Digital Lifestyle Intervention For Diabetes/Pre-Diabetes

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05247437
• Other study ID #: EA220053
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 19, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: February 2022
• Source: The University of Hong Kong
• Contact: Anna Lee, PhD
• Phone: 85239177124
• Email: slashlab[@]hku.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Glucose Intolerance
• Obesity
• PreDiabetes
• Prediabetic State
• Type 2 Diabetes

Intervention

Behavioral:
• Digital Intensive Lifestyle Intervention
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 Condition
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.

Locations

Country	Name	City	State
Hong Kong	The University of Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)