Nutrition Care Process in Mexican Older Adults

Study Overview
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Brief Summary
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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?

Detailed Description
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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).

Official Title
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Efficacy of the Application of the Nutrition Care Process on the Eating Habits of Older Adults in the State of Colima During 12 Months of Follow-up: a Randomized, Single-blind Clinical Trial.

Conditions
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Malnutrition

Intervention / Treatment
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* Behavioral: Nutrition care process


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Older adults ≥ 60 years old female or male who voluntarily agree to participate in the study. Exclusion Criteria: People who have a specific treatment determined by another health professional people with chronic kidney disease and hemodialysis or dialysis treatment. adherence less than 80% in the nutritional intervention incomplete data collection, participants who decide to leave the project people who are hospitalized or die.

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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).
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Nutrition care process<br> | Behavioral: Nutrition care process<br>* 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. The Nutrition Care Process is a standardized model intended to guide RDNs in providing high quality nutrition care. The NCP consists of four distinct, interrelated steps: Nutrition Assessment, Diagnosis, Intervention, and Monitoring/Evaluation (AND, 2023). In the case of Conventional nutritional intervention, we will base ourselves on the application of a habitual nutritional clinical history, where information will be obtained on the reasons for consultation and the specific needs of the patient to carry out an intervention based on their priorities.<br>|
| Placebo Comparator: Conventional nutritional intervention<br> | Behavioral: Nutrition care process<br>* 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. The Nutrition Care Process is a standardized model intended to guide RDNs in providing high quality nutrition care. The NCP consists of four distinct, interrelated steps: Nutrition Assessment, Diagnosis, Intervention, and Monitoring/Evaluation (AND, 2023). In the case of Conventional nutritional intervention, we will base ourselves on the application of a habitual nutritional clinical history, where information will be obtained on the reasons for consultation and the specific needs of the patient to carry out an intervention based on their priorities.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nutrition care process, Older adults, Malnutrition, Eating habits