Digital Lifestyle Intervention For Diabetes/Pre-Diabetes

Study Overview
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Brief Summary
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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.

Official Title
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A Pilot Cluster Randomized Controlled Trial of a Digital Lifestyle Intervention for Individuals With Prediabetes or Type 2 Diabetes

Conditions
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Type 2 Diabetes, PreDiabetes, Obesity

Intervention / Treatment
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* Behavioral: Digital Intensive Lifestyle Intervention
* Behavioral: Digital Self-Help Control Condition


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FitD full version<br> | Behavioral: Digital Intensive Lifestyle Intervention<br>* 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.<br>|
| Active Comparator: Digital Self-Help<br> | Behavioral: Digital Self-Help Control Condition<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | Baseline (week 0), posttreatment (week 9), follow-up (week 21) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | Baseline (week 0), posttreatment (week 9), follow-up (week 21) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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RCT, Intensive Lifestyle Intervention, mHealth, eHealth, digital intervention, efficacy