- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02118129
Vitamin D Among Young Adults: an Intervention Study Using a Mobile 'App'.
October 24, 2016 updated by: Kelly Anne Meckling, PhD, University of Guelph
Knowledge, Attitudes, Intake and Blood Levels of Vitamin D Among Young Adults: an Intervention Study Using a Mobile 'App'.
The purpose of this study is to examine whether a behavioural intervention changes attitudes, knowledge, intake or blood levels of vitamin D in young adults.
The hypothesis is that an educational component and use of a mobile smartphone 'app' will increase knowledge and/or intake of vitamin D.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
105
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
-
-
Ontario
-
Guelph, Ontario, Canada, N1G2W1
- University of Guelph
-
-
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
18 years to 25 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Men or women aged 18-25 years
- Must be fluent in English
- Must be currently living in Canada
- Must own iPhone, iPad or iPod Touch running iOS 7.0 or higher (handheld 'app' used in intervention is only available in Apple Store; not available for Android or Blackberry platforms at this time)
Exclusion Criteria:
- Outside age group
- Not fluent in English
- Not living in Canada
- Does not own the specified Apple device
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: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Behavioural intervention
Behavioural intervention consisting of an educational video component and use of a handheld mobile app to track vitamin D intake.
|
|
Placebo Comparator: Control group
Wait-list control group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Vitamin D blood levels
Time Frame: 12 weeks
|
Blood will be collected by finger prick at baseline and after the 12-week behavioural intervention to measure 25(OH)D.
|
12 weeks
|
Vitamin D Intake
Time Frame: 12 weeks
|
Vitamin D intake will be assessed using a food frequency questionnaire before and after the 12-week intervention.
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Knowledge & attitudes regarding vitamin D
Time Frame: 12 weeks
|
General knowledge & attitudes regarding vitamin D will be assessed via online questionnaire before, mid-way and after the 12-week intervention.
|
12 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Vitamin D app recordings
Time Frame: 12 weeks
|
Participants will enter their intake of foods & beverages into a handheld mobile 'app'.
The data will produce a daily total intake of calcium & vitamin D. This data will be analyzed to assess changes in vitamin D intake throughout the 12-week intervention.
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Kelly A Meckling, PhD, University of Guelph
- Study Director: Samantha E Goodman, MSc, University of Guelph
- Study Director: Barbara A Morrongiello, PhD, University of Guelph
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
September 1, 2014
Primary Completion (Actual)
December 1, 2015
Study Completion (Actual)
September 1, 2016
Study Registration Dates
First Submitted
April 16, 2014
First Submitted That Met QC Criteria
April 17, 2014
First Posted (Estimate)
April 21, 2014
Study Record Updates
Last Update Posted (Estimate)
October 26, 2016
Last Update Submitted That Met QC Criteria
October 24, 2016
Last Verified
October 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2014GoodmanVitD
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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