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Nutrition Care Process in Mexican Older Adults (NCP)

Primary Purpose

Malnutrition

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Nutrition care process
Sponsored by
Universidad de Colima
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malnutrition focused on measuring Nutrition care process, Older adults, Malnutrition, Eating habits

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Nutrition care process

    Conventional nutritional intervention

    Arm Description

    Outcomes

    Primary Outcome Measures

    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.
    Changes from baseline Malnutrition parameters measured by GLIM Criteria at 12 months
    Application of the Global Leadership Initiative on Malnutrition (GLIM)

    Secondary Outcome Measures

    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)
    Changes from lean body mass at 12 months
    Lean body mass measured by Bioelectrical Impedance Analysis (Tanita BC 568)
    Changes from baseline water mass at 12 months
    Water mass measured by Bioelectrical Impedance Analysis (Tanita BC 568)
    Changes from baseline fat body mass at 12 months
    Fat body mass measured by Bioelectrical Impedance Analysis (Tanita BC 568)
    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
    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.
    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.
    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.
    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.
    Changes from baseline diabetes mellitus control at 12 months
    diabetes mellitus control reported by a medical record
    Changes from baseline obesity control at 12 months
    Obesity control reported by a medical record
    Changes from baseline undernutrition control at 12 months
    Undernutrition control reported by a medical record
    Changes from baseline hypertension control at 12 months
    Hypertension control reported by a medical record
    Changes from baseline serum albumin at 12 months
    Measurement of albumin (g/dL) by serum blood sample (using a Spinreact kit).
    Changes from baseline serum total cholesterol at 12 months
    Measurement of total cholesterol (mg/dL) by serum blood sample (using a Spinreact kit).
    Changes from baseline serum HDL Cholesterol at 12 months
    Measurement of HDL Cholesterol (mg/dL) by serum blood sample (using a Spinreact kit).
    Changes from baseline serum triglycerides at 12 months
    Measurement of triglycerides (mg/dL) by serum blood sample (using a Spinreact kit).
    Changes from baseline fasting glucose at 12 months
    Measurement of fasting glucose (mg/dL) by serum blood sample (using a Spinreact kit).

    Full Information

    First Posted
    March 6, 2023
    Last Updated
    March 28, 2023
    Sponsor
    Universidad de Colima
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05808270
    Brief Title
    Nutrition Care Process in Mexican Older Adults
    Acronym
    NCP
    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.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 1, 2023 (Anticipated)
    Primary Completion Date
    July 31, 2024 (Anticipated)
    Study Completion Date
    July 31, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universidad de Colima

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. 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?
    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Malnutrition
    Keywords
    Nutrition care process, Older adults, Malnutrition, Eating habits

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    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
    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.
    Allocation
    Randomized
    Enrollment
    76 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Nutrition care process
    Arm Type
    Active Comparator
    Arm Title
    Conventional nutritional intervention
    Arm Type
    Placebo Comparator
    Intervention Type
    Behavioral
    Intervention Name(s)
    Nutrition care process
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Changes from baseline Eating Habits (Survey of Food Quality of the Older Person) at 12 months
    Description
    Application of the structured Survey of Food Quality of the Older Person.
    Time Frame
    12 months after the intervention with the Nutrition Care Process
    Title
    Changes from baseline Malnutrition parameters measured by GLIM Criteria at 12 months
    Description
    Application of the Global Leadership Initiative on Malnutrition (GLIM)
    Time Frame
    12 months after the intervention with the Nutrition Care Process
    Secondary Outcome Measure Information:
    Title
    Changes from baseline Quality of life perception (WHOQOL) at 12 months
    Description
    Application of the Quality of life perception (World Health Organization Quality of Life Questionnaire)
    Time Frame
    12 months after the intervention with the Nutrition Care Process
    Title
    Changes from lean body mass at 12 months
    Description
    Lean body mass measured by Bioelectrical Impedance Analysis (Tanita BC 568)
    Time Frame
    12 months after the intervention with the Nutrition Care Process
    Title
    Changes from baseline water mass at 12 months
    Description
    Water mass measured by Bioelectrical Impedance Analysis (Tanita BC 568)
    Time Frame
    12 months after the intervention with the Nutrition Care Process
    Title
    Changes from baseline fat body mass at 12 months
    Description
    Fat body mass measured by Bioelectrical Impedance Analysis (Tanita BC 568)
    Time Frame
    12 months after the intervention with the Nutrition Care Process
    Title
    Changes from baseline body mass index at 12 months
    Description
    weight (Tanita BC 568) and height (SECA 213) will be combined to report BMI in kg/m^2
    Time Frame
    12 months after the intervention with the Nutrition Care Process
    Title
    Changes from baseline energy intake (by a dietary recall) at 12 months
    Description
    Calorie intake measured by a 24 food dietary recall and reported in kcal.
    Time Frame
    12 months after the intervention with the Nutrition Care Process
    Title
    Changes from baseline carbohydrate intake (by a dietary recall) at 12 months
    Description
    Carbohydrate intake measured by a 24 food dietary recall and reported in grams.
    Time Frame
    12 months after the intervention with the Nutrition Care Process
    Title
    Changes from baseline protein intake (by a dietary recall) at 12 months
    Description
    Protein intake measured by a 24 food dietary recall and reported in grams.
    Time Frame
    12 months after the intervention with the Nutrition Care Process
    Title
    Changes from baseline lipid intake (by a dietary recall) at 12 months
    Description
    Lipid intake measured by a 24 food dietary recall and reported in grams.
    Time Frame
    12 months after the intervention with the Nutrition Care Process
    Title
    Changes from baseline diabetes mellitus control at 12 months
    Description
    diabetes mellitus control reported by a medical record
    Time Frame
    12 months after the intervention with the Nutrition Care Process
    Title
    Changes from baseline obesity control at 12 months
    Description
    Obesity control reported by a medical record
    Time Frame
    12 months after the intervention with the Nutrition Care Process
    Title
    Changes from baseline undernutrition control at 12 months
    Description
    Undernutrition control reported by a medical record
    Time Frame
    12 months after the intervention with the Nutrition Care Process
    Title
    Changes from baseline hypertension control at 12 months
    Description
    Hypertension control reported by a medical record
    Time Frame
    12 months after the intervention with the Nutrition Care Process
    Title
    Changes from baseline serum albumin at 12 months
    Description
    Measurement of albumin (g/dL) by serum blood sample (using a Spinreact kit).
    Time Frame
    12 months after the intervention with the Nutrition Care Process
    Title
    Changes from baseline serum total cholesterol at 12 months
    Description
    Measurement of total cholesterol (mg/dL) by serum blood sample (using a Spinreact kit).
    Time Frame
    12 months after the intervention with the Nutrition Care Process
    Title
    Changes from baseline serum HDL Cholesterol at 12 months
    Description
    Measurement of HDL Cholesterol (mg/dL) by serum blood sample (using a Spinreact kit).
    Time Frame
    12 months after the intervention with the Nutrition Care Process
    Title
    Changes from baseline serum triglycerides at 12 months
    Description
    Measurement of triglycerides (mg/dL) by serum blood sample (using a Spinreact kit).
    Time Frame
    12 months after the intervention with the Nutrition Care Process
    Title
    Changes from baseline fasting glucose at 12 months
    Description
    Measurement of fasting glucose (mg/dL) by serum blood sample (using a Spinreact kit).
    Time Frame
    12 months after the intervention with the Nutrition Care Process

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Alondra Elizabeth García-Ibáñez, MSc
    Phone
    +523121512015
    Email
    agarcia30@ucol.mx
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mónica Ríos Silva, PhD, MD
    Phone
    +523121206914
    Email
    mrios@ucol.mx

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Links:
    URL
    https://www.ncpro.org/nutrition-care-process
    Description
    Academy of Nutrition and Dietetics. Nutrition Care Process

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