Type 2 DiabetesNCT05247437
Digital Lifestyle Intervention For Diabetes/Pre-Diabetes
A study testing Digital Intensive Lifestyle Intervention in people with Type 2 Diabetes and PreDiabetes, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
The study aims to evaluate the acceptability, feasibility, and preliminary efficacy of a digital lifestyle intervention, called Fitness Digital (FitD), for individuals with prediabetes or type 2 diabetes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes, PreDiabetes, Obesity
- What is being tested?
- Digital Intensive Lifestyle Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteHong Kong
- Study dates
- 19 Feb 2022to 31 Dec 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18+
- Hong Kong resident
- Can understand Chinese and Cantonese
- Have self-reported diagnosis of type 2 diabetes or prediabetes
- Have a smart phone and able to use a mobile app
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
The University of Hong Kong
Hong Kong
Wai Sze Chan, PhD, slashlab@hku.hk
Anna Lee, 85239177124, slashlab@hku.hk
About this study
Official title: A Pilot Cluster Randomized Controlled Trial of a Digital Lifestyle Intervention for Individuals With Prediabetes or Type 2 Diabetes
The study aims to evaluate the acceptability, feasibility, and preliminary efficacy of a digital lifestyle intervention, called Fitness Digital (FitD), for individuals with prediabetes or type 2 diabetes.
- Conditions
- Type 2 Diabetes, PreDiabetes, Obesity
- Being tested
- Digital Intensive Lifestyle Intervention, Digital Self-Help Control Condition
- Keywords
- Intensive Lifestyle Intervention, mHealth, eHealth, digital intervention, efficacy, RCT
- Medical subject headings
- Diabetes Mellitus, Type 2, Prediabetic State, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Intensive Lifestyle InterventionBehavioural
The FitD consists of 8 digital lessons on how to improve dietary and exercise habits using self-monitoring, goal-setting, cognitive restructuring, and other behavioral and cognitive strategies. The FitD app offers a virtual coach that guides the participant to complete the treatment.
Digital Self-Help Control ConditionBehavioural
The digital self-help control condition consists of educational materials related to diet and exercise. The materials are open for access all at once. There is no guidance by a virtual coach or digital lessons.
| Study group | Role | What they receive |
|---|---|---|
| FitD full version | Experimental | Not described Receives: Behavioral: Digital Intensive Lifestyle Intervention |
| Digital Self-Help | Active comparator | Not described Receives: Behavioral: Digital Self-Help Control Condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the scores on the Summary of Diabetes Self-Care Activities - Revised (SDSCA)
The Summary of Diabetes Self-Care Activities consists of 11 items asking the frequency of diabetes self-care behavior in the following six areas: general diet, specific diet (ate fruit and vegetable/ low fat diet), exercise, blood glucose testing, foot care, and cigarette smoking. The maximum score is 70 and the minimum score is 0. A higher total score indicate better self-care.
Measured: Baseline (week 0), posttreatment (week 9), follow-up (week 21)
Changes in weight from baseline (week 0) to posttreatment (week 9)
Self-reported weight in kilograms
Measured: Baseline (week 0), posttreatment (week 9), follow-up (week 21)
Secondary outcomes (3)
Changes in the scores on the Weight Control Strategy Scale
The Weight Control Strategy Scale consists of 30 items measuring one's use of different weight control strategies. A higher score indicates greater use of effective weight control strategies.
Measured: Baseline (week 0), posttreatment (week 9), follow-up (week 21)
Changes in the scores on the Physical activity acceptance and action questionnaire
The Physical activity acceptance and action questionnaire consists of 10 items assessing one's readiness and motivation to engage in increased physical activity. A higher score indicates greater readiness and motivation.
Measured: Baseline (week 0), posttreatment (week 9), follow-up (week 21)
Changes in the scores on the Weight loss self-efficacy scale
The weight loss self-efficacy scale consists of 10 items assessing one's confidence in using effective strategies for weight loss. A higher score indicates greater confidence.
