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Clinical Trials/NCT03246672
NCT03246672
Completed
Not Applicable

Development of a Weight Maintenance Intervention for Bariatric Surgery Patients

VA Office of Research and Development1 site in 1 country33 target enrollmentJanuary 3, 2018
ConditionsObesity, Morbid

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obesity, Morbid
Sponsor
VA Office of Research and Development
Enrollment
33
Locations
1
Primary Endpoint
Retention Rate
Status
Completed
Last Updated
6 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
January 3, 2018
End Date
July 31, 2018
Last Updated
6 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Retention Rate

Time Frame: 16-week outcome assessment

Percentage of patients with baseline data who complete 16-week outcome assessments

Recruitment Rate

Time Frame: week 0

Percentage of contacted patients who consent to be in the study

Secondary Outcomes

  • Weight(16 weeks)

Study Sites (1)

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