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Diabetes Prevention Using SMS Technology

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Barts & The London NHS Trust
Basildon and Thurrock University Hospitals NHS Foundation Trust
Lister Hospital
Torbay Hospital
Queen Alexandra Hospital
East Surrey Hospital
Pennine Acute Hospitals NHS Trust
West Suffolk Hospital
Derriford Hospital
Exeter Hospital
Milton Keynes University Hospital NHS Foundation Trust
Royal Cornwall Hospitals Trust
Queen Margaret Hospital, Dunfermline
Monklands Hospital
Harrogate & District NHS Foundation Trust
Royal Berkshire NHS Foundation Trust
Rotherham NHS Trust
Information provided by (Responsible Party):
Imperial College London
ClinicalTrials.gov Identifier:
NCT01795833
First received: February 19, 2013
Last updated: February 22, 2016
Last verified: February 2016
  Purpose

Type 2 diabetes is a major healthcare problem in the developed and developing world. Recent clinical trials have demonstrated that it may be prevented by lifestyle intervention focused on diet and physical activity. These trials have been expensive and labour intensive and this has limited translation of the known benefits to the population at large.

We propose using a mobile phone intervention for lifestyle change and will assess it in a clinical trial(study) in people with impaired glucose regulation (high risk at developing type 2 diabetes).

The study will be conducted in both India and the UK. The purpose of the study is to assess the effectiveness and acceptability of a text messaging system to prevent the progression to diabetes in people with high risk. The study involves five visits to clinic over 2 year period.

Study participants will be divided into two groups by the computer generated random method - one is 'Usual Care' group and the other 'Text Messaging' group.

  • Usual care will consist of a 30 minute interview, delivering personalized diet and exercise advice, supplemented by written material and education regarding diabetes. This will be delivered once at the beginning of the study.
  • The intervention group will undergo the same initial interview and, in addition, will receive 3 times weekly text messaging with education, advice, support and motivation. These messages will be personalized to individual targets set at the initial interview.

The primary outcome will be progression to diabetes, with and without SMS intervention. Secondary outcomes will be improvements in physical activity (reported and directly measured), body weight and other cardiovascular risk factors (blood pressure, total and HDL cholesterol and serum triglycerides).


Condition Intervention
Prediabetes
Other: Short text messages

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Pragmatic and Scaleable Strategy Using Mobile Technology to Promote Sustained Lifestyle Changes to Prevent Type 2 Diabetes in India and the UK

Resource links provided by NLM:


Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • Progression to type 2 diabetes [ Time Frame: at baseline, 6 months, 12 months and 24 months following randomisaton ] [ Designated as safety issue: No ]
    The primary outcome will be progression to type 2 diabetes as measured by HbA1c at baseline, 6 months, 12 months and 24 months or by any validated criteria in any other care setting. the World health Organization (WHO) / International Diabetes Federation (IDF) criteria for diagnosis of diabetes will be used throughout.


Secondary Outcome Measures:
  • Change in physical measurements [ Time Frame: At baseline, 6 months, 12 months and 24 months following randomisation ] [ Designated as safety issue: No ]
    Change in physical measurements will be assessed by measuring weight, body mass index (BMI), waist circumference, hip circumference and waist: hip ratio at baseline, 6 months, 12 months and 24 months.


Enrollment: 2178
Study Start Date: April 2013
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Text Messages
Short text messages related to healthy lifestyle will be sent to half the subjects three times per week, in addition to one off 'one-to-one structured education' during the study period.
Other: Short text messages
In addition to structured education on healthy lifestyle provided at baseline, subjects in the arm will receive short text messages containing educational, motivational and supportive content on diet, physical activity, and smoking (if appropriate) during the study period. The content will be appropriate to the stage of the transtheoretical model of behavioural change that the subject is in. This will be assessed by questionnaire at each visit to clinic.
Other Names:
  • Text messages
  • SMS
  • Short Message Service
No Intervention: Control
Half of the subjects who has received only one off 'one-to-one structured education about healthy lifestyle during the study period

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 74 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults 18 yrs or over and less than 75 yrs
  • HbA1c between 6.0-6.4%

Exclusion Criteria:

  • Pregnant or planning pregnancy
  • Breastfeeding
  • Enrolled in other clinical trials
  • Have active malignancy or under investigation for malignancy
  • Are unable to follow the protocol for any other reason
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01795833

Locations
United Kingdom
Imperial college Healthcare NHS Trust
London, United Kingdom, W2 1NY
Sponsors and Collaborators
Imperial College London
Barts & The London NHS Trust
Basildon and Thurrock University Hospitals NHS Foundation Trust
Lister Hospital
Torbay Hospital
Queen Alexandra Hospital
East Surrey Hospital
Pennine Acute Hospitals NHS Trust
West Suffolk Hospital
Derriford Hospital
Exeter Hospital
Milton Keynes University Hospital NHS Foundation Trust
Royal Cornwall Hospitals Trust
Queen Margaret Hospital, Dunfermline
Monklands Hospital
Harrogate & District NHS Foundation Trust
Royal Berkshire NHS Foundation Trust
Rotherham NHS Trust
Investigators
Principal Investigator: Desmond G Johnston, PhD, MB ChB Imperial College London
  More Information

Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT01795833     History of Changes
Other Study ID Numbers: CRO1999  MR/J000183/1 
Study First Received: February 19, 2013
Last Updated: February 22, 2016
Health Authority: United Kingdom: National Institute for Health Research
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Imperial College London:
Prediabetes
Prediabetic State

Additional relevant MeSH terms:
Prediabetic State
Glucose Intolerance
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperglycemia

ClinicalTrials.gov processed this record on December 09, 2016