NCT02848547

Brief 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. 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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
537

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2016

Shorter than P25 for all trials

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

Study Start

First participant enrolled

January 1, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 26, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 28, 2016

Completed
Last Updated

August 2, 2016

Status Verified

July 1, 2016

Enrollment Period

3 months

First QC Date

July 26, 2016

Last Update Submit

July 30, 2016

Conditions

Diabetes

Outcome Measures

Primary Outcomes (1)

  • Incidence of type 2 diabetes among participants enrolled in the diabetes prevention programme.

    Two years

Secondary Outcomes (1)

  • Long-term impact of healthy lifestyle through mobile phone based text messaging

    Two years

Study Arms (2)

Intervention - SMS

Participants in the intervention group received periodic text messages on healthy lifestyle throughout the study period.

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.

Interventions

Text Messaging via Short Message ServiceBEHAVIORAL
Intervention - SMS

Eligibility Criteria

Age40 Years - 63 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Participants randomized (n=537) in the primary study NCT00819455.

You may qualify if:

  • Participants of the primary prevention programme - NCT00819455.

You may not qualify if:

  • Unwilling for participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 29859274DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Serum and blood cells are stored.

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 26, 2016

First Posted

July 28, 2016

Study Start

January 1, 2016

Primary Completion

April 1, 2016

Study Completion

May 1, 2016

Last Updated

August 2, 2016

Record last verified: 2016-07