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

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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

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Obesity, Morbid
Intervention Behavioral: maintenance intervention
Enrollment 33
Recruitment Details Participants were recruited from January to March 2018. These participants were identified using electronic medical record data indicating that they had bariatric surgery for weight loss at one of four VA hospitals: West Roxbury, MA; Long Beach, CA; Palo Alto, CA; and Ann Arbor, MI.
Pre-assignment Details 33 participants provided verbal consent. Of those, 3 were unable to be reached and 30 were reached by telephone to complete baseline measures and were scheduled for their first intervention phone call. Of those 30, 29 participants were reached for the first intervention phone call, and 1 participant unable to be reached for further participation.
Arm/Group Title Maintenance
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behavioral intervention to increase adherence to lifestyle recommendations

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.

Period Title: Overall Study
Started 30
Completed First Phone Call 29
Completed 28
Not Completed 2
Reason Not Completed
Lost to Follow-up             2
Arm/Group Title Maintenance
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behavioral intervention to increase adherence to lifestyle recommendations

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.

Overall Number of Baseline Participants 30
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30 participants completed baseline measures.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 30 participants
56.9  (10.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
Female
6
  20.0%
Male
24
  80.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
Hispanic or Latino
2
   6.7%
Not Hispanic or Latino
28
  93.3%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
4
  13.3%
White
22
  73.3%
More than one race
2
   6.7%
Unknown or Not Reported
2
   6.7%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 30 participants
30
 100.0%
1.Primary Outcome
Title Recruitment Rate
Hide Description Percentage of contacted patients who consent to be in the study
Time Frame week 0
Hide Outcome Measure Data
Hide Analysis Population Description
# of patients for whom phone screening was attempted
Arm/Group Title Maintenance
Hide Arm/Group Description:

behavioral intervention to increase adherence to lifestyle recommendations

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.

Overall Number of Participants Analyzed 69
Measure Type: Count of Participants
Unit of Measure: Participants
33
  47.8%
2.Primary Outcome
Title Retention Rate
Hide Description Percentage of patients with baseline data who complete 16-week outcome assessments
Time Frame 16-week outcome assessment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Maintenance
Hide Arm/Group Description:

behavioral intervention to increase adherence to lifestyle recommendations

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.

Overall Number of Participants Analyzed 30
Measure Type: Count of Participants
Unit of Measure: Participants
28
  93.3%
3.Secondary Outcome
Title Weight
Hide Description Patient weight obtained from the electronic medical record on the clinical visit date closest to the 16-week study assessment date
Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The N=30 is based on the number of participants who provided baseline data according to Intent-to-treat principles
Arm/Group Title Maintenance
Hide Arm/Group Description:

behavioral intervention to increase adherence to lifestyle recommendations

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.

Overall Number of Participants Analyzed 30
Mean (Standard Deviation)
Unit of Measure: pounds
213.7  (43.1)
Time Frame 16 weeks
Adverse Event Reporting Description Adverse events were volunteered by participants during intervention or assessment phone calls; they were not systematically queried in this minimal-risk intervention.
 
Arm/Group Title Maintenance
Hide Arm/Group Description

behavioral intervention to increase adherence to lifestyle recommendations

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.

All-Cause Mortality
Maintenance
Affected / at Risk (%)
Total   0/30 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Maintenance
Affected / at Risk (%)
Total   0/30 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Maintenance
Affected / at Risk (%)
Total   0/30 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Corrine Voils
Organization: William S Middleton Memorial Veterans Hospital
Phone: 608-262-9636
EMail: corrine.voils@va.gov
Layout table for additonal information
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT03246672     History of Changes
Other Study ID Numbers: PPO 16-331
First Submitted: August 7, 2017
First Posted: August 11, 2017
Results First Submitted: April 17, 2019
Results First Posted: August 19, 2019
Last Update Posted: August 19, 2019