Motivational Instant Messaging and E-diabetes Prevention Programme for High Risk of Type 2 Diabetes
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)
1 other identifier
interventional
200
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2016
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 20, 2016
CompletedFirst Posted
Study publicly available on registry
September 29, 2016
CompletedStudy Start
First participant enrolled
October 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 25, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 12, 2018
CompletedAugust 9, 2018
March 1, 2018
1.6 years
September 20, 2016
August 8, 2018
Conditions
Outcome Measures
Primary Outcomes (2)
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
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
At 12 month follow-up appointment
Secondary Outcomes (11)
HbA1c (mmol/mol)
At 12 month follow-up appointment
Height (cm)
At 12 month follow-up appointment
BMI (kg/m^2)
At 12 month follow-up appointment
Waist circumference (cm)
At 12 month follow-up appointment
Hip circumference (cm)
At 12 month follow-up appointment
- +6 more secondary outcomes
Study Arms (2)
Intervention
EXPERIMENTALIf 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.
Control
ACTIVE COMPARATORIf 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.
Interventions
Buddi wearable technology will record activity levels, participants will access activity data through smartphone application
Educational material accessed through smartphone application
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 32459651DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Khalida Ismail
King's College London
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 20, 2016
First Posted
September 29, 2016
Study Start
October 1, 2016
Primary Completion
May 25, 2018
Study Completion
July 12, 2018
Last Updated
August 9, 2018
Record last verified: 2018-03