Digital Lifestyle Intervention For Diabetes/Pre-Diabetes

NCT ID: NCT05247437

Last Updated: 2022-02-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-19

Study Completion Date

2023-12-31

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.

Detailed Description

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Conditions

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Type 2 Diabetes PreDiabetes Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

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FitD full version

Group Type EXPERIMENTAL

Digital Intensive Lifestyle Intervention

Intervention Type BEHAVIORAL

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

Group Type ACTIVE_COMPARATOR

Digital Self-Help Control Condition

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Dr. Chan Wai Sze

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wai Sze Chan, PhD

Role: PRINCIPAL_INVESTIGATOR

The University of Hong Kong

Locations

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The University of Hong Kong

Hong Kong, , Hong Kong

Site Status

Countries

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Hong Kong

Central Contacts

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Anna Lee, PhD

Role: CONTACT

85239177124

Facility Contacts

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Wai Sze Chan, PhD

Role: primary

Anna Lee

Role: backup

85239177124

Other Identifiers

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EA220053

Identifier Type: -

Identifier Source: org_study_id

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