Cardiometabolic SyndromeNCT04784624
Virtual Lifestyle Program Evaluation During Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
An observational study of Cardiometabolic Syndrome and Weight Loss, run by University of Manitoba at 1 site in Canada.
Trial summary
This is a pilot study evaluating an online cardiometabolic and weight loss program which is offered by The Wellness Institute. The program is 16 weeks and is developed by a multidisciplinary team and delivered by a degreed health professional (health coach) to assist participants in achieving their personal wellness… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiometabolic Syndrome, Weight Loss
- What is being tested?
- Lifestyle program
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- 1 Mar 2021to 31 Jul 2022
- How long will I take part?
- 16 Weeks
- Phase
- Observational
- 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
Study population: Participants will be recruited from individuals enrolled in the online program and willing and able to give informed consent for participation in the evaluation
Program inclusion criteria:
- Male or female, aged 18 years or above, have one or more of the following conditions: pre-diabetes, diabetes, high blood pressure, high triglycerides, low HDL, abdominal obesity, and BMI >25 kg/m2.
Program exclusion criteria:
- Female participant who is pregnant, lactating or planning pregnancy during the course of the program.
- Recent heart attack, stroke, heart surgery, and congestive heart failure.
- Participants who have unmanaged diabetes, chest pain or difficulty breathing.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Chronic Disease Innovation Centre, Seven Oaks Hospital
Winnipeg, Manitoba, R2V 3M3
About this study
Official title: Virtual Lifestyle Programming to Limit Collateral Health Damage From COVID 19 Pandemic: an Evaluation
This is a pilot study evaluating an online cardiometabolic and weight loss program which is offered by The Wellness Institute. The program is 16 weeks and is developed by a multidisciplinary team and delivered by a degreed health professional (health coach) to assist participants in achieving their personal wellness goals. This study will also investigate the impact of Coronavirus Disease (COVID-19) on participants lifestyles and access to lifestyle programs and supports.
Read the detailed description
The Wellness Institute is offering a new cardiometabolic and weight loss program. It is a digital behavior change program designed to help clients achieve healthy weight reduction, thereby improving cardiometabolic risk. The target population is overweight or obese individuals at risk for or living with health conditions such as pre-diabetes, diabetes, hypertension and high cholesterol. The purpose of this study is to evaluate the program following a mixed methods quasi-experimental approach using focus groups, questionnaires, and data collected over the 16 week duration of the program. Participants will be asked to fill in a set of questionnaires to measure physical activity, diet, sleep and stress at the start and end of the program. Other outcomes include changes in body weight, body mass index (BMI), blood pressure, clinical chemistry, and medication intake over the 16 week program. At the end of the program, adherence will be measured though attendance and platform usage and acceptability will be measured by an exit questionnaire and virtual focus groups. This study will investigate the impact of COVID-19 on participants lifestyles and access to lifestyle programs and support. The impact of COVID-19 will be assessed through a Covid-19 questionnaire and virtual focus groups.
- Conditions
- Cardiometabolic Syndrome, Weight Loss
- Being tested
- Lifestyle program
- Keywords
- virtual platform, evaluation, diet, physical activity, behavior change, sleep, stress
- Medical subject headings
- Metabolic Syndrome, Weight Loss, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle programBehavioural
The cardiometabolic and weight loss program is based on The Wellness Institute clinically validated lifestyle medicine program and will be delivered virtually using a digital platform and artificial intelligence that is supported by a health coach. The program focuses on building individual's self-efficacy, motivation and importance to make and sustain healthy choices. The 16-week program begins with a health risk assessment and a personalized wellness plan. The plan includes a personalized exercise plan and nutrition strategy. Each user will regularly check-in with their personal health coach whose role is to provide expert advice and also empower, support and help make the user accountable as they build a healthy lifestyle. Coaching includes identifying obstacles to changing behaviors and how to develop new behaviors that will become the norm.
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of COVID-19 survey
A COVID-19 wellbeing survey will be used to understand the impact of COVID-19 pandemic on lifestyle behaviours and programs and services have changed in response to COVID-19
Measured: Start of the program - first week of enrollment
Program adherence
Participants will be qualified as adhering to the program if they attend a minimum of 3 out of 4 health coaching sessions and have at least 1 activity during weeks 12-18.
Measured: 16 weeks
Secondary outcomes (25)
Physical activity level - International Physical Activity Questionnaire-Long (IPAQ-L)
International Physical Activity Questionnaire-Long (IPAQ-L) will be used to evaluate participant's physical activity level for the last 7 days at the start and end of program. It comprises a set of 4 questionnaires and 5 activity domains asked independently. This questionnaire assesses the types of intensity of physical activity and the amount of sitting time that people do as part of their daily lives. These are used to estimate total physical activity in MET-min/week and time spent sitting.
Measured: 16 weeks
Physical activity level - International Physical Activity Questionnaire-Short (IPAQ-S)
International Physical Activity Questionnaire-Short (IPAQ-S) will be used to evaluate participant's physical activity level for the last 7 days at the start and end of program. It comprises a set of 4 questionnaires and 4 generic items. This questionnaire assesses the types of intensity of physical activity and sitting time that people do as part of their daily lives. These are used to estimate total physical activity in MET-min/week and time spent sitting.
Measured: 16 weeks
Dietary intake
Automated Self-Administered Recall System (ASA24) 3-day food recall will be used as tool to recall 3 days of dietary intake at the start and end of program.
Measured: 16 weeks
Dietary behavior
Three factor questionnaire will evaluate changes in participant's dietary habits at the start and end of program. It measures 3 dimensions of human eating behavior: cognitive restraint of eating, disinhibition and hunger.
Measured: 16 weeks
Dietary habits
Mindful eating questionnaire will evaluate changes in participant's dietary behaviors at the start and end of program. It evaluates emotional and behavioral eating habits in designated populations. A higher score may indicate better outcome in long term body weight maintenance.
Measured: 16 weeks
Sleep
Pittsburgh sleep quality index (PSQI) questionnaire will be used to evaluate changes in sleep at the start and end of program. The PSQI is used to measure the quality and patterns of sleep in adults. It includes seven components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications and daytime dysfunction. A score of 5 or less is indicated as good sleep quality where a score of 6 or more is indicated as poor sleep quality.
Measured: 16 weeks
Stress
Perceived stress questionnaire (PSQ) will be used to evaluate changes in stress at the start and end of program. The PSQ is developed as an instrument for assessing the stressful life events and circumstances that tend to trigger or exacerbate disease symptoms.
Measured: 16 weeks
High-density lipoprotein Cholesterol (HDL-C)
HDL-C will be measured at the start and end of program.
Measured: 16 weeks
Total cholesterol
Total cholesterol will be measured at the start and end of program.
Measured: 16 weeks
Low-density lipoprotein cholesterol (LDL-C)
LDL-C will be measured at the start and end of program.
Measured: 16 weeks
Triglycerides
Triglycerides will be measured at the start and end of program.
Measured: 16 weeks
Total cholesterol/HDL ratio
Total cholesterol/HDL ratio will be measured at the start and end of program.
Measured: 16 weeks
Fasting blood glucose
Fasting blood glucose will be measured at the start and end of program.
Measured: 16 weeks
Insulin
Insulin will be measured at the start and end of program.
Measured: 16 weeks
Hemoglobin A1C
Hemoglobin A1C will be measured at the start and end of program.
Measured: 16 weeks
Body weight
Body weight will be measured at the start and end of program.
Measured: 16 weeks
BMI
BMI will be measured at the start and end of program.
Measured: 16 weeks
Systolic blood pressure
Systolic blood pressure will be measured in triplicate the start and end of program.
Measured: 16 weeks
Diastolic blood pressure
Diastolic blood pressure will be measured in triplicate the start and end of program.
Measured: 16 weeks
Medication intake
Participant's medication intake will be tracked and assessed the start and end of program.
Measured: 16 weeks
Cardiovascular assessment
Framingham score will be used to assess participant's 10-year risk of cardiovascular disease the start and end of program.
Measured: 16 weeks
Impact of COVID-19-focus groups
Focus groups will be conducted with a subset of participants to understand the impact of the COVID-19 pandemic on lifestyle behaviors and on how individuals' needs and perspectives on lifestyle programs and services have changed in response to COVID-19
Measured: First 3 months of program initiation
Program acceptability - exit survey
A study exit survey will be used to evaluate the program acceptability.
Measured: Program completion at 16 weeks
Program acceptability - focus groups
Focus groups will be conducted with a subset of participants after completion of the program to obtain feedback.
Measured: Within 3 months of completing the program
Evaluate participant's program engagement and learning
Participant's involvement will be assessed by measuring participant learning and engagement. Participant learning will be measured by the proportion of the workbook steps completed and review of health library educational materials. Engagement in the program will be estimated by the average activity participants engaged in per week.
Measured: At the end of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2021
- Study start1 Mar 2021
- Primary completion31 May 2022 (estimated)
- Study completion31 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiometabolic SyndromeStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 16 Weeks
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- Seven Oaks Hospital Chronic Disease Innovation Centre
- Responsible party
- Principal investigator, Claudio Rigatto, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04784624
- Sponsor's protocol ID
- HS24424(H2020:495)
- Status last verified
- Apr 2022
- First submitted
- 8 Feb 2021
- Last updated
- 29 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Dandeneau D, Leon S, Cameranesi M, Alexiuk M, Protudjer J, Bohm C, DiNella M, Solmundson C, Talson M, Wang H, Whitlock R, Rigatto C, Mollard RC. Evaluation of an online cardiometabolic and weight loss program: a mixed methods study. Appl Physiol Nutr Metab. 2025 Jan 1;50:1-11. doi: 10.1139/apnm-2024-0190.
PubMed 39854690
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Lifestyle Programming to Limit Collateral Health Damage From COVID 19 Pandemic: an Evaluation
- ClinicalTrials.gov ID
- NCT04784624
- Acronym / sponsor ID
- HS24424(H2020:495)
- Conditions
- Cardiometabolic Syndrome, Weight Loss
- Keywords
- virtual platform, evaluation, diet, physical activity, behavior change, sleep, stress
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- Seven Oaks Hospital Chronic Disease Innovation Centre
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 31 May 2022 (estimated)
- Study completion
- 31 Jul 2022 (estimated)
- First posted
- 5 Mar 2021 (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.
This is a pilot study evaluating an online cardiometabolic and weight loss program which is offered by The Wellness Institute. The program is 16 weeks and is developed by a multidisciplinary team and delivered by a degreed health professional (health coach) to assist participants in achieving their personal wellness goals. This study will also investigate the impact of Coronavirus Disease (COVID-19) on participants lifestyles and access to lifestyle programs and supports.
