Vitamin D DeficiencyNCT02118129
Vitamin D Among Young Adults: an Intervention Study Using a Mobile 'App'.
A study testing an educational video and wait listed in people with Vitamin D Deficiency, run by University of Guelph at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency
- What is being tested?
- an educational video and wait listed
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2014to Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- Outside age group
- Not fluent in English
- Not living in Canada
- Does not own the specified Apple device
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Vitamin D Deficiency
- Being tested
- an educational video, wait listed
- Keywords
- Vitamin D, Intervention, Behaviour, Mobile app
- Medical subject headings
- Vitamin D Deficiency, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
an educational videoBehavioural
wait listedOther
| Study group | Role | What they receive |
|---|---|---|
| Behavioural intervention | Experimental | Behavioural intervention consisting of an educational video component and use of a handheld mobile app to track vitamin D intake. Receives: Behavioral: an educational video |
| Control group | Placebo comparator | Wait-list control group Receives: Other: wait listed |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Vitamin D Intake
Vitamin D intake will be assessed using a food frequency questionnaire before and after the 12-week intervention.
Measured: 12 weeks
Secondary outcomes (1)
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2014 (estimated)
- Study startSep 2014
- Primary completionDec 2015
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vitamin D DeficiencyStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Guelph
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Vitamin D Society
- Responsible party
- Principal investigator, Kelly Anne Meckling, PhD, University of Guelph
- Investigators
- Kelly A Meckling, PhD, Principal investigator, University of GuelphSamantha E Goodman, MSc, Study director, University of GuelphBarbara A Morrongiello, PhD, Study director, University of Guelph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02118129
- Sponsor's protocol ID
- 2014GoodmanVitD
- Status last verified
- Oct 2016
- First submitted
- 16 Apr 2014
- Last updated
- 26 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 27836017
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Knowledge, Attitudes, Intake and Blood Levels of Vitamin D Among Young Adults: an Intervention Study Using a Mobile 'App'.
- ClinicalTrials.gov ID
- NCT02118129
- Acronym / sponsor ID
- 2014GoodmanVitD
- Conditions
- Vitamin D Deficiency
- Keywords
- Vitamin D, Intervention, Behaviour, Mobile app
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- University of GuelphUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Vitamin D Society
- Study start
- Sep 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 21 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Behavioural intervention | Experimental | Behavioral: an educational videoBehavioural intervention consisting of an educational video component and use of a handheld mobile app to track vitamin D intake. |
| Control group | Placebo comparator | Other: wait listedWait-list control group |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (4 listed)
- Outside age group
- Not fluent in English
- Not living in Canada
- Does not own the specified Apple device
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 |
|---|---|---|
| an educational video | Behavioural | Behavioural intervention |
| wait listed | Other | Control group |
Primary outcome
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.
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.
1 secondary outcome
Knowledge & attitudes regarding vitamin D
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2016.
- Derived from this study: PubMed 27836017Goodman 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.
- Individual participant dataSharing planned: No
Related trials for Vitamin D Deficiency
Not yet recruiting
Effect of Vitamin D Supplementation Added to Iron Therapy in Children With Iron Deficiency Anemia
Iron Deficiency Anemia
RecruitingObservational study
A Natural History Study of Bone and Mineral Disorders
Tumor Induced Osteomalcia, Osteomalacia
Enrolling by invitationObservational study
Strategies for Proactive Health in People With Kidney Function Decline
Renal Insufficiency,Chronic, Dietary Intake Patterns
Active, not recruiting
Preeclampsia Research on Vitamin D, Inflammation, & Depression
Pre-Eclampsia, Depression
Not yet recruiting
The Effectiveness of a Weight-dependent Algorithm for Dosing Vitamin D.
Hypovitaminosis D
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.
Kelly A Meckling, PhD principal investigator
University of Guelph
Samantha E Goodman, MSc study director
University of Guelph
Barbara A Morrongiello, PhD study director
University of Guelph
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing an educational video and wait listed in people with Vitamin D Deficiency, run by University of Guelph at 1 site in Canada.
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 4 inclusion and 4 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 26 Oct 2016. 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 Canada. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Vitamin D blood levels (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02118129, which also lists 1 linked publication.
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 26 Oct 2016.