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

Pre-diabetes Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02919397
• Other study ID #: 197384
• Status: Completed
• Phase: N/A
• Start date: October 1, 2016
• Est. completion date: July 12, 2018

Study information

• Verified date: March 2018
• Source: King's College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: July 12, 2018
• Est. primary completion date: May 25, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Glucose Intolerance
• Pre-diabetes
• Prediabetic State

Intervention

Device:
• Wearable technology
Buddi wearable technology will record activity levels, participants will access activity data through smartphone application

Behavioral:
• Diabetes Prevention Programme educational material
Educational material accessed through smartphone application
• Motivational messaging
Messages sent via smartphone application

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
King's College London

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	HbA1c (mmol/mol)		At 12 month follow-up appointment
Secondary	Height (cm)		At 12 month follow-up appointment
Secondary	BMI (kg/m^2)		At 12 month follow-up appointment
Secondary	Waist circumference (cm)		At 12 month follow-up appointment
Secondary	Hip circumference (cm)		At 12 month follow-up appointment
Secondary	Total cholesterol (mmol/L)		At 12 month follow-up appointment
Secondary	High density lipoprotein cholesterol (mmol/L)		At 12 month follow-up appointment
Secondary	Low density lipoprotein cholesterol (mmol/L)		At 12 month follow-up appointment
Secondary	Systolic blood pressure (mmHg)		At 12 month follow-up appointment
Secondary	Diastolic blood pressure (mmHg)		At 12 month follow-up appointment
Secondary	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