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Digital Lifestyle Intervention For Diabetes/Pre-Diabetes

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05247437
Enrollment
120
Registered
2022-02-18
Start date
2022-02-19
Completion date
2023-12-31
Last updated
2022-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, PreDiabetes, Type 2 Diabetes

Keywords

Intensive Lifestyle Intervention, mHealth, eHealth, digital intervention, efficacy, RCT

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.

Interventions

BEHAVIORALDigital 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.

BEHAVIORALDigital 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.

Sponsors

The University of Hong Kong
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
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

MeasureTime frameDescription
Changes in the scores on the Weight Control Strategy ScaleBaseline (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 questionnaireBaseline (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 scaleBaseline (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.

Countries

Hong Kong

Contacts

Primary ContactAnna Lee, PhD
slashlab@hku.hk85239177124

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026