Multivitamin Adherence Following Bariatric Surgery

NCT ID: NCT02124889

Last Updated: 2019-05-31

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2016-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants are assigned to either receive the weekly survey or not.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Investigators
The Pi does not know which participants are randomized to get the weekly survey.

Study Groups

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Weekly surveys

Subjects will take the multivitamin, and will also receive weekly Internet surveys asking them questions about the multivitamin treatment.

Group Type EXPERIMENTAL

Weekly Internet surveys

Intervention Type 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.

No Survey

Subjects will take the multivitamin.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Weekly 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Celebrate Vitamins

UNKNOWN

Sponsor Role collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Adolfo Z Fernandez, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

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Wake Forest Baptist Health

Winston-Salem, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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IRB00027050

Identifier Type: -

Identifier Source: org_study_id

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