CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 730 enrolled
Drug / intervention
Lifestyle intervention (nutrition) +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01296100
NCT01296100N/ACompleted
CompareCT.gov

DEMOnstration Area for Primary Prevention of Type 2 Diabetes, JUAN Mina and Barranquilla, Colombia

Centro de Investigacion Sanitaria·interventional·Posted Feb 15, 2011·Updated Jul 26, 2016

In Brief

A clinical study evaluating Lifestyle intervention (nutrition) and Lifestyle intervention (physical activity) for Type 2 Diabetes and Glucose Metabolism Disorders. Completed, enrolled 730 participants across 5 sites.

Detailed Summary

The main aim of this study is to investigate to what extent it is possible to reach normal glucose metabolism and optimal cardiovascular disease (CVD) risk factor levels with early lifestyle interventions in people at high risk of type 2 diabetes compared with those who receive standard therapy (usual care) only. The project will show the effect of these interventions for the first time in people of low socio-economic levels living in a Caribbean environment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes, Glucose Metabolism Disorders
CountriesColombia
CollaboratorsInternational Diabetes Federation, University of Helsinki

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 15, 2011
Enrollment StartFeb 1, 2011
Primary CompletionJan 1, 2013
Study CompletionMar 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 15.4 years ago

Interventions

Lifestyle intervention (nutrition)behavioral

The 200 study participants of this arm will first receive 6 months of Nutritional counseling and thereafter combined nutrition/physical activity counseling during 18 month. The counseling sessions consists of monthly group seminars (10 participants/group) and totally 6 individual visits with a nutritionist and 6 visits with a physical activity expert.

Lifestyle intervention (physical activity)behavioral

The 200 study participants of this arm will first receive 6 months of physical activity counseling and thereafter combined nutrition/physical activity counseling during 18 month. The counseling sessions consists of monthly group seminars (10 participants/group) and totally 6 individual visits with a nutritionist and 6 visits with a physical activity expert.