Trial Outcomes & Findings for Development of a Weight Maintenance Intervention for Bariatric Surgery Patients (NCT NCT03246672)

NCT ID: NCT03246672

Last Updated: 2019-08-19

Results Overview

Percentage of contacted patients who consent to be in the study

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 33 participants
• Primary outcome timeframe: week 0
• Results posted on: 2019-08-19

Participant Flow

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.

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.

Participant milestones

Measure	Maintenance 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 Study STARTED	30
Overall Study Completed First Phone Call	29
Overall Study COMPLETED	28
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	Maintenance 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 Study Lost to Follow-up	2

Baseline Characteristics

Development of a Weight Maintenance Intervention for Bariatric Surgery Patients

Baseline characteristics by cohort

Measure	Maintenance n=30 Participants 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.
Age, Continuous	56.9 years STANDARD_DEVIATION 10.0 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	24 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	28 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants
Race (NIH/OMB) White	22 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Region of Enrollment United States	30 Participants n=5 Participants

PRIMARY outcome

Timeframe: week 0

Population: \# of patients for whom phone screening was attempted

Percentage of contacted patients who consent to be in the study

Outcome measures

Measure	Maintenance n=69 Participants 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.
Recruitment Rate	33 Participants

PRIMARY outcome

Timeframe: 16-week outcome assessment

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

Outcome measures

Measure	Maintenance n=30 Participants 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.
Retention Rate	28 Participants

SECONDARY outcome

Timeframe: 16 weeks

Population: The N=30 is based on the number of participants who provided baseline data according to Intent-to-treat principles

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

Outcome measures

Measure	Maintenance n=30 Participants 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.
Weight	213.7 pounds Standard Deviation 43.1

Adverse Events

Maintenance

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Corrine Voils

William S Middleton Memorial Veterans Hospital

Phone: 608-262-9636

Email: corrine.voils@va.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place