Development of a Weight Maintenance Intervention for Bariatric Surgery Patients

NCT ID: NCT03246672

Last Updated: 2019-08-19

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-03

Study Completion Date

2018-07-31

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).

Conditions

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Obesity, Morbid

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

All participants receive the intervention
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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maintenance

behavioral intervention to increase adherence to lifestyle recommendations

Group Type EXPERIMENTAL

maintenance intervention

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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VA Office of Research and Development

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Corrine I. Voils, PhD

Role: PRINCIPAL_INVESTIGATOR

William S. Middleton Memorial Veterans Hospital, Madison, WI

Locations

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William S. Middleton Memorial Veterans Hospital, Madison, WI

Madison, Wisconsin, United States

Site Status

Countries

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United States

References

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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. doi: 10.1161/JAHA.118.011448.

Reference Type RESULT
PMID: 30712488 (View on PubMed)

Voils CI, Adler R, Strawbridge E, Grubber J, Allen KD, Olsen MK, McVay MA, Raghavan S, Raffa SD, Funk LM. Early-phase study of a telephone-based intervention to reduce weight regain among bariatric surgery patients. Health Psychol. 2020 May;39(5):391-402. doi: 10.1037/hea0000835. Epub 2020 Jan 30.

Reference Type DERIVED
PMID: 31999175 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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PPO 16-331

Identifier Type: -

Identifier Source: org_study_id

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