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

Primary Purpose

Old Age; Cachexia, Dietary Habits, Sarcopenia

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
educational intervention
Sponsored by
Hospital Israelita Albert Einstein
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Old Age; Cachexia focused on measuring Malnutrition, Sarcopenia, Hospitalized Patients, Elderly, Patient-Centered Care, Food Intake, Protein, Nutritional Supplements

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital Israelita Albert Einstein

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Control Group

Intervention Group

Arm Description

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

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).

Outcomes

Primary Outcome Measures

Total energy and protein needs and intakes from dietary and oral nutritional supplements during hospitalization, according to the study group
Energy and protein intakes per kg of actual body weight and per day

Secondary Outcome Measures

Assessment and screening of sarcopenia risk by SARC-F questionnaire
Patients who present a result greater than or equal to 4 of this questionnaire are classified as risk of sarcopenia
Assessment of low muscle strength
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
Assessment of low muscle mass by measuring the calf circumference
the cutoff points of 33cm for females and 34cm for males were used
Assessment and screening of nutritional risk
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
Dietary prescription of hospitalized elderly
to evaluate the number of hospitalized elderly who remained with salt and sugar restriction in the diet, according to medical prescription
Questionnaire on previous knowledge of protein source foods and sarcopenia
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

Full Information

First Posted
August 9, 2022
Last Updated
August 12, 2022
Sponsor
Hospital Israelita Albert Einstein
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1. Study Identification

Unique Protocol Identification Number
NCT05502445
Brief Title
The Nutritionist's Educational Intervention on the Protein Intake in Hospitalized Elderly People
Official Title
Does the Nutritionist's Educational Intervention Influence Protein Intake in Hospitalized Elderly People?
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
March 16, 2022 (Actual)
Study Completion Date
March 16, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Israelita Albert Einstein

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 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Old Age; Cachexia, Dietary Habits, Sarcopenia, Protein Malnutrition, Patient Participation
Keywords
Malnutrition, Sarcopenia, Hospitalized Patients, Elderly, Patient-Centered Care, Food Intake, Protein, Nutritional Supplements

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A prospective, correlational, comparative and randomized study, with hospitalized elderly over 60 years, at a private hospital. Patients will be randomized through a numerical sequence list, into Intervention Group (IG) or Control Group (CG). Before the nutritionist performs the first assessment, the envelope to determine which group the patient would be allocated will be selective. The CG will follow the flow of nutritional assessment and monitoring while the IG 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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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
Arm Title
Intervention Group
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
educational intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Total energy and protein needs and intakes from dietary and oral nutritional supplements during hospitalization, according to the study group
Description
Energy and protein intakes per kg of actual body weight and per day
Time Frame
three days
Secondary Outcome Measure Information:
Title
Assessment and screening of sarcopenia risk by SARC-F questionnaire
Description
Patients who present a result greater than or equal to 4 of this questionnaire are classified as risk of sarcopenia
Time Frame
one day (first day of assessment)
Title
Assessment of low muscle strength
Description
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
Time Frame
one day (first day of assessment)
Title
Assessment of low muscle mass by measuring the calf circumference
Description
the cutoff points of 33cm for females and 34cm for males were used
Time Frame
one day (first day of assessment)
Title
Assessment and screening of nutritional risk
Description
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
Time Frame
one day (first day of assessment)
Title
Dietary prescription of hospitalized elderly
Description
to evaluate the number of hospitalized elderly who remained with salt and sugar restriction in the diet, according to medical prescription
Time Frame
three days
Title
Questionnaire on previous knowledge of protein source foods and sarcopenia
Description
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
Time Frame
one day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ana P Lottenberg
Organizational Affiliation
Hospital Israelita Albert Einstein
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Israelita Albert Einstein
City
São Paulo
State/Province
SP
ZIP/Postal Code
05652-900
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
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The Nutritionist's Educational Intervention on the Protein Intake in Hospitalized Elderly People

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