NCP: Nutrition Care Process in Mexican Older Adults

Sponsor

Universidad de Colima (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05808270

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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?

Condition or Disease	Intervention/Treatment	Phase
Malnutrition	Behavioral: Nutrition care process	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

76 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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).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 (Participant)

Masking Description:

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.

Primary Purpose:

Treatment

Official Title:

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.

Anticipated Study Start Date :

Aug 1, 2023

Anticipated Primary Completion Date :

Jul 31, 2024

Anticipated Study Completion Date :

Jul 31, 2024

Arms and Interventions

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.

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

Outcome Measures

Primary Outcome Measures

Changes from baseline Eating Habits (Survey of Food Quality of the Older Person) at 12 months [12 months after the intervention with the Nutrition Care Process]
Application of the structured Survey of Food Quality of the Older Person.
Changes from baseline Malnutrition parameters measured by GLIM Criteria at 12 months [12 months after the intervention with the Nutrition Care Process]
Application of the Global Leadership Initiative on Malnutrition (GLIM)

Secondary Outcome Measures

Changes from baseline Quality of life perception (WHOQOL) at 12 months [12 months after the intervention with the Nutrition Care Process]
Application of the Quality of life perception (World Health Organization Quality of Life Questionnaire)
Changes from lean body mass at 12 months [12 months after the intervention with the Nutrition Care Process]
Lean body mass measured by Bioelectrical Impedance Analysis (Tanita BC 568)
Changes from baseline water mass at 12 months [12 months after the intervention with the Nutrition Care Process]
Water mass measured by Bioelectrical Impedance Analysis (Tanita BC 568)
Changes from baseline fat body mass at 12 months [12 months after the intervention with the Nutrition Care Process]
Fat body mass measured by Bioelectrical Impedance Analysis (Tanita BC 568)
Changes from baseline body mass index at 12 months [12 months after the intervention with the Nutrition Care Process]
weight (Tanita BC 568) and height (SECA 213) will be combined to report BMI in kg/m^2
Changes from baseline energy intake (by a dietary recall) at 12 months [12 months after the intervention with the Nutrition Care Process]
Calorie intake measured by a 24 food dietary recall and reported in kcal.
Changes from baseline carbohydrate intake (by a dietary recall) at 12 months [12 months after the intervention with the Nutrition Care Process]
Carbohydrate intake measured by a 24 food dietary recall and reported in grams.
Changes from baseline protein intake (by a dietary recall) at 12 months [12 months after the intervention with the Nutrition Care Process]
Protein intake measured by a 24 food dietary recall and reported in grams.
Changes from baseline lipid intake (by a dietary recall) at 12 months [12 months after the intervention with the Nutrition Care Process]
Lipid intake measured by a 24 food dietary recall and reported in grams.
Changes from baseline diabetes mellitus control at 12 months [12 months after the intervention with the Nutrition Care Process]
diabetes mellitus control reported by a medical record
Changes from baseline obesity control at 12 months [12 months after the intervention with the Nutrition Care Process]
Obesity control reported by a medical record
Changes from baseline undernutrition control at 12 months [12 months after the intervention with the Nutrition Care Process]
Undernutrition control reported by a medical record
Changes from baseline hypertension control at 12 months [12 months after the intervention with the Nutrition Care Process]
Hypertension control reported by a medical record
Changes from baseline serum albumin at 12 months [12 months after the intervention with the Nutrition Care Process]
Measurement of albumin (g/dL) by serum blood sample (using a Spinreact kit).
Changes from baseline serum total cholesterol at 12 months [12 months after the intervention with the Nutrition Care Process]
Measurement of total cholesterol (mg/dL) by serum blood sample (using a Spinreact kit).
Changes from baseline serum HDL Cholesterol at 12 months [12 months after the intervention with the Nutrition Care Process]
Measurement of HDL Cholesterol (mg/dL) by serum blood sample (using a Spinreact kit).
Changes from baseline serum triglycerides at 12 months [12 months after the intervention with the Nutrition Care Process]
Measurement of triglycerides (mg/dL) by serum blood sample (using a Spinreact kit).
Changes from baseline fasting glucose at 12 months [12 months after the intervention with the Nutrition Care Process]
Measurement of fasting glucose (mg/dL) by serum blood sample (using a Spinreact kit).

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Universidad de Colima

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Academy of Nutrition and Dietetics. Nutrition Care Process

Publications

None provided.

Responsible Party:

Miguel Huerta, Professor, Universidad de Colima

ClinicalTrials.gov Identifier:

NCT05808270

Other Study ID Numbers:

Universidad de Colima

First Posted:

Apr 11, 2023

Last Update Posted:

Apr 11, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Miguel Huerta, Professor, Universidad de Colima

Nutrition care process

Older adults

Malnutrition

Eating habits

Additional relevant MeSH terms:

Malnutrition

Study Results

No Results Posted as of Apr 11, 2023