Digital Intervention for Behaviour Change and Chronic Disease Prevention

Obesity Clinical Trial

— DIRECTION  

Official title:

Digital Intervention for Behaviour Change and Chronic Disease Prevention

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05579704
• Other study ID #: Pro00121051
• Status: Recruiting
• Phase: N/A
• Start date: November 23, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: University of Alberta
• Contact: Teresita Gormaz, MSc
• Phone: 780-492-780
• Email: gormazre[@]ualberta.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Chronic Disease
• Obesity

Intervention

Behavioral:
• Web-based wellness platform
A web-based wellness platform is based on preventive self-care and contains tools to monitor nutrition, physical activity, and mental wellbeing.
• Healthcare professional-facilitated online support group
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.

Locations

Country	Name	City	State
Canada	University of Alberta	Edmonton	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Alberta

Country where clinical trial is conducted

Canada, 

Outcome

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.