DiabetesNCT02848547
Post Trial Analysis of a Primary Prevention Study in Asian Indians
An observational study of Diabetes, run by India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals.
Trial summary
An extended follow-up study of NCT00819455 conducted 5 years post randomization. In this study we estimate the incidence of type 2 diabetes among participants enrolled in the diabetes prevention programme. Read more about this study
- Who is it for?
- Ages 40 to 63 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes
- What is being tested?
- Text Messaging via Short Message Service
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 537 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to May 2016
- Phase
- Observational
- 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 40 to 63 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Participants randomized (n=537) in the primary study NCT00819455.
Who may be able to join
- Participants of the primary prevention programme - NCT00819455.
Who cannot join
- Unwilling for participation
About this study
Official title: The Role of Information Technology in the Prevention of Type 2 Diabetes - An Extended Follow-up Study
An extended follow-up study of NCT00819455 conducted 5 years post randomization. In this study we estimate the incidence of type 2 diabetes among participants enrolled in the diabetes prevention programme. This will provide comparison of the progression to diabetes among group motivated through text messages and the group educated only during enrollment. A total of 537 participants were enrolled in the primary study and are invited to participate in a follow-up visit 3 years post active trial period.
- Conditions
- Diabetes
- Being tested
- Text Messaging via Short Message Service
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Text Messaging via Short Message ServiceBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Intervention - SMS | Participants in the intervention group received periodic text messages on healthy lifestyle throughout the study period. Receives: Behavioral: Text Messaging via Short Message Service | |
| Control - Standard Care | Participants in the control group received standard one time advice at entry in the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of type 2 diabetes among participants enrolled in the diabetes prevention programme.
Measured: Two years
Secondary outcomes (1)
Long-term impact of healthy lifestyle through mobile phone based text messaging
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2016 (estimated)
- Study startJan 2016
- Primary completionApr 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 537 participants (actual)
Sponsor and investigators
- Lead sponsor
- India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02848547
- Sponsor's protocol ID
- IDRFARH010
- Status last verified
- Jul 2016
- First submitted
- 26 Jul 2016
- Last updated
- 2 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Nanditha A, Snehalatha C, Raghavan A, Vinitha R, Satheesh K, Susairaj P, Simon M, Selvam S, Ram J, Naveen Kumar AP, Godsland IF, Oliver N, Johnston DG, Ramachandran A. The post-trial analysis of the Indian SMS diabetes prevention study shows persistent beneficial effects of lifestyle intervention. Diabetes Res Clin Pract. 2018 Aug;142:213-221. doi: 10.1016/j.diabres.2018.05.042. Epub 2018 May 31.
PubMed 29859274
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Information Technology in the Prevention of Type 2 Diabetes - An Extended Follow-up Study
- ClinicalTrials.gov ID
- NCT02848547
- Acronym / sponsor ID
- IDRFARH010
- Conditions
- Diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 537 participants (actual)
- Lead sponsor
- India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes HospitalsUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Apr 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 28 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An extended follow-up study of NCT00819455 conducted 5 years post randomization. In this study we estimate the incidence of type 2 diabetes among participants enrolled in the diabetes prevention programme. This will provide comparison of the progression to diabetes among group motivated through text messages and the group educated only during enrollment. A total of 537 participants were enrolled in the primary study and are invited to participate in a follow-up visit 3 years post active trial period.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention - SMS | – | Behavioral: Text Messaging via Short Message ServiceParticipants in the intervention group received periodic text messages on healthy lifestyle throughout the study period. |
| Control - Standard Care | – | –Participants in the control group received standard one time advice at entry in the study. |
Who may qualify
- Ages
- 40 to 63 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Participants randomized (n=537) in the primary study NCT00819455.
Key inclusion criteria (1 listed)
- Participants of the primary prevention programme - NCT00819455.
Key exclusion criteria (1 listed)
- Unwilling for participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Text Messaging via Short Message Service | Behavioural | Intervention - SMS |
Primary outcome
Incidence of type 2 diabetes among participants enrolled in the diabetes prevention programme.
Time frame: Two years
1 secondary outcome
Long-term impact of healthy lifestyle through mobile phone based text messaging
Time frame: Two years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2016.
- Derived from this study: PubMed 29859274Nanditha A, Snehalatha C, Raghavan A, Vinitha R, Satheesh K, Susairaj P, Simon M, Selvam S, Ram J, Naveen Kumar AP, Godsland IF, Oliver N, Johnston DG, Ramachandran A. The post-trial analysis of the Indian SMS diabetes prevention study shows persistent beneficial effects of lifestyle intervention. Diabetes Res Clin Pract. 2018 Aug;142:213-221. doi: 10.1016/j.diabres.2018.05.042. Epub 2018 May 31.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes, run by India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals.
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 1 inclusion and 1 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 2 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Incidence of type 2 diabetes among participants enrolled in the diabetes prevention programme. (time frame: Two 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 NCT02848547, which also lists 1 linked publication.
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 2 Aug 2016.