NCT00819455

Brief Summary

Type 2 diabetes is a major and increasing problem in India and the UK. In clinical trials it can be prevented in people at high risk by lifestyle intervention. While these trials established the proof of principle, they involved a degree of input from healthcare professionals not feasible outside the trial situation. We hypothesize that diabetes prevention can be achieved at lower cost using personalised feedback via mobile phone, based on information on healthy diet and physical activity habits. We shall develop research protocols and computerized algorithms to test this hypothesis in India for application subsequently in the UK and elsewhere.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
537

participants targeted

Target at P75+ for not_applicable type-2-diabetes

Timeline
Completed

Started Mar 2009

Longer than P75 for not_applicable type-2-diabetes

Geographic Reach
1 country

1 active site

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

January 8, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 9, 2009

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2009

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

February 15, 2013

Status Verified

February 1, 2013

Enrollment Period

3.7 years

First QC Date

January 8, 2009

Last Update Submit

February 13, 2013

Conditions

Type 2 Diabetes

Keywords

DiabetesPrevention of DiabetesLifestyle ModificationText messages

Outcome Measures

Primary Outcomes (1)

  • Progression to diabetes

    Prevention of type 2 diabetes in high-risk subjects by lifestyle modification

    6 monthly intervals for 2 years

Secondary Outcomes (2)

  • Improvement in metabolic risk factors for diabetes and cardiovascular diseases and improvement in quality of life

    two years

  • Acceptability of text messaging as tool to prevent diabetes.

    Two years

Study Arms (2)

2

ACTIVE COMPARATOR

In person lifestyle advice at baseline, 6, 12, 18 months.

Behavioral: Control arm (usual care/standard care arm)

1

EXPERIMENTAL

In person lifestyle advice at baseline, 6, 12, 18 months. Receive reminders by internet based, mobile phone text messaging (Frequency, time and number(s) of messages according to participants requirement)

Behavioral: Experimental

Interventions

ExperimentalBEHAVIORAL

Active Life style modification-motivation by I.T technology

1
Control arm (usual care/standard care arm)BEHAVIORAL

Life style modification only once

2

Eligibility Criteria

Age35 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Body mass index ≥ 23
  • Age ≥ 35 years
  • A 1st degree relative with type 2 diabetes

You may not qualify if:

  • Normal and diabetic subjects
  • Presence of other serious illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr.Ambady Ramachandran

Chennai, Tamil Nadu, 600 008, India

Location

Related Publications (6)

  • 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;49:289-97. PMID: 16391903 Snehalatha C, Mary S, Joshi VV, Ramachandran A. Beneficial effects of strategies for primary prevention of diabetes on cardiovascular risk factors: results of the Indian Diabetes Prevention Programme. Diab Vasc Dis Res. 2008 Mar;5:25-9. PMID: 18398809 Murugesan N, Snehalatha C, Shobhana R, Roglic G, Ramachandran A. Awareness about diabetes and its complications in the general and diabetic population in a city in southern India. Diabetes Res Clin Pract. 2007 Sep;77:433-7. PMID: 17291622 Ramachandran A, Mary S, Yamuna A, Murugesan N, Snehalatha C. High prevalence of diabetes and cardiovascular risk factors associated with urbanization in India. Diabetes Care. 2008 May;31:893-8. PMID: 18310309 Ramachandran A. Epidemiology of diabetes in India--three decades of research. J Assoc Physicians India. 2005 Jan;53:34-8. Review. PMID: 15857011

    BACKGROUND

  • Nanditha A, Jagannathan R, Sundaram S, Susairaj P, Shetty AS, Snehalatha C, Ian GF, Johnston DG, Ramachandran A. Combining Fasting Plasma Glucose with Gamma-glutamyl Transferase Improves the Sensitivity to Predict Incident Diabetes in Asian Indian Men with Impaired Glucose Tolerance. J Assoc Physicians India. 2014 Nov;62(11):18-22.

    PMID: 26281475DERIVED

  • Ram J, Selvam S, Snehalatha C, Nanditha A, Simon M, Shetty AS, Godsland IF, Johnston DG, Ramachandran A. Improvement in diet habits, independent of physical activity helps to reduce incident diabetes among prediabetic Asian Indian men. Diabetes Res Clin Pract. 2014 Dec;106(3):491-5. doi: 10.1016/j.diabres.2014.09.043. Epub 2014 Oct 25.

    PMID: 25458326DERIVED

  • Nanditha A, Ram J, Snehalatha C, Selvam S, Priscilla S, Shetty AS, Arun R, Godsland IF, Johnston DG, Ramachandran A. Early improvement predicts reduced risk of incident diabetes and improved cardiovascular risk in prediabetic Asian Indian men participating in a 2-year lifestyle intervention program. Diabetes Care. 2014 Nov;37(11):3009-15. doi: 10.2337/dc14-0407. Epub 2014 Sep 11.

    PMID: 25216506DERIVED

  • Hughes RC, Moore MP, Gullam JE, Mohamed K, Rowan J. An early pregnancy HbA1c >/=5.9% (41 mmol/mol) is optimal for detecting diabetes and identifies women at increased risk of adverse pregnancy outcomes. Diabetes Care. 2014 Nov;37(11):2953-9. doi: 10.2337/dc14-1312. Epub 2014 Sep 4.

    PMID: 25190675DERIVED

  • Ramachandran A, Snehalatha C, Ram J, Selvam S, Simon M, Nanditha A, Shetty AS, Godsland IF, Chaturvedi N, Majeed A, Oliver N, Toumazou C, Alberti KG, Johnston DG. Effectiveness of mobile phone messaging in prevention of type 2 diabetes by lifestyle modification in men in India: a prospective, parallel-group, randomised controlled trial. Lancet Diabetes Endocrinol. 2013 Nov;1(3):191-8. doi: 10.1016/S2213-8587(13)70067-6. Epub 2013 Sep 11.

    PMID: 24622367DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Ambady Ramachandran, M.D, D.Sc

    President, India Diabetes Research Foundation and Chairman & Managing Director, Dr.A.Ramachandran's Diabetes Hospitals

    PRINCIPAL INVESTIGATOR

  • Desmond Geoffrey Johnston, MB Ch B, Ph.D

    Professor of Clinical Endocrinology, Imperial College, London

    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

Study Record Dates

First Submitted

January 8, 2009

First Posted

January 9, 2009

Study Start

March 1, 2009

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

February 15, 2013

Record last verified: 2013-02

Locations

IN(1)