Back to resultsVitamin D Among Young Adults: an Intervention Study Using a Mobile 'App'.
Primary Purpose
Vitamin D Deficiency
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
an educational video
wait listed
Sponsored by
About this trial
This is an interventional prevention trial for Vitamin D Deficiency focused on measuring Vitamin D, Intervention, Behaviour, Mobile app
Eligibility Criteria
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
Sites / Locations
- University of Guelph
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Behavioural intervention
Control group
Arm Description
Behavioural intervention consisting of an educational video component and use of a handheld mobile app to track vitamin D intake.
Wait-list control group
Outcomes
Primary Outcome Measures
Vitamin D blood levels
Blood will be collected by finger prick at baseline and after the 12-week behavioural intervention to measure 25(OH)D.
Vitamin D Intake
Vitamin D intake will be assessed using a food frequency questionnaire before and after the 12-week intervention.
Secondary Outcome Measures
Knowledge & attitudes regarding vitamin D
General knowledge & attitudes regarding vitamin D will be assessed via online questionnaire before, mid-way and after the 12-week intervention.
Full Information
NCT ID
NCT02118129
First Posted
April 16, 2014
Last Updated
October 24, 2016
Sponsor
University of Guelph
Collaborators
Canadian Institutes of Health Research (CIHR), Vitamin D Society
1. Study Identification
Unique Protocol Identification Number
NCT02118129
Brief Title
Vitamin D Among Young Adults: an Intervention Study Using a Mobile 'App'.
Official Title
Knowledge, Attitudes, Intake and Blood Levels of Vitamin D Among Young Adults: an Intervention Study Using a Mobile 'App'.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
September 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Guelph
Collaborators
Canadian Institutes of Health Research (CIHR), Vitamin D Society
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin D Deficiency
Keywords
Vitamin D, Intervention, Behaviour, Mobile app
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
105 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Behavioural intervention
Arm Type
Experimental
Arm Description
Behavioural intervention consisting of an educational video component and use of a handheld mobile app to track vitamin D intake.
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Wait-list control group
Intervention Type
Behavioral
Intervention Name(s)
an educational video
Intervention Type
Other
Intervention Name(s)
wait listed
Primary Outcome Measure Information:
Title
Vitamin D blood levels
Description
Blood will be collected by finger prick at baseline and after the 12-week behavioural intervention to measure 25(OH)D.
Time Frame
12 weeks
Title
Vitamin D Intake
Description
Vitamin D intake will be assessed using a food frequency questionnaire before and after the 12-week intervention.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Knowledge & attitudes regarding vitamin D
Description
General knowledge & attitudes regarding vitamin D will be assessed via online questionnaire before, mid-way and after the 12-week intervention.
Time Frame
12 weeks
Other Pre-specified Outcome Measures:
Title
Vitamin D app recordings
Description
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.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kelly A Meckling, PhD
Organizational Affiliation
University of Guelph
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Samantha E Goodman, MSc
Organizational Affiliation
University of Guelph
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Barbara A Morrongiello, PhD
Organizational Affiliation
University of Guelph
Official's Role
Study Director
Facility Information:
Facility Name
University of Guelph
City
Guelph
State/Province
Ontario
ZIP/Postal Code
N1G2W1
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
27836017
Citation
Goodman S, Morrongiello B, Meckling K. A randomized, controlled trial evaluating the efficacy of an online intervention targeting vitamin D intake, knowledge and status among young adults. Int J Behav Nutr Phys Act. 2016 Nov 11;13(1):116. doi: 10.1186/s12966-016-0443-1.
Results Reference
derived
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Vitamin D Among Young Adults: an Intervention Study Using a Mobile 'App'.
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