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Development of a Weight Maintenance Intervention for Bariatric Surgery Patients (MAINTAIN-B)

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ClinicalTrials.gov Identifier: NCT03246672
Recruitment Status : Completed
First Posted : August 11, 2017
Results First Posted : August 19, 2019
Last Update Posted : August 19, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

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.

Condition or disease Intervention/treatment Phase
Obesity, Morbid Behavioral: maintenance intervention Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Intervention Model: Single Group Assignment
Intervention Model Description: All participants receive the intervention
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Development of a Weight Maintenance Intervention for Bariatric Surgery Patients
Actual Study Start Date : January 3, 2018
Actual Primary Completion Date : June 22, 2018
Actual Study Completion Date : July 31, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: maintenance
behavioral intervention to increase adherence to lifestyle recommendations
Behavioral: maintenance intervention
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 Measures :
  1. Recruitment Rate [ Time Frame: week 0 ]
    Percentage of contacted patients who consent to be in the study

  2. Retention Rate [ Time Frame: 16-week outcome assessment ]
    Percentage of patients with baseline data who complete 16-week outcome assessments


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03246672


Locations
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United States, Wisconsin
William S. Middleton Memorial Veterans Hospital, Madison, WI
Madison, Wisconsin, United States, 53705
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Corrine I. Voils, PhD William S. Middleton Memorial Veterans Hospital, Madison, WI
  Study Documents (Full-Text)

Documents provided by VA Office of Research and Development:

Publications of Results:
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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT03246672     History of Changes
Other Study ID Numbers: PPO 16-331
First Posted: August 11, 2017    Key Record Dates
Results First Posted: August 19, 2019
Last Update Posted: August 19, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by VA Office of Research and Development:
obesity, morbid
Additional relevant MeSH terms:
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Obesity, Morbid
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms