Multidisciplinary Care for Lifestyle Change for Metabolic Control and Quality of Life in Prediabetes (PreCPro) (PreCPro)

June 15, 2024 updated by: Clinica Especializada en el Manejo de la Diabetes en la Ciudad de Mexico

Impact of a Multidisciplinary Care Program for Lifestyle Change for Metabolic Control and Quality of Life in Prediabetes: Prediabetes Care Program of Mexico City

Prediabetes is part of the natural history of type 2 diabetes mellitus, which is one of the main causes of morbidity and mortality in Mexico. It is known that overweight and obesity are the main risk factors for producing insulin resistance and this in turn leads to prediabetes-diabetes mellitus 2, acting alone or together, excess adipose tissue, mainly visceral, and Prediabetes increase cardiovascular risk before hyperglycemia occurs in the diagnostic criteria for diabetes. Effective strategies have been developed focused on changing lifestyle habits (changes in dietary patterns and increased physical activity) to promote weight loss in populations with and without glucose alterations present, but with limitations in the scope for the size of the affected population. There is a small number of studies developed for this purpose, focused on a multidisciplinary intervention in low- and middle-income countries. The prediabetes care program (PreCPro) is a care initiative developed by the primary care public health services of the Government of Mexico City (CDMX) to promote weight reduction and reduction of hyperglycemia through a intervention composed of an interdisciplinary care team, centered on the patient with a focus on promoting change in people's behavior to adopt healthy eating and physical activity habits. The target population of the prediabetes care program (PreCPro) is made up of patients with prediabetes, without advanced diseases, who receive regular care in public primary care services in Mexico City.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Prediabetes is part of a continuum of progressive dysglycemia that is identified with the presence of hyperglycemia resulting from the destruction or dysfunction of β cells that progresses until plasma glucose concentrations are in the range of diabetes mellitus, by which time the condition has already been detected. presence of organ damage that can no longer be fully reversed and subsequently results in increased disability, morbidity and mortality for families and the high cost of treatment for national healthcare systems. The treatment established for the prevention of diabetes mellitus 2 from stages identifiable through the diagnosis of prediabetes focuses on promoting behavioral changes for the adoption of a healthy diet and increased physical activity with the aim of producing weight reduction with consequent remission of the hyperglycemic state. Although effective behavioral programs have been created for this purpose, the best known being the Diabetes Prevention Program (DPP) in the United States and which is part of its national care strategy, similar care has been carried out in low- and middle-income countries with limited scope because it only focuses on small research studies. The barriers to the implementation of this type of care programs are usually lack of financial resources on the part of health institutions, difficulty in adapting established programs to the specific sociocultural characteristics of each population, lack of access to these programs either due to lack of of time or difficulties in attending due to distance on the part of the participants, among others. Weight loss through changes in dietary patterns and increased physical activity has been shown to prevent or delay the progression of prediabetes to diabetes mellitus 2. The PreCPro program is a care initiative developed by the public health services of primary care of the Government of Mexico City based on the pillars (diet and physical activity) recommended by national and international diabetes mellitus prevention guidelines. The target population of the PreCPro program is made up of patients with prediabetes without advanced diseases, who receive regular care in public primary care services in Mexico City.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Mexico
    • Iztapalapa
      • Mexico City, Iztapalapa, Mexico, 09060
        • Recruiting
        • Clinica Especializada en el Manejo de la Diabetes
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Having diagnosis of prediabetes
  • Acceptance for participation in the program by signing informed consent sheet

Exclusion Criteria:

  • Any type of diabetes
  • Advanced diseases such as ischemic heart disease, heart failure, KDOQI renal failure ≥1, cerebral vascular disease with functional sequelae or those who have comorbidities that limit their life expectancy such as malignant tumors in advanced stages
  • Dependence of illicit drugs
  • Conditions that require short-term surgical treatment.
  • Pregnancy
  • Advanced cognitive deficit or serious psychiatric disorders that hinder treatment adherence
  • Use of medications whose use is associated with alterations in blood glucose levels or weight gain or loss, e.g. e.g. metformin, Glucagon-like peptide-1 receptor agonists, orlistat or corticosteroids
  • Actively taking any supplements dietary or under naturopathic, homeopathic or alternative therapies
  • Have any type of bariatric surgery procedure or weight loss device
  • Current participation in another lifestyle, behavior change, or weight loss or gain program or research study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Prediabetes Care Program
Intervention composed of an interdisciplinary care team, patient-centered care approach for behavior change for the adoption of healthy eating and physical activity
Behavioral: Prediabetes Care Program
Patients are cared for by the medical, nutritionist and psychology team, in a total of 14 individual and group visits, during 12 months of care. The intervention has an initial stage lasting 6 months in which 12 visits will be scheduled and a transition stage lasting 6 more months in which 2 more visits will be scheduled. Patients will be evaluated at 6 months, 12 months and 24 months
Other Names:
  • PreCPro

