Obesity, Morbid
Conditions
Keywords
obesity, morbid
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).
Interventions
BEHAVIORALmaintenance 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.
Sponsors
VA Office of Research and Development
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
All participants receive the intervention
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment Rate | week 0 | Percentage of contacted patients who consent to be in the study |
| Retention Rate | 16-week outcome assessment | Percentage of patients with baseline data who complete 16-week outcome assessments |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Weight | 16 weeks | Patient weight obtained from the electronic medical record on the clinical visit date closest to the 16-week study assessment date |
Countries
United States
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 30 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 2 |
Baseline characteristics
| Characteristic | Maintenance |
|---|---|
| Age, Continuous | 56.9 years STANDARD_DEVIATION 10 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 28 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 22 Participants |
| Region of Enrollment United States | 30 Participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 30 |
| other Total, other adverse events | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 |
Outcome results
Primary
Recruitment Rate
Percentage of contacted patients who consent to be in the study
Time frame: week 0
Population: \# of patients for whom phone screening was attempted
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Maintenance | Recruitment Rate | 33 Participants |
Primary
Retention Rate
Percentage of patients with baseline data who complete 16-week outcome assessments
Time frame: 16-week outcome assessment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Maintenance | Retention Rate | 28 Participants |
Secondary
Weight
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
Population: The N=30 is based on the number of participants who provided baseline data according to Intent-to-treat principles
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Maintenance | Weight | 213.7 pounds | Standard Deviation 43.1 |