- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03579264
Experience and Health Impact of University Students Accessing a Digital Nutrition, Fitness and Mindfulness Platform
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
When individuals look after their own health using online applications they can expect similar or even better health outcomes compared to those obtained by using conventional methods. These kind of tools are popular among University students. Due to the many changes and challenges that students face in the first year of University, this sector of our population is at higher risk of presenting nutritional problems, anxiety, depression and suicidal thoughts.
Recently, a Canadian online application called My Viva Plan® became available. This program is based on preventive self-care and it includes three key pillars of health: nutrition, fitness, and mindfulness. Changes in dietary choices, quality of life and stress will be evaluated in a sample of 100 undergraduate students who are in their first year of university. Students will be randomized into the following two groups; students who will use the program vs. students who will not use the program. Questionnaires regarding physical activity, mindfulness and mental well-being will be evaluated at baseline, week 6 and week 12. Body composition characteristics using bioelectrical impedance analysis will be collected at the start and end of the study (baseline and week 12).
The objective is to determine if the use of an online application based on preventive self-care will result in better food choices, better quality of life, and reduced stress in first year university students.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Alberta
-
Edmonton, Alberta, Canada, T6G 2E1
- University of Alberta
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- First-year undergraduate university students attending the University of Alberta's North Campus
- Students who are able to complete study assessments in their first year of university
- 17-30 years of age
Exclusion Criteria:
- Students with self-reported eating disorders
- Students with self-reported untreated depression, anxiety or other mood disorders
- Students who do not own a device to access the internet (i.e. tablet, computer, laptop, smart phone)
- Students who are not able to communicate in English
- Pregnant or lactating women
- Individuals with pace-makers or electronic implantable devices
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Standard Arm
No use of My Viva Plan.
|
|
|
Experimental: Intervention Arm
Use of My Viva Plan.
|
Use of the online platform, My Viva Plan, to support health and wellness.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Stress
Time Frame: Baseline, week 12
|
To assess the change in self reported stress from baseline to week 12 using the Stress Indicators Questionnaire by the International Counselling Team.
|
Baseline, week 12
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Dietary Choices
Time Frame: Baseline, week 12
|
To assess the change in dietary choices from baseline to week 12 using three-day food records collected at baseline and week 12.
|
Baseline, week 12
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Carla Prado, PhD, University of Alberta
Publications and helpful links
General Publications
- Lieffers JRL, Quintanilha M, Trottier CF, Johnson ST, Mota JF, Prado CM. Experiences with and Perception of a Web-Based Mindfulness, Nutrition, and Fitness Platform Reported by First-Year University Students: A Qualitative Study. J Acad Nutr Diet. 2021 Dec;121(12):2409-2418.e3. doi: 10.1016/j.jand.2021.04.019. Epub 2021 Jun 10.
- Trottier CF, Lieffers JRL, Johnson ST, Mota JF, Gill RK, Prado CM. The Impact of a Web-Based Mindfulness, Nutrition, and Physical Activity Platform on the Health Status of First-Year University Students: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2021 Mar 10;10(3):e24534. doi: 10.2196/24534.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Pro00079680
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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