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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
5
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.
Centro de Promoción de Salud Nutricional (CPSN), Hermosillo, Sonora 83000
Hermosillo, Sonora, Mexico
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.
Time frame: 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 (%)
Time frame: Baseline to 12 weeks post intervention.
Change in Glycated Hemoglobin
Measured using standardized blood tests to assess glycemic control. Unit of Measure: %
Time frame: Baseline and 12 weeks post-intervention
Change in body fat
Measured in using medical body composition analyzer (Seca mBCA 514) under standardized conditions. Unit of measure (kg of body fat)
Time frame: Baseline and 12 weeks post-intervention
Change in Body Mass Index
Calculated as weight (kg) divided by height squared (m²), using standardized equipment and protocol. Unit of measure: kg/m²
Time frame: Baseline and 12 weeks post-intervention
Change in waist circumference
Measured with anthropometric tape (Lufkin Executive W606PMMX) at the umbilical level. Unit of measure: cm
Time frame: Baseline and 12 weeks post-intervention
Change in Blood Pressure
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
Time frame: Baseline and 12 weeks post-intervention
Change in Health-Related Quality of Life
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
Time frame: Baseline and 12 weeks post-intervention
Change in Fasting Glucose
Measured via standardized laboratory testing. Unit of Measure: mg/dL
Time frame: Baseline and 12 weeks post-intervention
Change in Perceived Stress
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)
Time frame: Baseline and 12 weeks post-intervention.
Change in Depression Symptoms
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
Time frame: Baseline and 12 weeks post intervention.
Change in Anxiety Symptoms
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
Time frame: Baseline and 12 weeks post intervention.
Change in Diabetes Knowledge
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
Time frame: Baseline and 12 weeks post intervention.
Change in Total Cholesterol
Measured via standardized laboratory testing. Unit of Measure: mg/dL
Time frame: Baseline and 12 weeks post intervention
Change in HDL Cholesterol
Measured via standardized laboratory testing. Higher values indicated better cardiovascular profile. Unit of Measure: mg/dL
Time frame: Baseline and 12 weeks post intervention
Change in LDL Cholesterol
Measured via standardized laboratory testing. Unit of Measure: mg/dL
Time frame: Baseline and 12 weeks post intervention
Change in Triglycerides
Measured via standardized laboratory testing. Unit of Measure: mg/dL
Time frame: Baseline and 12 weeks post intervention
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