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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Glycated Hemoglobin | Measured using standardized blood tests to assess glycemic control. Unit of Measure: % | 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) |
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Inclusion Criteria:
Exclusion Criteria:
Diabetes-related complications, including:
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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro de Promoción de Salud Nutricional (CPSN), Hermosillo, Sonora 83000 | Hermosillo | Sonora | 83000 | Mexico |
Individual participant data (IPD) will not be shared, as this study corresponds to a pilot phase with a small sample size.
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D015596 | Nutrition Assessment |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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Single-arm interventional study where all participants received the AMENUCED program.
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| 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 | 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 | 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 | 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 | Baseline and 12 weeks post-intervention |
| Change in Fasting Glucose | Measured via standardized laboratory testing. Unit of Measure: mg/dL | 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) | 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 | 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 | 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 | Baseline and 12 weeks post intervention. |
| Change in Total Cholesterol | Measured via standardized laboratory testing. Unit of Measure: mg/dL | 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 | Baseline and 12 weeks post intervention |
| Change in LDL Cholesterol | Measured via standardized laboratory testing. Unit of Measure: mg/dL | Baseline and 12 weeks post intervention |
| Change in Triglycerides | Measured via standardized laboratory testing. Unit of Measure: mg/dL | Baseline and 12 weeks post intervention |
| D004700 | Endocrine System Diseases |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
| D004778 | Environment and Public Health |