Detailed description
The Wellness Institute is offering a new cardiometabolic and weight loss program. It is a digital behavior change program designed to help clients achieve healthy weight reduction, thereby improving cardiometabolic risk. The target population is overweight or obese individuals at risk for or living with health conditions such as pre-diabetes, diabetes, hypertension and high cholesterol. The purpose of this study is to evaluate the program following a mixed methods quasi-experimental approach using focus groups, questionnaires, and data collected over the 16 week duration of the program. Participants will be asked to fill in a set of questionnaires to measure physical activity, diet, sleep and stress at the start and end of the program. Other outcomes include changes in body weight, body mass index (BMI), blood pressure, clinical chemistry, and medication intake over the 16 week program. At the end of the program, adherence will be measured though attendance and platform usage and acceptability will be measured by an exit questionnaire and virtual focus groups. This study will investigate the impact of COVID-19 on participants lifestyles and access to lifestyle programs and support. The impact of COVID-19 will be assessed through a Covid-19 questionnaire and virtual focus groups.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 16 Weeks
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be recruited from individuals enrolled in the online program and willing and able to give informed consent for participation in the evaluation
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 |
|---|---|---|
| Lifestyle programThe cardiometabolic and weight loss program is based on The Wellness Institute clinically validated lifestyle medicine program and will be delivered virtually using a digital platform and artificial intelligence that is supported by a health coach. The program focuses on building individual's self-efficacy, motivation and importance to make and sustain healthy choices. The 16-week program begins with a health risk assessment and a personalized wellness plan. The plan includes a personalized exercise plan and nutrition strategy. Each user will regularly check-in with their personal health coach whose role is to provide expert advice and also empower, support and help make the user accountable as they build a healthy lifestyle. Coaching includes identifying obstacles to changing behaviors and how to develop new behaviors that will become the norm. | Behavioural | – |
Primary outcome
Impact of COVID-19 survey
Time frame: Start of the program - first week of enrollment
A COVID-19 wellbeing survey will be used to understand the impact of COVID-19 pandemic on lifestyle behaviours and programs and services have changed in response to COVID-19
Program adherence
Time frame: 16 weeks
Participants will be qualified as adhering to the program if they attend a minimum of 3 out of 4 health coaching sessions and have at least 1 activity during weeks 12-18.
25 secondary outcomes
Physical activity level - International Physical Activity Questionnaire-Long (IPAQ-L)
Time frame: 16 weeks
Physical activity level - International Physical Activity Questionnaire-Short (IPAQ-S)
Time frame: 16 weeks
Dietary intake
Time frame: 16 weeks
Dietary behavior
Time frame: 16 weeks
Dietary habits
Time frame: 16 weeks
Sleep
Time frame: 16 weeks
Stress
Time frame: 16 weeks
High-density lipoprotein Cholesterol (HDL-C)
Time frame: 16 weeks
Total cholesterol
Time frame: 16 weeks
Low-density lipoprotein cholesterol (LDL-C)
Time frame: 16 weeks
Triglycerides
Time frame: 16 weeks
Total cholesterol/HDL ratio
Time frame: 16 weeks
Fasting blood glucose
Time frame: 16 weeks
Insulin
Time frame: 16 weeks
Hemoglobin A1C
Time frame: 16 weeks
Body weight
Time frame: 16 weeks
BMI
Time frame: 16 weeks
Systolic blood pressure
Time frame: 16 weeks
Diastolic blood pressure
Time frame: 16 weeks
Medication intake
Time frame: 16 weeks
Cardiovascular assessment
Time frame: 16 weeks
Impact of COVID-19-focus groups
Time frame: First 3 months of program initiation
Program acceptability - exit survey
Time frame: Program completion at 16 weeks
Program acceptability - focus groups
Time frame: Within 3 months of completing the program
Evaluate participant's program engagement and learning
Time frame: At the end of the study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2022.
- Derived from this study: PubMed 39854690Dandeneau D, Leon S, Cameranesi M, Alexiuk M, Protudjer J, Bohm C, DiNella M, Solmundson C, Talson M, Wang H, Whitlock R, Rigatto C, Mollard RC. Evaluation of an online cardiometabolic and weight loss program: a mixed methods study. Appl Physiol Nutr Metab. 2025 Jan 1;50:1-11. doi: 10.1139/apnm-2024-0190.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiometabolic Syndrome and Weight Loss, run by University of Manitoba 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?
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: status not confirmed, as of the sponsor's last update on 29 Apr 2022. 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?
Results are not available in the source record.
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?
Impact of COVID-19 survey (time frame: Start of the program - first week of enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04784624, which also lists 1 linked publication.
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 29 Apr 2022.