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

King's College London

Status: Completed

Conditions: Pre-diabetes

Treatments: Behavioral: Motivational messaging; Device: Wearable technology; Behavioral: Diabetes Prevention Programme educational material

Study type: Interventional

Funder types: Other

Identifiers

NCT02919397

197384

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups

Intervention

Experimental group

Description:

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.

Treatment:

Device: Wearable technology

Behavioral: Motivational messaging

Behavioral: Diabetes Prevention Programme educational material

Control

Active Comparator group

Description:

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.

Treatment:

Device: Wearable technology

Behavioral: Diabetes Prevention Programme educational material