Virtual Lifestyle Program Evaluation During Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
- Conditions
- Cardiometabolic SyndromeWeight Loss
- Registration Number
- NCT04784624
- Lead Sponsor
- University of Manitoba
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 100
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Program adherence 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.
Impact of COVID-19 survey 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
- Secondary Outcome Measures
Name Time Method Dietary intake 16 weeks 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.
Low-density lipoprotein cholesterol (LDL-C) 16 weeks LDL-C will be measured at the start and end of program.
Triglycerides 16 weeks Triglycerides will be measured at the start and end of program.
Total cholesterol/HDL ratio 16 weeks Total cholesterol/HDL ratio will be measured at the start and end of program.
Total cholesterol 16 weeks Total cholesterol will be measured at the start and end of program.
Insulin 16 weeks Insulin will be measured at the start and end of program.
Systolic blood pressure 16 weeks Systolic blood pressure will be measured in triplicate the start and end of program.
Cardiovascular assessment 16 weeks Framingham score will be used to assess participant's 10-year risk of cardiovascular disease the start and end of program.
Physical activity level - International Physical Activity Questionnaire-Long (IPAQ-L) 16 weeks 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.
Dietary habits 16 weeks 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.
Stress 16 weeks 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.
Program acceptability - exit survey Program completion at 16 weeks A study exit survey will be used to evaluate the program acceptability.
Dietary behavior 16 weeks 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.
Fasting blood glucose 16 weeks Fasting blood glucose will be measured at the start and end of program.
Sleep 16 weeks 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.
Hemoglobin A1C 16 weeks Hemoglobin A1C will be measured at the start and end of program.
BMI 16 weeks BMI will be measured at the start and end of program.
Medication intake 16 weeks Participant's medication intake will be tracked and assessed the start and end of program.
Physical activity level - International Physical Activity Questionnaire-Short (IPAQ-S) 16 weeks 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.
High-density lipoprotein Cholesterol (HDL-C) 16 weeks HDL-C will be measured at the start and end of program.
Body weight 16 weeks Body weight will be measured at the start and end of program.
Diastolic blood pressure 16 weeks Diastolic blood pressure will be measured in triplicate the start and end of program.
Impact of COVID-19-focus groups First 3 months of program initiation 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
Program acceptability - focus groups Within 3 months of completing the program Focus groups will be conducted with a subset of participants after completion of the program to obtain feedback.
Evaluate participant's program engagement and learning At the end of the study 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.
Trial Locations
- Locations (1)
Chronic Disease Innovation Centre, Seven Oaks Hospital
🇨🇦Winnipeg, Manitoba, Canada