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| Name | Class |
|---|---|
| Celebrate Vitamins | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Weekly surveys | Experimental | Subjects will take the multivitamin, and will also receive weekly Internet surveys asking them questions about the multivitamin treatment. |
|
| No Survey | No Intervention | Subjects will take the multivitamin. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Weekly Internet surveys | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Adherence to Multivitamin | Percent of anticipated number of doses the patient has taken, as recorded by a Medication Event Monitoring System (MEMS) cap. | 50 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adolfo Z Fernandez, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest Baptist Health | Winston-Salem | North Carolina | 27104 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | No Survey | Group will only get multivitamin - no weekly survey |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Adherence to Multivitamin | Percent of anticipated number of doses the patient has taken, as recorded by a Medication Event Monitoring System (MEMS) cap. | Posted | Mean | Standard Error | percentage of doses taken | 50 days |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Adolfo Fernandez | WakeForest | 336-716-6099 | 336 | afernand@wakehealth.edu |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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Participants are assigned to either receive the weekly survey or not.
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The Pi does not know which participants are randomized to get the weekly survey.
| BG001 |
| No Survey - Control |
Subjects will take the multivitamin but will not receive surveys. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | No Survey - Control | Subjects will take the multivitamin without additional contact. | 0 | 12 | 0 | 12 | 0 | 12 |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |