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

Primary Purpose

Prediabetic State

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Lifestyle Modification
Sponsored by
India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Prediabetic State focused on measuring Lifestyle changes to prevent type 2 diabetes

Eligibility Criteria

35 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • India Diabetes Research Foundation
  • Imperial College

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Lifestyle modification

Standard Care

Arm Description

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

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

Outcomes

Primary Outcome Measures

Progression to diabetes
The primary outcome is progression to diabetes assessed by HbA1c ≥6.5%.

Secondary Outcome Measures

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).
Improvements in cardiovascular risk factors
Measurement of insulin and lipid levels
Improvements in Quality of Life
Quality of life measured by EQ-5D

Full Information

First Posted
March 3, 2012
Last Updated
December 29, 2015
Sponsor
India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals
Collaborators
Indian Council of Medical Research, Medical Research Council, Imperial College London
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1. Study Identification

Unique Protocol Identification Number
NCT01570946
Brief Title
Use of Mobile Technology to Promote Sustained Lifestyle Changes to Prevent Type 2 Diabetes in India and the UK
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 Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals
Collaborators
Indian Council of Medical Research, Medical Research Council, Imperial College London

4. Oversight

Data Monitoring Committee
Yes

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prediabetic State
Keywords
Lifestyle changes to prevent type 2 diabetes

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1171 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lifestyle modification
Arm Type
Experimental
Arm Description
The mobile phone based intervention will use short messaging service (SMS or text messaging) to deliver education, treatment targets, advice, support and motivation.
Arm Title
Standard Care
Arm Type
No Intervention
Arm Description
Baseline 30-minute interview delivering personalised diet and exercise advice supplemented with educational material on diabetes.
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle Modification
Intervention Description
The mobile phone based intervention will use short messaging service (SMS or text messaging) to deliver education, treatment targets, advice, support and motivation.
Primary Outcome Measure Information:
Title
Progression to diabetes
Description
The primary outcome is progression to diabetes assessed by HbA1c ≥6.5%.
Time Frame
Participants will be assessed at 12-month, 24-month intervals from the time of randomisation for 2 years.
Secondary Outcome Measure Information:
Title
Improvements in physical activity
Description
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).
Time Frame
Participants will be assessed at 6 month intervals for 2 years.
Title
Improvements in cardiovascular risk factors
Description
Measurement of insulin and lipid levels
Time Frame
Participants will be assessed at 6-month, 12-month and 24-month intervals for 2 years.
Title
Improvements in Quality of Life
Description
Quality of life measured by EQ-5D
Time Frame
Participants will be assessed at 12-month and 24-month intervals for 2 years.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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% Exclusion Criteria: Known diabetes Any other illness Unwilling to participate
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ramachandran Ambady, MD., Ph.D., D.Sc., FRCP
Organizational Affiliation
President
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Desmond G Johnston, MB ChB.,PhD.,FRCP.,FRCPath
Organizational Affiliation
Campus Dean, Imperial College London,Director, UK Diabetes Research Network
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nicholas J Wareham, MBBS.,M.Sc.Ph.D
Organizational Affiliation
Director, MRC Epidemiology Unit and co-Director Institute of Metabolic Science, University of Cambridge
Official's Role
Principal Investigator
Facility Information:
Facility Name
India Diabetes Research Foundation
City
Chennai
State/Province
Tamil Nadu
ZIP/Postal Code
600 008
Country
India
Facility Name
Imperial College
City
London
ZIP/Postal Code
SW1P 3NE
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
21790773
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.
Results Reference
background
PubMed Identifier
22616337
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.
Results Reference
background
PubMed Identifier
16391903
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. doi: 10.1007/s00125-005-0097-z. Epub 2006 Jan 4.
Results Reference
background
PubMed Identifier
19277602
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.
Results Reference
background
PubMed Identifier
17670917
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. doi: 10.2337/dc07-0150. Epub 2007 Aug 1.
Results Reference
background
PubMed Identifier
22323416
Citation
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.
Results Reference
background
PubMed Identifier
31919539
Citation
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.
Results Reference
derived
PubMed Identifier
30200935
Citation
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.
Results Reference
derived

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

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