ObesityDIRECTIONNCT05579704
Digital Intervention for Behaviour Change and Chronic Disease Prevention
A study testing Web-based wellness platform and Healthcare professional-facilitated online support group in people with Obesity, run by University of Alberta at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 40 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Web-based wellness platform and Healthcare professional-facilitated online support group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 186 participants
- Where
- 1 siteCanada
- Study dates
- 23 Nov 2022to 1 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read the 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
- Obesity
- Being tested
- Web-based wellness platform, Healthcare professional-facilitated online support group
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web-based wellness platformBehavioural
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 groupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Web-based wellness platform | Active comparator | Participants 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). Receives: Behavioral: Web-based wellness platform |
| Web-based wellness platform with healthcare professional-facilitated online support | Experimental | Participants 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. Receives: Behavioral: Web-based wellness platform; Behavioral: Healthcare professional-facilitated online support group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body weight.
Body weight changes will be measured using Bluetooth enabled smart scales (Fitbit Aria scale) for daily tracking of body weight.
Measured: Baseline to Week 16.
Secondary outcomes (7)
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).
Measured: Baseline to Week 16.
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.
Measured: Baseline to Week 16.
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.
Measured: Baseline to Week 16.
Change in physical activity.
Physical activity changes will be measured using a wrist-worn wearable activity monitor (Fitbit Inspire 2) to track active minutes.
Measured: Baseline to Week 16.
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.
Measured: Baseline to Week 16.
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.
Measured: Baseline to Week 16.
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.
Measured: Baseline to Week 16.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2022
- Study start23 Nov 2022
- Primary completion1 Nov 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 186 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carla Prado, PhD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05579704
- Sponsor's protocol ID
- Pro00121051
- Acronym
- DIRECTION
- Status last verified
- Mar 2025
- First submitted
- 3 Oct 2022
- Last updated
- 27 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Intervention for Behaviour Change and Chronic Disease Prevention
- ClinicalTrials.gov ID
- NCT05579704
- Acronym / sponsor ID
- DIRECTION / Pro00121051
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 186 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- 23 Nov 2022 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 14 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Web-based wellness platform | Active comparator | Behavioral: Web-based wellness platformParticipants 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 | Experimental | Behavioral: Web-based wellness platform, Behavioral: Healthcare professional-facilitated online support groupParticipants 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. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Web-based wellness platformA web-based wellness platform is based on preventive self-care and contains tools to monitor nutrition, physical activity, and mental wellbeing. | Behavioural | Web-based wellness platform, Web-based wellness platform with healthcare professional-facilitated online support |
| Healthcare 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. | Behavioural | Web-based wellness platform with healthcare professional-facilitated online support |
Primary outcome
Change in body weight.
Time frame: Baseline to Week 16.
Body weight changes will be measured using Bluetooth enabled smart scales (Fitbit Aria scale) for daily tracking of body weight.
7 secondary outcomes
Change in diet quality.
Time frame: Baseline to Week 16.
Change in self-reported physical activity.
Time frame: Baseline to Week 16.
Change in measured step counts.
Time frame: Baseline to Week 16.
Change in physical activity.
Time frame: Baseline to Week 16.
Change in self-reported stress.
Time frame: Baseline to Week 16.
Change in self-reported sleep quality.
Time frame: Baseline to Week 16.
Change in self-reported alcohol use.
Time frame: Baseline to Week 16.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carla Prado, PhD principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Web-based wellness platform and Healthcare professional-facilitated online support group in people with Obesity, run by University of Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in body weight. (time frame: Baseline to Week 16.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2025.