Measured: Baseline (week 0), posttreatment (week 9), follow-up (week 21)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2022
- Study start19 Feb 2022 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Chan Wai Sze, The University of Hong Kong
- Investigators
- Wai Sze Chan, PhD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05247437
- Sponsor's protocol ID
- EA220053
- Status last verified
- Feb 2022
- First submitted
- 28 Jan 2022
- Last updated
- 18 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data will be available for sharing upon request.
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Cluster Randomized Controlled Trial of a Digital Lifestyle Intervention for Individuals With Prediabetes or Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT05247437
- Acronym / sponsor ID
- EA220053
- Conditions
- Type 2 Diabetes, PreDiabetes, Obesity
- Keywords
- Intensive Lifestyle Intervention, mHealth, eHealth, digital intervention, efficacy, RCT
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 19 Feb 2022 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 18 Feb 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.
The study aims to evaluate the acceptability, feasibility, and preliminary efficacy of a digital lifestyle intervention, called Fitness Digital (FitD), for individuals with prediabetes or type 2 diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FitD full version | Experimental | Behavioral: Digital Intensive Lifestyle Intervention |
| Digital Self-Help | Active comparator | Behavioral: Digital Self-Help Control Condition |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18+
- Hong Kong resident
- Can understand Chinese and Cantonese
- Have self-reported diagnosis of type 2 diabetes or prediabetes
- Have a smart phone and able to use a mobile app
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Digital Intensive Lifestyle InterventionThe FitD consists of 8 digital lessons on how to improve dietary and exercise habits using self-monitoring, goal-setting, cognitive restructuring, and other behavioral and cognitive strategies. The FitD app offers a virtual coach that guides the participant to complete the treatment. | Behavioural | FitD full version |
| Digital Self-Help Control ConditionThe digital self-help control condition consists of educational materials related to diet and exercise. The materials are open for access all at once. There is no guidance by a virtual coach or digital lessons. | Behavioural | Digital Self-Help |
Primary outcome
Changes in the scores on the Summary of Diabetes Self-Care Activities - Revised (SDSCA)
Time frame: Baseline (week 0), posttreatment (week 9), follow-up (week 21)
The Summary of Diabetes Self-Care Activities consists of 11 items asking the frequency of diabetes self-care behavior in the following six areas: general diet, specific diet (ate fruit and vegetable/ low fat diet), exercise, blood glucose testing, foot care, and cigarette smoking. The maximum score is 70 and the minimum score is 0. A higher total score indicate better self-care.
Changes in weight from baseline (week 0) to posttreatment (week 9)
Time frame: Baseline (week 0), posttreatment (week 9), follow-up (week 21)
Self-reported weight in kilograms
3 secondary outcomes
Changes in the scores on the Weight Control Strategy Scale
Time frame: Baseline (week 0), posttreatment (week 9), follow-up (week 21)
Changes in the scores on the Physical activity acceptance and action questionnaire
Time frame: Baseline (week 0), posttreatment (week 9), follow-up (week 21)
Changes in the scores on the Weight loss self-efficacy scale
Time frame: Baseline (week 0), posttreatment (week 9), follow-up (week 21)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2022.
- Individual participant dataSharing planned: Yes. De-identified data will be available for sharing upon request.
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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.
Wai Sze Chan, PhD principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital Intensive Lifestyle Intervention in people with Type 2 Diabetes and PreDiabetes, run by The University of Hong Kong at 1 site in Hong Kong.
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 5 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 18 Feb 2022. 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 Hong Kong. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anna Lee, PhD (85239177124, slashlab@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the scores on the Summary of Diabetes Self-Care Activities - Revised (SDSCA) (time frame: Baseline (week 0), posttreatment (week 9), follow-up (week 21)). The study lists 2 primary outcomes in all. 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 18 Feb 2022.