- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03246672
Development of a Weight Maintenance Intervention for Bariatric Surgery Patients (MAINTAIN-B)
July 15, 2019 updated by: VA Office of Research and Development
Although bariatric surgery is highly effective for inducing significant weight loss and resolution of comorbidities, weight regain following surgery is a common problem.
This pilot study will test the feasibility and acceptability of an intervention designed to help bariatric surgery patients maintain weight loss.
Findings from this pilot will provide the foundation for a randomized controlled trial to evaluate the efficacy of the intervention.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The first intervention telephone call will occur one week following the baseline assessment.
Calls will be made weekly in the first month (weeks 1, 2, 3, 4) and biweekly calls during months 2-4 (weeks 6, 8, 10, 12, 14).
The goal of this intervention is to increase adherence to recommendations that patients are already receiving from their bariatric team as part of standard of care.
Thus, each call will address maintenance skill building and anticipatory problem solving based on the processes outlined in the investigators' conceptual model and operationalized in the investigators' previous weight loss maintenance protocol.
Relapse prevention planning will help patients identify situations in which overeating is common in the bariatric population (e.g., loss of control eating related to emotions, disinhibition).
Study Type
Interventional
Enrollment (Actual)
33
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Wisconsin
-
Madison, Wisconsin, United States, 53705
- William S. Middleton Memorial Veterans Hospital, Madison, WI
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Bariatric surgery at a participating VA site
- Laparoscopic Roux-en-Y gastric bypass (RYGB) or laparoscopic vertical sleeve gastrectomy (SG) six to 18 months prior to the time of data pull
- English as preferred language
- Regular access to a telephone
Exclusion Criteria:
- Receipt of procedure to prevent gastric cancer
- Revisional bariatric surgery
- Hearing impairment
- Cancer not in remission
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: maintenance
behavioral intervention to increase adherence to lifestyle recommendations
|
Participants will receive calls at weeks 1, 2, 3, 4, 6, 8, 10, 12, and 14 that focus on satisfaction with outcomes of behavior change, self-monitoring, relapse planning, and social support.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Recruitment Rate
Time Frame: week 0
|
Percentage of contacted patients who consent to be in the study
|
week 0
|
Retention Rate
Time Frame: 16-week outcome assessment
|
Percentage of patients with baseline data who complete 16-week outcome assessments
|
16-week outcome assessment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Weight
Time Frame: 16 weeks
|
Patient weight obtained from the electronic medical record on the clinical visit date closest to the 16-week study assessment date
|
16 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Corrine I. Voils, PhD, William S. Middleton Memorial Veterans Hospital, Madison, WI
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Adamek KE, Ramadurai D, Gunzburger E, Plomondon ME, Ho PM, Raghavan S. Association of Diabetes Mellitus Status and Glycemic Control With Secondary Prevention Medication Adherence After Acute Myocardial Infarction. J Am Heart Assoc. 2019 Feb 5;8(3):e011448. doi: 10.1161/JAHA.118.011448.
- Voils CI, Adler R, Strawbridge E, Grubber J, Allen KD, Olsen MK, McVay MA, Raghavan S, Raffa SD, Funk LM. Early-phase study of a telephone-based intervention to reduce weight regain among bariatric surgery patients. Health Psychol. 2020 May;39(5):391-402. doi: 10.1037/hea0000835. Epub 2020 Jan 30.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 3, 2018
Primary Completion (Actual)
June 22, 2018
Study Completion (Actual)
July 31, 2018
Study Registration Dates
First Submitted
August 7, 2017
First Submitted That Met QC Criteria
August 7, 2017
First Posted (Actual)
August 11, 2017
Study Record Updates
Last Update Posted (Actual)
August 19, 2019
Last Update Submitted That Met QC Criteria
July 15, 2019
Last Verified
July 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PPO 16-331
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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