ObesityPhase 1NCT01125397
Behavior Therapy Prior to Bariatric Surgery
A Phase 1 study testing LEARN group in people with Obesity, run by Mayo Clinic at 1 site in United States.
Trial summary
Obesity is an ever increasing public health problem in this country. Bariatric surgery is currently the most effective treatment for morbid obesity and two hundred thousand surgeries are performed in the United States each year. Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Obesity
- What is being tested?
- LEARN group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2009to Oct 2012
- Phase
- Phase 1
- 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 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMI between 40 and 60
- age 25 to 65
- ability to participate in weekly LEARN groups for 3 months at Mayo Clinic (local to the Rochester, MN area)
- seeking RYGB procedure
Who cannot join
- patients seeking surgical revision of a previous bariatric procedure
- diagnosis of schizophrenia
- diagnosis of bipolar disorder
- diagnosis of borderline personality disorder
- non-local patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Potential Effectiveness of Behavior Therapy on Weight Loss Following Bariatric Surgery
Obesity is an ever increasing public health problem in this country. Bariatric surgery is currently the most effective treatment for morbid obesity and two hundred thousand surgeries are performed in the United States each year. Unfortunately, despite anatomically successful surgery, it is estimated that at most surgical centers about 30 percent of patients will not achieve significant weight loss following surgery. It has been proposed that participation in preoperative behavior therapy can enhance postoperative outcomes, although empirical evidence for this premise is lacking. The current study is a pilot project designed to conduct a prospective randomized trial to examine the impact of participation in a 12-week standardized preoperative behavioral weight management program on percentage of excess weight loss and psychosocial and medical outcomes at six months after roux-en-Y gastric bypass surgery. The cost of bariatric surgery is not covered by this study and only patients local to the Rochester, Minnesota area are eligible to participate.
It is hypothesized that patients who complete the 12-week behavioral program will experience greater weight loss and improved psychosocial and medical outcomes compared to controls.
- Conditions
- Obesity
- Being tested
- LEARN group
- Keywords
- bariatric surgery, behavioral weight management, psychosocial outcomes following bariatric surgery
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LEARN groupBehavioural
Participants will complete a 12-week behavioral weight management intervention (the LEARN program) prior to bariatric surgery, which is the current standard clinical practice at Mayo Clinic Rochester. This involves weekly group meetings, weigh-ins, and goal setting.
| Study group | Role | What they receive |
|---|---|---|
| Behavioral Intervention | Experimental | Not described Receives: Behavioral: LEARN group |
| Control | No intervention | These participants will be randomized to receive no behavioral intervention prior to bariatric surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent excess weight loss following bariatric surgery
The study will compare percent excess weight loss between the two groups (behavioral intervention vs. control)
Measured: 6 months post-surgery
Secondary outcomes (2)
Psychosocial outcomes
Psychological outcomes that will be assessed at baseline and 6 months postoperatively include quality of life (SF-36), depression (BDI-II, PHQ-9), anxiety (GAD-7), alcohol use (AUDIT), distress tolerance (DTS), emotional eating (EOQ), and eating self-efficacy (WEL). All questionnaires are validated and possess good psychometric properties. All measures except the SF-36 are currently given as routine practice during psychological evaluations of bariatric patients, enhancing feasibility for the current study.
Measured: 6 months post-surgery
Resolution of medical comorbidities
Resolution rates of comorbidities will be assessed 6 months post-surgery defined as follows: diabetes as no longer requiring medication and A1C level <7, hypertension as no longer requiring medication and blood pressure of <140 mm Hg (systolic)/90 mm Hg (diastolic). Patients are typically seen at 2 and 6 weeks postoperatively in the surgery clinic and 3 and 6 months in Endocrinology, therefore percentage of follow-up will be calculated as appointments attended/appointments scheduled. Time from initial evaluation until surgery will also be assessed as a possible covariate.
Measured: 6 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2010 (estimated)
- Study startNov 2009
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karen Grothe, Mayo Clinic
- Investigators
- Karen B Grothe, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01125397
- Sponsor's protocol ID
- 09-007135
- Other IDs
- FP00054166
- Status last verified
- May 2013
- First submitted
- 17 May 2010
- Last updated
- 10 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Potential Effectiveness of Behavior Therapy on Weight Loss Following Bariatric Surgery
- ClinicalTrials.gov ID
- NCT01125397
- Acronym / sponsor ID
- 09-007135
- Conditions
- Obesity
- Keywords
- bariatric surgery, behavioral weight management, psychosocial outcomes following bariatric surgery
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 18 May 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.
Obesity is an ever increasing public health problem in this country. Bariatric surgery is currently the most effective treatment for morbid obesity and two hundred thousand surgeries are performed in the United States each year. Unfortunately, despite anatomically successful surgery, it is estimated that at most surgical centers about 30 percent of patients will not achieve significant weight loss following surgery. It has been proposed that participation in preoperative behavior therapy can enhance postoperative outcomes, although empirical evidence for this premise is lacking. The current study is a pilot project designed to conduct a prospective randomized trial to examine the impact of participation in a 12-week standardized preoperative behavioral weight management program on percentage of excess weight loss and psychosocial and medical outcomes at six months after roux-en-Y gastric bypass surgery. The cost of bariatric surgery is not covered by this study and only patients local to the Rochester, Minnesota area are eligible to participate.
It is hypothesized that patients who complete the 12-week behavioral program will experience greater weight loss and improved psychosocial and medical outcomes compared to controls.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Behavioral Intervention | Experimental | Behavioral: LEARN group |
| Control | No intervention | –These participants will be randomized to receive no behavioral intervention prior to bariatric surgery. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- BMI between 40 and 60
- age 25 to 65
- ability to participate in weekly LEARN groups for 3 months at Mayo Clinic (local to the Rochester, MN area)
- seeking RYGB procedure
Key exclusion criteria (5 listed)
- patients seeking surgical revision of a previous bariatric procedure
- diagnosis of schizophrenia
- diagnosis of bipolar disorder
- diagnosis of borderline personality disorder
- non-local patients
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 |
|---|---|---|
| LEARN groupParticipants will complete a 12-week behavioral weight management intervention (the LEARN program) prior to bariatric surgery, which is the current standard clinical practice at Mayo Clinic Rochester. This involves weekly group meetings, weigh-ins, and goal setting. | Behavioural | Behavioral Intervention |
Primary outcome
Percent excess weight loss following bariatric surgery
Time frame: 6 months post-surgery
The study will compare percent excess weight loss between the two groups (behavioral intervention vs. control)
2 secondary outcomes
Psychosocial outcomes
Time frame: 6 months post-surgery
Resolution of medical comorbidities
Time frame: 6 months post-surgery
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 May 2013.
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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.
Karen B Grothe, PhD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LEARN group in people with Obesity, run by Mayo Clinic at 1 site in United States.
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 4 inclusion and 5 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 May 2013. 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 United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Percent excess weight loss following bariatric surgery (time frame: 6 months post-surgery). 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 10 May 2013.