Digital Intervention for Behaviour Change and Chronic Disease Prevention
DIRECTION
1 other identifier
interventional
186
1 country
1
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable obesity
Started Nov 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 3, 2022
CompletedFirst Posted
Study publicly available on registry
October 14, 2022
CompletedStudy Start
First participant enrolled
November 23, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2024
CompletedMarch 27, 2025
March 1, 2025
1.9 years
October 3, 2022
March 24, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (7)
Change in diet quality.
Baseline to Week 16.
Change in self-reported physical activity.
Baseline to Week 16.
Change in measured step counts.
Baseline to Week 16.
Change in physical activity.
Baseline to Week 16.
Change in self-reported stress.
Baseline to Week 16.
- +2 more secondary outcomes
Study Arms (2)
Web-based wellness platform
ACTIVE COMPARATORParticipants will receive access to a web-based wellness platform focused on nutrition, physical activity, and mindfulness. Interactions with the platform will be fully self-guided (without weekly group video conferencing sessions healthcare professionals and peers).
Web-based wellness platform with healthcare professional-facilitated online support
EXPERIMENTALParticipants will receive access to a web-based wellness platform focused on nutrition, physical activity, and mindfulness. In addition to the platform access, participants will take part in weekly group video conferencing sessions with various healthcare professionals (registered dietitian, mental health therapist, and exercise professional). The sessions will occur once per week for 1 hour each. The group sessions will contain cohorts of approximately 10 individuals.
Interventions
A web-based wellness platform is based on preventive self-care and contains tools to monitor nutrition, physical activity, and mental wellbeing.
Participants will take part in weekly group video conferencing sessions with various health professionals (registered dietitian, mental health therapist, and exercise professional). The sessions will occur once per week for 1 hour each. The group sessions will contain cohorts of approximately 10 individuals.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Alberta
Edmonton, Alberta, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Carla Prado, PhD
University of Alberta
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 3, 2022
First Posted
October 14, 2022
Study Start
November 23, 2022
Primary Completion
November 1, 2024
Study Completion
December 1, 2024
Last Updated
March 27, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will not share