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
About this trial
This is an interventional treatment trial for Malnutrition focused on measuring Nutrition care process, Older adults, Malnutrition, Eating habits
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.
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
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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Nutrition Care Process in Mexican Older Adults
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