Development of a Weight Maintenance Intervention for Bariatric Surgery Patients

Study Overview
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Brief Summary
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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
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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).

Official Title
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Development of a Weight Maintenance Intervention for Bariatric Surgery Patients

Conditions
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Obesity, Morbid

Intervention / Treatment
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* Behavioral: maintenance intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: All participants receive the intervention
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: maintenance<br>behavioral intervention to increase adherence to lifestyle recommendations | Behavioral: maintenance intervention<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recruitment Rate | Percentage of contacted patients who consent to be in the study | week 0 | 
| Retention Rate | 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 | Patient weight obtained from the electronic medical record on the clinical visit date closest to the 16-week study assessment date | 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obesity, morbid