Development of a Weight Maintenance Intervention for Bariatric Surgery Patients (MAINTAIN-B)
Primary Purpose
Obesity, Morbid
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
maintenance intervention
Sponsored by
About this trial
This is an interventional treatment trial for Obesity, Morbid focused on measuring obesity, morbid
Eligibility Criteria
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
Sites / Locations
- William S. Middleton Memorial Veterans Hospital, Madison, WI
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
maintenance
Arm Description
behavioral intervention to increase adherence to lifestyle recommendations
Outcomes
Primary Outcome Measures
Recruitment Rate
Percentage of contacted patients who consent to be in the study
Retention Rate
Percentage of patients with baseline data who complete 16-week outcome assessments
Secondary Outcome Measures
Weight
Patient weight obtained from the electronic medical record on the clinical visit date closest to the 16-week study assessment date
Full Information
NCT ID
NCT03246672
First Posted
August 7, 2017
Last Updated
July 15, 2019
Sponsor
VA Office of Research and Development
1. Study Identification
Unique Protocol Identification Number
NCT03246672
Brief Title
Development of a Weight Maintenance Intervention for Bariatric Surgery Patients
Acronym
MAINTAIN-B
Official Title
Development of a Weight Maintenance Intervention for Bariatric Surgery Patients
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
January 3, 2018 (Actual)
Primary Completion Date
June 22, 2018 (Actual)
Study Completion Date
July 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Morbid
Keywords
obesity, morbid
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
All participants receive the intervention
Masking
None (Open Label)
Allocation
N/A
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
maintenance
Arm Type
Experimental
Arm Description
behavioral intervention to increase adherence to lifestyle recommendations
Intervention Type
Behavioral
Intervention Name(s)
maintenance intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Recruitment Rate
Description
Percentage of contacted patients who consent to be in the study
Time Frame
week 0
Title
Retention Rate
Description
Percentage of patients with baseline data who complete 16-week outcome assessments
Time Frame
16-week outcome assessment
Secondary Outcome Measure Information:
Title
Weight
Description
Patient weight obtained from the electronic medical record on the clinical visit date closest to the 16-week study assessment date
Time Frame
16 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Corrine I. Voils, PhD
Organizational Affiliation
William S. Middleton Memorial Veterans Hospital, Madison, WI
Official's Role
Principal Investigator
Facility Information:
Facility Name
William S. Middleton Memorial Veterans Hospital, Madison, WI
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30712488
Citation
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.
Results Reference
result
PubMed Identifier
31999175
Citation
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.
Results Reference
derived
Learn more about this trial
Development of a Weight Maintenance Intervention for Bariatric Surgery Patients
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