course - a two-year follow-up study. Health Qual Life Outcomes. 2017 May 15;15(1):103. doi: 10.1186/s12955-017-0675-z.
PubMed 28506306Andenaes R, Fagermoen MS, Eide H, Lerdal A. Changes in health-related quality of life in people with morbid obesity attending a learning and mastery course. A longitudinal study with 12-months follow-up. Health Qual Life Outcomes. 2012 Aug 18;10:95. doi: 10.1186/1477-7525-10-95.
PubMed 22901031
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Learning and Coping With Chronic Illness
- ClinicalTrials.gov ID
- NCT01336725
- Acronym / sponsor ID
- S-08662c 2008/17575 (REK)
- Conditions
- Morbid Obesity
- Keywords
- Morbid obesity, Patient education
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Sep 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 18 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether the participants have improved their scores on health related quality of life (HRQL) 1 year after completing a learning and mastery course and whether sociodemographic variables are associated with HRQL.
Detailed description
Persons with chronic illnesses have to adjust to changes in their life-style. In the last 10 years Learning and Mastery Centres have been established in Norwegian hospitals to offer patient education for the chronically ill. It is not known whether these courses impact any changes in HRQL 1 year after course completion.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Morbid obesity | – | Behavioral: Teaching life style changes, Other: Active participation, Other: TeachingAll attending learning and mastery courses for persons with morbid obesity |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Learning and mastery centre
Key inclusion criteria (2 listed)
- diagnosis of morbid obesity
- attending learning and mastery course for the obese
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Teaching life style changesSingle group: Teaching, group sessions, physical activity | Behavioural | Morbid obesity |
| Active participationObesity group attend 10 group sessions,are informed about and discuss needed life style changes such as weight loss and participate in physical activity and cooking. | Other | Morbid obesity |
| TeachingMorbid obesity group attend 40 hours of group sessions | Other | Morbid obesity |
Primary outcome
Health related quality of life
Time frame: 1 year after course completion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2011.
- Derived from this study: PubMed 28506306Lerdal A, Gay CL, Bonsaksen T, Fagermoen MS. Predictors of physical and mental health in persons with morbid obesity attending a patient education course - a two-year follow-up study. Health Qual Life Outcomes. 2017 May 15;15(1):103. doi: 10.1186/s12955-017-0675-z.
- Derived from this study: PubMed 22901031Andenaes R, Fagermoen MS, Eide H, Lerdal A. Changes in health-related quality of life in people with morbid obesity attending a learning and mastery course. A longitudinal study with 12-months follow-up. Health Qual Life Outcomes. 2012 Aug 18;10:95. doi: 10.1186/1477-7525-10-95.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Morbid Obesity, run by Oslo University Hospital 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 2 inclusion and 0 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 18 Apr 2011. 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?
Health related quality of life (time frame: 1 year after course completion). 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 NCT01336725, which also lists 2 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 18 Apr 2011.