Digital Lifestyle Intervention For Diabetes/Pre-Diabetes

February 9, 2022 updated by: Dr. Chan Wai Sze, The University of Hong Kong

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • The University of Hong Kong
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: FitD full version
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.
ACTIVE_COMPARATOR: Digital Self-Help
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in the scores on the Summary of Diabetes Self-Care Activities - Revised (SDSCA)
Time Frame: 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.
Baseline (week 0), posttreatment (week 9), follow-up (week 21)
Changes in weight from baseline (week 0) to posttreatment (week 9)
Time Frame: Baseline (week 0), posttreatment (week 9), follow-up (week 21)
Self-reported weight in kilograms
Baseline (week 0), posttreatment (week 9), follow-up (week 21)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in the scores on the Weight Control Strategy Scale
Time Frame: 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.
Baseline (week 0), posttreatment (week 9), follow-up (week 21)
Changes in the scores on the Physical activity acceptance and action questionnaire
Time Frame: 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.
Baseline (week 0), posttreatment (week 9), follow-up (week 21)
Changes in the scores on the Weight loss self-efficacy scale
Time Frame: 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.
Baseline (week 0), posttreatment (week 9), follow-up (week 21)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

February 19, 2022

Primary Completion (ANTICIPATED)

December 31, 2022

Study Completion (ANTICIPATED)

December 31, 2023

Study Registration Dates

First Submitted

January 28, 2022

First Submitted That Met QC Criteria

February 9, 2022

First Posted (ACTUAL)

February 18, 2022

Study Record Updates

Last Update Posted (ACTUAL)

February 18, 2022

Last Update Submitted That Met QC Criteria

February 9, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EA220053

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

IPD Sharing Time Frame

During review of or after the publication of the study findings.

IPD Sharing Access Criteria

For other research teams' secondary analysis

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Obesity

Clinical Trials on Digital Intensive Lifestyle Intervention

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Italy

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe