NCT07186686

Feasibility Study of AMENUCED Program in Type 2 Diabetes

Development of the AMENUCED Program and Evaluation of Its Feasibility in Adults With Type 2 Diabetes: A Pre-Post Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Universidad de Sonora · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Type 2 diabetes is characterized by progressive resistance to the effects of insulin, along with deficient insulin production. In Mexico, it affects 18.4% of adults and is the second leading cause of death. According to ENSANUT 2023, 74.2% of adults with diabetes have poor glycemic control. Achieving adequate glycemic control requires multiple interventions. The AMENUCED program is multicomponent and includes medical care, nutritional guidance, lifestyle support, and diabetes education. Each component has independently shown positive outcomes in diabetes management, yet few Mexicans receive this comprehensive care. This study aims to develop the AMENUCED program and evaluate its feasibility (acceptance and retention) after a 3-month intervention in adults with type 2 diabetes. A pre-post pilot study will be conducted. The primary outcome is program feasibility, while secondary outcomes include HbA1c, body weight, BMI, waist circumference, body fat, fasting glucose, plasma lipids, blood pressure, mental health aspects, and diabetes knowledge. Statistical analysis will be exploratory, using paired t-tests or Wilcoxon tests to compare pre- and post-intervention data, and McNemar's test to compare proportions.

Conditions

• Diabete Type 2

Interventions

Type	Name	Description
OTHER	Participants will receive the AMENUCED program including medical care, nutritional counseling, and structured sessions focused on behavioral change and diabetes education.	Medical Attention: Medical management will be provided by a physician who will assess the participant at the beginning and end of the intervention. The physician will be responsible for pharmacological treatment and follow-up throughout the process. Nutritional Attention: Nutritional consultations will be provided by a registered nutritionist over a three-month period, with sessions held weekly. During each consultation, the participant will receive an individualized nutrition plan based on scientific evidence and dietary recommendations. The plan will be tailored to the participant's specific needs, including metabolic control and a hypocaloric intake (ranging from 1200 to 1800 kcal), with the goal of achieving a 5-10% reduction in body weight. Behavioral Lifestyle Change Program: The behavior modification program used in the Action for Health in Diabetes Program (Look AHEAD) study will be adapted to include diabetes self-management activities through a structured manual.

Timeline

• Start date: 2025-09-18
• Primary completion: 2025-12-03
• Completion: 2025-12-12
• First posted: 2025-09-22
• Last updated: 2026-03-25

Locations

1 site across 1 country: Mexico