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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | 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 | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wearable technology | Device | Buddi wearable technology will record activity levels, participants will access activity data through smartphone application |
|
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
When in doubt the investigators will seek the GP opinion and approval.
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| Name | Affiliation | Role |
|---|---|---|
| Khalida Ismail | King's College London | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32459651 | Derived | 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. |
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| ID | Term |
|---|---|
| D018149 | Glucose Intolerance |
| ID | Term |
|---|---|
| D006943 | Hyperglycemia |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000076251 | Wearable Electronic Devices |
| ID | Term |
|---|---|
| D055615 | Electrical Equipment and Supplies |
| D004864 | Equipment and Supplies |
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| Diabetes Prevention Programme educational material | Behavioral | Educational material accessed through smartphone application |
|
| Motivational messaging | Behavioral | Messages sent via smartphone application |
|
| 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 |