Multidisciplinary Care for Lifestyle Change for Metabolic Control and Quality of Life in Prediabetes (PreCPro)
NCT Number: NCT06468553
Acronym: PreCPro
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: PreDiabetes
Interventions: BEHAVIORAL: Prediabetes Care Program
Sponsor: Clinica Especializada en el Manejo de la Diabetes en la Ciudad de Mexico
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2023-03-01
Completion Date: 2027-03-01
Locations: Clinica Especializada en el Manejo de la Diabetes, Mexico City, Iztapalapa, 09060, Mexico

Summary:
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.

Primary Outcome Measures: Glycemic control after the initial stage of the program, 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, Weight in kilograms. Weight will be compared from the first visit with the visit to six months later, six months
Secondary Outcome Measures: Glycemic control, HbA1c (percentage): HbA1c will be compared from the last visit (twelve months) and the 24-month visit, twenty four months|Weight change, Weight change (kg) will be compared from the last visit (twelve months) and the 24-month visit, twenty four months|Lipid control, 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, 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, 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, HbA1c (percentage): HbA1c will be compared from the visit on the six months with the last visit (12 month), twelve months|Weight change, Weight Change in kilograms will be compared from the visit on the six months with the last visit (12 month), twelve months|Lipid control, 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, 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, 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, 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, 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, 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