NCT05247437

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable type-2-diabetes

Timeline
Completed

Started Feb 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 28, 2022

Completed
21 days until next milestone

First Posted

Study publicly available on registry

February 18, 2022

Completed
1 day until next milestone

Study Start

First participant enrolled

February 19, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

February 18, 2022

Status Verified

February 1, 2022

Enrollment Period

11 months

First QC Date

January 28, 2022

Last Update Submit

February 9, 2022

Conditions

Type 2 DiabetesPreDiabetesObesity

Keywords

Intensive Lifestyle InterventionmHealtheHealthdigital interventionefficacyRCT

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (3)

  • Changes in the scores on the Weight Control Strategy Scale

    Baseline (week 0), posttreatment (week 9), follow-up (week 21)

  • Changes in the scores on the Physical activity acceptance and action questionnaire

    Baseline (week 0), posttreatment (week 9), follow-up (week 21)

  • Changes in the scores on the Weight loss self-efficacy scale

    Baseline (week 0), posttreatment (week 9), follow-up (week 21)

Study Arms (2)

FitD full version

EXPERIMENTAL
Behavioral: Digital Intensive Lifestyle Intervention

Digital Self-Help

ACTIVE COMPARATOR
Behavioral: Digital Self-Help Control Condition

Interventions

Digital Intensive Lifestyle InterventionBEHAVIORAL

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.

FitD full version
Digital Self-Help Control ConditionBEHAVIORAL

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.

Digital Self-Help

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Hong Kong

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Prediabetic StateObesity

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Wai Sze Chan, PhD

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna Lee, PhD

CONTACT

85239177124slashlab@hku.hk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 28, 2022

First Posted

February 18, 2022

Study Start

February 19, 2022

Primary Completion

December 31, 2022

Study Completion

December 31, 2023

Last Updated

February 18, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will share

De-identified data will be available for sharing upon request.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
During review of or after the publication of the study findings.
Access Criteria
For other research teams' secondary analysis

Locations

HK(1)