Pre-diabetes
Conditions
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.
Interventions
DEVICEWearable technology
Buddi wearable technology will record activity levels, participants will access activity data through smartphone application
BEHAVIORALDiabetes Prevention Programme educational material
Educational material accessed through smartphone application
BEHAVIORALMotivational messaging
Messages sent via smartphone application
Sponsors
King's College London
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| HbA1c (mmol/mol) | 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. |
| High density lipoprotein cholesterol (mmol/L) | At 12 month follow-up appointment | — |
| Height (cm) | At 12 month follow-up appointment | — |
Outcome results
None listed