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The aim of this clinical trial is to determine the efficacy at 12 months of the application of the nutrition care process in the eating habits of older adults in the state of Colima, Mexico compared to a conventional nutritional intervention.
The main questions it aims to answer is: what is the efficacy of the application of the nutrition care process vs. a conventional nutritional intervention on the eating habits of older adults in the state of Colima, Mexico after 12 months of follow-up?
Participants will be two study groups. Group 1 will apply the nutritional care process and Group 2 will use standard care. The Structured Survey of Food Quality of the older adult will be applied to classify eating habits as good and bad; as well as the reduction of malnutrition in the study participants, in addition, the 24-hour reminder and the food consumption frequency questionnaire will be evaluated before and after the nutritional intervention, an eating plan will be determined according to the needs and later, follow-up will be given for 8 weeks, finally monitoring will be done at 3, 6 and 12 months in order to detect changes in eating habits.
The financial resources will be financed by resources own in the Social Coexistence Center for the older adults in the metropolitan area of Colima, Mexico. Group experience: there are health professionals specialized in patient care.
The protocol has the approval of a local research ethics committee (CEICANCL220223-NUTRICIA-02).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nutrition care process | Active Comparator |
| |
| Conventional nutritional intervention | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nutrition care process | Behavioral | According to the randomization and simple blinding, there will be 2 study groups in which group 1 will be operated on Nutrition care process and group 2 with Conventional nutritional intervention.
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes from baseline Eating Habits (Survey of Food Quality of the Older Person) at 12 months | Application of the structured Survey of Food Quality of the Older Person. | 12 months after the intervention with the Nutrition Care Process |
| Changes from baseline Malnutrition parameters measured by GLIM Criteria at 12 months | Application of the Global Leadership Initiative on Malnutrition (GLIM) | 12 months after the intervention with the Nutrition Care Process |
| Measure | Description | Time Frame |
|---|---|---|
| Changes from baseline Quality of life perception (WHOQOL) at 12 months | Application of the Quality of life perception (World Health Organization Quality of Life Questionnaire) | 12 months after the intervention with the Nutrition Care Process |
| Changes from lean body mass at 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alondra Elizabeth GarcĂa-Ibáñez, MSc | Contact | +523121512015 | agarcia30@ucol.mx | |
| MĂłnica RĂos Silva, PhD, MD | Contact | +523121206914 | mrios@ucol.mx |
| Name | Affiliation | Role |
|---|---|---|
| Miguel Huerta, PhD | Universyty of Colima | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| DIF Estatal Colima | Recruiting | Colima | 28000 | Mexico |
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| Label | URL |
|---|---|
| Academy of Nutrition and Dietetics. Nutrition Care Process | View source |
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| ID | Term |
|---|---|
| D044342 | Malnutrition |
| D005247 | Feeding Behavior |
| ID | Term |
|---|---|
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001522 | Behavior, Animal |
| D001519 | Behavior |
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There will be two groups in which one group will be given a conventional intervention, a second group will use the nutrition care process (NCP). A nutritional clinical history will be applied to each of the older adults to know general data, body composition, biochemical and clinical parameters, nutritional evaluation (considered step 1 of the NCP), then a nutritional diagnosis will be given (step 2) , to give a dietary prescription, objectives, action plan, intervention and nutritional education to the patient for a period of 8 weeks (step 3) to monitor adherence to the nutritional prescription, which will be monitored at 3 , 6 and 12 months (step 4).
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Each participant belonging to this institution has the same probability of being selected for the study. On this occasion, a numbered list of the subjects candidates to participate in the study will be needed. Subsequently, by means of a raffle with balls numbered from 1 to 2, the subjects will be assigned to each of the interventions, number 1 corresponds to the intervention with the nutrition care process and number 2 to the conventional nutritional intervention.
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Lean body mass measured by Bioelectrical Impedance Analysis (Tanita BC 568) |
| 12 months after the intervention with the Nutrition Care Process |
| Changes from baseline water mass at 12 months | Water mass measured by Bioelectrical Impedance Analysis (Tanita BC 568) | 12 months after the intervention with the Nutrition Care Process |
| Changes from baseline fat body mass at 12 months | Fat body mass measured by Bioelectrical Impedance Analysis (Tanita BC 568) | 12 months after the intervention with the Nutrition Care Process |
| Changes from baseline body mass index at 12 months | weight (Tanita BC 568) and height (SECA 213) will be combined to report BMI in kg/m^2 | 12 months after the intervention with the Nutrition Care Process |
| Changes from baseline energy intake (by a dietary recall) at 12 months | Calorie intake measured by a 24 food dietary recall and reported in kcal. | 12 months after the intervention with the Nutrition Care Process |
| Changes from baseline carbohydrate intake (by a dietary recall) at 12 months | Carbohydrate intake measured by a 24 food dietary recall and reported in grams. | 12 months after the intervention with the Nutrition Care Process |
| Changes from baseline protein intake (by a dietary recall) at 12 months | Protein intake measured by a 24 food dietary recall and reported in grams. | 12 months after the intervention with the Nutrition Care Process |
| Changes from baseline lipid intake (by a dietary recall) at 12 months | Lipid intake measured by a 24 food dietary recall and reported in grams. | 12 months after the intervention with the Nutrition Care Process |
| Changes from baseline diabetes mellitus control at 12 months | diabetes mellitus control reported by a medical record | 12 months after the intervention with the Nutrition Care Process |
| Changes from baseline obesity control at 12 months | Obesity control reported by a medical record | 12 months after the intervention with the Nutrition Care Process |
| Changes from baseline undernutrition control at 12 months | Undernutrition control reported by a medical record | 12 months after the intervention with the Nutrition Care Process |
| Changes from baseline hypertension control at 12 months | Hypertension control reported by a medical record | 12 months after the intervention with the Nutrition Care Process |
| Changes from baseline serum albumin at 12 months | Measurement of albumin (g/dL) by serum blood sample (using a Spinreact kit). | 12 months after the intervention with the Nutrition Care Process |
| Changes from baseline serum total cholesterol at 12 months | Measurement of total cholesterol (mg/dL) by serum blood sample (using a Spinreact kit). | 12 months after the intervention with the Nutrition Care Process |
| Changes from baseline serum HDL Cholesterol at 12 months | Measurement of HDL Cholesterol (mg/dL) by serum blood sample (using a Spinreact kit). | 12 months after the intervention with the Nutrition Care Process |
| Changes from baseline serum triglycerides at 12 months | Measurement of triglycerides (mg/dL) by serum blood sample (using a Spinreact kit). | 12 months after the intervention with the Nutrition Care Process |
| Changes from baseline fasting glucose at 12 months | Measurement of fasting glucose (mg/dL) by serum blood sample (using a Spinreact kit). | 12 months after the intervention with the Nutrition Care Process |