Nutrition Care Process in Mexican Older Adults

NCT ID: NCT05808270

Last Updated: 2023-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-01

Study Completion Date

2024-07-31

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).

Conditions

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Malnutrition

Keywords

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Nutrition care process Older adults Malnutrition Eating habits

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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).
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
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.

Study Groups

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Nutrition care process

Group Type ACTIVE_COMPARATOR

Nutrition care process

Intervention Type 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

Group Type PLACEBO_COMPARATOR

Nutrition care process

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

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.
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universidad de Colima

OTHER

Sponsor Role lead

Responsible Party

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Miguel Huerta

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Miguel Huerta, PhD

Role: STUDY_CHAIR

Universyty of Colima

Locations

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DIF Estatal Colima

Colima, , Mexico

Site Status RECRUITING

Countries

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Mexico

Central Contacts

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Alondra Elizabeth García-Ibáñez, MSc

Role: CONTACT

Phone: +523121512015

Email: [email protected]

Mónica Ríos Silva, PhD, MD

Role: CONTACT

Phone: +523121206914

Email: [email protected]

Facility Contacts

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Rocío Banda, MSc

Role: primary

Related Links

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https://www.ncpro.org/nutrition-care-process

Academy of Nutrition and Dietetics. Nutrition Care Process

Other Identifiers

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Universidad de Colima

Identifier Type: -

Identifier Source: org_study_id