Clinical Trials Directory

Trials / Completed

CompletedNCT05579704

Digital Intervention for Behaviour Change and Chronic Disease Prevention

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
186 (actual)
Sponsor
University of Alberta · Academic / Other
Sex
All
Age
40 Years – 65 Years
Healthy volunteers
Accepted

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).

Detailed description

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 between-group difference in weight loss. Secondary outcomes include improvements in dietary intake, 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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALWeb-based wellness platformA web-based wellness platform is based on preventive self-care and contains tools to monitor nutrition, physical activity, and mental wellbeing.
BEHAVIORALHealthcare professional-facilitated online support groupParticipants 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.

Timeline

Start date
2022-11-23
Primary completion
2024-11-01
Completion
2024-12-01
First posted
2022-10-14
Last updated
2025-03-27

Locations

1 site across 1 country: Canada

Source: ClinicalTrials.gov record NCT05579704. Inclusion in this directory is not an endorsement.