Clinical trial NCT02919397: Motivational Instant Messaging and E-diabetes Prevention Programme for High Risk of Type 2 Diabetes
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pre-diabetes
Lead sponsor: King's College London
Sponsor class: OTHER
First posted: 2016-09-29
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Physical activity (average steps per day)
timeFrame: 7 days
measure: Weight (kg)
timeFrame: At 12 month follow-up appointment
Secondary outcomes:
measure: HbA1c (mmol/mol)
timeFrame: At 12 month follow-up appointment
measure: Height (cm)
timeFrame: At 12 month follow-up appointment
measure: BMI (kg/m^2)
timeFrame: At 12 month follow-up appointment
measure: Waist circumference (cm)
timeFrame: At 12 month follow-up appointment
measure: Hip circumference (cm)
timeFrame: At 12 month follow-up appointment
measure: Total cholesterol (mmol/L)
timeFrame: At 12 month follow-up appointment
measure: High density lipoprotein cholesterol (mmol/L)
timeFrame: At 12 month follow-up appointment
measure: Low density lipoprotein cholesterol (mmol/L)
timeFrame: At 12 month follow-up appointment
measure: Systolic blood pressure (mmHg)
timeFrame: At 12 month follow-up appointment
measure: Diastolic blood pressure (mmHg)
timeFrame: At 12 month follow-up appointment
measure: Sleep duration (average hours per night)
timeFrame: 7 days
Other outcomes:
Locations:
Study officials:
affiliation: King's College London
name: Khalida Ismail
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.