Long COVIDBLENDNCT05422924
A Web-based Platform to Improve Physical Function, Nutrition, and Mindfulness in Patients With Long COVID
A study testing Web-based platform. (My Viva Plan) in people with Long COVID, run by University of Alberta at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Long COVID
- What is being tested?
- Web-based platform. (My Viva Plan)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteCanada
- Study dates
- 25 Aug 2023to 31 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
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- 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 locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot and Feasibility Study of a Web-based Platform to Improve Physical Function, Nutrition, and Mindfulness in Patients With Long COVID
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.
Read the 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
- Being tested
- Web-based platform. (My Viva Plan)
- Keywords
- Nutrition, Physical activity, Feasibility, Body composition
- Medical subject headings
- Post-Acute COVID-19 Syndrome, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web-based platform. (My Viva Plan)Behavioural
Participants will use a web-based platform (i.e. My Viva Plan®) to improve physical function, nutrition and mindfulness.
| Study group | Role | What they receive |
|---|---|---|
| Control Arm | No intervention | No use of My Viva Plan |
| Intervention Arm | Experimental | Use of My Viva Plan Receives: Behavioral: Web-based platform. (My Viva Plan) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility (defined by recruitment, adherence, and retention).
The proportion of participants that agreed to participate, the engagement in the platform (login), participants who complete both visits
Measured: Baseline, week 8
Secondary outcomes (12)
Changes in quality of life parameters
Changes in scores of quality of life assessed by EuroQol 5-level EQ-5D.
Measured: Baseline, week 8
Changes in fat mass
Changes in fat mass (kg) using bioelectrical impedance analysis
Measured: Baseline, week 8
Changes in lean mass
Changes in lean mass (kg) using bioelectrical impedance analysis
Measured: Baseline, week 8
Changes in muscle cross sectional area
Changes in muscle cross sectional area (cm2) using an ultrasound
Measured: Baseline, week 8
Changes in dietary intake
Changes in diet quality assessed by dietary intake assessed by Automated Self-Administered 24-hour dietary assessment tool and analysed with Canadian version of the Healthy Eating Index
Measured: Baseline, week 8
Changes in mindfulness with Mental health questionnaire from the Symptom Burden Questionnaire for Long COVID
Changes in mindfulness assessed by Mental health questionnaire from the Symptom Burden Questionnaire for Long COVID (SBQ-LC). 9-item measure. Scores are to 0-100 linear. Higher scores indicate greater symptom burden.
Measured: Baseline, week 8
Changes in self-efficacy assessed with Patient-Reported Outcomes Measurement Information System
Changes in self-efficacy for managing chronic conditions with of 8-item questionnaire that is based on a Patient-Reported Outcomes Measurement Information System (PROMIS).The total raw score (ranging from 8 to 40) will be transferred to a T-score. A mean of 50 and a standard deviation (SD) of 10 will be the average. A higher PROMIS T-score indicates that the respondent has greater self-efficacy for managing their emotions than the general chronic condition population.
Measured: Baseline, week 8
Changes in physical function
Changes in physical function assessed by handgrip strength
Measured: Baseline, week 8
Changes in physical performance
Changes in physical performance assessed by 6-minute walk test
Measured: Baseline, week 8
Changes in physical activity (daily activities subscale) by the Symptom Burden Questionnaire for Long COVID.
Changes in physical activity assessed by Daily Activities Symptom Burden Questionnaire for Long COVID (SBQ-LC). Raw scores (ranging from 0 to 24) will be converted to 0-100 linear scores with conversion tables. Higher scores indicate greater symptom burden.
Measured: Baseline, week 8
Changes in physical activity using the International Physical Activity Questionnaire
Changes in physical activity assessed by International Physical Activity Questionnaire (IPAQ). This questionnaire collects information about three specific types of physical activity: walking, moderate-intensity activities and vigorous intensity activities. To compute the total score, measures of frequency (measured in days per week) and duration (time per day) are needed. We will use this information to compare over time.
Measured: Baseline, week 8
Changes in resting energy expenditure
Changes in resting energy expenditure assessed by a metabolic cart (indirect calorimetry)
Measured: Baseline, week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start25 Aug 2023
- Primary completion31 Oct 2023
- Study completion31 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Long COVIDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Revive Wellness Inc.
- Responsible party
- Sponsor
- Investigators
- Carla Prado, PhD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05422924
- Sponsor's protocol ID
- Pro00120894
- Acronym
- BLEND
- Status last verified
- Mar 2025
- First submitted
- 16 Jun 2022
- Last updated
- 6 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot and Feasibility Study of a Web-based Platform to Improve Physical Function, Nutrition, and Mindfulness in Patients With Long COVID
- ClinicalTrials.gov ID
- NCT05422924
- Acronym / sponsor ID
- BLEND / Pro00120894
- Conditions
- Long COVID
- Keywords
- Nutrition, Physical activity, Feasibility, Body composition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- Revive Wellness Inc.
- Study start
- 25 Aug 2023 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 21 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Arm | No intervention | –No use of My Viva Plan |
| Intervention Arm | Experimental | Behavioral: Web-based platform. (My Viva Plan)Use of My Viva Plan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Intervention Arm |
Primary outcome
Feasibility (defined by recruitment, adherence, and retention).
Time frame: Baseline, week 8
The proportion of participants that agreed to participate, the engagement in the platform (login), participants who complete both visits
12 secondary outcomes
Changes in quality of life parameters
Time frame: Baseline, week 8
Changes in fat mass
Time frame: Baseline, week 8
Changes in lean mass
Time frame: Baseline, week 8
Changes in muscle cross sectional area
Time frame: Baseline, week 8
Changes in dietary intake
Time frame: Baseline, week 8
Changes in mindfulness with Mental health questionnaire from the Symptom Burden Questionnaire for Long COVID
Time frame: Baseline, week 8
Changes in self-efficacy assessed with Patient-Reported Outcomes Measurement Information System
Time frame: Baseline, week 8
Changes in physical function
Time frame: Baseline, week 8
Changes in physical performance
Time frame: Baseline, week 8
Changes in physical activity (daily activities subscale) by the Symptom Burden Questionnaire for Long COVID.
Time frame: Baseline, week 8
Changes in physical activity using the International Physical Activity Questionnaire
Time frame: Baseline, week 8
Changes in resting energy expenditure
Time frame: Baseline, week 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2025.
- Individual participant dataSharing planned: No
Related trials for Long COVID
Active, not recruiting
Long COVID Brain Fog: Cognitive Rehabilitation Trial
Long COVID, Brain Fog
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
RecruitingPhase 2
SARS-CoV-2 and Herpesvirus Inhibition for Ending Long COVID Dysfunction
Post-acute Sequelae of COVID-19, Long COVID
Enrolling by invitation
Fareon Open Label Device Clinical Trial
Cognitive Dysfunction, Acquired Brain Injury
Not yet recruitingPhase 2
Study of VYD2311 for the Treatment of Adults With Long-COVID or Post-Vaccination Syndrome
Long COVID, COVID-19 (SARS-CoV-2 Infection)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carla Prado, PhD principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Web-based platform. (My Viva Plan) in people with Long COVID, run by University of Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility (defined by recruitment, adherence, and retention). (time frame: Baseline, week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2025.