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

Primary Purpose

Pre-diabetes

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Wearable technology
Diabetes Prevention Programme educational material
Motivational messaging
Sponsored by
King's College London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pre-diabetes

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Intervention

    Control

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Physical activity (average steps per day)
    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
    Weight (kg)
    Measured in light clothing, without shoes, on the a Class 3 Tanita SC240 weighing digital scale to 0.01 kg for weight

    Secondary Outcome Measures

    HbA1c (mmol/mol)
    Height (cm)
    BMI (kg/m^2)
    Waist circumference (cm)
    Hip circumference (cm)
    Total cholesterol (mmol/L)
    High density lipoprotein cholesterol (mmol/L)
    Low density lipoprotein cholesterol (mmol/L)
    Systolic blood pressure (mmHg)
    Diastolic blood pressure (mmHg)
    Sleep duration (average hours per night)
    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.

    Full Information

    First Posted
    September 20, 2016
    Last Updated
    August 8, 2018
    Sponsor
    King's College London
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02919397
    Brief Title
    Motivational Instant Messaging and E-diabetes Prevention Programme for High Risk of Type 2 Diabetes
    Official Title
    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)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    October 1, 2016 (Actual)
    Primary Completion Date
    May 25, 2018 (Actual)
    Study Completion Date
    July 12, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    King's College London

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pre-diabetes

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    200 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Control
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    Wearable technology
    Intervention Description
    Buddi wearable technology will record activity levels, participants will access activity data through smartphone application
    Intervention Type
    Behavioral
    Intervention Name(s)
    Diabetes Prevention Programme educational material
    Intervention Description
    Educational material accessed through smartphone application
    Intervention Type
    Behavioral
    Intervention Name(s)
    Motivational messaging
    Intervention Description
    Messages sent via smartphone application
    Primary Outcome Measure Information:
    Title
    Physical activity (average steps per day)
    Description
    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
    Time Frame
    7 days
    Title
    Weight (kg)
    Description
    Measured in light clothing, without shoes, on the a Class 3 Tanita SC240 weighing digital scale to 0.01 kg for weight
    Time Frame
    At 12 month follow-up appointment
    Secondary Outcome Measure Information:
    Title
    HbA1c (mmol/mol)
    Time Frame
    At 12 month follow-up appointment
    Title
    Height (cm)
    Time Frame
    At 12 month follow-up appointment
    Title
    BMI (kg/m^2)
    Time Frame
    At 12 month follow-up appointment
    Title
    Waist circumference (cm)
    Time Frame
    At 12 month follow-up appointment
    Title
    Hip circumference (cm)
    Time Frame
    At 12 month follow-up appointment
    Title
    Total cholesterol (mmol/L)
    Time Frame
    At 12 month follow-up appointment
    Title
    High density lipoprotein cholesterol (mmol/L)
    Time Frame
    At 12 month follow-up appointment
    Title
    Low density lipoprotein cholesterol (mmol/L)
    Time Frame
    At 12 month follow-up appointment
    Title
    Systolic blood pressure (mmHg)
    Time Frame
    At 12 month follow-up appointment
    Title
    Diastolic blood pressure (mmHg)
    Time Frame
    At 12 month follow-up appointment
    Title
    Sleep duration (average hours per night)
    Description
    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.
    Time Frame
    7 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Khalida Ismail
    Organizational Affiliation
    King's College London
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    32459651
    Citation
    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.
    Results Reference
    derived

    Learn more about this trial

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

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