BehavioralNCT02754453
Weight Regain Study After Bariatric Surgery-A Pilot Project
A study testing Behavioral lifestyle intervention in people with Behavioral and Activity, run by The Cleveland Clinic at 1 site in United States.
Trial summary
There are three different phases to this study: 1. Screening phase to determine if you are eligible to participate in the study. 2. Study phase, which will entail diet and activity, exercise and then finally self monitoring goals. 3. End of treatment phase where you will be asked to complete questionnaires. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Behavioral, Activity, Weight Loss
- What is being tested?
- Behavioral 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 siteUnited States
- Study dates
- Jul 2013to Oct 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Weight regain post-RYGB of at least 5 kg since reaching their weight nadir.
- Male or Female age 18 - 65.
- Undergone RYGB 12 - 36 month prior.
- Ability to read, write and understand English.
- Experienced at least a 25% total weight loss since surgery.
- BMI at least 27 kg/m.
- Weight regain of no more than half of excess body weight. These cases will be referred back to the surgeon.
Who cannot join
- Taking Weight-suppressing medication (e.g. phentermine, bupropion)
- On medications known to cause weight gain
- Change in smoking status with past three months
- Change in antidepressant or other psychotropic medication or dosage in past six weeks
- Change in psychotherapy status in past six weeks
- Current purging behaviors occurring more than once per week over the past six weeks (vomiting or laxative/diuretic use for the purpose of weight loss
Show all 14Show fewer
- Current alcohol abuse or dependence or illicit drug use in past three months
- Active bipolar or psychotic spectrum disorder
- Current suicidality or homicidality
- Severe neuropsychological disease (history of seizure, uncontrolled hypertension
- Condition associated with cognitive dysfunction (e.g. Alzheimer's dementia, other neurological conditions)
- Medically unstable condition or one which the investigators feel put the participant at risk in the study
- Functional limitations-not able to walk 2 block without assistance
- Exercise is contra-indicated (e.g., severe cardiovascular disease, uncontrolled hypertension, hematocrit.<30%, chronic kidney disease, severe pulmonary disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Evaluation of the Efficacy of a Group Treatment Intervention for Weight Regain After Bariatric Surgery-A Pilot Project
There are three different phases to this study:
- Screening phase to determine if you are eligible to participate in the study.
- Study phase, which will entail diet and activity, exercise and then finally self monitoring goals.
- End of treatment phase where you will be asked to complete questionnaires.
Read the detailed description
The purpose of this study is to determine the feasibility of a group treatment program for individuals experiencing weight regain after bariatric surgery and to evaluate the effectiveness of the group treatment program. There is little information on programs to assist patients who experience weight regain after bariatric surgery. This treatment program will focus on behavioral changes and activity.
- Conditions
- Behavioral, Activity, Weight Loss
- Being tested
- Behavioral lifestyle intervention
- Keywords
- Weight Regain, Group Treatment, Weight Loss
- Medical subject headings
- Behavior, Motor Activity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral lifestyle interventionBehavioural
20 session lifestyle behavioral intervention with the goal of altering diet and physical activity and decreasing problematic behaviors associated with weight regain and session behavioral intervention addressing increasing physical activity, improving adherence to dietary recommendations and altering problematic eating behaviors.
| Study group | Role | What they receive |
|---|---|---|
| Behavioral | Other | Not described Receives: Behavioral: Behavioral lifestyle intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight Regain After Bariatric Surgery
The overall goal of the project is to collect pilot data for a RO1 application. The primary outcome will be kg lost and BMI units lost from pre- to post-treatment. The effect size (Mean1 - Mean2 / pooled s.d.) of the intervention will be determined for within subject and between subject differences. It is hypothesized that a moderate effect size (.5) will be demonstrated and that has been selected a priori as the criteria for pursuing a larger-scale randomized clinical trial.
Measured: 6 months
Secondary outcomes (4)
Daily caloric intake
Subjects will keep a food intake diary and bring it to their appointments where calorie intake will be calculated
Measured: 6 months
Daily protein intake
Subjects will keep a food intake diary and bring it to their appointment where daily protein intake will be calculated
Measured: 6 months
Number of minutes of physical activity
Subjects will wear a pedometer to track their daily activity
Measured: 6 months
Presence of disordered eating behaviors
Subjects will complete pre and post treatment questionnaires to assess for disordered eating behaviors
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2016 (estimated)
- Study startJul 2013
- Primary completionOct 2015
- Study completionOct 2015
Why it stopped: No funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BehavioralStudies of the same condition, open and under way.
- More trials run by The Cleveland 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Leslie Heinberg, PhD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02754453
- Sponsor's protocol ID
- 13-129
- Status last verified
- Feb 2016
- First submitted
- 25 Sep 2013
- Last updated
- 28 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of the Efficacy of a Group Treatment Intervention for Weight Regain After Bariatric Surgery-A Pilot Project
- ClinicalTrials.gov ID
- NCT02754453
- Acronym / sponsor ID
- 13-129
- Conditions
- Behavioral, Activity, Weight Loss
- Keywords
- Weight Regain, Group Treatment, Weight Loss
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 28 Apr 2016 (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.
There are three different phases to this study:
- Screening phase to determine if you are eligible to participate in the study.
- Study phase, which will entail diet and activity, exercise and then finally self monitoring goals.
- End of treatment phase where you will be asked to complete questionnaires.
Detailed description
The purpose of this study is to determine the feasibility of a group treatment program for individuals experiencing weight regain after bariatric surgery and to evaluate the effectiveness of the group treatment program. There is little information on programs to assist patients who experience weight regain after bariatric surgery. This treatment program will focus on behavioral changes and activity.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Behavioral | Other | Behavioral: Behavioral lifestyle intervention |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Weight regain post-RYGB of at least 5 kg since reaching their weight nadir.
- Male or Female age 18 - 65.
- Undergone RYGB 12 - 36 month prior.
- Ability to read, write and understand English.
- Experienced at least a 25% total weight loss since surgery.
Key exclusion criteria (14 listed)
- Taking Weight-suppressing medication (e.g. phentermine, bupropion)
- On medications known to cause weight gain
- Change in smoking status with past three months
- Change in antidepressant or other psychotropic medication or dosage in past six weeks
- Change in psychotherapy status in past six weeks
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 |
|---|---|---|
| Behavioral lifestyle intervention20 session lifestyle behavioral intervention with the goal of altering diet and physical activity and decreasing problematic behaviors associated with weight regain and session behavioral intervention addressing increasing physical activity, improving adherence to dietary recommendations and altering problematic eating behaviors. | Behavioural | Behavioral |
Primary outcome
Weight Regain After Bariatric Surgery
Time frame: 6 months
The overall goal of the project is to collect pilot data for a RO1 application. The primary outcome will be kg lost and BMI units lost from pre- to post-treatment. The effect size (Mean1 - Mean2 / pooled s.d.) of the intervention will be determined for within subject and between subject differences. It is hypothesized that a moderate effect size (.5) will be demonstrated and that has been selected a priori as the criteria for pursuing a larger-scale randomized clinical trial.
4 secondary outcomes
Daily caloric intake
Time frame: 6 months
Daily protein intake
Time frame: 6 months
Number of minutes of physical activity
Time frame: 6 months
Presence of disordered eating behaviors
Time frame: 6 months
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 Apr 2016.
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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.
Leslie Heinberg, PhD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral lifestyle intervention in people with Behavioral and Activity, run by The Cleveland 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 7 inclusion and 14 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 Apr 2016. 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.
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 Regain After Bariatric Surgery (time frame: 6 months). 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 28 Apr 2016.