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Development of a Weight Maintenance Intervention for Bariatric Surgery Patients (MAINTAIN-B)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03246672
Recruitment Status : Completed
First Posted : August 11, 2017
Results First Posted : August 19, 2019
Last Update Posted : August 19, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Tracking Information
First Submitted Date  ICMJE August 7, 2017
First Posted Date  ICMJE August 11, 2017
Results First Submitted Date  ICMJE April 17, 2019
Results First Posted Date  ICMJE August 19, 2019
Last Update Posted Date August 19, 2019
Actual Study Start Date  ICMJE January 3, 2018
Actual Primary Completion Date June 22, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 15, 2019)
  • Recruitment Rate [ Time Frame: week 0 ]
    Percentage of contacted patients who consent to be in the study
  • Retention Rate [ Time Frame: 16-week outcome assessment ]
    Percentage of patients with baseline data who complete 16-week outcome assessments
Original Primary Outcome Measures  ICMJE
 (submitted: August 7, 2017)
  • Recruitment Rate [ Time Frame: week 0 ]
    Percentage of contacted patients who consent to be in the study
  • Retention Rate [ Time Frame: 16-week outcome assessment ]
    Percentage of consented patients who complete 16-week outcome assessments
Change History Complete list of historical versions of study NCT03246672 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 7, 2017)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Development of a Weight Maintenance Intervention for Bariatric Surgery Patients
Official Title  ICMJE Development of a Weight Maintenance Intervention for Bariatric Surgery Patients
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Intervention Model Description:
All participants receive the intervention
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Obesity, Morbid
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: maintenance
behavioral intervention to increase adherence to lifestyle recommendations
Intervention: Behavioral: maintenance intervention
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 8, 2018)
33
Original Estimated Enrollment  ICMJE
 (submitted: August 7, 2017)
30
Actual Study Completion Date  ICMJE July 31, 2018
Actual Primary Completion Date June 22, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03246672
Other Study ID Numbers  ICMJE PPO 16-331
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party VA Office of Research and Development
Study Sponsor  ICMJE VA Office of Research and Development
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Corrine I. Voils, PhD William S. Middleton Memorial Veterans Hospital, Madison, WI
PRS Account VA Office of Research and Development
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP