AzTrials
AzTrials

Prediabetic StateNCT01570946

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

A study testing Lifestyle Modification in people with Prediabetic State, run by India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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%. Read more about this study

Who is it for?
Ages 35 to 55 years
Conditions the study is for
Prediabetic State
What is being tested?
Lifestyle Modification
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,171 participants
Where
2 sitesin 2 countries
Study dates
May 2012to Dec 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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
Show all 9Show fewer
  • Hypertension
  • Sedentary habits
  • HbA1c 6.0% - <6.5%

Who cannot join

  • Known diabetes
  • Any other illness
  • Unwilling to participate

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

India1 site

  • India Diabetes Research Foundation

    Chennai, Tamil Nadu, 600 008

Other trials in India

United Kingdom1 site

  • Imperial College

    London, SW1P 3NE

Other trials in United Kingdom

About this study

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

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.

Read more

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).

Being tested
Lifestyle Modification
Keywords
Lifestyle changes to prevent type 2 diabetes
Medical subject headings
Prediabetic State

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lifestyle ModificationBehavioural

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

Study groups in NCT01570946
Study groupRoleWhat they receive
Lifestyle modificationExperimentalThe mobile phone based intervention will use short messaging service (SMS or text messaging) to deliver education, treatment targets, advice, support and motivation.
Receives: Behavioral: Lifestyle Modification
Standard CareNo interventionBaseline 30-minute interview delivering personalised diet and exercise advice supplemented with educational material on diabetes.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression to diabetes

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

    Measured: Participants will be assessed at 12-month, 24-month intervals from the time of randomisation for 2 years.

Secondary outcomes (3)

  1. 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).

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

  2. Improvements in cardiovascular risk factors

    Measurement of insulin and lipid levels

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

  3. Improvements in Quality of Life

    Quality of life measured by EQ-5D

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Apr 2012 (estimated)
  2. Study startMay 2012
  3. Primary completionNov 2015
  4. Study completionDec 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,171 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01570946
Sponsor's protocol ID
58/1/MRC-ICMR/09/NCD-II_018
Status last verified
Dec 2015
First submitted
3 Mar 2012
Last updated
30 Dec 2015
Results posted
No
Data monitoring committee
Yes

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.

    PubMed 21790773

  • 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.

    PubMed 22616337

  • 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.

    PubMed 16391903

  • 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.

    PubMed 19277602

  • 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.

    PubMed 17670917

  • 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.

    PubMed 22323416

  • 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.

    PubMed 31919539

  • 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.

    PubMed 30200935

Questions about this trial

What is this clinical trial studying?

A study testing Lifestyle Modification in people with Prediabetic State, run by India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in India, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression to diabetes (time frame: Participants will be assessed at 12-month, 24-month intervals from the time of randomisation for 2 years.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01570946, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2015.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in