Digital Intervention for Behaviour Change and Chronic Disease Prevention

Study Overview
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Brief Summary
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Body weight, diet quality, physical activity, stress, sleep and alcohol use will be evaluated in a sample of 180 Albertans with excess body weight. Participants will be randomized into the following two groups; active control arm (access to a preventative self-care web-based platform for 16 weeks) vs. intervention arm (access to a preventative self-care web-based platform for 16 weeks plus health professional guidance and supervision).

Detailed Description
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Excess body weight, poor diet, physical inactivity, alcohol consumption, stress, and sleep deprivation/disruption are modifiable risk factors associated with chronic diseases, such as cancer. While most Canadians may be aware that these play a role in chronic disease prevention, individualized tools are needed to foster sustainable, long-term habits. Digital health solutions have become commonplace in self-care. They offer an opportunity to reach a large number of individuals with personalized programs to improve health and lower the risk of developing chronic disease. Many digital applications are available for individuals to monitor their diet, activity and weight; however, few have been validated and are based on scientific evidence. Recently, a Canadian web-based platform centered on preventive self-care became available. This platform was created by health care professionals and encompasses three key pillars of health: nutrition, physical activity, and mindfulness. The effectiveness of this web-based wellness platform will be evaluated in people living with excess body weight to improve six chronic disease risk factors: body weight, diet quality, physical activity, alcohol intake, stress, and sleep habits. A fully self-guided approach (active control, Arm 1) will be compared to an approach guided by a healthcare professional (Arm 2) and compare risk factors pre- and post-intervention. Investigators hypothesize that both approaches will improve modifiable risk factors, but participants guided by a healthcare professional will have greater improvements. Qualitatively, the experiences of immigrants using the platform will be explored. Participants will use the web-based platform for 16 weeks. Our primary outcome is 5% weight loss, which has been shown to reduce chronic disease incidence. Secondary outcomes include improvements in overall diet quality, physical activity and sleep quality, and decrease in alcohol intake and stress. To assess the primary and one of the secondary outcomes (physical activity), a smart scale and a wearable device will be used. Wearable devices are widely used and an effective approach to body weight reduction. Additionally, immigrants' experiences and perspectives of participating in this study will be explored using semi-structured interviews.

Official Title
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Digital Intervention for Behaviour Change and Chronic Disease Prevention

Conditions
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Obesity

Intervention / Treatment
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* Behavioral: My Viva Plan (www.myvivaplan.com)
* Behavioral: Online support group with health professionals


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Albertans with excess body weight (BMI 30-35 kg/m2) Individuals who are seeking weight loss as screened by the S-Weight Questionnaire Ages 40-65 years of age, any sex/gender Able to safely exercise as screened by the 2022 Physical Activity Readiness Questionnaire (PAR-Q+) Must have a cell phone with internet access and Bluetooth capabilities Able to participate in video conferencing on evenings and/or weekends Willing to wear a Fitbit activity monitor on the wrist for 16 weeks. Able to speak, read and understand English Exclusion Criteria: Participating in intensive lifestyle interventions, structured exercise programming (> 3hrs of vigorous physical activity per week) or structured diet programming Taking any medication or supplements that may alter energy metabolism, body weight and composition, as evaluated by study investigators; Chronic conditions in which weight loss is not indicated or controversial. Significant medical self-reported comorbidities, including uncontrolled metabolic disorders (e.g., cancer, thyroid, stroke, kidney, liver, respiratory, heart disease, type 1 or uncontrolled type 2 diabetes) Self-reported eating disorders, untreated depression, anxiety or other mood disorders Weight loss greater than 25 lbs (11 kg) in the past 6 months Previous bariatric surgery Active substance abuse (alcohol, cannabis, illicit drugs, prescription drugs) Unable to adhere to the study protocol

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: My Viva Plan Access<br>Participants will receive access to a web-based platform called My Viva Plan® (MVP, www.myvivaplan.com). Interactions with the platform will be fully self-guided (without weekly group video conferencing sessions health professionals). | Behavioral: My Viva Plan (www.myvivaplan.com)<br>* A web-based platform is based on preventive self-care and contains tools to monitor nutrition, physical activity, and mental wellbeing.<br>|
| Experimental: My Viva Plan Access with Health Professional Support<br>Participants will receive access to a web-based platform called My Viva Plan® (MVP, www.myvivaplan.com). In addition to MVP access, participants will take part in weekly group video conferencing sessions with various health professionals (registered dietitian, psychologist, and exercise specialist). The sessions will occur once per week for 1 hour each. The group sessions will contain cohorts of approximately 10 individuals. | Behavioral: My Viva Plan (www.myvivaplan.com)<br>* A web-based platform is based on preventive self-care and contains tools to monitor nutrition, physical activity, and mental wellbeing.<br>Behavioral: Online support group with health professionals<br>* Participants will take part in weekly group video conferencing sessions with various health professionals (registered dietitian, psychologist, and exercise specialist). The sessions will occur once per week for 1 hour each. The group sessions will contain cohorts of approximately 10 individuals.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in body weight. | Body weight changes will be measured using Bluetooth enabled smart scales (Fitbit Aria scale) for daily tracking of body weight. | Baseline to Week 16. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in diet quality. | Diet quality changes will be assessed using the Canadian version of the Healthy Eating Index (HEI) measured using the Automated Self-Administered 24-h Dietary Assessment Tool (ASA 24). | Baseline to Week 16. | 
| Change in self-reported physical activity. | Self-reported physical activity will be assessed using the Godin-Shephard Leisure Time Physical Activity Questionnaire (GLTEQ). Scored as a range from 0 to 24+, where <14 indicates sedentary, 14-23 indicates moderately active and >24 indicates active. | Baseline to Week 16. | 
| Change in measured step counts. | Physical activity changes will be measured using a wrist-worn wearable activity monitor (Fitbit Inspire 2) to track step counts. | Baseline to Week 16. | 
| Change in physical activity. | Physical activity changes will be measured using a wrist-worn wearable activity monitor (Fitbit Inspire 2) to track active minutes. | Baseline to Week 16. | 
| Change in self-reported stress. | Self-reported stress will be assessed using the Perceived Stress Scale (PSS). Scored as a range from 0 to 40, where <14 indicates low stress, 14-26 indicates moderate stress and >26 indicates high perceived stress. | Baseline to Week 16. | 
| Change in self-reported sleep quality. | Self-reported sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI). Scored as a range from 0 to 21, where a higher score indicates worse sleep quality. | Baseline to Week 16. | 
| Change in self-reported alcohol use. | Self-reported alcohol use will be assessed using the Alcohol Use Disorders Identification Test (AUDIT). Scored as a range from 0 to 40, where a score of 0 indicates an abstainer, a score of 1-7 suggests low-risk consumption, a scores of 8-14 suggest hazardous consumption and a score >15 indicates the likelihood of alcohol dependence. | Baseline to Week 16. |