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

NCT01296100 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 730

Last updated 2016-07-26

No results posted yet for this study

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.

Conditions

Interventions

BEHAVIORAL

Lifestyle intervention (nutrition)

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.

BEHAVIORAL

Lifestyle intervention (physical activity)

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.

Sponsors & Collaborators

Principal Investigators

  • Jaakko O Tuomilehto, MD, PhD · University of Helsinki

  • Tania Acosta, MD · CIIS LTDA

  • Noël C Barengo, MD, PhD, MPH · CIIS LTDA

  • Astrid Arrieta, MD · CIIS LTDA

  • Carlos Ricaurte · CIIS LTDA

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
34 Years
Max Age
69 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2013-01-31
Completion
2015-03-31

Countries

  • Colombia

Study Locations

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01296100 on ClinicalTrials.gov