StressNCT03579264
Experience and Health Impact of University Students Accessing a Digital Nutrition, Fitness and Mindfulness Platform
A study testing My Viva Plan in people with Stress and Health Behavior, run by University of Alberta at 1 site in Canada.
Trial summary
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; intervention arm (students who will use a preventative self-care program for 12 weeks) vs. Read more about this study
- Who is it for?
- Ages 17 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress, Health Behavior, Nutrition
- What is being tested?
- My Viva Plan
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 1 siteCanada
- Study dates
- 28 Aug 2018to 1 May 2019
- 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 17 to 30 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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; intervention arm (students who will use a preventative self-care program for 12 weeks) vs. control arm (students who will not use a preventative self-care program for 12 weeks).
Read the 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.
- Conditions
- Stress, Health Behavior, Nutrition, Physical Activity
- Being tested
- My Viva Plan
- Medical subject headings
- Health Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
My Viva PlanBehavioural
Use of the online platform, My Viva Plan, to support health and wellness.
| Study group | Role | What they receive |
|---|---|---|
| Standard Arm | No intervention | No use of My Viva Plan. |
| Intervention Arm | Experimental | Use of My Viva Plan. Receives: Behavioral: My Viva Plan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Stress
To assess the change in self reported stress from baseline to week 12 using the Stress Indicators Questionnaire by the International Counselling Team.
Measured: Baseline, week 12
Secondary outcomes (1)
Change in Dietary Choices
To assess the change in dietary choices from baseline to week 12 using three-day food records collected at baseline and week 12.
Measured: Baseline, week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2018
- Study start28 Aug 2018
- Primary completion1 May 2019
- Study completion1 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for StressStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Revive Wellness Inc., Canadian Foundation for Dietetic Research (CFDR), Mitacs
- Responsible party
- Principal investigator, Carla Prado, University of Alberta
- Investigators
- Carla Prado, PhD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03579264
- Sponsor's protocol ID
- Pro00079680
- Status last verified
- Dec 2019
- First submitted
- 13 Jun 2018
- Last updated
- 16 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Mota JF, Lopes LCC, Trottier CF, Johnson ST, Lieffers J, Prado CM. A Randomized Controlled Trial of the Effects of a Web-Based Intervention on Perceived Stress and Diet Quality Among First-Year University Students. Telemed Rep. 2023 Oct 26;4(1):327-335. doi: 10.1089/tmr.2023.0041. eCollection 2023.
PubMed 37908625Lieffers 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.
PubMed 34119458Trottier 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.
PubMed 33688844
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Experience and Health Impact of University Students Accessing a Digital Nutrition, Fitness and Mindfulness Platform
- ClinicalTrials.gov ID
- NCT03579264
- Acronym / sponsor ID
- Pro00079680
- Conditions
- Stress, Health Behavior, Nutrition, Physical Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- Revive Wellness Inc., Canadian Foundation for Dietetic Research (CFDR), Mitacs
- Study start
- 28 Aug 2018 (actual)
- Primary completion
- 1 May 2019 (actual)
- Study completion
- 1 May 2019 (actual)
- First posted
- 6 Jul 2018 (actual)
- 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.
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; intervention arm (students who will use a preventative self-care program for 12 weeks) vs. control arm (students who will not use a preventative self-care program for 12 weeks).
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Arm | No intervention | –No use of My Viva Plan. |
| Intervention Arm | Experimental | Behavioral: My Viva PlanUse of My Viva Plan. |
Who may qualify
- Ages
- 17 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| My Viva PlanUse of the online platform, My Viva Plan, to support health and wellness. | Behavioural | Intervention Arm |
Primary outcome
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.
1 secondary outcome
Change in Dietary Choices
Time frame: Baseline, week 12
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 16 Dec 2019.
- Derived from this study: PubMed 37908625Mota JF, Lopes LCC, Trottier CF, Johnson ST, Lieffers J, Prado CM. A Randomized Controlled Trial of the Effects of a Web-Based Intervention on Perceived Stress and Diet Quality Among First-Year University Students. Telemed Rep. 2023 Oct 26;4(1):327-335. doi: 10.1089/tmr.2023.0041. eCollection 2023.
- Derived from this study: PubMed 34119458Lieffers 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.
- Derived from this study: PubMed 33688844Trottier 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.
- Individual participant dataSharing planned: Undecided
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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.
Carla Prado, PhD principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing My Viva Plan in people with Stress and Health Behavior, run by University of Alberta 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 3 inclusion and 6 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 16 Dec 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 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. 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?
Change in Stress (time frame: Baseline, week 12). 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 NCT03579264, which also lists 3 linked publications.
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 16 Dec 2019.