Virtual Lifestyle Program Evaluation During Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)

University of Manitoba

Status: Unknown

Conditions: Weight Loss; Cardiometabolic Syndrome

Treatments: Behavioral: Lifestyle program

Study type: Observational

Funder types: Other; NETWORK

Identifiers

NCT04784624

HS24424(H2020:495)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.