Motivational Instant Messaging and E-diabetes Prevention Programme for High Risk of Type 2 Diabetes

NCT ID: NCT02919397

Last Updated: 2018-08-09

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

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-01

Study Completion Date

2018-07-12

Brief Summary

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The overall aim of this feasibility trial is to assess the effectiveness of a wearable technology and an e-diabetes prevention programme delivered via a smartphone application, including motivational messaging, in reducing weight and increasing physical activity in people at risk of developing type 2 diabetes.

Detailed Description

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The study will examine whether a wearable technology, combined with biofeedback, motivational messaging and an e-diabetes prevention programme, is effective in reducing weight and increasing physical activity after 12 months.

The intervention will consist of a wearable technology and a smartphone application made available for a 12 month period. 22 online multimedia sessions targeting diet, physical activity and mental resilience delivered via the smartphone application. Motivational messaging based on the diabetes prevention module content and biofeedback will be sent to participants via the application.

The control group will receive the wearable technology and will have access to a smartphone application detailing their activity. Participants will be directed to the same educational material as is made available via the multimedia sessions, but will not receive motivational messages.

Conditions

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Pre-diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Intervention

If participants are allocated to the intervention group, participants will receive the wearable technology and access to the smartphone application. Motivational messages based on diabetes prevention programme content, and biofeedback messages based on physical activity data provided via the wearable technology, will be received by participants via the application. The diabetes prevention programme educational material will be available via the application.

Group Type EXPERIMENTAL

Wearable technology

Intervention Type DEVICE

Buddi wearable technology will record activity levels, participants will access activity data through smartphone application

Diabetes Prevention Programme educational material

Intervention Type BEHAVIORAL

Educational material accessed through smartphone application

Motivational messaging

Intervention Type BEHAVIORAL

Messages sent via smartphone application

Control

If participants are allocated to the control group, participants will receive the wearable technology and will be able to access their activity data via the smartphone application. Participants will also have have access to the diabetes prevention programme educational material via the application. Participants will not receive motivational messages related to the education content or activity data.

Group Type ACTIVE_COMPARATOR

Wearable technology

Intervention Type DEVICE

Buddi wearable technology will record activity levels, participants will access activity data through smartphone application

Diabetes Prevention Programme educational material

Intervention Type BEHAVIORAL

Educational material accessed through smartphone application

Interventions

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Wearable technology

Buddi wearable technology will record activity levels, participants will access activity data through smartphone application

Intervention Type DEVICE

Diabetes Prevention Programme educational material

Educational material accessed through smartphone application

Intervention Type BEHAVIORAL

Motivational messaging

Messages sent via smartphone application

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* HbA1c between 42 and 47 mmol/mol
* BMI≥25 kg/m²
* Fluent in conversational English
* Permanent resident in Lambeth, Southwark or Lewisham
* Ownership of a smartphone (iPhone or Android only) for communication defined as logging on at least once/day to the internet
* Ambulatory.

Exclusion Criteria

* Known diabetes
* Pregnancy or planning pregnancy during the duration of the study
* Severe mental illness (severe depression, psychosis, bipolar affective disorder, dementia, learning difficulties, substance problem use or dependence)
* Severe physical disability e.g. that would prevent any increased uptake of physical exercise
* Advanced active disease such as cancer or heart failure
* Any other condition which requires glucose altering drugs
* Morbid obesity (BMI ≥50 kg/m²)
* Current participation in a weight loss programme.

When in doubt the investigators will seek the GP opinion and approval.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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King's College London

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Khalida Ismail

Role: PRINCIPAL_INVESTIGATOR

King's College London

References

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Staite E, Bayley A, Al-Ozairi E, Stewart K, Hopkins D, Rundle J, Basudev N, Mohamedali Z, Ismail K. A Wearable Technology Delivering a Web-Based Diabetes Prevention Program to People at High Risk of Type 2 Diabetes: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2020 Jul 15;8(7):e15448. doi: 10.2196/15448.

Reference Type DERIVED
PMID: 32459651 (View on PubMed)

Other Identifiers

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197384

Identifier Type: -

Identifier Source: org_study_id

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