Development of a Weight Maintenance Intervention for Bariatric Surgery Patients

Not Applicable

Completed

• Conditions: Obesity, Morbid
• Interventions: Behavioral: maintenance intervention

• Registration Number: NCT03246672
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2017-08-07
• Study First Submitted QC: 2017-08-07
• Study First Posted: 2017-08-11
• Study Start: 2018-01-03
• Primary Completion: 2018-06-22
• Study Completion: 2018-07-31
• Results First Submitted: 2019-04-17
• Status Verified: 2019-07
• Results First Submitted QC: 2019-07-15
• Last Update Submitted: 2019-07-15
• Results First Posted: 2019-08-19
• Last Update Posted: 2019-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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

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Exclusion Criteria

• Receipt of procedure to prevent gastric cancer
• Revisional bariatric surgery
• Hearing impairment
• Cancer not in remission

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
maintenance	maintenance intervention	behavioral intervention to increase adherence to lifestyle recommendations

Primary Outcome Measures

Name	Time	Method
Retention Rate	16-week outcome assessment	Percentage of patients with baseline data who complete 16-week outcome assessments
Recruitment Rate	week 0	Percentage of contacted patients who consent to be in the study

Secondary Outcome Measures

Name	Time	Method
Weight	16 weeks	Patient weight obtained from the electronic medical record on the clinical visit date closest to the 16-week study assessment date

Trial Locations

Locations (1)

William S. Middleton Memorial Veterans Hospital, Madison, WI; 🇺🇸 Madison, Wisconsin, United States