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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03579264
Other study ID # Pro00079680
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 28, 2018
Est. completion date May 1, 2019

Study information

Verified date December 2019
Source University of Alberta
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. control arm (students who will not use a preventative self-care program for 12 weeks).


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 PlanĀ® 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.


Recruitment information / eligibility

Status Completed
Enrollment 97
Est. completion date May 1, 2019
Est. primary completion date May 1, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 17 Years to 30 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
My Viva Plan
Use of the online platform, My Viva Plan, to support health and wellness.

Locations

Country Name City State
Canada University of Alberta Edmonton Alberta

Sponsors (4)

Lead Sponsor Collaborator
University of Alberta Canadian Foundation for Dietetic Research (CFDR), Mitacs, Revive Wellness Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Baseline, week 12
Secondary 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. Baseline, week 12
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