NCT03579264

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
97

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 13, 2018

Completed
23 days until next milestone

First Posted

Study publicly available on registry

July 6, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

August 28, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
Last Updated

December 16, 2019

Status Verified

December 1, 2019

Enrollment Period

8 months

First QC Date

June 13, 2018

Last Update Submit

December 12, 2019

Conditions

StressHealth BehaviorNutritionPhysical Activity

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Change in Dietary Choices

    Baseline, week 12

Study Arms (2)

Standard Arm

NO INTERVENTION

No use of My Viva Plan.

Intervention Arm

EXPERIMENTAL

Use of My Viva Plan.

Behavioral: My Viva Plan

Interventions

My Viva PlanBEHAVIORAL

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

Intervention Arm

Eligibility Criteria

Age17 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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
  • years of age

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alberta

Edmonton, Alberta, T6G 2E1, Canada

Location

Related Publications (3)

  • 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.

    PMID: 37908625DERIVED

  • 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.

    PMID: 34119458DERIVED

  • 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.

    PMID: 33688844DERIVED

MeSH Terms

Conditions

Health BehaviorMotor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Carla Prado, PhD

    University of Alberta

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 13, 2018

First Posted

July 6, 2018

Study Start

August 28, 2018

Primary Completion

May 1, 2019

Study Completion

May 1, 2019

Last Updated

December 16, 2019

Record last verified: 2019-12

Locations

CA(1)