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

• ClinicalTrials.gov Identifier: NCT01570946
• Recruitment Status: Completed
• First Posted: April 4, 2012
• Last Update Posted: December 30, 2015
• Sponsor: India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals
• Collaborators: Indian Council of Medical Research; Medical Research Council; Imperial College London
• Information provided by (Responsible Party): Dr.A.Ramachandran, India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals

Study Description

Brief 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).

Condition or disease	Intervention/treatment	Phase
Prediabetic State	Behavioral: Lifestyle Modification	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 1171 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• 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
• Study Start Date: May 2012
• Actual Primary Completion Date: November 2015
• Actual Study Completion Date: December 2015

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	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.
No Intervention: Standard Care; Baseline 30-minute interview delivering personalised diet and exercise advice supplemented with educational material on diabetes.

Outcome Measures

Primary Outcome Measures :

1. Progression to diabetes [ Time Frame: Participants will be assessed at 12-month, 24-month intervals from the time of randomisation for 2 years. ]
   The primary outcome is progression to diabetes assessed by HbA1c ≥6.5%.

Secondary Outcome Measures :

1. Improvements in physical activity [ Time Frame: Participants will be assessed at 6 month intervals for 2 years. ]
   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).
2. Improvements in cardiovascular risk factors [ Time Frame: Participants will be assessed at 6-month, 12-month and 24-month intervals for 2 years. ]
   Measurement of insulin and lipid levels
3. Improvements in Quality of Life [ Time Frame: Participants will be assessed at 12-month and 24-month intervals for 2 years. ]
   Quality of life measured by EQ-5D

Eligibility Criteria

• Ages Eligible for Study: 35 Years to 55 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

India

India Diabetes Research Foundation

Chennai, Tamil Nadu, India, 600 008

United Kingdom

Imperial College

London, United Kingdom, SW1P 3NE

Sponsors and Collaborators

India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals

Indian Council of Medical Research

Medical Research Council

Imperial College London

Investigators

• Principal Investigator: Ramachandran Ambady, MD., Ph.D., D.Sc., FRCP; President
• Principal Investigator: Desmond G Johnston, MB ChB.,PhD.,FRCP.,FRCPath; Campus Dean, Imperial College London,Director, UK Diabetes Research Network
• Principal Investigator: Nicholas J Wareham, MBBS.,M.Sc.Ph.D; Director, MRC Epidemiology Unit and co-Director Institute of Metabolic Science, University of Cambridge

More Information

Publications:

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.

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.

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.

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.

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.

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.

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

Thomson H, Oliver N, Godsland IF, Darzi A, Srivanichakorn W, Majeed A, Johnston DG, Nanditha A, Snehalatha C, Raghavan A, Susairaj P, Simon M, Satheesh K, Ramachandran A, Sharp S, Westgate K, Brage S, Wareham N. Protocol for a clinical trial of text messaging in addition to standard care versus standard care alone in prevention of type 2 diabetes through lifestyle modification in India and the UK. BMC Endocr Disord. 2018 Sep 10;18(1):63. doi: 10.1186/s12902-018-0293-8.

• Responsible Party: Dr.A.Ramachandran, President, India Diabetes Research Foundation, India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals
• ClinicalTrials.gov Identifier: NCT01570946 History of Changes
• Other Study ID Numbers: 58/1/MRC-ICMR/09/NCD-II_018
• First Posted: April 4, 2012
• Last Update Posted: December 30, 2015
• Last Verified: December 2015

Keywords provided by Dr.A.Ramachandran, India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals:

Lifestyle changes to prevent type 2 diabetes

Additional relevant MeSH terms:

Diabetes Mellitus, Type 2; Prediabetic State; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases