NCT05502445

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 16, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 16, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 9, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 16, 2022

Completed
Last Updated

August 16, 2022

Status Verified

August 1, 2022

Enrollment Period

7 months

First QC Date

August 9, 2022

Last Update Submit

August 12, 2022

Conditions

Keywords

MalnutritionSarcopeniaHospitalized PatientsElderlyPatient-Centered CareFood IntakeProteinNutritional Supplements

Outcome Measures

Primary Outcomes (1)

  • 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

    three days

Secondary Outcomes (6)

  • Assessment and screening of sarcopenia risk by SARC-F questionnaire

    one day (first day of assessment)

  • Assessment of low muscle strength

    one day (first day of assessment)

  • Assessment of low muscle mass by measuring the calf circumference

    one day (first day of assessment)

  • Assessment and screening of nutritional risk

    one day (first day of assessment)

  • Dietary prescription of hospitalized elderly

    three days

  • +1 more secondary outcomes

Study Arms (2)

Control Group

NO INTERVENTION

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

Intervention Group

ACTIVE COMPARATOR

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

Interventions

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.

Intervention Group

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Israelita Albert Einstein

SĂ£o Paulo, SĂ£o Paulo, 05652-900, Brazil

Location

Related Publications (38)

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Related Links

MeSH Terms

Conditions

CachexiaFeeding BehaviorSarcopeniaKwashiorkorPatient ParticipationMalnutrition

Interventions

Early Intervention, Educational

Condition Hierarchy (Ancestors)

Weight LossBody Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsThinnessBehavior, AnimalBehaviorMuscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalSevere Acute MalnutritionNutrition DisordersNutritional and Metabolic DiseasesPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth Behavior

Intervention Hierarchy (Ancestors)

Child Health ServicesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPreventive Health Services

Study Officials

  • Ana P Lottenberg

    Hospital Israelita Albert Einstein

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Nutritionist of Clinical Nutrition Department

Study Record Dates

First Submitted

August 9, 2022

First Posted

August 16, 2022

Study Start

September 1, 2021

Primary Completion

March 16, 2022

Study Completion

March 16, 2022

Last Updated

August 16, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
from 6 months after publication up to 2 years
Access Criteria
to obtain the study protocol and details of statistical analyses and supplementary materials, contact the author to make a request.

Locations