Morbid ObesityNCT01249209
Outpatient Treatment of Patients With Morbid Obesity - a Two-year Follow up
A study testing lifestyle advice in people with Morbid Obesity, run by Sykehuset Innlandet HF at 1 site in Norway.
Trial summary
This study is a pilot project to investigate any effect on these markers in conjunction with lifestyle changes / conservative treatment. Useful and significant information in this pilot project is intended to be used as background for further research on this issue in connection with a doctorate. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Morbid Obesity
- What is being tested?
- lifestyle advice
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteNorway
- Study dates
- May 2010to Oct 2010
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults from 18 - 60 years, both sex
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Qualitative Retrospective Study Where the Intervention Consisted of Group Therapy and Individual Interviews Over a Two-year Period
This study is a pilot project to investigate any effect on these markers in conjunction with lifestyle changes / conservative treatment. Useful and significant information in this pilot project is intended to be used as background for further research on this issue in connection with a doctorate.
What is the effect of two years of outpatient treatment for lifestyle change for weight markers, waist, BMI, HbA1c, HDL and LDL cholesterol, triglycerides and uric acid in adults with morbid obesity?
- Conditions
- Morbid Obesity
- Being tested
- lifestyle advice
- Keywords
- obesity, adults, lifestyle intervention, effect after two years treatment for lifestyle change - morbid obesity adults
- Medical subject headings
- Obesity, Morbid, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lifestyle adviceDevice
| Study group | Role | What they receive |
|---|---|---|
| lifestyle advice | Other | Not described Receives: Device: lifestyle advice |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2010 (estimated)
- Study startMay 2010
- Primary completionSep 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Morbid ObesityStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sykehuset Innlandet HF
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01249209
- Sponsor's protocol ID
- SI HF Kongsvinger
- Other IDs
- skyrud,randi
- Status last verified
- Jun 2010
- First submitted
- 24 Nov 2010
- Last updated
- 29 Nov 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Qualitative Retrospective Study Where the Intervention Consisted of Group Therapy and Individual Interviews Over a Two-year Period
- ClinicalTrials.gov ID
- NCT01249209
- Acronym / sponsor ID
- SI HF Kongsvinger
- Conditions
- Morbid Obesity
- Keywords
- obesity, adults, lifestyle intervention, effect after two years treatment for lifestyle change - morbid obesity adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Sykehuset Innlandet HFUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Sep 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 29 Nov 2010 (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.
This study is a pilot project to investigate any effect on these markers in conjunction with lifestyle changes / conservative treatment. Useful and significant information in this pilot project is intended to be used as background for further research on this issue in connection with a doctorate.
What is the effect of two years of outpatient treatment for lifestyle change for weight markers, waist, BMI, HbA1c, HDL and LDL cholesterol, triglycerides and uric acid in adults with morbid obesity?
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| lifestyle advice | Other | Device: lifestyle advice |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Adults from 18 - 60 years, both sex
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 |
|---|---|---|
| lifestyle advice | Device | lifestyle advice |
Primary outcome
Not reported in the source record.
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 29 Nov 2010.
Related trials for Morbid Obesity
Not yet recruitingObservational study
Pilot Study on the Effectiveness and Safety of OPTILENE® SILVER MESH ELASTIC in Prevention of Surgical Site Infection (SSI) and Incisional Hernia (IH)
Abdominal Aortic Aneurysm, Morbid Obesity
Not yet recruitingObservational study
Evaluating Metabolic Health in Individuals With Extreme Obesity
BMI>40
Enrolling by invitationObservational study
Bariatric Surgery Registry
Obesity, Morbid
Not yet recruitingObservational study
Serum Estradiol and Endometrial Thickness After Bariatric Surgery in Postmenopausal Women With Obesity
Obesity, Morbid, Postmenopause
Active, not recruiting
Mindfulness Based Eating Awareness Training for Bariatric Surgery Patients
Obesity, Morbid, Eating Disorder Symptom
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?
A study testing lifestyle advice in people with Morbid Obesity, run by Sykehuset Innlandet HF 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 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 29 Nov 2010. 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.
Where can I read the original study information?
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 29 Nov 2010.