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OpenTrials
Completed

NCT Number: NCT03246672

Development of a Weight Maintenance Intervention for Bariatric Surgery Patients

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.

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Key information

Conditions

Obesity, Morbid Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

William S. Middleton Memorial Veterans Hospital, Madison, WI

Madison, Wisconsin, 53705, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Maintenance Intervention

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.

Primary outcomes

  1. Recruitment Rate

    Time frame: week 0

    Percentage of contacted patients who consent to be in the study

  2. Retention Rate

    Time frame: 16-week outcome assessment

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

Secondary outcomes

  1. Weight

    Time frame: 16 weeks

    Patient weight obtained from the electronic medical record on the clinical visit date closest to the 16-week study assessment date

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Acronym: MAINTAIN-B

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Aug 11, 2017
Registry last updated
Aug 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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