Trial Outcomes & Findings for Diabetes Prevention Using SMS Technology (NCT NCT01795833)

Results Overview

The primary outcome will be progression to type 2 diabetes as measured by HbA1c at baseline, 6 months, 12 months and 24 months or by any validated criteria in any other care setting. the World health Organization (WHO) / International Diabetes Federation (IDF) criteria for diagnosis of diabetes will be used throughout.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

2062 participants

Primary outcome timeframe

24 months

Results posted on

2020-10-30

Participant Flow

Participant milestones

Participant milestones
Measure	Text Messages Short text messages related to healthy lifestyle will be sent to half the subjects three times per week, in addition to one off 'one-to-one structured education' during the study period. Short text messages: In addition to structured education on healthy lifestyle provided at baseline, subjects in the arm will receive short text messages containing educational, motivational and supportive content on diet, physical activity, and smoking (if appropriate) during the study period. The content will be appropriate to the stage of the transtheoretical model of behavioural change that the subject is in. This will be assessed by questionnaire at each visit to clinic.	Control Half of the subjects who has received only one off 'one-to-one structured education about healthy lifestyle during the study period
Overall Study STARTED	1031	1031
Overall Study COMPLETED	881	882
Overall Study NOT COMPLETED	150	149

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Text Message - India n=584 Participants Short text messages related to healthy lifestyle will be sent to half the subjects three times per week, in addition to one off 'one-to-one structured education' during the study period. Short text messages: In addition to structured education on healthy lifestyle provided at baseline, subjects in the arm will receive short text messages containing educational, motivational and supportive content on diet, physical activity, and smoking (if appropriate) during the study period. The content will be appropriate to the stage of the transtheoretical model of behavioural change that the subject is in. This will be assessed by questionnaire at each visit to clinic.	Text Message - UK n=447 Participants Short text messages related to healthy lifestyle will be sent to half the subjects three times per week, in addition to one off 'one-to-one structured education' during the study period. Short text messages: In addition to structured education on healthy lifestyle provided at baseline, subjects in the arm will receive short text messages containing educational, motivational and supportive content on diet, physical activity, and smoking (if appropriate) during the study period. The content will be appropriate to the stage of the transtheoretical model of behavioural change that the subject is in. This will be assessed by questionnaire at each visit to clinic.	Control - India n=587 Participants Half of the subjects who has received only one off 'one-to-one structured education about healthy lifestyle during the study period	Control - UK n=444 Participants Half of the subjects who has received only one off 'one-to-one structured education about healthy lifestyle during the study period	Total n=2062 Participants Total of all reporting groups
Age, Continuous	45.8 years STANDARD_DEVIATION 5.4 • n=584 Participants	60.3 years STANDARD_DEVIATION 9.4 • n=447 Participants	45.8 years STANDARD_DEVIATION 5.4 • n=587 Participants	60.2 years STANDARD_DEVIATION 9.3 • n=444 Participants	53 years STANDARD_DEVIATION 7.3 • n=2062 Participants
Sex: Female, Male Female	142 Participants n=584 Participants	231 Participants n=447 Participants	142 Participants n=587 Participants	228 Participants n=444 Participants	743 Participants n=2062 Participants
Sex: Female, Male Male	442 Participants n=584 Participants	216 Participants n=447 Participants	445 Participants n=587 Participants	216 Participants n=444 Participants	1319 Participants n=2062 Participants
Race and Ethnicity Not Collected	—	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United Kingdom	0 participants n=584 Participants	447 participants n=447 Participants	0 participants n=587 Participants	444 participants n=444 Participants	891 participants n=2062 Participants
Region of Enrollment India	584 participants n=584 Participants	0 participants n=447 Participants	587 participants n=587 Participants	0 participants n=444 Participants	1171 participants n=2062 Participants
HbA1c	43.6 mmol/mol STANDARD_DEVIATION 1.4 • n=584 Participants	43.8 mmol/mol STANDARD_DEVIATION 1.4 • n=447 Participants	43.5 mmol/mol STANDARD_DEVIATION 1.4 • n=587 Participants	43.8 mmol/mol STANDARD_DEVIATION 1.4 • n=444 Participants	43.7 mmol/mol STANDARD_DEVIATION 1.4 • n=2062 Participants

PRIMARY outcome

Timeframe: 24 months

The primary outcome will be progression to type 2 diabetes as measured by HbA1c at baseline, 6 months, 12 months and 24 months or by any validated criteria in any other care setting. the World health Organization (WHO) / International Diabetes Federation (IDF) criteria for diagnosis of diabetes will be used throughout.