App-based Diabetes Management and Community-based Interventions

NCT ID: NCT06688903

Last Updated: 2025-02-25

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

RECRUITING

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-06

Study Completion Date

2026-06-30

Brief Summary

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Community-based health coaching interventions play a vital role in complementing the traditional chronic disease management model for type 2 diabetes patients. Compared to conventional approaches that often focus on periodic clinical visits, community-based coaching could provide continuous, personalised support within patients in everyday environments. Health coaches work directly with patients to set realistic goals, develop individualised action plans, and provide ongoing motivation and accountability. This personalised attention helps to improve self-management skills, such as medication adherence, dietary choices, and physical activity, which are crucial for chronic disease management and preventing complications. Our mobile health app, EMPOWER+ has multiple logging features, gamified elements to help users set goals and provide rewards, educational resources, and personalised nudges generated based on real users; inputs and predictive modeling. It has demonstrated some preliminary effectiveness and acceptability within the clinical settings. This trial aims to assess its effectiveness, adoption, and sustainability in the less-controlled community settings, preparing for its large implementation in the future.

Detailed Description

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Conditions

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Diabetes Mellitus Type 2

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Intervention

Group Type EXPERIMENTAL

App-based diabetes management and community-based health coaching

Intervention Type BEHAVIORAL

All participants will use the EMPOWER+ app and a Fitbit wearable. They will also received community-based health coaching and/or other prescribed structured programmes.

Interventions

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App-based diabetes management and community-based health coaching

All participants will use the EMPOWER+ app and a Fitbit wearable. They will also received community-based health coaching and/or other prescribed structured programmes.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Aged 21 years and above
* Having been diagnosed with type 2 diabetes mellitus
* Having most recent HbA1c ≥ 6.5%
* Physically able to exercise
* Able to read, write, and converse in English
* Able to comply with study procedures

Exclusion Criteria

* Requiring assistance with basic activities of daily living (BADL)
* Have planned major operation or surgical procedure within 6 months from the time of recruitment
* Current pregnant or lactating
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Singapore General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Singapore General Hospital

Singapore, , Singapore

Site Status NOT_YET_RECRUITING

Singapore General Hospital

Singapore, , Singapore

Site Status RECRUITING

Countries

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Singapore

Central Contacts

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Research coordinators

Role: CONTACT

6562223222

Facility Contacts

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Lian Leng Low

Role: primary

Research coordinators

Role: primary

6562223222

Other Identifiers

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202409-00001

Identifier Type: -

Identifier Source: org_study_id

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