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

Study Overview
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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.

Official Title
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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)

Conditions
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Pre-diabetes

Intervention / Treatment
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* Device: Wearable technology
* Behavioral: Diabetes Prevention Programme educational material
* Behavioral: Motivational messaging


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>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<br>* Buddi wearable technology will record activity levels, participants will access activity data through smartphone application<br>Behavioral: Diabetes Prevention Programme educational material<br>* Educational material accessed through smartphone application<br>Behavioral: Motivational messaging<br>* Messages sent via smartphone application<br>|
| Active Comparator: Control<br>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<br>* Buddi wearable technology will record activity levels, participants will access activity data through smartphone application<br>Behavioral: Diabetes Prevention Programme educational material<br>* Educational material accessed through smartphone application<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Total cholesterol (mmol/L) |  | At 12 month follow-up appointment | 
| High density lipoprotein cholesterol (mmol/L) |  | At 12 month follow-up appointment | 
| Low density lipoprotein cholesterol (mmol/L) |  | At 12 month follow-up appointment | 
| Systolic blood pressure (mmHg) |  | At 12 month follow-up appointment | 
| Diastolic blood pressure (mmHg) |  | At 12 month follow-up appointment | 
| 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. | 7 days |