ObesityNCT00477399
Long Term Follow up After 1 Year Initial Lifestyle Intervention
A study testing Long term follow up after intensive lifestyle intervention in people with Obesity, run by Tor-Ivar Karlsen at 1 site in Norway.
Trial summary
The effect of non-surgical methods for obesity treatment are not fully documented. This study focus on the long term effect of an intensiv follow up (the "Evje Model") compared to a regular follow up. Read more about this study
- Who is it for?
- Ages 18 to 67 years
- Conditions the study is for
- Obesity
- What is being tested?
- Long term follow up after intensive lifestyle intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteNorway
- Study dates
- May 2007to Nov 2015
- 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 67 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients, referred from Public Hospitals, with morbid obesity that have undergone one year intensive life style intervention in accordance with the Evje Model.
Who cannot join
- Pregnancy, major and active psychiatric disease, active and serious eating disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Four Years Intensive- Versus Regular Follow up, After a One Year Weight Loss Period, in Patients With Morbid Obesity.
The effect of non-surgical methods for obesity treatment are not fully documented. This study focus on the long term effect of an intensiv follow up (the "Evje Model") compared to a regular follow up.
The "Evje Model" is a combined model, consisting of repeated stays at a specialist centre, telephone follow up at home, home groups, self monitoring and close contact with the patients' local physician.
Read the detailed description
200 patients will undergo a 1 year intensive lifestyle intervention.This group will be randomised into an intervention group (n=100) and a control group (n=100). The intervention group will undergo four years of further follow up in accordance with the intervention model, which means two one weeks stays each year at the Evje Clinic, telephone follow up, self monitoring and collaboration with the patients' local physician.
The control group will be followed up by the patients local physician and a yearly control at the Center for Morbid Obesity at Vestfold Hospital (Sykehuset i Vestfold HF).
The purpose is to measure the effect of these two follow up models in regard to weight loss maintanance, Quality of Life and comorbidities.
- Conditions
- Obesity
- Being tested
- Long term follow up after intensive lifestyle intervention
- Keywords
- Obesity, Weight loss maintenance, QOL, Life Style, Follow Up
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Long term follow up after intensive lifestyle interventionBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Other | Receiving active follow up (two yearly 1 week stays, telephone follow up, GP-visits) Receives: Behavioral: Long term follow up after intensive lifestyle intervention |
| Control | No intervention | Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight loss
Measured: 03.2015
Secondary outcomes (2)
Health related quality of life
Measured: 03.2015
Anthropometrics
Measured: 03.2015
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2007 (estimated)
- Study startMay 2007 (estimated)
- Primary completionMar 2015 (estimated)
- Study completionNov 2015 (estimated)
Why it stopped: lack of recruitment of study participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tor-Ivar Karlsen
- Sponsor type
- University, hospital or other
- Collaborators
- Sykehuset i Vestfold HF
- Responsible party
- Sponsor-investigator, Tor-Ivar Karlsen, Evjeklinikken
- Investigators
- Joran Hjelmesath, Dr. Med., Study chair, Sykehuset i Vestfold HF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00477399
- Sponsor's protocol ID
- EK0701
- Status last verified
- Aug 2024
- First submitted
- 22 May 2007
- Last updated
- 28 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Karlsen TI, Sohagen M, Hjelmesaeth J. Predictors of weight loss after an intensive lifestyle intervention program in obese patients: a 1-year prospective cohort study. Health Qual Life Outcomes. 2013 Oct 3;11:165. doi: 10.1186/1477-7525-11-165.
PubMed 24090083
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Four Years Intensive- Versus Regular Follow up, After a One Year Weight Loss Period, in Patients With Morbid Obesity.
- ClinicalTrials.gov ID
- NCT00477399
- Acronym / sponsor ID
- EK0701
- Conditions
- Obesity
- Keywords
- Obesity, Weight loss maintenance, QOL, Life Style, Follow Up
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: lack of recruitment of study participants
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Tor-Ivar KarlsenUniversity, hospital or other
- Collaborators
- Sykehuset i Vestfold HF
- Study start
- May 2007 (estimated)
- Primary completion
- Mar 2015 (estimated)
- Study completion
- Nov 2015 (estimated)
- First posted
- 23 May 2007 (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 effect of non-surgical methods for obesity treatment are not fully documented. This study focus on the long term effect of an intensiv follow up (the "Evje Model") compared to a regular follow up.
The "Evje Model" is a combined model, consisting of repeated stays at a specialist centre, telephone follow up at home, home groups, self monitoring and close contact with the patients' local physician.
Detailed description
200 patients will undergo a 1 year intensive lifestyle intervention.This group will be randomised into an intervention group (n=100) and a control group (n=100). The intervention group will undergo four years of further follow up in accordance with the intervention model, which means two one weeks stays each year at the Evje Clinic, telephone follow up, self monitoring and collaboration with the patients' local physician.
The control group will be followed up by the patients local physician and a yearly control at the Center for Morbid Obesity at Vestfold Hospital (Sykehuset i Vestfold HF).
The purpose is to measure the effect of these two follow up models in regard to weight loss maintanance, Quality of Life and comorbidities.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Other | Behavioral: Long term follow up after intensive lifestyle interventionReceiving active follow up (two yearly 1 week stays, telephone follow up, GP-visits) |
| Control | No intervention | –Control group |
Who may qualify
- Ages
- 18 to 67 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients, referred from Public Hospitals, with morbid obesity that have undergone one year intensive life style intervention in accordance with the Evje Model.
Key exclusion criteria (1 listed)
- Pregnancy, major and active psychiatric disease, active and serious eating disorder
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 |
|---|---|---|
| Long term follow up after intensive lifestyle intervention | Behavioural | Intervention |
Primary outcome
Weight loss
Time frame: 03.2015
2 secondary outcomes
Health related quality of life
Time frame: 03.2015
Anthropometrics
Time frame: 03.2015
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2024.
- Derived from this study: PubMed 24090083Karlsen TI, Sohagen M, Hjelmesaeth J. Predictors of weight loss after an intensive lifestyle intervention program in obese patients: a 1-year prospective cohort study. Health Qual Life Outcomes. 2013 Oct 3;11:165. doi: 10.1186/1477-7525-11-165.
- Home page of EvjeklinikkenLink provided by the sponsor.
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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.
Joran Hjelmesath, Dr. Med. study chair
Sykehuset i Vestfold HF
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Long term follow up after intensive lifestyle intervention in people with Obesity, run by Tor-Ivar Karlsen 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: withdrawn, as of the sponsor's last update on 28 Aug 2024. 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 was withdrawn before enrolling participants, so there are no results.
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?
Weight loss (time frame: 03.2015). 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 NCT00477399, which also lists 1 linked publication.
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 28 Aug 2024.