Obesity
Conditions
Keywords
bariatric surgery, multivitamin, weight loss, adherence
Brief summary
Additional micronutrient supplementation is required due to the changes in the gastrointestinal anatomy and physiology following bariatric surgery along with decreased dietary intake and rapid weight loss. Good adherence to post-operative vitamins is essential to maintain healthy vitamin levels in the body following bariatric surgery. The hypothesis of this study is that patients receiving a weekly survey intervention will have better adherence to post-operative vitamins.
Interventions
BEHAVIORALWeekly Internet surveys
Subjects will receive weekly Internet surveys asking them how their treatment is working, how often they took the medication, and how easy it was to use the medication.
Sponsors
Celebrate Vitamins
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Investigator)
Masking description
The Pi does not know which participants are randomized to get the weekly survey.
Intervention model description
Participants are assigned to either receive the weekly survey or not.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Planning to undergo a Roux En Y Gastric Bypass or Sleeve Gastrectomy at Wake Forest Baptist Health
Exclusion criteria
* Admission for a psychiatric event in the past year * History of nausea and/or significant complaint of post-operative nausea * History of stricture and/or significant complaint of post-operative stricture * History of ulcer and/or significant complaint of post-operative ulcer * History of major depression or psychiatric disorder
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adherence to Multivitamin | 50 days | Percent of anticipated number of doses the patient has taken, as recorded by a Medication Event Monitoring System (MEMS) cap. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Weekly Surveys Subjects will take the multivitamin, and will also receive weekly Internet surveys asking them questions about the multivitamin treatment.
Weekly Internet surveys: Subjects in this arm will receive weekly Internet surveys asking them how their treatment is working, how often they took the medication, and how easy it was to use the medication. | 12 |
| No Survey - Control Subjects will take the multivitamin but will not receive surveys. | 12 |
| Total | 24 |
Baseline characteristics
| Characteristic | No Survey - Control | Total | Weekly Surveys |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants | 24 Participants | 12 Participants |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 12 participants | 24 participants | 12 participants |
| Sex: Female, Male Female | 9 Participants | 19 Participants | 10 Participants |
| Sex: Female, Male Male | 3 Participants | 5 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 12 |
| other Total, other adverse events | 0 / 12 | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 | 0 / 12 |
Outcome results
Primary
Adherence to Multivitamin
Percent of anticipated number of doses the patient has taken, as recorded by a Medication Event Monitoring System (MEMS) cap.
Time frame: 50 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Weekly Surveys | Adherence to Multivitamin | 32.9 percentage of doses taken | Standard Error 5.93 |
| No Survey | Adherence to Multivitamin | 34.9 percentage of doses taken | Standard Error 5.91 |