Obesity Clinical Trial
— DIRECTIONOfficial title:
Digital Intervention for Behaviour Change and Chronic Disease Prevention
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).
Status | Recruiting |
Enrollment | 180 |
Est. completion date | December 31, 2024 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 40 Years to 65 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Canada | University of Alberta | Edmonton | Alberta |
Lead Sponsor | Collaborator |
---|---|
University of Alberta |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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. | |
Secondary | 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. | |
Secondary | 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. | |
Secondary | 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. | |
Secondary | 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. | |
Secondary | 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. | |
Secondary | 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. |
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