Digital Lifestyle Intervention For Diabetes/Pre-Diabetes

Sponsor
The University of Hong Kong (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05247437
Collaborator
(none)
120
1
2
22.3
5.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Digital Intensive Lifestyle Intervention
  • Behavioral: Digital Self-Help Control Condition
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Care Provider, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Pilot Cluster Randomized Controlled Trial of a Digital Lifestyle Intervention for Individuals With Prediabetes or Type 2 Diabetes
Anticipated Study Start Date :
Feb 19, 2022
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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

  1. 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.

  2. 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.

  3. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 The University of Hong Kong Hong Kong Hong Kong

Sponsors and Collaborators

  • The University of Hong Kong

Investigators

  • Principal Investigator: Wai Sze Chan, PhD, The University of Hong Kong

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dr. Chan Wai Sze, Assistant Professor, The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT05247437
Other Study ID Numbers:
  • EA220053
First Posted:
Feb 18, 2022
Last Update Posted:
Feb 18, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Dr. Chan Wai Sze, Assistant Professor, The University of Hong Kong
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 18, 2022