Multivitamin Adherence Following Bariatric Surgery

February 14, 2019 updated by: Wake Forest University Health Sciences

Adherence to Multivitamin Use Following Bariatric Surgery for Weight Loss

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27104
        • Wake Forest Baptist Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Weekly surveys
Subjects will take the multivitamin, and will also receive weekly Internet surveys asking them questions about the multivitamin treatment.
Behavioral: 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.
No Intervention: No Survey
Subjects will take the multivitamin.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence to Multivitamin
Time Frame: 50 days
Percent of anticipated number of doses the patient has taken, as recorded by a Medication Event Monitoring System (MEMS) cap.
50 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wake Forest University Health Sciences

Collaborators

Celebrate Vitamins

Investigators

  • Principal Investigator: Adolfo Z Fernandez, MD, Wake Forest University Health Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2014

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

April 24, 2014

First Submitted That Met QC Criteria

April 25, 2014

First Posted (Estimate)

April 28, 2014

Study Record Updates

Last Update Posted (Actual)

May 31, 2019

Last Update Submitted That Met QC Criteria

February 14, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IRB00027050

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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