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Experience and Health Impact of University Students Accessing a Digital Nutrition, Fitness and Mindfulness Platform

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ClinicalTrials.gov Identifier: NCT03579264
Recruitment Status : Completed
First Posted : July 6, 2018
Last Update Posted : December 16, 2019
Sponsor:
Collaborators:
Revive Wellness Inc.
Canadian Foundation for Dietetic Research (CFDR)
Mitacs
Information provided by (Responsible Party):
Carla Prado, University of Alberta

Brief 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).

Condition or disease Intervention/treatment Phase
Stress Health Behavior Nutrition Physical Activity Behavioral: My Viva Plan Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 97 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Experience and Health Impact of University Students Accessing a Digital Nutrition, Fitness and Mindfulness Platform
Actual Study Start Date : August 28, 2018
Actual Primary Completion Date : May 1, 2019
Actual Study Completion Date : May 1, 2019

Arm Intervention/treatment
No Intervention: Standard Arm
No use of My Viva Plan.
Experimental: Intervention Arm
Use of My Viva Plan.
Behavioral: My Viva Plan
Use of the online platform, My Viva Plan, to support health and wellness.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   17 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03579264


Locations
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Canada, Alberta
University of Alberta
Edmonton, Alberta, Canada, T6G 2E1
Sponsors and Collaborators
University of Alberta
Revive Wellness Inc.
Canadian Foundation for Dietetic Research (CFDR)
Mitacs
Investigators
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Principal Investigator: Carla Prado, PhD University of Alberta
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Responsible Party: Carla Prado, Associate Professor, University of Alberta
ClinicalTrials.gov Identifier: NCT03579264    
Other Study ID Numbers: Pro00079680
First Posted: July 6, 2018    Key Record Dates
Last Update Posted: December 16, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No