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)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pre-diabetes
- Sponsor
- King's College London
- Enrollment
- 200
- Primary Endpoint
- Physical activity (average steps per day)
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
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.
Outcomes
Primary Outcomes
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
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 Outcomes
- 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)