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

Weight Loss Clinical Trial

Official title:

Virtual Lifestyle Programming to Limit Collateral Health Damage From COVID 19 Pandemic: an Evaluation

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04784624
• Other study ID #: HS24424(H2020:495)
• Status: Active, not recruiting
• Start date: March 1, 2021
• Est. completion date: July 31, 2022

Study information

• Verified date: April 2022
• Source: University of Manitoba
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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 goals. This study will also investigate the impact of Coronavirus Disease (COVID-19) on participants lifestyles and access to lifestyle programs and supports.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: July 31, 2022
• Est. primary completion date: May 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiometabolic Syndrome
• Metabolic Syndrome
• Syndrome
• Weight Loss

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Canada	Chronic Disease Innovation Centre, Seven Oaks Hospital	Winnipeg	Manitoba

Sponsors (2)

Lead Sponsor	Collaborator
University of Manitoba	Chronic Disease Innovation Centre, Seven Oaks Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Start of the program - first week of enrollment
Primary	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.	16 weeks
Secondary	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.	16 weeks
Secondary	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.	16 weeks
Secondary	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.	16 weeks
Secondary	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.	16 weeks
Secondary	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.	16 weeks
Secondary	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.	16 weeks
Secondary	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.	16 weeks
Secondary	High-density lipoprotein Cholesterol (HDL-C)	HDL-C will be measured at the start and end of program.	16 weeks
Secondary	Total cholesterol	Total cholesterol will be measured at the start and end of program.	16 weeks
Secondary	Low-density lipoprotein cholesterol (LDL-C)	LDL-C will be measured at the start and end of program.	16 weeks
Secondary	Triglycerides	Triglycerides will be measured at the start and end of program.	16 weeks
Secondary	Total cholesterol/HDL ratio	Total cholesterol/HDL ratio will be measured at the start and end of program.	16 weeks
Secondary	Fasting blood glucose	Fasting blood glucose will be measured at the start and end of program.	16 weeks
Secondary	Insulin	Insulin will be measured at the start and end of program.	16 weeks
Secondary	Hemoglobin A1C	Hemoglobin A1C will be measured at the start and end of program.	16 weeks
Secondary	Body weight	Body weight will be measured at the start and end of program.	16 weeks
Secondary	BMI	BMI will be measured at the start and end of program.	16 weeks
Secondary	Systolic blood pressure	Systolic blood pressure will be measured in triplicate the start and end of program.	16 weeks
Secondary	Diastolic blood pressure	Diastolic blood pressure will be measured in triplicate the start and end of program.	16 weeks
Secondary	Medication intake	Participant's medication intake will be tracked and assessed the start and end of program.	16 weeks
Secondary	Cardiovascular assessment	Framingham score will be used to assess participant's 10-year risk of cardiovascular disease the start and end of program.	16 weeks
Secondary	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	First 3 months of program initiation
Secondary	Program acceptability - exit survey	A study exit survey will be used to evaluate the program acceptability.	Program completion at 16 weeks
Secondary	Program acceptability - focus groups	Focus groups will be conducted with a subset of participants after completion of the program to obtain feedback.	Within 3 months of completing the program
Secondary	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.	At the end of the study