The Nutritionist's Educational Intervention on the Protein Intake in Hospitalized Elderly People

August 12, 2022 updated by: Vanessa AC Ramis Figueira, Hospital Israelita Albert Einstein

Does the Nutritionist's Educational Intervention Influence Protein Intake in Hospitalized Elderly People?

The food intake is often compromised in the elderly, and during hospitalization, dietary restrictions may be imposed, making them more susceptible to the risk of malnutrition and sarcopenia. It is essential to make an early identification of the elderly with low intake and involve them in their self-care. The aims will be assess the influence of the nutritionist's educational action to increase protein intake in elderly patients, to analyze the knowledge on its importance in the prevention of sarcopenia and to identify the prevalence of nutritional risk. This is a field, prospective, correlational, comparative and randomized study. The elderly patients will be randomized into a Control Group and Intervention Group.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The Control Group will follow the flow of nutritional assessment and monitoring while the Intervention Group will receive daily visits to monitor food intake, leaflet and educational video on the importance of protein and its source foods. In both groups, a questionnaire on knowledge of protein sources and its importance will be applied, and we will calculated the 24-hour recall of a regular day and for three days of hospitalization. Patients will be assessment by Mini Nutritional Assessment-Short Form and SARC-F and will be the measurements of calf circumference and hand grip strength.

Study Type

Interventional

Enrollment (Actual)

58

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • São Paulo, SP, Brazil, 05652-900
        • Hospital Israelita Albert Einstein

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • elderly patients aged 60 years or older,
  • with a prescription of oral feeding, exclusively,
  • minimum period of three days.

Exclusion Criteria:

  • palliative care,
  • treatment for chronic renal failure,
  • patients with neurological deficit and dysphagia,
  • readmissions during the study,
  • receiving enteral and/or parenteral nutritional therapy,
  • patients in isolation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Group

This group will follow the hospital's standard nutritional assessment and monitoring flow:

  • 24-hour recall: patients will be interviewed to report about one day of their usual diet.
  • Application of a questionnaire: to assess the knowledge about the importance of protein intake in the prevention of sarcopenia and functionality, and whether the participant regularly performs physical activity.
  • Energy and protein needs: estimated according to the clinical status and patient associated pathologies. The protocol of the Clinical Nutrition Service will be followed.
  • Calculation of the Body Mass Index (BMI)
  • Nutritional risk was determined using the Mini Nutritional Assessment-Short Form
  • Screening for sarcopenia: SARC-F ,Calf Circumference and Hand Grip Strength
Active Comparator: Intervention Group

In this group, the steps below are added:

  • On the first day, the delivery of the leaflet on the importance of nutrition in the hospital environment will be added in addition to verbal guidance.
  • On the second day, an educational institutional video with duration of two minutes, will be shown with the title "Food Intake and Oral Supplement in Nutritional Rehabilitation" via tablet or mobile phone.
  • When the 24-hour recall will be collected, an assessment of food intake will be performed, mainly of foods that are sources of protein and, when they were less than 75%, strategies must be designed to increase the acceptance or indication of oral nutritional supplements (ONS).
Other: educational intervention

In this group, the steps below are added:on the first day, the delivery of the leaflet on the importance of nutrition in the hospital environment will be added in addition to verbal guidance. On the second day, an educational institutional video with duration of two minutes, will be shown with the title "Food Intake and Oral Supplement in Nutritional Rehabilitation" via tablet or mobile phone.

When the 24-hour recall will be collected, an assessment of food intake will be performed, mainly of foods that are sources of protein and, when they were less than 75%, strategies must be designed to increase the acceptance or indication of oral nutritional supplements.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total energy and protein needs and intakes from dietary and oral nutritional supplements during hospitalization, according to the study group
Time Frame: three days
Energy and protein intakes per kg of actual body weight and per day
three days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment and screening of sarcopenia risk by SARC-F questionnaire
Time Frame: one day (first day of assessment)
Patients who present a result greater than or equal to 4 of this questionnaire are classified as risk of sarcopenia
one day (first day of assessment)
Assessment of low muscle strength
Time Frame: one day (first day of assessment)
The values that discriminate the altered exam are different for each age and sex. The result will be expressed as normal or low muscle strength
one day (first day of assessment)
Assessment of low muscle mass by measuring the calf circumference
Time Frame: one day (first day of assessment)
the cutoff points of 33cm for females and 34cm for males were used
one day (first day of assessment)
Assessment and screening of nutritional risk
Time Frame: one day (first day of assessment)
Assessment by Mini Nutritional Assessment-Short Form, it has the three classifications: 0-7 points: malnourished; 8 -11 points: at risk of malnutrition; or 12-14 points: well-nourished
one day (first day of assessment)
Dietary prescription of hospitalized elderly
Time Frame: three days
to evaluate the number of hospitalized elderly who remained with salt and sugar restriction in the diet, according to medical prescription
three days
Questionnaire on previous knowledge of protein source foods and sarcopenia
Time Frame: one day
The questionnaire has 9 questions related to knowledge of protein source foods and their importance on health and impact when consumption is not adequate. The last question is about physical activity, to assess how many patients follow the World Health Organization's recommendation. Was evaluated how many patients answered the questions correctly and how many practiced physical activity
one day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Israelita Albert Einstein

Investigators

  • Principal Investigator: Ana P Lottenberg, Hospital Israelita Albert Einstein

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2021

Primary Completion (Actual)

March 16, 2022

Study Completion (Actual)

March 16, 2022

Study Registration Dates

First Submitted

August 9, 2022

First Submitted That Met QC Criteria

August 12, 2022

First Posted (Actual)

August 16, 2022

Study Record Updates

Last Update Posted (Actual)

August 16, 2022

Last Update Submitted That Met QC Criteria

August 12, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VFigueira

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

we will available the study protocol, educational instruments applied in the intervention group (educational and video brochure) and the results of the statistical analysis

IPD Sharing Time Frame

from 6 months after publication up to 2 years

IPD Sharing Access Criteria

to obtain the study protocol and details of statistical analyses and supplementary materials, contact the author to make a request.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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