Clinical trial NCT04784624: Virtual Lifestyle Program Evaluation During Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
Official title: Virtual Lifestyle Programming to Limit Collateral Health Damage From COVID 19 Pandemic: an Evaluation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiometabolic Syndrome
Weight Loss
Keywords: virtual platform
evaluation
diet
physical activity
behavior change
sleep
stress
Lead sponsor: University of Manitoba
Sponsor class: OTHER
Collaborators: name: Seven Oaks Hospital Chronic Disease Innovation Centre
First posted: 2021-03-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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

Brief 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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Impact of COVID-19 survey
timeFrame: Start of the program - first week of enrollment
measure: Program adherence
timeFrame: 16 weeks
Secondary outcomes:
measure: Physical activity level - International Physical Activity Questionnaire-Long (IPAQ-L)
timeFrame: 16 weeks
measure: Physical activity level - International Physical Activity Questionnaire-Short (IPAQ-S)
timeFrame: 16 weeks
measure: Dietary intake
timeFrame: 16 weeks
measure: Dietary behavior
timeFrame: 16 weeks
measure: Dietary habits
timeFrame: 16 weeks
measure: Sleep
timeFrame: 16 weeks
measure: Stress
timeFrame: 16 weeks
measure: High-density lipoprotein Cholesterol (HDL-C)
timeFrame: 16 weeks
measure: Total cholesterol
timeFrame: 16 weeks
measure: Low-density lipoprotein cholesterol (LDL-C)
timeFrame: 16 weeks
measure: Triglycerides
timeFrame: 16 weeks
measure: Total cholesterol/HDL ratio
timeFrame: 16 weeks
measure: Fasting blood glucose
timeFrame: 16 weeks
measure: Insulin
timeFrame: 16 weeks
measure: Hemoglobin A1C
timeFrame: 16 weeks
measure: Body weight
timeFrame: 16 weeks
measure: BMI
timeFrame: 16 weeks
measure: Systolic blood pressure
timeFrame: 16 weeks
measure: Diastolic blood pressure
timeFrame: 16 weeks
measure: Medication intake
timeFrame: 16 weeks
measure: Cardiovascular assessment
timeFrame: 16 weeks
measure: Impact of COVID-19-focus groups
timeFrame: First 3 months of program initiation
measure: Program acceptability - exit survey
timeFrame: Program completion at 16 weeks
measure: Program acceptability - focus groups
timeFrame: Within 3 months of completing the program
measure: Evaluate participant's program engagement and learning
timeFrame: At the end of the study
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: Chronic Disease Innovation Centre, Seven Oaks Hospital
state: Manitoba
Study officials:
References: