Weight LossNCT00590655
Maintenance Programme After Weight Loss
A study testing weight loss programme with maintenance programme and weight loss programme in people with Weight Loss and Morbid Obesity, run by University of Helsinki at 1 site in Finland.
Trial summary
The aim of this study is to compare a weight reduction programme with and without a maintenance programme in patients with severe obesity. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Weight Loss, Morbid Obesity
- What is being tested?
- weight loss programme with maintenance programme and weight loss programme
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 201 participants
- Where
- 1 siteFinland
- Study dates
- Aug 2002to May 2006
- 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
- BMI 35 kg/m2 or more
- Age 18-65 years
Who cannot join
- Type 1 diabetes
- Major alcohol problem
- Acute psychic disease, eating behavior, pregnancy, severe disease (cancer, unstable coronary disease, severe liver or kidney disease), or the patient has been in this treatment within the past 5 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Maintenance Programme on the Long Term Weight Reduction in Severely Obese Patients. A Randomized Controlled Trial
The aim of this study is to compare a weight reduction programme with and without a maintenance programme in patients with severe obesity.
- Conditions
- Weight Loss, Morbid Obesity
- Being tested
- weight loss programme with maintenance programme, weight loss programme
- Keywords
- maintenance therapy
- Medical subject headings
- Weight Loss, Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
weight loss programme with maintenance programmeBehavioural
After usual weight loss treatment, there will be a one-year maintenance programme with monthly visits.
weight loss programmeBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 2 | Active comparator | Treatment B includes a four month weight loss programme (10 weeks on a VLED and 17 weeks behavior modification visits). Treatment lasts 17 weeks and after that there will be one and two year control visits including weighing and questionnaires for eating behavior and quality of life. Receives: Behavioral: weight loss programme |
| 1 | Experimental | Treatment includes a four month weight loss programme (10 weeks on a VLED and 17 weeks behavior modification visits). After that a maintenance programme starts with monthly sessions for one year. Weight loss, quality of life, and eating behavior will be assessed at the end of the maintenance program and one year later. Receives: Behavioral: weight loss programme with maintenance programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
weight result
Measured: 2 years after weight loss phase
Secondary outcomes (1)
quality of life and eating behavior
Measured: 2 years after active weight loss
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2008 (estimated)
- Study startAug 2002
- Study completionMay 2006
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 Weight LossStudies 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
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Helsinki
- Sponsor type
- University, hospital or other
- Collaborators
- Finnish Medical Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00590655
- Sponsor's protocol ID
- 231410
- Other IDs
- Finnish Medical Foundation
- Status last verified
- Dec 2007
- First submitted
- 26 Dec 2007
- Last updated
- 10 Jan 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Pekkarinen T, Kaukua J, Mustajoki P. Long-term weight maintenance after a 17-week weight loss intervention with or without a one-year maintenance program: a randomized controlled trial. J Obes. 2015;2015:651460. doi: 10.1155/2015/651460. Epub 2015 Mar 30.
PubMed 25918644
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Maintenance Programme on the Long Term Weight Reduction in Severely Obese Patients. A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00590655
- Acronym / sponsor ID
- 231410
- Conditions
- Weight Loss, Morbid Obesity
- Keywords
- maintenance therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- University of HelsinkiUniversity, hospital or other
- Collaborators
- Finnish Medical Foundation
- Study start
- Aug 2002
- Study completion
- May 2006 (actual)
- First posted
- 10 Jan 2008 (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 aim of this study is to compare a weight reduction programme with and without a maintenance programme in patients with severe obesity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 | Active comparator | Behavioral: weight loss programmeTreatment B includes a four month weight loss programme (10 weeks on a VLED and 17 weeks behavior modification visits). Treatment lasts 17 weeks and after that there will be one and two year control visits including weighing and questionnaires for eating behavior and quality of life. |
| 1 | Experimental | Behavioral: weight loss programme with maintenance programmeTreatment includes a four month weight loss programme (10 weeks on a VLED and 17 weeks behavior modification visits). After that a maintenance programme starts with monthly sessions for one year. Weight loss, quality of life, and eating behavior will be assessed at the end of the maintenance program and one year later. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- BMI 35 kg/m2 or more
- Age 18-65 years
Key exclusion criteria (3 listed)
- Type 1 diabetes
- Major alcohol problem
- Acute psychic disease, eating behavior, pregnancy, severe disease (cancer, unstable coronary disease, severe liver or kidney disease), or the patient has been in this treatment within the past 5 years
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 |
|---|---|---|
| weight loss programme with maintenance programmeAfter usual weight loss treatment, there will be a one-year maintenance programme with monthly visits. | Behavioural | 1 |
| weight loss programme | Behavioural | 2 |
Primary outcome
weight result
Time frame: 2 years after weight loss phase
1 secondary outcome
quality of life and eating behavior
Time frame: 2 years after active weight loss
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 10 Jan 2008.
- Derived from this study: PubMed 25918644Pekkarinen T, Kaukua J, Mustajoki P. Long-term weight maintenance after a 17-week weight loss intervention with or without a one-year maintenance program: a randomized controlled trial. J Obes. 2015;2015:651460. doi: 10.1155/2015/651460. Epub 2015 Mar 30.
Related trials for Weight Loss
Active, not recruitingPhase 2
Effects of Brain Stimulation on Food Intake and Behavioral Weight Loss Treatment
Electric Stimulation Therapy, Obesity
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Not yet recruitingPhase 2/3
Master Protocol for the Study of Rilogrotug for the Treatment of Weight Loss and Anorexia in Patients With Cancer Cachexia and mCRC or mNSCLC
Cachexia; Cancer, Cachexia
RecruitingPhase 4
Mechanisms of Weight Loss: Tirzepatide vs Semaglutide
Obesity (Disorder)
Enrolling by invitationObservational study
Sustaining Health After an Intensive Weight-loss Pro-gramme
Obesity & Overweight, Weight Loss
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 weight loss programme with maintenance programme and weight loss programme in people with Weight Loss and Morbid Obesity, run by University of Helsinki at 1 site in Finland.
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 3 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 10 Jan 2008. 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 Finland. 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?
weight result (time frame: 2 years after weight loss phase). 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 NCT00590655, 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 10 Jan 2008; AzTrials last refreshed its copy on 30 Oct 2026.