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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02919397
Recruitment Status : Completed
First Posted : September 29, 2016
Last Update Posted : August 9, 2018
Sponsor:
Information provided by (Responsible Party):
King's College London

Study Description
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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.

Condition or disease Intervention/treatment Phase
Pre-diabetes Device: Wearable technology Behavioral: Diabetes Prevention Programme educational material Behavioral: Motivational messaging Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
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)
Actual Study Start Date : October 1, 2016
Actual Primary Completion Date : May 25, 2018
Actual Study Completion Date : July 12, 2018

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Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. HbA1c (mmol/mol) [ Time Frame: At 12 month follow-up appointment ]
  2. Height (cm) [ Time Frame: At 12 month follow-up appointment ]
  3. BMI (kg/m^2) [ Time Frame: At 12 month follow-up appointment ]
  4. Waist circumference (cm) [ Time Frame: At 12 month follow-up appointment ]
  5. Hip circumference (cm) [ Time Frame: At 12 month follow-up appointment ]
  6. Total cholesterol (mmol/L) [ Time Frame: At 12 month follow-up appointment ]
  7. High density lipoprotein cholesterol (mmol/L) [ Time Frame: At 12 month follow-up appointment ]
  8. Low density lipoprotein cholesterol (mmol/L) [ Time Frame: At 12 month follow-up appointment ]
  9. Systolic blood pressure (mmHg) [ Time Frame: At 12 month follow-up appointment ]
  10. Diastolic blood pressure (mmHg) [ Time Frame: At 12 month follow-up appointment ]
  11. 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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02919397


Sponsors and Collaborators
King's College London
Investigators
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Principal Investigator: Khalida Ismail King's College London
More Information
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Responsible Party: King's College London
ClinicalTrials.gov Identifier: NCT02919397    
Other Study ID Numbers: 197384
First Posted: September 29, 2016    Key Record Dates
Last Update Posted: August 9, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Diabetes Mellitus
Prediabetic State
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases