ObesityNCT02124889
Multivitamin Adherence Following Bariatric Surgery
A study testing Weekly Internet surveys in people with Obesity, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity
- What is being tested?
- Weekly Internet surveys
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to Oct 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Planning to undergo a Roux En Y Gastric Bypass or Sleeve Gastrectomy at Wake Forest Baptist Health
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27104
About this study
Official title: 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.
- Conditions
- Obesity
- Being tested
- Weekly Internet surveys
- Keywords
- bariatric surgery, multivitamin, weight loss, adherence
- Medical subject headings
- Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weekly Internet surveysBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Weekly surveys | Experimental | Subjects will take the multivitamin, and will also receive weekly Internet surveys asking them questions about the multivitamin treatment. Receives: Behavioral: Weekly Internet surveys |
| No Survey | No intervention | Subjects will take the multivitamin. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to Multivitamin
Percent of anticipated number of doses the patient has taken, as recorded by a Medication Event Monitoring System (MEMS) cap.
Measured: 50 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionApr 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are assigned to either receive the weekly survey or not.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Celebrate Vitamins
- Responsible party
- Sponsor
- Investigators
- Adolfo Z Fernandez, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02124889
- Sponsor's protocol ID
- IRB00027050
- Status last verified
- Feb 2019
- First submitted
- 24 Apr 2014
- Last updated
- 31 May 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adherence to Multivitamin Use Following Bariatric Surgery for Weight Loss
- ClinicalTrials.gov ID
- NCT02124889
- Acronym / sponsor ID
- IRB00027050
- Conditions
- Obesity
- Keywords
- bariatric surgery, multivitamin, weight loss, adherence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- Celebrate Vitamins
- Study start
- Apr 2014 (actual)
- Primary completion
- Apr 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 28 Apr 2014 (estimated)
- Results
- Posted 31 May 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Participants are assigned to either receive the weekly survey or not.
| Arm | Type | Receives |
|---|---|---|
| Weekly surveys | Experimental | Behavioral: Weekly Internet surveysSubjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Planning to undergo a Roux En Y Gastric Bypass or Sleeve Gastrectomy at Wake Forest Baptist Health
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Weekly Internet surveysSubjects 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. | Behavioural | Weekly surveys |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Obesity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adolfo Z Fernandez, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weekly Internet surveys in people with Obesity, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to Multivitamin (time frame: 50 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2019.