Multivitamin Adherence Following Bariatric Surgery

NCT02124889 | Completed Results

• 1 other identifier: IRB00027050
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

bariatric surgery; multivitamin; weight loss; adherence

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Weekly surveys

EXPERIMENTAL

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

Behavioral: Weekly Internet surveys

No Survey

NO INTERVENTION

Subjects will take the multivitamin.

Interventions

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.

Weekly surveys

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Planning to undergo a Roux En Y Gastric Bypass or Sleeve Gastrectomy at Wake Forest Baptist Health

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• Celebrate Vitamins: collaborator

Study Sites (1)

Wake Forest Baptist Health

Winston-Salem, North Carolina, 27104, United States

Location

MeSH Terms

Conditions

Obesity; Weight Loss

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Results Point of Contact

• Title: Dr. Adolfo Fernandez
• Organization: WakeForest

afernand@wakehealth.edu

336-716-6099

Study Officials

• Adolfo Z Fernandez, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The Pi does not know which participants are randomized to get the weekly survey.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are assigned to either receive the weekly survey or not.

Study Record Dates

• First Submitted: April 24, 2014
• First Posted: April 28, 2014
• Study Start: April 1, 2014
• Primary Completion: April 1, 2016
• Study Completion: October 1, 2016
• Last Updated: May 31, 2019
• Results First Posted: May 31, 2019

Record last verified: 2019-02

Locations

US (1)