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

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

Recruiting

Conditions

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

Interventional

Enrollment (Estimated)

80

Phase

  • 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 Backup

Study Locations

    • 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

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
Intervention / Treatment
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
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

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

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.

Investigators

  • 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.

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)

March 1, 2023

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

June 15, 2024

First Submitted That Met QC Criteria

June 15, 2024

First Posted (Actual)

June 21, 2024

Study Record Updates

Last Update Posted (Actual)

June 21, 2024

Last Update Submitted That Met QC Criteria

June 15, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

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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