Feasibility Study of AMENUCED Program in Type 2 Diabetes

NCT07186686 | Completed

• 1 other identifier: AMENUCED-DT2-01
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Type 2 Diabetes Mellitus; Pilot Study; Feasibility; Self management education; Lifestyle intervention

Outcome Measures

Primary Outcomes (2)

• Acceptance of the AMENUCED Program

  Acceptance will be assessed by participant ratings using a 1-10 scale (where 1= lowest acceptance and 10 = highest acceptance) for each component of the program, including educational content, delivery format, and perceived usefulness. Unit of measure: Score 1 - 10.

  Baseline to 12 weeks post intervention

• Retention in the AMENUCED Program

  Retention will be measured by the percentage of participants who remain in the program. Unit of Measure: Percentage of participants (%)

  Baseline to 12 weeks post intervention.

Secondary Outcomes (15)

• Change in Glycated Hemoglobin

  Baseline and 12 weeks post-intervention

• Change in body fat

  Baseline and 12 weeks post-intervention

• Change in Body Mass Index

  Baseline and 12 weeks post-intervention

• Change in waist circumference

  Baseline and 12 weeks post-intervention

• Change in Blood Pressure

  Baseline and 12 weeks post-intervention

Study Arms (1)

AMENUCED Intervention Group

EXPERIMENTAL

Participants will receive the AMENUCED program including medical care, nutritional counseling, and structured sessions focused on behavioral change and diabetes education. The study is designed to assess the feasibility and acceptability of the AMANUCED program in adults with Type 2 Diabetes. This intervention does not involve any pharmacological or device-based components.

Other: Participants will receive the AMENUCED program including medical care, nutritional counseling, and structured sessions focused on behavioral change and diabetes education.

Interventions

Participants will receive the AMENUCED program including medical care, nutritional counseling, and structured sessions focused on behavioral change and diabetes education. OTHER

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.

AMENUCED Intervention Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged ≥18 and ≤65 years
• Residing in Hermosillo, Sonora
• Body Mass Index (BMI) ≥25
• Prior diagnosis of Type 2 Diabetes
• Individuals who cannot read or write may be included if accompanied by someone willing to attend sessions and assist with comprehension
• Must have active medical insurance

You may not qualify if:

• Diabetes-related complications, including:
• Advanced diabetic nephropathy
• Neuropathy
• Retinopathy
• Cardiovascular or cerebrovascular diseases
• History of severe hypoglycemia
• Significant metabolic dysregulation (HbA1c ≥10%)
• Use of insulin, sulfonylureas, or meglitinides
• Pregnancy or breastfeeding within the past 6 months
• Diagnosed psychiatric disorders
• Consumption of ≥14 alcoholic beverages per week
• Serious illnesses (e.g., cancer, liver failure, kidney disease)
• Chronic use of corticosteroids
• Plans to relocate during the study period
• Weight loss greater than 5% in the past three months

Sponsors & Collaborators

• Universidad de Sonora: lead

Study Sites (1)

Centro de Promoción de Salud Nutricional (CPSN), Hermosillo, Sonora 83000

Hermosillo, Sonora, 83000, Mexico

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full-time professor

Model Details: Single-arm interventional study where all participants received the AMENUCED program.

Study Record Dates

• First Submitted: September 2, 2025
• First Posted: September 22, 2025
• Study Start: September 18, 2025
• Primary Completion: December 3, 2025
• Study Completion: December 12, 2025
• Last Updated: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)