A Web-based Platform to Improve Physical Function, Nutrition, and Mindfulness in Patients With Long COVID

NCT ID: NCT05422924

Last Updated: 2025-03-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-25
• Study Completion Date: 2025-01-31

Brief Summary

Patients with COVID-19 may experience prolonged physical and psychological symptoms after weeks or months of the infection. This may be caused by a combination of factors including poor nutrition, low physical activity, and lack of emotional support. Leading to poor overall health and low quality of life. This evidence indicated that people with long COVID-19 need a personalized intervention. Our objective is to determine if the use of an online application that is based on preventive self-care and that includes nutrition and mindfulness will be feasible to use for patients with long COVID.

Detailed Description

A Canadian web-based platform called My Viva Plan® became available. This web-based platform is based on preventive self-care and it includes three key pillars of health: nutrition and mindfulness.

Long COVID patients will be randomized into the following two groups; intervention arm (will use a web-based platform for 8 weeks) vs. control arm (will not use a web-based platform for 8 weeks).The primary aim of this study is to investigate the feasibility (defined by recruitment, adherence, and retention) of an 8-week digital nutrition and mindfulness self-care intervention program using My Viva Plan® versus usual care (i.e. general advice) in patients with long COVID who continue to have signs and symptoms not explainable by other causes. Dietary intake, physical function, body composition and mental health variables will also be explored.

Conditions

Long COVID

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Control Arm

No use of My Viva Plan

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention Arm

Use of My Viva Plan

Group Type: EXPERIMENTAL

Web-based platform. (My Viva Plan)

Intervention Type: BEHAVIORAL

Participants will use a web-based platform (i.e. My Viva Plan®) to improve physical function, nutrition and mindfulness.

Interventions

Web-based platform. (My Viva Plan)

Participants will use a web-based platform (i.e. My Viva Plan®) to improve physical function, nutrition and mindfulness.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Aged ≥ 18 years.
• COVID diagnosed (PCR positivity) >12 weeks at time of screening and have persistent symptoms.
• Body mass index (BMI) >18.5kg/m2 and < 35 kg/m2.
• People with long COVID syndrome diagnosis enrolled in the Kaye Edmonton Clinic.
• Have mild to moderate long COVID syndrome (Based on the Post COVID-19 Functional Status Scale from 0-3).

Exclusion Criteria

• Patients with severe mobility impairment (People without sufficiently mobile to come to the study centre).
• Diagnosis of severe mental health disorders (e.g., depression, anxiety, eating disorders).
• Individuals with pacemakers or other internal electrical medical devices.
• Suffer from claustrophobia.
• Pregnancy or lactation.
• No internet access.
• Not able to understand and communicate in English.
• Major visual or hearing impairment or other serious illness that would preclude participation.
• Living in assisted living situations or a nursing home.
• Individuals who fell more than 3 times in the last month. Because of the risk of doing a physical activity unsupervised.
• Not willing to make a change in their lifestyle (Readiness to change).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Revive Wellness Inc.

UNKNOWN

Sponsor Role: collaborator

University of Alberta

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Carla Prado, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Alberta

Locations

University of Alberta

Edmonton, Alberta, Canada

Countries

Canada

Other Identifiers

Pro00120894

Identifier Type: -

Identifier Source: org_study_id