Prediabetic StatePREDICOLNCT03049839
Evaluation of a Community Health Program for the Prevention of Type 2 Diabetes and Other Cardio-metabolic Risk Factors in Adults: Districts of Barranquilla and Bogota, Colombia - January 2017 - December 2019
A study testing Intervention_ S, Intervention_ I and Intervention_ C in people with Prediabetic State, run by Universidad del Norte at 2 sites in Colombia.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Prediabetic State
- What is being tested?
- Intervention_ S, Intervention_ I and Intervention_ C
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 650 participants
- Where
- 2 sitesColombia
- Study dates
- 1 Aug 2017to 30 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Colombia2 sites, 2 recruiting
- Recruiting
Universidad Del Norte
Barranquilla
tania Acosta, MD, MPH, PhD, 00573106331321, tacosta@uninorte.edu.co
Tania Acosta, MD, MPH
- Recruiting
Asociación Colombiana de Diabetes
Bogotá
Pablo Aschner, MD, 00573102118652, pabloaschner@gmail.com
Pablo Aschner, MD
About this study
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) .
Read the detailed description
Cardiovascular disease (CVD) and type 2 diabetes (T2D) are currently the public health problems fastest growing globally. According to the International Diabetes Federation (IDF) is estimated to have diabetes approximately 382 million people in the world. It is shown that early interventions in lifestyle can reduce the burden of type 2 diabetes and factors of cardiovascular modifiable risk.
This is an intervention study in cluster. 36-month integrated into 4 phases:
- Design and adaptation of educational intervention
- Population Screening
- Stepwise intervention program
- Evaluation results.
For population screening test FINDRISC validated for the Latin American population will be employed and a score of 12 will be considered as a cutoff to all who have a score equal to or greater than 12 (moderate or high risk) they perform a test oral glucose tolerance (OGTT) according to the results 3 groups will be established
- High risk group: Subjects with FINDRISC score ≥12 and impaired glucose tolerance (IGT)
- Moderate risk group: Subjects with FINDRISC score ≥12 and impaired fasting glucose or norm tolerant
- Low risk group: Subjects with FINDRISC score <12.
Intervention program: One year of duration, 3 types of programs are established.
- Lifestyle Intervention program_ Communitarian: Intervention program at Community level with Low risk group.
- Lifestyle Intervention program_ Informative: Program information intervention for the group with moderate risk.
- Lifestyle Intervention program_ structured: intervention program for members of high-risk group.
An evaluation of the different variables are studied at baseline and the final of the intervention in the three groups established.
- Conditions
- Prediabetic State
- Being tested
- Intervention_ S, Intervention_ I, Intervention_ C
- Medical subject headings
- Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention_ SBehavioural
Also called LIP_Structures
One year Structured intervention program for members of high-risk group (Subjects with FINDRISC score ≥12 points and impaired glucose tolerance (IGT))
Intervention_ IBehavioural
Also called LIP_Informative
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)
Intervention_ CBehavioural
Also called LIP_Communitarian
One year, Intervention program at Community level. People with a FINDRISC less than 12 points
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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 Receives: 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 Receives: Behavioral: Intervention_ C |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of body weight average at year-end structured intervention compared with the baseline.
Reduction of body weight in kilograms
Measured: 12 Months
Secondary outcomes (3)
Reduction of fasting glucose level at year-end intervention program (all groups) compared with baseline.
Reduction of fasting glucose level in mg/dl
Measured: 12 Months
Reduction of 2-hour glucose level at year-end structured and informative intervention program compared with baseline.
Reduction of 2-hour glucose level in mg/dl
Measured: 12 Months
Reduced of waist circumference average at year-end structured intervention program compared with baseline.
