An interventional study of Nutrition care process in Malnutrition, sponsored by Universidad de Colima. Status unknown at 1 site in Mexico. Open to participants aged 60 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-12-27.
Sponsored by Universidad de Colima · Not applicable, Interventional, and Treatment
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?
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).
1,619 studies on the registry are indexed under Malnutrition; 241 are open to participants now.
This study's planned enrollment of 76 is below the median of 90 across 1,152 interventional studies indexed under Malnutrition.
Browse Malnutrition studies →Universidad de Colima is the lead sponsor of 12 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Behavioral: 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.
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.
Time frame: 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)
Time frame: 12 months after the intervention with the Nutrition Care Process
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)
Time frame: 12 months after the intervention with the Nutrition Care Process
Changes from lean body mass at 12 months
Lean body mass measured by Bioelectrical Impedance Analysis (Tanita BC 568)
Time frame: 12 months after the intervention with the Nutrition Care Process
Changes from baseline water mass at 12 months
Water mass measured by Bioelectrical Impedance Analysis (Tanita BC 568)
Time frame: 12 months after the intervention with the Nutrition Care Process
Changes from baseline fat body mass at 12 months
Fat body mass measured by Bioelectrical Impedance Analysis (Tanita BC 568)
Time frame: 12 months after the intervention with the Nutrition Care Process
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
Time frame: 12 months after the intervention with the Nutrition Care Process
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.
Time frame: 12 months after the intervention with the Nutrition Care Process
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.
Time frame: 12 months after the intervention with the Nutrition Care Process
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.
Time frame: 12 months after the intervention with the Nutrition Care Process
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.
Time frame: 12 months after the intervention with the Nutrition Care Process
Changes from baseline diabetes mellitus control at 12 months
diabetes mellitus control reported by a medical record
Time frame: 12 months after the intervention with the Nutrition Care Process
Changes from baseline obesity control at 12 months
Obesity control reported by a medical record
Time frame: 12 months after the intervention with the Nutrition Care Process
Changes from baseline undernutrition control at 12 months
Undernutrition control reported by a medical record
Time frame: 12 months after the intervention with the Nutrition Care Process
Changes from baseline hypertension control at 12 months
Hypertension control reported by a medical record
Time frame: 12 months after the intervention with the Nutrition Care Process
Changes from baseline serum albumin at 12 months
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
Changes from baseline serum total cholesterol at 12 months
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
Changes from baseline serum HDL Cholesterol at 12 months
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
Changes from baseline serum triglycerides at 12 months
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
Changes from baseline fasting glucose at 12 months
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
Plan to share: No
Started Aug 2023 (actual). Primary completion is estimated for Jul 2024, 11 months after the start.
Of 438 non-industry interventional studies with no phase under Malnutrition, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 34. This study's planned 11 months is below that.
Counting every sponsor, half of 469 studies reached it within 20 months; a quarter within 10 and three quarters within 34.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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Universidad de Colima