Nutrition Care Process in Mexican Older Adults

NCT05808270 | Unknown DMC

• 1 other identifier: Universidad de Colima
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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?

Conditions

Malnutrition

Keywords

Nutrition care process; Older adults; Malnutrition; Eating habits

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (18)

• Changes from baseline Quality of life perception (WHOQOL) at 12 months

  12 months after the intervention with the Nutrition Care Process

• Changes from lean body mass at 12 months

  12 months after the intervention with the Nutrition Care Process

• Changes from baseline water mass at 12 months

  12 months after the intervention with the Nutrition Care Process

• Changes from baseline fat body mass at 12 months

  12 months after the intervention with the Nutrition Care Process

• Changes from baseline body mass index at 12 months

  12 months after the intervention with the Nutrition Care Process

Study Arms (2)

Nutrition care process

ACTIVE COMPARATOR

Behavioral: Nutrition care process

Conventional nutritional intervention

PLACEBO COMPARATOR

Behavioral: Nutrition care process

Interventions

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. * 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.

Conventional nutritional intervention; Nutrition care process

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Older adults ≥ 60 years old
• female or male
• who voluntarily agree to participate in the study.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad de Colima: lead

Study Sites (1)

DIF Estatal Colima

Colima, 28000, Mexico

RECRUITING

Related Links

• Academy of Nutrition and Dietetics. Nutrition Care Process

MeSH Terms

Conditions

Malnutrition; Feeding Behavior

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases; Behavior, Animal; Behavior

Study Officials

• Miguel Huerta, PhD

  Universyty of Colima

  STUDY CHAIR

Central Study Contacts

Alondra Elizabeth García-Ibáñez, MSc

CONTACT

+523121512015; agarcia30@ucol.mx

Mónica Ríos Silva, PhD, MD

CONTACT

+523121206914; mrios@ucol.mx

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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).

Study Record Dates

• First Submitted: March 6, 2023
• First Posted: April 11, 2023
• Study Start: August 1, 2023
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: December 27, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)