Reduction of waist circumference in centimeters
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2017
- Study start1 Aug 2017
- Primary completion30 Oct 2019 (estimated)
- Study completion30 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prediabetic StateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 650 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad del Norte
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tania Acosta, MD, MPH, Principal investigator, Universidad del NortePablo Achner, MD, ENDOCRINOLOGIST, Principal investigator, ASOCIACIÓN COLOMBIANA DE DIABETES
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03049839
- Sponsor's protocol ID
- 55657
- Acronym
- PREDICOL
- Status last verified
- Mar 2019
- First submitted
- 21 Oct 2016
- Last updated
- 12 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Community Health Program for the Prevention of Type 2 Diabetes and Other Cardio-metabolic Risk Factors in Adults: Districts of Barranquilla and Bogota, Colombia - January 2017 - December 2019
- ClinicalTrials.gov ID
- NCT03049839
- Acronym / sponsor ID
- PREDICOL / 55657
- Conditions
- Prediabetic State
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 650 participants (estimated)
- Lead sponsor
- Universidad del NorteUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 30 Oct 2019 (estimated)
- Study completion
- 30 Dec 2019 (estimated)
- First posted
- 10 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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) .
Detailed description
Cardiovascular disease (CVD) and type 2 diabetes (T2D) are currently the public health problems fastest growing globally. According to the International Diabetes Federation (IDF) is estimated to have diabetes approximately 382 million people in the world. It is shown that early interventions in lifestyle can reduce the burden of type 2 diabetes and factors of cardiovascular modifiable risk.
This is an intervention study in cluster. 36-month integrated into 4 phases:
- Design and adaptation of educational intervention
- Population Screening
- Stepwise intervention program
- Evaluation results.
For population screening test FINDRISC validated for the Latin American population will be employed and a score of 12 will be considered as a cutoff to all who have a score equal to or greater than 12 (moderate or high risk) they perform a test oral glucose tolerance (OGTT) according to the results 3 groups will be established
- High risk group: Subjects with FINDRISC score ≥12 and impaired glucose tolerance (IGT)
- Moderate risk group: Subjects with FINDRISC score ≥12 and impaired fasting glucose or norm tolerant
- Low risk group: Subjects with FINDRISC score <12.
Intervention program: One year of duration, 3 types of programs are established.
- Lifestyle Intervention program_ Communitarian: Intervention program at Community level with Low risk group.
- Lifestyle Intervention program_ Informative: Program information intervention for the group with moderate risk.
- Lifestyle Intervention program_ structured: intervention program for members of high-risk group.
An evaluation of the different variables are studied at baseline and the final of the intervention in the three groups established.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intervention_ structured | Experimental | Behavioral: Intervention_ SOne 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) |
| Intervention_ Informative | Experimental | Behavioral: Intervention_ IProgram 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 |
| Intervention_ Communitarian | Experimental | Behavioral: Intervention_ COne 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 |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention_ SAlso: LIP_StructuresOne year Structured intervention program for members of high-risk group (Subjects with FINDRISC score ≥12 points and impaired glucose tolerance (IGT)) | Behavioural | Intervention_ structured |
| Intervention_ IAlso: LIP_InformativeOne 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) | Behavioural | Intervention_ Informative |
| Intervention_ CAlso: LIP_CommunitarianOne year, Intervention program at Community level. People with a FINDRISC less than 12 points | Behavioural | Intervention_ Communitarian |
Primary outcome
Reduction of body weight average at year-end structured intervention compared with the baseline.
Time frame: 12 Months
Reduction of body weight in kilograms
3 secondary outcomes
Reduction of fasting glucose level at year-end intervention program (all groups) compared with baseline.
Time frame: 12 Months
Reduction of 2-hour glucose level at year-end structured and informative intervention program compared with baseline.
Time frame: 12 Months
Reduced of waist circumference average at year-end structured intervention program compared with baseline.
Time frame: 12 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tania Acosta, MD, MPH principal investigator
Universidad del Norte
Pablo Achner, MD, ENDOCRINOLOGIST principal investigator
ASOCIACIÓN COLOMBIANA DE DIABETES
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention_ S, Intervention_ I and Intervention_ C in people with Prediabetic State, run by Universidad del Norte at 2 sites in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tania Acosta (00573106331321, tacosta@uninorte.edu.co), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of body weight average at year-end structured intervention compared with the baseline. (time frame: 12 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2019.