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

NCT ID: NCT04784624

Last Updated: 2022-04-29

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-03-01
• Study Completion Date: 2022-07-31

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.

Conditions

Cardiometabolic Syndrome; Weight Loss

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Lifestyle program

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seven Oaks Hospital Chronic Disease Innovation Centre

NETWORK

Sponsor Role: collaborator

University of Manitoba

OTHER

Sponsor Role: lead

Responsible Party

Claudio Rigatto

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Chronic Disease Innovation Centre, Seven Oaks Hospital

Winnipeg, Manitoba, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 39854690 (View on PubMed)

Other Identifiers

HS24424(H2020:495)

Identifier Type: -

Identifier Source: org_study_id