Nutrition Care Process in Mexican Older Adults (NCP)

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.

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?

Study Overview

• Status: Recruiting
• Conditions: Malnutrition
• Intervention / Treatment: Behavioral: Nutrition care process

Detailed Description

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).

• Study Type: Interventional
• Enrollment (Estimated): 76
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alondra Elizabeth García-Ibáñez, MSc; Phone Number: +523121512015; Email: agarcia30@ucol.mx
• Study Contact Backup: Name: Mónica Ríos Silva, PhD, MD; Phone Number: +523121206914; Email: mrios@ucol.mx

Study Locations

• Mexico
  • Colima, Mexico, 28000
    • Recruiting
    • DIF Estatal Colima
    • Contact: Rocío Banda, MSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Nutrition care process	Behavioral: Nutrition care process; 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.
Placebo Comparator: Conventional nutritional intervention	Behavioral: Nutrition care process; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Universidad de Colima
• Investigators: Study Chair: Miguel Huerta, PhD, Universyty of Colima

Publications and helpful links

Helpful Links

• Academy of Nutrition and Dietetics. Nutrition Care Process

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2023
• Primary Completion (Estimated): July 31, 2024
• Study Completion (Estimated): July 31, 2024

Study Registration Dates

• First Submitted: March 6, 2023
• First Submitted That Met QC Criteria: March 28, 2023
• First Posted (Actual): April 11, 2023

Study Record Updates

• Last Update Posted (Actual): December 27, 2023
• Last Update Submitted That Met QC Criteria: December 22, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Eating habits; Older adults; Malnutrition; Nutrition care process
• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition
• Other Study ID Numbers: Universidad de Colima

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No