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Completed

NCT Number: NCT02919397

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

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.

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Key information

Conditions

Pre-diabetes Glucose Intolerance Glucose Metabolism Disorders Hyperglycemia Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Wearable technology

Device

Buddi wearable technology will record activity levels, participants will access activity data through smartphone application

Diabetes Prevention Programme educational material

Behavioral

Educational material accessed through smartphone application

Motivational messaging

Behavioral

Messages sent via smartphone application

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

King's College London

Other

Registry information

Official study 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)

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Sep 29, 2016
Registry last updated
Aug 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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