Use of Mobile Technology to Promote Sustained Lifestyle Changes to Prevent Type 2 Diabetes in India and the UK

Prediabetic State Clinical Trial

Official title:

A Pragmatic and Scalable Strategy Using Mobile Technology to Promote Sustained Lifestyle Changes to Prevent Type 2 Diabetes in India and the UK

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01570946
• Other study ID #: 58/1/MRC-ICMR/09/NCD-II_018
• Status: Completed
• Phase: N/A
• First received: March 3, 2012
• Last updated: December 29, 2015
• Start date: May 2012
• Est. completion date: December 2015

Study information

• Verified date: December 2015
• Source: India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Indian Council of Medical Research
• Study type: Interventional

Clinical Trial Summary

Primary prevention of diabetes is of paramount importance in both developed and in developing countries. Several studies including the Indian Diabetes Prevention Programmes have shown that Lifestyle modification in people with prediabetes can reduce the progression to diabetes by 58%. However, there are two main problems in applying diabetes prevention strategies to the population as a whole. (1) Trial based interventions are unrealistic on a population level in any country. (2) The oral glucose tolerance test applied so far to identify those at high risk is a poorly reproducible and time consuming test both for the participant and for health care workers. Hence more practical means of defining individuals who would benefit from lifestyle intervention are required.

The current study proposes a prevention strategy that will employ a lifestyle modification programme delivered by text messaging in both India and the UK.Subjects will be identified based on the HbA1c measurement instead of the oral glucose tolerance test. The study will also assess the efficacy, acceptability and cost effectiveness of mobile phone based intervention both in India and the UK.

Messages will be based to deliver education, treatment targets, advice, support and motivation. Subjects will be invited to participate and, once recruited, will be randomised to usual care or the SMS intervention group.

Usual care will consist of a one-to-one 30 minute interview, conducted by the research team, delivering personalised diet and exercise advice.

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 personalised to individual targets set at the initial interview.

Primary Outcome:Progression to Diabetes Secondary Outcomes will be based on Physical activity / Cardiovascular risk factors/and quality of life.

The study programme is compatible with major initiatives in both the UK and India for the prevention of diabetes and cardiovascular disease (CVD).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1171
• Est. completion date: December 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 55 Years

Eligibility

Inclusion Criteria:

• Men and women with no history of diabetes

• Persons with 2 or more risk factors including

1. Age 35-55 years

2. Positive family history of diabetes

3. Body mass index =23kg/m2

4. Waist circumference >90cm for men and >80cm for women

5. Hypertension

6. Sedentary habits

• HbA1c 6.0% - <6.5%

Exclusion Criteria:

• Known diabetes

• Any other illness

• Unwilling to participate

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Prediabetic State

Intervention

Behavioral:
• Lifestyle Modification
The mobile phone based intervention will use short messaging service (SMS or text messaging) to deliver education, treatment targets, advice, support and motivation.

Locations

Country	Name	City	State
India	India Diabetes Research Foundation	Chennai	Tamil Nadu
United Kingdom	Imperial College	London

Sponsors (4)

Lead Sponsor	Collaborator
India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals	Imperial College London, Indian Council of Medical Research, Medical Research Council

Countries where clinical trial is conducted

India,  United Kingdom, 

References & Publications (6)

Ramachandran A, Riddle MC, Kabali C, Gerstein HC; ORIGIN Investigators. Relationship between A1C and fasting plasma glucose in dysglycemia or type 2 diabetes: an analysis of baseline data from the ORIGIN trial. Diabetes Care. 2012 Apr;35(4):749-53. doi: 10.2337/dc11-1918. Epub 2012 Feb 8. — View Citation

Ramachandran A, Snehalatha C, Mary S, Mukesh B, Bhaskar AD, Vijay V; Indian Diabetes Prevention Programme (IDPP). The Indian Diabetes Prevention Programme shows that lifestyle modification and metformin prevent type 2 diabetes in Asian Indian subjects with impaired glucose tolerance (IDPP-1). Diabetologia. 2006 Feb;49(2):289-97. Epub 2006 Jan 4. — View Citation

Ramachandran A, Snehalatha C, Mary S, Selvam S, Kumar CK, Seeli AC, Shetty AS. Pioglitazone does not enhance the effectiveness of lifestyle modification in preventing conversion of impaired glucose tolerance to diabetes in Asian Indians: results of the Indian Diabetes Prevention Programme-2 (IDPP-2). Diabetologia. 2009 Jun;52(6):1019-26. doi: 10.1007/s00125-009-1315-x. Epub 2009 Mar 10. — View Citation

Ramachandran A, Snehalatha C, Samith Shetty A, Nanditha A. Predictive value of HbA1c for incident diabetes among subjects with impaired glucose tolerance--analysis of the Indian Diabetes Prevention Programmes. Diabet Med. 2012 Jan;29(1):94-8. doi: 10.1111/j.1464-5491.2011.03392.x. — View Citation

Ramachandran A, Snehalatha C, Yamuna A, Mary S, Ping Z. Cost-effectiveness of the interventions in the primary prevention of diabetes among Asian Indians: within-trial results of the Indian Diabetes Prevention Programme (IDPP). Diabetes Care. 2007 Oct;30(10):2548-52. Epub 2007 Aug 1. — View Citation

Shetty AS, Chamukuttan S, Nanditha A, Raj RK, Ramachandran A. Reinforcement of adherence to prescription recommendations in Asian Indian diabetes patients using short message service (SMS)--a pilot study. J Assoc Physicians India. 2011 Nov;59:711-4. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression to diabetes	The primary outcome is progression to diabetes assessed by HbA1c =6.5%.	Participants will be assessed at 12-month, 24-month intervals from the time of randomisation for 2 years.	No
Secondary	Improvements in physical activity	Improvement in physical activity defined as minutes per day of moderate-to-vigorous physical activity (MVPA) measured by Actigraph, total and domain-specific physical activity measured by Recent Physical Activity Questionnaire (RPAQ).	Participants will be assessed at 6 month intervals for 2 years.	No
Secondary	Improvements in cardiovascular risk factors	Measurement of insulin and lipid levels	Participants will be assessed at 6-month, 12-month and 24-month intervals for 2 years.	No
Secondary	Improvements in Quality of Life	Quality of life measured by EQ-5D	Participants will be assessed at 12-month and 24-month intervals for 2 years.	No