Back to resultsDigital Lifestyle Intervention For Diabetes/Pre-Diabetes
Primary Purpose
Type 2 Diabetes, PreDiabetes, Obesity
Status
Not yet recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Digital Intensive Lifestyle Intervention
Digital Self-Help Control Condition
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes focused on measuring Intensive Lifestyle Intervention, mHealth, eHealth, digital intervention, efficacy, RCT
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- None
Sites / Locations
- The University of Hong Kong
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
FitD full version
Digital Self-Help
Arm Description
Outcomes
Primary Outcome Measures
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.
Changes in weight from baseline (week 0) to posttreatment (week 9)
Self-reported weight in kilograms
Secondary Outcome Measures
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.
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.
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.
Full Information
NCT ID
NCT05247437
First Posted
January 28, 2022
Last Updated
February 9, 2022
Sponsor
The University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT05247437
Brief Title
Digital Lifestyle Intervention For Diabetes/Pre-Diabetes
Official Title
A Pilot Cluster Randomized Controlled Trial of a Digital Lifestyle Intervention for Individuals With Prediabetes or Type 2 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 19, 2022 (Anticipated)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Hong Kong
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes, PreDiabetes, Obesity
Keywords
Intensive Lifestyle Intervention, mHealth, eHealth, digital intervention, efficacy, RCT
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
FitD full version
Arm Type
Experimental
Arm Title
Digital Self-Help
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Digital Intensive Lifestyle Intervention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Digital Self-Help Control Condition
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in the scores on the Summary of Diabetes Self-Care Activities - Revised (SDSCA)
Description
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.
Time Frame
Baseline (week 0), posttreatment (week 9), follow-up (week 21)
Title
Changes in weight from baseline (week 0) to posttreatment (week 9)
Description
Self-reported weight in kilograms
Time Frame
Baseline (week 0), posttreatment (week 9), follow-up (week 21)
Secondary Outcome Measure Information:
Title
Changes in the scores on the Weight Control Strategy Scale
Description
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.
Time Frame
Baseline (week 0), posttreatment (week 9), follow-up (week 21)
Title
Changes in the scores on the Physical activity acceptance and action questionnaire
Description
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.
Time Frame
Baseline (week 0), posttreatment (week 9), follow-up (week 21)
Title
Changes in the scores on the Weight loss self-efficacy scale
Description
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.
Time Frame
Baseline (week 0), posttreatment (week 9), follow-up (week 21)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
None
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anna Lee, PhD
Phone
85239177124
Email
slashlab@hku.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wai Sze Chan, PhD
Organizational Affiliation
The University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Hong Kong
City
Hong Kong
Country
Hong Kong
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wai Sze Chan, PhD
Email
slashlab@hku.hk
First Name & Middle Initial & Last Name & Degree
Anna Lee
Phone
85239177124
Email
slashlab@hku.hk
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified data will be available for sharing upon request.
IPD Sharing Time Frame
During review of or after the publication of the study findings.
IPD Sharing Access Criteria
For other research teams' secondary analysis
Learn more about this trial
Digital Lifestyle Intervention For Diabetes/Pre-Diabetes
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