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Glycemic control after the initial stage of the program
Time Frame: six months
HbA1c (percentage): HbA1c will be compared from the first visit with the visit six months later
six months
Change in weight after the initial stage of the program
Time Frame: six months
Weight in kilograms. Weight will be compared from the first visit with the visit to six months later
six months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Glycemic control
Time Frame: twenty four months
HbA1c (percentage): HbA1c will be compared from the last visit (twelve months) and the 24-month visit
twenty four months
Weight change
Time Frame: twenty four months
Weight change (kg) will be compared from the last visit (twelve months) and the 24-month visit
twenty four months
Lipid control
Time Frame: twenty four months
Total Cholesterol, HDL-Cholesterol, Non-HDL Cholesterol and triglycerides in mg/dL will be compared from the last visit (twelve months) and the 24-month visit
twenty four months
Blood pressure
Time Frame: twenty four months
Systolic and diastolic blood pressure (mmHg) will be compared from the last visit (twelve months) and the 24-month visit
twenty four months
Health-related Quality of Life perception assessed by EuroQol (EQ-5D) Visual Analogue Scale questionnaire
Time Frame: twenty four months
Health-related Quality of life perception with EQ-5D questionnaire visual analogue scale (0-100, higher score means better self-care). Health-related Quality of Life will be compared from the last visit (twelve months) and the 24-month visit
twenty four months
Glycemic control
Time Frame: twelve months
HbA1c (percentage): HbA1c will be compared from the visit on the six months with the last visit (12 month)
twelve months
Weight change
Time Frame: twelve months
Weight Change in kilograms will be compared from the visit on the six months with the last visit (12 month)
twelve months
Lipid control
Time Frame: twelve months
Total Cholesterol, HDL-Cholesterol, Non-HDL Cholesterol and triglycerides in mg/dL will be compared from the visit on the six months with the last visit (12 month)
twelve months
Blood pressure
Time Frame: twelve months
Systolic and diastolic blood pressure (mmHg) will be compared from the visit on the six months with the last visit (12 month)
twelve months
Health-related Quality of Life perception assessed by EuroQol (EQ-5D) Visual Analogue Scale questionnaire
Time Frame: twelve months
Health-related Quality of life perception with EQ-5D questionnaire visual analogue scale (0-100, higher score means better self-care). Health-related Quality of Life will be compared from the visit on the six months with the last visit (12 month)
twelve months
Lipid control
Time Frame: six months
Total Cholesterol, HDL-Cholesterol, Non-HDL Cholesterol and triglycerides in mg/dL will be compared from the first visit with the visit to six months late
six months
Blood pressure
Time Frame: six months
Systolic and diastolic blood pressure (mmHg) will be compared from the first visit with the visit to six months later
six months
Health-related Quality of Life perception assessed by EuroQol (EQ-5D) Visual Analogue Scale questionnaire
Time Frame: six months
Health-related Quality of life perception with EQ-5D questionnaire visual analogue scale (0-100, higher score means better self-care). Health-related Quality of Life will be compared from the first visit with the visit to six months later
six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Clinica Especializada en el Manejo de la Diabetes en la Ciudad de Mexico

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Ruben Silva-Tinoco, MD, Clinica Especializada en el Manejo de la Diabetes
  • Principal Investigator: Viridiana De la Torre-Saldaña, MD, Clinica Especializada en el Manejo de la Diabetes

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 15, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 15, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 21, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 21, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 15, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 101 - 010 - 022 - 23

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The availability to share any data from individual participants must be requested primarily to the institutional Research and Ethics Committee by the study investigators.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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