Motivational Instant Messaging and E-diabetes Prevention Programme for High Risk of Type 2 Diabetes
- Conditions
- Pre-diabetes
- Interventions
- Device: Wearable technologyBehavioral: Diabetes Prevention Programme educational materialBehavioral: Motivational messaging
- Registration Number
- NCT02919397
- Lead Sponsor
- King's College London
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 200
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Motivational messaging 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. Control Diabetes Prevention Programme educational material 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 Diabetes Prevention Programme educational material 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. Intervention Wearable technology 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. Control Wearable technology 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.
- Primary Outcome Measures
Name Time Method Physical activity (average steps per day) 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
Weight (kg) 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
Name Time Method 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) 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.