Morbid ObesityPhase 3NCT02122029
Lifestyle vs.Surgery for Morbid Obesity Treatment
A Phase 3 study testing Lifestyle counselling and Bariatric Surgery in people with Morbid Obesity, run by Harokopio University at 1 site in Greece.
Trial summary
The purpose of the current study is to determine whether an intensive lifestyle intervention was as effective as surgery to treat morbid obesity nine years post-intervention. Read more about this study
- Who is it for?
- Ages 21 to 51 years, women only
- Conditions the study is for
- Morbid Obesity
- What is being tested?
- Lifestyle counselling and Bariatric Surgery
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteGreece
- Study dates
- Feb 2003to Oct 2013
- Phase
- Phase 3
- 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 21 to 51 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- female sex
- Age ≥ 18 years
- BMI ≥ 40 kg/m2
- Absence of mental illness as determined by evaluation by an experienced psychiatrist
- Additional inclusion criteria for vertical banded gastroplasty were history of multiple, non-successful, previous attempts for weight loss
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Nine-Year Follow-up of Intensive Lifestyle Intervention vs Surgery to Treat Morbidly Obese Women: a Non-randomized Human Subject Research.
The purpose of the current study is to determine whether an intensive lifestyle intervention was as effective as surgery to treat morbid obesity nine years post-intervention.
Read the detailed description
Behavioral/lifestyle interventions produce acceptable success in treating moderately obese subjects. However, their effectiveness on weight loss and maintenance in morbidly obese subjects remains elusive.
Twenty-nine morbidly obese females participated in this non-randomized study. Fifteen subjects were assigned to the lifestyle group and 14 underwent vertical banded gastroplasty. Subjects in the lifestyle group attended 30 behavioral modification sessions over three years, whereas the surgery group received the standard of care nutrition. Body weight, resting metabolic rate, physical activity, body composition measurements and dietary intake data were assessed at standard time points during the first 3 years post-intervention. Follow-up data on body weight and physical activity were also collected 9 years later.
- Conditions
- Morbid Obesity
- Being tested
- Lifestyle counselling, Bariatric Surgery
- Keywords
- Lifestyle intervention, Bariatric surgery, Weight management, 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.
Lifestyle counsellingBehavioural
Behavioral techniques for weight management
Bariatric SurgeryProcedure or surgery
Vertical Banding Gastroplasty
| Study group | Role | What they receive |
|---|---|---|
| Bariatric Surgery | Experimental | Not described Receives: Behavioral: Lifestyle counselling |
| Lifestyle counselling | Experimental | Not described Receives: Procedure: Bariatric Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
The weight lost (kg) and maintained (kg) following each intervention (bariatric surgery and behavioural modification)
Measured: 9 years
Secondary outcomes (4)
Physical Activity Level post bariatric surgery and behavioural modification of morbid obese patients.
Measured: 9 years
Resting Metabolic Rate (kcal/d) post bariatric surgery and behavioral modofication in morbid obese patients.
Measured: 3 years
Fat mass (kg) and fat free mass (kg) post bariatric surgery and behavioural modification in morbid obese patients.
Measured: 3 years
Changes in dietary intake and eating habits post bariatric surgery and behavioural modification.
Dietary intake measured as energy intake (kcal/d) derived from fat, protein and carbohydrate.
Eating habits were reflected by the reported consumption of fruits, vegetables, sweets (portions/d).
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2014 (estimated)
- Study startFeb 2003
- Primary completionSep 2013
- Study completionOct 2013
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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harokopio University
- Sponsor type
- University, hospital or other
- Collaborators
- The University of Texas Medical Branch, Galveston
- Responsible party
- Principal investigator, M. Yannakoulia, Harokopio University
- Investigators
- Labros S Sidossis, Professor, Study director, Department of Internal Medicine, Surgery, and Nutrition and Metabolism, University of Texas Medical Branch at Galveston, Texas, USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02122029
- Sponsor's protocol ID
- LVS
- Status last verified
- Apr 2014
- First submitted
- 15 Apr 2014
- Last updated
- 24 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Nine-Year Follow-up of Intensive Lifestyle Intervention vs Surgery to Treat Morbidly Obese Women: a Non-randomized Human Subject Research.
- ClinicalTrials.gov ID
- NCT02122029
- Acronym / sponsor ID
- LVS
- Conditions
- Morbid Obesity
- Keywords
- Lifestyle intervention, Bariatric surgery, Weight management, Physical activity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Harokopio UniversityUniversity, hospital or other
- Collaborators
- The University of Texas Medical Branch, Galveston
- Study start
- Feb 2003
- Primary completion
- Sep 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 24 Apr 2014 (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 the current study is to determine whether an intensive lifestyle intervention was as effective as surgery to treat morbid obesity nine years post-intervention.
Detailed description
Behavioral/lifestyle interventions produce acceptable success in treating moderately obese subjects. However, their effectiveness on weight loss and maintenance in morbidly obese subjects remains elusive.
Twenty-nine morbidly obese females participated in this non-randomized study. Fifteen subjects were assigned to the lifestyle group and 14 underwent vertical banded gastroplasty. Subjects in the lifestyle group attended 30 behavioral modification sessions over three years, whereas the surgery group received the standard of care nutrition. Body weight, resting metabolic rate, physical activity, body composition measurements and dietary intake data were assessed at standard time points during the first 3 years post-intervention. Follow-up data on body weight and physical activity were also collected 9 years later.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bariatric Surgery | Experimental | Behavioral: Lifestyle counselling |
| Lifestyle counselling | Experimental | Procedure: Bariatric Surgery |
Who may qualify
- Ages
- 21 to 51 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- female sex
- Age ≥ 18 years
- BMI ≥ 40 kg/m2
- Absence of mental illness as determined by evaluation by an experienced psychiatrist
- Additional inclusion criteria for vertical banded gastroplasty were history of multiple, non-successful, previous attempts for weight loss
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 counsellingBehavioral techniques for weight management | Behavioural | Bariatric Surgery |
| Bariatric SurgeryVertical Banding Gastroplasty | Procedure or surgery | Lifestyle counselling |
Primary outcome
The weight lost (kg) and maintained (kg) following each intervention (bariatric surgery and behavioural modification)
Time frame: 9 years
4 secondary outcomes
Physical Activity Level post bariatric surgery and behavioural modification of morbid obese patients.
Time frame: 9 years
Resting Metabolic Rate (kcal/d) post bariatric surgery and behavioral modofication in morbid obese patients.
Time frame: 3 years
Fat mass (kg) and fat free mass (kg) post bariatric surgery and behavioural modification in morbid obese patients.
Time frame: 3 years
Changes in dietary intake and eating habits post bariatric surgery and behavioural modification.
Time frame: 3 years
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 24 Apr 2014.
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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.
Labros S Sidossis, Professor study director
Department of Internal Medicine, Surgery, and Nutrition and Metabolism, University of Texas Medical Branch at Galveston, Texas, USA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lifestyle counselling and Bariatric Surgery in people with Morbid Obesity, run by Harokopio University at 1 site in Greece.
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 5 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 24 Apr 2014. 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 Greece. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The weight lost (kg) and maintained (kg) following each intervention (bariatric surgery and behavioural modification) (time frame: 9 years). It is what the study was designed to measure, not a finding.
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 24 Apr 2014.