NCT03049839

Brief Summary

The main aim of this study is to evaluate the feasibility and effectiveness of a program for modifying lifestyles for diabetes prevention type 2 and control cardio-metabolic risk factors in adults with different categories of risk from the primary health care strategy. The project will show the effect of these interventions for the first time in people With different risk of developing type 2 diabetes throughout the life in populations living in Colombia Located in 2 different cities, one of them in the interior of the country (districts of Bogota) and another in the north coast (districts of Barranquilla) .

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
650

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2017

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 21, 2016

Completed
4 months until next milestone

First Posted

Study publicly available on registry

February 10, 2017

Completed
6 months until next milestone

Study Start

First participant enrolled

August 1, 2017

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2019

Completed
Last Updated

March 12, 2019

Status Verified

March 1, 2019

Enrollment Period

2.2 years

First QC Date

October 21, 2016

Last Update Submit

March 8, 2019

Conditions

Prediabetic State

Outcome Measures

Primary Outcomes (1)

  • Reduction of body weight average at year-end structured intervention compared with the baseline.

    Reduction of body weight in kilograms

    12 Months

Secondary Outcomes (3)

  • Reduction of fasting glucose level at year-end intervention program (all groups) compared with baseline.

    12 Months

  • Reduction of 2-hour glucose level at year-end structured and informative intervention program compared with baseline.

    12 Months

  • Reduced of waist circumference average at year-end structured intervention program compared with baseline.

    12 Months

Study Arms (3)

Intervention_ structured

EXPERIMENTAL

One year Structured intervention program for members of high-risk group (People with glucose intolerance in the OGTT and FINDRISC score ≥12 points) 10 educational group sessions where they will receive information to change lifestyle (1 per 1.5 month)

Behavioral: Intervention_ S

Intervention_ Informative

EXPERIMENTAL

Program information intervention for the group with moderate risk. One year Informative intervention program (People with normotolerant or impaired fasting glucose in the OGTT and FINDRISC score ≥12 points). There is a single group session where they receive information to prevent cardiomatabolic risk factors

Behavioral: Intervention_ I

Intervention_ Communitarian

EXPERIMENTAL

One year, Intervention program at Community level. People with a FINDRISC less than 12 points. Campaigns are carried out at the community level with different strategies (leaflets, booklets) to prevent cardiomatabolic risk factors

Behavioral: Intervention_ C

Interventions

Intervention_ SBEHAVIORAL

One year Structured intervention program for members of high-risk group (Subjects with FINDRISC score ≥12 points and impaired glucose tolerance (IGT))

Also known as: LIP_Structures
Intervention_ structured
Intervention_ IBEHAVIORAL

One year Informative intervention program for members of moderate risk group (People with normotolerant or impaired fasting glucose in the OGTT and a FINDRISC score ≥12 points)

Also known as: LIP_Informative
Intervention_ Informative
Intervention_ CBEHAVIORAL

One year, Intervention program at Community level. People with a FINDRISC less than 12 points

Also known as: LIP_Communitarian
Intervention_ Communitarian

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • People over age 30 years, residents within the perimeter of the conglomerate in the districts of Barranquilla and Bogota
  • Wishing to participate and sign informed consent

You may not qualify if:

  • DT2 known and / or treated
  • History of diseases or events that prevent their participation
  • Neurological disability that does not allow you to make own decisions
  • Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Universidad Del Norte

Barranquilla, Colombia

RECRUITING

Asociación Colombiana de Diabetes

Bogotá, Colombia

RECRUITING

MeSH Terms

Conditions

Prediabetic State

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Tania Acosta, MD, MPH

    Universidad del Norte

    PRINCIPAL INVESTIGATOR

  • Pablo Achner, MD, ENDOCRINOLOGIST

    ASOCIACIÓN COLOMBIANA DE DIABETES

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tania Acosta

CONTACT

00573106331321tacosta@uninorte.edu.co

Pablo Aschner

CONTACT

00573106331321pabloaschner@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 21, 2016

First Posted

February 10, 2017

Study Start

August 1, 2017

Primary Completion

October 30, 2019

Study Completion

December 30, 2019

Last Updated

March 12, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

CO(2)