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

U

University of Alberta

Status

Completed

Conditions

Long COVID

Treatments

Behavioral: Web-based platform. (My Viva Plan)

Study type

Interventional

Funder types

Other

Identifiers

NCT05422924
Pro00120894

Details and patient eligibility

About

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.

Full 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.

Enrollment

45 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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).

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

45 participants in 2 patient groups

Control Arm
No Intervention group
Description:
No use of My Viva Plan
Intervention Arm
Experimental group
Description:
Use of My Viva Plan
Treatment:
Behavioral: Web-based platform. (My Viva Plan)

Trial contacts and locations

1

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Central trial contact

Anne Caretero, BSc; Montserrat Montes de Oca, MSc

Data sourced from clinicaltrials.gov

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