Digital Lifestyle Intervention For Diabetes/Pre-Diabetes

Not Applicable

• Conditions: PreDiabetes; Type 2 Diabetes; Obesity
• Interventions: Behavioral: Digital Self-Help Control Condition; Behavioral: Digital Intensive Lifestyle Intervention

• Registration Number: NCT05247437
• Lead Sponsor: The University of Hong Kong

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-28
• Status Verified: 2022-02
• Study First Submitted QC: 2022-02-09
• Last Update Submitted: 2022-02-09
• Study First Posted: 2022-02-18
• Last Update Posted: 2022-02-18
• Study Start: 2022-02-19
• Primary Completion: 2022-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Digital Self-Help	Digital Self-Help Control Condition	-
FitD full version	Digital Intensive Lifestyle Intervention	-

Primary Outcome Measures

Name	Time	Method
Changes in the scores on the Summary of Diabetes Self-Care Activities - Revised (SDSCA)	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)	Baseline (week 0), posttreatment (week 9), follow-up (week 21)	Self-reported weight in kilograms

Secondary Outcome Measures

Name	Time	Method
Changes in the scores on the Weight Control Strategy Scale	Baseline (week 0), posttreatment (week 9), follow-up (week 21)	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	Baseline (week 0), posttreatment (week 9), follow-up (week 21)	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	Baseline (week 0), posttreatment (week 9), follow-up (week 21)	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.

Trial Locations

Locations (1)

The University of Hong Kong; 🇭🇰 Hong Kong, Hong Kong