Feasibility Study of AMENUCED Program in Type 2 Diabetes

Not Applicable

Not yet recruiting

• Conditions: Diabete Type 2

• Registration Number: NCT07186686
• Lead Sponsor: Universidad de Sonora

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-08
• Study Start: 2025-09-01
• Study First Submitted: 2025-09-02
• Study First Submitted QC: 2025-09-18
• Last Update Submitted: 2025-09-18
• Study First Posted: 2025-09-22
• Last Update Posted: 2025-09-22
• Primary Completion: 2025-12
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• History of bariatric surgery

• Any other medical, psychiatric, or behavioral condition that, in the investigator's judgment, may interfere with participation in the intervention

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Acceptance of the AMENUCED Program	Baseline to 12 weeks post intervention	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.
Retention in the AMENUCED Program	Baseline to 12 weeks post intervention.	Retention will be measured by the percentage of participants who remain in the program. Unit of Measure: Percentage of participants (%)

Secondary Outcome Measures

Name	Time	Method
Change in Glycated Hemoglobin	Baseline and 12 weeks post-intervention	Measured using standardized blood tests to assess glycemic control. Unit of Measure: %
Change in body fat	Baseline and 12 weeks post-intervention	Measured in using medical body composition analyzer (Seca mBCA 514) under standardized conditions. Unit of measure (kg of body fat)
Change in Body Mass Index	Baseline and 12 weeks post-intervention	Calculated as weight (kg) divided by height squared (m²), using standardized equipment and protocol. Unit of measure: kg/m²
Change in waist circumference	Baseline and 12 weeks post-intervention	Measured with anthropometric tape (Lufkin Executive W606PMMX) at the umbilical level. Unit of measure: cm
Change in Blood Pressure	Baseline and 12 weeks post-intervention	Systolic and diastolic blood pressure will be measured using an Omron digital sphygmomanometer (HEM-907XL) on the upper arm, following American Heart Association guidelines. Unit of Measure: mmHg
Change in Health-Related Quality of Life	Baseline and 12 weeks post-intervention	Assessed using the "SF-36 Health Survey", with scores ranging from 0 = worst possible health status, to 100 = best possible health status. Unit of measure: 0 - 100
Change in Fasting Glucose	Baseline and 12 weeks post-intervention	Measured via standardized laboratory testing. Unit of Measure: mg/dL
Change in Perceived Stress	Baseline and 12 weeks post-intervention.	Assessed using "The Coping Stress Questionnaire (CAE): Validation in a Mexican Sample". The CAE includes seven subscales: problem-solving focus, negative self-focus, positive reappraisal, open emotional expression, avoidance, social support seeking and religious coping. Participants rate each item on a 6-point Likert scale (0 = never, 5 = always). Higher scores indicate more frequent use of the corresponding coping strategy. Use of Measure: Subscale scores (range: 0-5 per item; total score varies by subscale)
Change in Depression Symptoms	Baseline and 12 weeks post intervention.	Assessed using the Beck Depression Inventory-II, a 21 item self-report questionnaire designed to measure the severity of depression. Each item is rated on a 4 point Likert scale (0 = not al all, 3 = severe), with total scores ranging from 0 to 63. Higher scores indicate greater severity of depressive symptoms. Unit of Measure: Total score range 0 - 63
Change in Anxiety Symptoms	Baseline and 12 weeks post intervention.	Assessed using the "Beck Anxiety Inventory (BIA), a 21 item self report questionnaire designed to measure the severity of anxiety in adults. Each item is rated on a 4 point likert scale (0 = not al all, 3 = severely), with total scores ranging from 0 to 63. Higher scores indicate greater severity of anxiety symptoms. The BAI has demonstrated strong psychometric properties in general Mexican populations. Unit of Measure: Total score range 0 - 63
Change in Diabetes Knowledge	Baseline and 12 weeks post intervention.	Assessed using the "24 - item version of the Diabetes Knowledge Questionnaire (DKQ-24), developed and validated in Spanish for Mexican-American populations. Each item is scored as correct or incorrect, with total scores ranging from 0 to 24. Higher scores indicate greater diabetes-related knowledge. Unit of Measure: Total score, range 0 - 24
Change in Total Cholesterol	Baseline and 12 weeks post intervention	Measured via standardized laboratory testing. Unit of Measure: mg/dL
Change in HDL Cholesterol	Baseline and 12 weeks post intervention	Measured via standardized laboratory testing. Higher values indicated better cardiovascular profile. Unit of Measure: mg/dL
Change in LDL Cholesterol	Baseline and 12 weeks post intervention	Measured via standardized laboratory testing. Unit of Measure: mg/dL
Change in Triglycerides	Baseline and 12 weeks post intervention	Measured via standardized laboratory testing. Unit of Measure: mg/dL

Trial Locations

Locations (1)

Centro de Promoción de Salud Nutricional (CPSN), Hermosillo, Sonora 83000; 🇲🇽 Hermosillo, Sonora, Mexico