Experience and Health Impact of University Students Acces... | NCT03579264

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

NCT03579264

Sponsor

University of Alberta

Status

Completed

Last Update Posted

Dec 16, 2019Actual

Enrollment

97Actual

Phase

Not Applicable

Conditions

Stress
Health Behavior
Nutrition
Physical Activity

Interventions

My Viva Plan

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 28, 2018Actual

Primary Completion Date

May 1, 2019Actual

Completion Date

May 1, 2019Actual

First Submitted Date

Jun 13, 2018

First Submission Date that Met QC Criteria

Jun 25, 2018

First Posted Date

Jul 6, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 12, 2019

Last Update Posted Date

Dec 16, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Carla Prado, Associate Professor, University of AlbertaPrincipal Investigator

Lead Sponsor

University of AlbertaOTHER

Collaborators

Name	Class
Revive Wellness Inc.	UNKNOWN
Canadian Foundation for Dietetic Research (CFDR)	OTHER
Mitacs	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

97Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Standard Arm	No Intervention	No use of My Viva Plan.
Intervention Arm	Experimental	Use of My Viva Plan.	Behavioral: My Viva Plan

Interventions

Name	Type	Description	Arm Group Labels	Other Names
My Viva Plan	Behavioral	Use of the online platform, My Viva Plan, to support health and wellness.	Intervention Arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

17 Years

Maximum Age

30 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Carla Prado, PhD	University of Alberta	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Alberta		Edmonton	Alberta	T6G 2E1	Canada

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
37908625	Derived	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.
34119458	Derived

ID	Term
D015438	Health Behavior
D009043	Motor Activity