NCT01570946

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).

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,171

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2012

Longer than P75 for not_applicable

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 3, 2012

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 4, 2012

Completed
27 days until next milestone

Study Start

First participant enrolled

May 1, 2012

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

December 30, 2015

Status Verified

December 1, 2015

Enrollment Period

3.5 years

First QC Date

March 3, 2012

Last Update Submit

December 29, 2015

Conditions

Prediabetic State

Keywords

Lifestyle changes to prevent type 2 diabetes

Outcome Measures

Primary Outcomes (1)

  • 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.

Secondary Outcomes (3)

  • Improvements in physical activity

    Participants will be assessed at 6 month intervals for 2 years.

  • Improvements in cardiovascular risk factors

    Participants will be assessed at 6-month, 12-month and 24-month intervals for 2 years.

  • Improvements in Quality of Life

    Participants will be assessed at 12-month and 24-month intervals for 2 years.

Study Arms (2)

Lifestyle modification

EXPERIMENTAL

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

Standard Care

NO INTERVENTION

Baseline 30-minute interview delivering personalised diet and exercise advice supplemented with educational material on diabetes.

Interventions

Lifestyle ModificationBEHAVIORAL

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

Lifestyle modification

Eligibility Criteria

Age35 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Men and women with no history of diabetes
  • Persons with 2 or more risk factors including
  • Age 35-55 years
  • Positive family history of diabetes
  • Body mass index ≥23kg/m2
  • Waist circumference \>90cm for men and \>80cm for women
  • Hypertension
  • Sedentary habits
  • HbA1c 6.0% - \<6.5%

You may not qualify if:

  • Known diabetes
  • Any other illness
  • Unwilling to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

India Diabetes Research Foundation

Chennai, Tamil Nadu, 600 008, India

Location

Imperial College

London, SW1P 3NE, United Kingdom

Location

Related Publications (8)

  • 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.

    PMID: 21790773BACKGROUND

  • 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.

    PMID: 22616337BACKGROUND

  • 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. doi: 10.1007/s00125-005-0097-z. Epub 2006 Jan 4.

    PMID: 16391903BACKGROUND

  • 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.

    PMID: 19277602BACKGROUND

  • 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. doi: 10.2337/dc07-0150. Epub 2007 Aug 1.

    PMID: 17670917BACKGROUND

  • 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.

    PMID: 22323416BACKGROUND

  • Nanditha A, Thomson H, Susairaj P, Srivanichakorn W, Oliver N, Godsland IF, Majeed A, Darzi A, Satheesh K, Simon M, Raghavan A, Vinitha R, Snehalatha C, Westgate K, Brage S, Sharp SJ, Wareham NJ, Johnston DG, Ramachandran A. A pragmatic and scalable strategy using mobile technology to promote sustained lifestyle changes to prevent type 2 diabetes in India and the UK: a randomised controlled trial. Diabetologia. 2020 Mar;63(3):486-496. doi: 10.1007/s00125-019-05061-y. Epub 2020 Jan 9.

    PMID: 31919539DERIVED

  • 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.

    PMID: 30200935DERIVED

MeSH Terms

Conditions

Prediabetic State

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
President, India Diabetes Research Foundation

Study Record Dates

First Submitted

March 3, 2012

First Posted

April 4, 2012

Study Start

May 1, 2012

Primary Completion

November 1, 2015

Study Completion

December 1, 2015

Last Updated

December 30, 2015

Record last verified: 2015-12

Locations

IN(1)GB(1)