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

August 8, 2018 updated by: King's College London

Effectiveness of Integrating Motivational Instant Messaging Into an E-diabetes Prevention Programme in People at High Risk of Type 2 Diabetes: a Prospective, Parallel-group, Randomised Controlled Trial (Diabetes Stopwatch)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

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 to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Device: Wearable technology
Buddi wearable technology will record activity levels, participants will access activity data through smartphone application
Behavioral: Diabetes Prevention Programme educational material
Educational material accessed through smartphone application
Behavioral: Motivational messaging
Messages sent via smartphone application
Active Comparator: 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.
Device: Wearable technology
Buddi wearable technology will record activity levels, participants will access activity data through smartphone application
Behavioral: Diabetes Prevention Programme educational material
Educational material accessed through smartphone application

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical activity (average steps per day)
Time Frame: 7 days
Average steps taken per day from 7 days wear measured using the Buddi wearable technology, which will be worn 24 hours per day for 7 days
7 days
Weight (kg)
Time Frame: At 12 month follow-up appointment
Measured in light clothing, without shoes, on the a Class 3 Tanita SC240 weighing digital scale to 0.01 kg for weight
At 12 month follow-up appointment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HbA1c (mmol/mol)
Time Frame: At 12 month follow-up appointment
At 12 month follow-up appointment
Height (cm)
Time Frame: At 12 month follow-up appointment
At 12 month follow-up appointment
BMI (kg/m^2)
Time Frame: At 12 month follow-up appointment
At 12 month follow-up appointment
Waist circumference (cm)
Time Frame: At 12 month follow-up appointment
At 12 month follow-up appointment
Hip circumference (cm)
Time Frame: At 12 month follow-up appointment
At 12 month follow-up appointment
Total cholesterol (mmol/L)
Time Frame: At 12 month follow-up appointment
At 12 month follow-up appointment
High density lipoprotein cholesterol (mmol/L)
Time Frame: At 12 month follow-up appointment
At 12 month follow-up appointment
Low density lipoprotein cholesterol (mmol/L)
Time Frame: At 12 month follow-up appointment
At 12 month follow-up appointment
Systolic blood pressure (mmHg)
Time Frame: At 12 month follow-up appointment
At 12 month follow-up appointment
Diastolic blood pressure (mmHg)
Time Frame: At 12 month follow-up appointment
At 12 month follow-up appointment
Sleep duration (average hours per night)
Time Frame: 7 days
The Buddi wearable technology will be worn for 24 hours per day. Therefore, during sleeping hours participant activity will be measured and duration of sleep can be calculated. Participants will wear the Buddi device for 7 days, and the average number of hours sleep per night will be calculated.
7 days

Collaborators and Investigators

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

Sponsor

King's College London

Investigators

  • Principal Investigator: Khalida Ismail, King's College London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

October 1, 2016

Primary Completion (Actual)

May 25, 2018

Study Completion (Actual)

July 12, 2018

Study Registration Dates

First Submitted

September 20, 2016

First Submitted That Met QC Criteria

September 27, 2016

First Posted (Estimate)

September 29, 2016

Study Record Updates

Last Update Posted (Actual)

August 9, 2018

Last Update Submitted That Met QC Criteria

August 8, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 197384

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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.

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