Development of a Weight Maintenance Intervention for Bariatric Surgery Patients

Obesity, Morbid Clinical Trial

— MAINTAIN-B  

Official title:

Development of a Weight Maintenance Intervention for Bariatric Surgery Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03246672
• Other study ID #: PPO 16-331
• Status: Completed
• Phase: N/A
• Start date: January 3, 2018
• Est. completion date: July 31, 2018

Study information

• Verified date: July 2019
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: July 31, 2018
• Est. primary completion date: June 22, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obesity, Morbid

Intervention

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.

Locations

Country	Name	City	State
United States	William S. Middleton Memorial Veterans Hospital, Madison, WI	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment Rate	Percentage of contacted patients who consent to be in the study	week 0
Primary	Retention Rate	Percentage of patients with baseline data who complete 16-week outcome assessments	16-week outcome assessment
Secondary	Weight	Patient weight obtained from the electronic medical record on the clinical visit date closest to the 16-week study assessment date	16 weeks