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

• ClinicalTrials.gov Identifier: NCT02919397
• Recruitment Status: Completed
• First Posted: September 29, 2016
• Last Update Posted: August 9, 2018
• Sponsor: King's College London
• Information provided by (Responsible Party): King's College London

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Pre-diabetes	Device: Wearable technology; Behavioral: Diabetes Prevention Programme educational material; Behavioral: Motivational messaging	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Prevention
• 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)
• Actual Study Start Date: October 1, 2016
• Actual Primary Completion Date: May 25, 2018
• Actual Study Completion Date: July 12, 2018

Arms and Interventions

Arm	Intervention/treatment
Experimental: Intervention; 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.	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; Behavioral: Motivational messaging; Messages sent via smartphone application
Active Comparator: Control; 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.	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

Outcome Measures

Primary Outcome Measures :

1. Physical activity (average steps per day) [ Time Frame: 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
2. Weight (kg) [ Time Frame: 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 Outcome Measures :

1. HbA1c (mmol/mol) [ Time Frame: At 12 month follow-up appointment ]
2. Height (cm) [ Time Frame: At 12 month follow-up appointment ]
3. BMI (kg/m^2) [ Time Frame: At 12 month follow-up appointment ]
4. Waist circumference (cm) [ Time Frame: At 12 month follow-up appointment ]
5. Hip circumference (cm) [ Time Frame: At 12 month follow-up appointment ]
6. Total cholesterol (mmol/L) [ Time Frame: At 12 month follow-up appointment ]
7. High density lipoprotein cholesterol (mmol/L) [ Time Frame: At 12 month follow-up appointment ]
8. Low density lipoprotein cholesterol (mmol/L) [ Time Frame: At 12 month follow-up appointment ]
9. Systolic blood pressure (mmHg) [ Time Frame: At 12 month follow-up appointment ]
10. Diastolic blood pressure (mmHg) [ Time Frame: At 12 month follow-up appointment ]
11. Sleep duration (average hours per night) [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Sponsors and Collaborators

King's College London

Investigators

• Principal Investigator: Khalida Ismail; King's College London

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: King's College London
• ClinicalTrials.gov Identifier: NCT02919397
• Other Study ID Numbers: 197384
• First Posted: September 29, 2016
• Last Update Posted: August 9, 2018
• Last Verified: March 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

Additional relevant MeSH terms:

Diabetes Mellitus; Prediabetic State; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases