MalnutritionNCPNCT05808270
Nutrition Care Process in Mexican Older Adults
A study testing Nutrition care process in people with Malnutrition, run by Universidad de Colima at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Malnutrition
- What is being tested?
- Nutrition care process
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 1 siteMexico
- Study dates
- 1 Aug 2023to 31 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Older adults ≥ 60 years old
- female or male
- who voluntarily agree to participate in the study.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
DIF Estatal Colima
Colima, 28000
Rocío Banda, MSc
About this study
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.
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?
Read the 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).
- Conditions
- Malnutrition
- Being tested
- Nutrition care process
- Keywords
- Nutrition care process, Older adults, Malnutrition, Eating habits
- Medical subject headings
- Malnutrition, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrition care processBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Nutrition care process | Active comparator | Not described Receives: Behavioral: Nutrition care process |
| Conventional nutritional intervention | Placebo comparator | Not described Receives: Behavioral: Nutrition care process |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: 12 months after the intervention with the Nutrition Care Process
Secondary outcomes (18)
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 12 months after the intervention with the Nutrition Care Process
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2023
- Study start1 Aug 2023
- Primary completion31 Jul 2024 (estimated)
- Study completion31 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalnutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Colima
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Miguel Huerta, Universidad de Colima
- Investigators
- Miguel Huerta, PhD, Study chair, Universyty of Colima
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05808270
- Sponsor's protocol ID
- Universidad de Colima
- Acronym
- NCP
- Status last verified
- Dec 2023
- First submitted
- 6 Mar 2023
- Last updated
- 27 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05808270
- Acronym / sponsor ID
- NCP / Universidad de Colima
- Conditions
- Malnutrition
- Keywords
- Nutrition care process, Older adults, Malnutrition, Eating habits
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Universidad de ColimaUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 31 Jul 2024 (estimated)
- Study completion
- 31 Jul 2024 (estimated)
- First posted
- 11 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Nutrition care process | Active comparator | Behavioral: Nutrition care process |
| Conventional nutritional intervention | Placebo comparator | Behavioral: Nutrition care process |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Older adults ≥ 60 years old
- female or male
- who voluntarily agree to participate in the study.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutrition care processAccording 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. | Behavioural | Conventional nutritional intervention, Nutrition care process |
Primary outcome
Changes from baseline Eating Habits (Survey of Food Quality of the Older Person) at 12 months
Time frame: 12 months after the intervention with the Nutrition Care Process
Application of the structured Survey of Food Quality of the Older Person.
Changes from baseline Malnutrition parameters measured by GLIM Criteria at 12 months
Time frame: 12 months after the intervention with the Nutrition Care Process
Application of the Global Leadership Initiative on Malnutrition (GLIM)
18 secondary outcomes
Changes from baseline Quality of life perception (WHOQOL) at 12 months
Time frame: 12 months after the intervention with the Nutrition Care Process
Changes from lean body mass at 12 months
Time frame: 12 months after the intervention with the Nutrition Care Process
Changes from baseline water mass at 12 months
Time frame: 12 months after the intervention with the Nutrition Care Process
Changes from baseline fat body mass at 12 months
Time frame: 12 months after the intervention with the Nutrition Care Process
Changes from baseline body mass index at 12 months
Time frame: 12 months after the intervention with the Nutrition Care Process
Changes from baseline energy intake (by a dietary recall) at 12 months
Time frame: 12 months after the intervention with the Nutrition Care Process
Changes from baseline carbohydrate intake (by a dietary recall) at 12 months
Time frame: 12 months after the intervention with the Nutrition Care Process
Changes from baseline protein intake (by a dietary recall) at 12 months
Time frame: 12 months after the intervention with the Nutrition Care Process
Changes from baseline lipid intake (by a dietary recall) at 12 months
Time frame: 12 months after the intervention with the Nutrition Care Process
Changes from baseline diabetes mellitus control at 12 months
Time frame: 12 months after the intervention with the Nutrition Care Process
Changes from baseline obesity control at 12 months
Time frame: 12 months after the intervention with the Nutrition Care Process
Changes from baseline undernutrition control at 12 months
Time frame: 12 months after the intervention with the Nutrition Care Process
Changes from baseline hypertension control at 12 months
Time frame: 12 months after the intervention with the Nutrition Care Process
Changes from baseline serum albumin at 12 months
Time frame: 12 months after the intervention with the Nutrition Care Process
Changes from baseline serum total cholesterol at 12 months
Time frame: 12 months after the intervention with the Nutrition Care Process
Changes from baseline serum HDL Cholesterol at 12 months
Time frame: 12 months after the intervention with the Nutrition Care Process
Changes from baseline serum triglycerides at 12 months
Time frame: 12 months after the intervention with the Nutrition Care Process
Changes from baseline fasting glucose at 12 months
Time frame: 12 months after the intervention with the Nutrition Care Process
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2023.
- Academy of Nutrition and Dietetics. Nutrition Care ProcessLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Miguel Huerta, PhD study chair
Universyty of Colima
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutrition care process in people with Malnutrition, run by Universidad de Colima at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alondra Elizabeth García-Ibáñez, MSc (+523121512015, agarcia30@ucol.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes from baseline Eating Habits (Survey of Food Quality of the Older Person) at 12 months (time frame: 12 months after the intervention with the Nutrition Care Process). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2023.