Clinical trial NCT05579704: Digital Intervention for Behaviour Change and Chronic Disease Prevention
Official title: Digital Intervention for Behaviour Change and Chronic Disease Prevention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: University of Alberta
Sponsor class: OTHER
First posted: 2022-10-14
Enrollment: 186
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in body weight.
timeFrame: Baseline to Week 16.
Secondary outcomes:
measure: Change in diet quality.
timeFrame: Baseline to Week 16.
measure: Change in self-reported physical activity.
timeFrame: Baseline to Week 16.
measure: Change in measured step counts.
timeFrame: Baseline to Week 16.
measure: Change in physical activity.
timeFrame: Baseline to Week 16.
measure: Change in self-reported stress.
timeFrame: Baseline to Week 16.
measure: Change in self-reported sleep quality.
timeFrame: Baseline to Week 16.
measure: Change in self-reported alcohol use.
timeFrame: Baseline to Week 16.
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
Study officials:
affiliation: University of Alberta
name: Carla Prado, PhD
role: PRINCIPAL_INVESTIGATOR
References: