Clinical trial NCT05808270: Nutrition Care Process in Mexican Older Adults
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
Overall status: RECRUITING
Phase: NA
Conditions: Malnutrition
Keywords: Nutrition care process
Older adults
Malnutrition
Eating habits
Lead sponsor: Universidad de Colima
Sponsor class: OTHER
First posted: 2023-04-11
Enrollment: 76
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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).
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: Changes from baseline Eating Habits (Survey of Food Quality of the Older Person) at 12 months
timeFrame: 12 months after the intervention with the Nutrition Care Process
measure: Changes from baseline Malnutrition parameters measured by GLIM Criteria at 12 months
timeFrame: 12 months after the intervention with the Nutrition Care Process
Secondary outcomes:
measure: Changes from baseline Quality of life perception (WHOQOL) at 12 months
timeFrame: 12 months after the intervention with the Nutrition Care Process
measure: Changes from lean body mass at 12 months
timeFrame: 12 months after the intervention with the Nutrition Care Process
measure: Changes from baseline water mass at 12 months
timeFrame: 12 months after the intervention with the Nutrition Care Process
measure: Changes from baseline fat body mass at 12 months
timeFrame: 12 months after the intervention with the Nutrition Care Process
measure: Changes from baseline body mass index at 12 months
timeFrame: 12 months after the intervention with the Nutrition Care Process
measure: Changes from baseline energy intake (by a dietary recall) at 12 months
timeFrame: 12 months after the intervention with the Nutrition Care Process
measure: Changes from baseline carbohydrate intake (by a dietary recall) at 12 months
timeFrame: 12 months after the intervention with the Nutrition Care Process
measure: Changes from baseline protein intake (by a dietary recall) at 12 months
timeFrame: 12 months after the intervention with the Nutrition Care Process
measure: Changes from baseline lipid intake (by a dietary recall) at 12 months
timeFrame: 12 months after the intervention with the Nutrition Care Process
measure: Changes from baseline diabetes mellitus control at 12 months
timeFrame: 12 months after the intervention with the Nutrition Care Process
measure: Changes from baseline obesity control at 12 months
timeFrame: 12 months after the intervention with the Nutrition Care Process
measure: Changes from baseline undernutrition control at 12 months
timeFrame: 12 months after the intervention with the Nutrition Care Process
measure: Changes from baseline hypertension control at 12 months
timeFrame: 12 months after the intervention with the Nutrition Care Process
measure: Changes from baseline serum albumin at 12 months
timeFrame: 12 months after the intervention with the Nutrition Care Process
measure: Changes from baseline serum total cholesterol at 12 months
timeFrame: 12 months after the intervention with the Nutrition Care Process
measure: Changes from baseline serum HDL Cholesterol at 12 months
timeFrame: 12 months after the intervention with the Nutrition Care Process
measure: Changes from baseline serum triglycerides at 12 months
timeFrame: 12 months after the intervention with the Nutrition Care Process
measure: Changes from baseline fasting glucose at 12 months
timeFrame: 12 months after the intervention with the Nutrition Care Process
Other outcomes:
Locations:
city: Colima
country: Mexico
facility: DIF Estatal Colima
Study officials:
affiliation: Universyty of Colima
name: Miguel Huerta, PhD
role: STUDY_CHAIR
References: