Old Age; CachexiaNCT05502445
The Nutritionist's Educational Intervention on the Protein Intake in Hospitalized Elderly People
A study testing educational intervention in people with Old Age; Cachexia and Dietary Habits, run by Hospital Israelita Albert Einstein at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Old Age; Cachexia, Dietary Habits, Sarcopenia
- What is being tested?
- educational intervention
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Sep 2021to 16 Mar 2022
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- elderly patients aged 60 years or older,
- with a prescription of oral feeding, exclusively,
- minimum period of three days.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital Israelita Albert Einstein
São Paulo, São Paulo, 05652-900
About this study
Official title: 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.
Read the 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.
- Conditions
- Old Age; Cachexia, Dietary Habits, Sarcopenia, Protein Malnutrition, Patient Participation
- Being tested
- educational intervention
- Keywords
- Malnutrition, Sarcopenia, Hospitalized Patients, Elderly, Patient-Centered Care, Food Intake, Protein, Nutritional Supplements
- Medical subject headings
- Cachexia, Feeding Behavior, Sarcopenia, Kwashiorkor, Patient Participation, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
educational interventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: educational intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: three days
Secondary outcomes (6)
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
Measured: one day (first day of assessment)
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
Measured: one day (first day of assessment)
Assessment of low muscle mass by measuring the calf circumference
the cutoff points of 33cm for females and 34cm for males were used
Measured: one day (first day of assessment)
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
Measured: one day (first day of assessment)
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
Measured: three days
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
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2022
- Study start1 Sep 2021
- Primary completion16 Mar 2022
- Study completion16 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (38)Papers the sponsor has linked to this study.
- Other trials for Old Age; CachexiaStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Israelita Albert Einstein
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vanessa AC Ramis Figueira, Hospital Israelita Albert Einstein
- Investigators
- Ana P Lottenberg, Principal investigator, Hospital Israelita Albert Einstein
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05502445
- Sponsor's protocol ID
- VFigueira
- Status last verified
- Aug 2022
- First submitted
- 9 Aug 2022
- Last updated
- 16 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: we will available the study protocol, educational instruments applied in the intervention group (educational and video brochure) and the results of the statistical analysis
Publications
Cruz-Jentoft AJ, Baeyens JP, Bauer JM, Boirie Y, Cederholm T, Landi F, Martin FC, Michel JP, Rolland Y, Schneider SM, Topinkova E, Vandewoude M, Zamboni M; European Working Group on Sarcopenia in Older People. Sarcopenia: European consensus on definition and diagnosis: Report of the European Working Group on Sarcopenia in Older People. Age Ageing. 2010 Jul;39(4):412-23. doi: 10.1093/ageing/afq034. Epub 2010 Apr 13.
PubMed 20392703Clegg A, Young J, Iliffe S, Rikkert MO, Rockwood K. Frailty in elderly people. Lancet. 2013 Mar 2;381(9868):752-62. doi: 10.1016/S0140-6736(12)62167-9. Epub 2013 Feb 8.
PubMed 23395245Morley JE. Anorexia of ageing: a key component in the pathogenesis of both sarcopenia and cachexia. J Cachexia Sarcopenia Muscle. 2017 Aug;8(4):523-526. doi: 10.1002/jcsm.12192. Epub 2017 Apr 27.
PubMed 28452130Correia MI, Hegazi RA, Higashiguchi T, Michel JP, Reddy BR, Tappenden KA, Uyar M, Muscaritoli M. Evidence-based recommendations for addressing malnutrition in health care: an updated strategy from the feedM.E. Global Study Group. J Am Med Dir Assoc. 2014 Aug;15(8):544-50. doi: 10.1016/j.jamda.2014.05.011. Epub 2014 Jul 2.
PubMed 24997720Kaiser MJ, Bauer JM, Ramsch C, Uter W, Guigoz Y, Cederholm T, Thomas DR, Anthony PS, Charlton KE, Maggio M, Tsai AC, Vellas B, Sieber CC; Mini Nutritional Assessment International Group. Frequency of malnutrition in older adults: a multinational perspective using the mini nutritional assessment. J Am Geriatr Soc. 2010 Sep;58(9):1734-8. doi: 10.1111/j.1532-5415.2010.03016.x.
PubMed 20863332Cruz-Jentoft AJ, Bahat G, Bauer J, Boirie Y, Bruyere O, Cederholm T, Cooper C, Landi F, Rolland Y, Sayer AA, Schneider SM, Sieber CC, Topinkova E, Vandewoude M, Visser M, Zamboni M; Writing Group for the European Working Group on Sarcopenia in Older People 2 (EWGSOP2), and the Extended Group for EWGSOP2. Sarcopenia: revised European consensus on definition and diagnosis. Age Ageing. 2019 Jan 1;48(1):16-31. doi: 10.1093/ageing/afy169.
PubMed 30312372Gray-Donald K, St-Arnaud-McKenzie D, Gaudreau P, Morais JA, Shatenstein B, Payette H. Protein intake protects against weight loss in healthy community-dwelling older adults. J Nutr. 2014 Mar;144(3):321-6. doi: 10.3945/jn.113.184705. Epub 2013 Dec 19.
PubMed 24357473Houston DK, Nicklas BJ, Ding J, Harris TB, Tylavsky FA, Newman AB, Lee JS, Sahyoun NR, Visser M, Kritchevsky SB; Health ABC Study. Dietary protein intake is associated with lean mass change in older, community-dwelling adults: the Health, Aging, and Body Composition (Health ABC) Study. Am J Clin Nutr. 2008 Jan;87(1):150-5. doi: 10.1093/ajcn/87.1.150.
PubMed 18175749Cederholm T, Barazzoni R, Austin P, Ballmer P, Biolo G, Bischoff SC, Compher C, Correia I, Higashiguchi T, Holst M, Jensen GL, Malone A, Muscaritoli M, Nyulasi I, Pirlich M, Rothenberg E, Schindler K, Schneider SM, de van der Schueren MA, Sieber C, Valentini L, Yu JC, Van Gossum A, Singer P. ESPEN guidelines on definitions and terminology of clinical nutrition. Clin Nutr. 2017 Feb;36(1):49-64. doi: 10.1016/j.clnu.2016.09.004. Epub 2016 Sep 14.
PubMed 27642056Pilgrim AL, Robinson SM, Sayer AA, Roberts HC. An overview of appetite decline in older people. Nurs Older People. 2015 Jun;27(5):29-35. doi: 10.7748/nop.27.5.29.e697.
PubMed 26018489Cox NJ, Morrison L, Ibrahim K, Robinson SM, Sayer AA, Roberts HC. New horizons in appetite and the anorexia of ageing. Age Ageing. 2020 Jul 1;49(4):526-534. doi: 10.1093/ageing/afaa014.
PubMed 32043144de van der Schueren MA, Wijnhoven HA, Kruizenga HM, Visser M. A critical appraisal of nutritional intervention studies in malnourished, community dwelling older persons. Clin Nutr. 2016 Oct;35(5):1008-14. doi: 10.1016/j.clnu.2015.12.013. Epub 2015 Dec 29.
PubMed 26774525Morley JE. Nutrition in the elderly. Curr Opin Gastroenterol. 2002 Mar;18(2):240-5. doi: 10.1097/00001574-200203000-00015.
PubMed 17033294Landi F, Picca A, Calvani R, Marzetti E. Anorexia of Aging: Assessment and Management. Clin Geriatr Med. 2017 Aug;33(3):315-323. doi: 10.1016/j.cger.2017.02.004. Epub 2017 May 20.
PubMed 28689565Malafarina V, Uriz-Otano F, Iniesta R, Gil-Guerrero L. Effectiveness of nutritional supplementation on muscle mass in treatment of sarcopenia in old age: a systematic review. J Am Med Dir Assoc. 2013 Jan;14(1):10-7. doi: 10.1016/j.jamda.2012.08.001. Epub 2012 Sep 13.
PubMed 22980996
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does the Nutritionist's Educational Intervention Influence Protein Intake in Hospitalized Elderly People?
- ClinicalTrials.gov ID
- NCT05502445
- Acronym / sponsor ID
- VFigueira
- Conditions
- Old Age; Cachexia, Dietary Habits, Sarcopenia, Protein Malnutrition, Patient Participation
- Keywords
- Malnutrition, Sarcopenia, Hospitalized Patients, Elderly, Patient-Centered Care, Food Intake, Protein, Nutritional Supplements
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Hospital Israelita Albert EinsteinUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 16 Mar 2022 (actual)
- Study completion
- 16 Mar 2022 (actual)
- First posted
- 16 Aug 2022 (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 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: educational interventionIn 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). |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- elderly patients aged 60 years or older,
- with a prescription of oral feeding, exclusively,
- minimum period of three days.
Key exclusion criteria (6 listed)
- palliative care,
- treatment for chronic renal failure,
- patients with neurological deficit and dysphagia,
- readmissions during the study,
- receiving enteral and/or parenteral nutritional therapy,
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 |
|---|---|---|
| educational interventionIn 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. | Other | Intervention Group |
Primary outcome
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
6 secondary outcomes
Assessment and screening of sarcopenia risk by SARC-F questionnaire
Time frame: one day (first day of assessment)
Assessment of low muscle strength
Time frame: one day (first day of assessment)
Assessment of low muscle mass by measuring the calf circumference
Time frame: one day (first day of assessment)
Assessment and screening of nutritional risk
Time frame: one day (first day of assessment)
Dietary prescription of hospitalized elderly
Time frame: three days
Questionnaire on previous knowledge of protein source foods and sarcopenia
Time frame: one day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2022.
- Background: PubMed 20392703Cruz-Jentoft AJ, Baeyens JP, Bauer JM, Boirie Y, Cederholm T, Landi F, Martin FC, Michel JP, Rolland Y, Schneider SM, Topinkova E, Vandewoude M, Zamboni M; European Working Group on Sarcopenia in Older People. Sarcopenia: European consensus on definition and diagnosis: Report of the European Working Group on Sarcopenia in Older People. Age Ageing. 2010 Jul;39(4):412-23. doi: 10.1093/ageing/afq034. Epub 2010 Apr 13.
- Background: PubMed 23395245Clegg A, Young J, Iliffe S, Rikkert MO, Rockwood K. Frailty in elderly people. Lancet. 2013 Mar 2;381(9868):752-62. doi: 10.1016/S0140-6736(12)62167-9. Epub 2013 Feb 8.
- Background: PubMed 28452130Morley JE. Anorexia of ageing: a key component in the pathogenesis of both sarcopenia and cachexia. J Cachexia Sarcopenia Muscle. 2017 Aug;8(4):523-526. doi: 10.1002/jcsm.12192. Epub 2017 Apr 27.
- Background: PubMed 24997720Correia MI, Hegazi RA, Higashiguchi T, Michel JP, Reddy BR, Tappenden KA, Uyar M, Muscaritoli M. Evidence-based recommendations for addressing malnutrition in health care: an updated strategy from the feedM.E. Global Study Group. J Am Med Dir Assoc. 2014 Aug;15(8):544-50. doi: 10.1016/j.jamda.2014.05.011. Epub 2014 Jul 2.
- Background: PubMed 20863332Kaiser MJ, Bauer JM, Ramsch C, Uter W, Guigoz Y, Cederholm T, Thomas DR, Anthony PS, Charlton KE, Maggio M, Tsai AC, Vellas B, Sieber CC; Mini Nutritional Assessment International Group. Frequency of malnutrition in older adults: a multinational perspective using the mini nutritional assessment. J Am Geriatr Soc. 2010 Sep;58(9):1734-8. doi: 10.1111/j.1532-5415.2010.03016.x.
- Background: PubMed 30312372Cruz-Jentoft AJ, Bahat G, Bauer J, Boirie Y, Bruyere O, Cederholm T, Cooper C, Landi F, Rolland Y, Sayer AA, Schneider SM, Sieber CC, Topinkova E, Vandewoude M, Visser M, Zamboni M; Writing Group for the European Working Group on Sarcopenia in Older People 2 (EWGSOP2), and the Extended Group for EWGSOP2. Sarcopenia: revised European consensus on definition and diagnosis. Age Ageing. 2019 Jan 1;48(1):16-31. doi: 10.1093/ageing/afy169.
- Background: PubMed 24357473Gray-Donald K, St-Arnaud-McKenzie D, Gaudreau P, Morais JA, Shatenstein B, Payette H. Protein intake protects against weight loss in healthy community-dwelling older adults. J Nutr. 2014 Mar;144(3):321-6. doi: 10.3945/jn.113.184705. Epub 2013 Dec 19.
- Background: PubMed 18175749Houston DK, Nicklas BJ, Ding J, Harris TB, Tylavsky FA, Newman AB, Lee JS, Sahyoun NR, Visser M, Kritchevsky SB; Health ABC Study. Dietary protein intake is associated with lean mass change in older, community-dwelling adults: the Health, Aging, and Body Composition (Health ABC) Study. Am J Clin Nutr. 2008 Jan;87(1):150-5. doi: 10.1093/ajcn/87.1.150.
- Background: PubMed 27642056Cederholm T, Barazzoni R, Austin P, Ballmer P, Biolo G, Bischoff SC, Compher C, Correia I, Higashiguchi T, Holst M, Jensen GL, Malone A, Muscaritoli M, Nyulasi I, Pirlich M, Rothenberg E, Schindler K, Schneider SM, de van der Schueren MA, Sieber C, Valentini L, Yu JC, Van Gossum A, Singer P. ESPEN guidelines on definitions and terminology of clinical nutrition. Clin Nutr. 2017 Feb;36(1):49-64. doi: 10.1016/j.clnu.2016.09.004. Epub 2016 Sep 14.
- Background: PubMed 26018489Pilgrim AL, Robinson SM, Sayer AA, Roberts HC. An overview of appetite decline in older people. Nurs Older People. 2015 Jun;27(5):29-35. doi: 10.7748/nop.27.5.29.e697.
- Background: PubMed 32043144Cox NJ, Morrison L, Ibrahim K, Robinson SM, Sayer AA, Roberts HC. New horizons in appetite and the anorexia of ageing. Age Ageing. 2020 Jul 1;49(4):526-534. doi: 10.1093/ageing/afaa014.
- Background: PubMed 26774525de van der Schueren MA, Wijnhoven HA, Kruizenga HM, Visser M. A critical appraisal of nutritional intervention studies in malnourished, community dwelling older persons. Clin Nutr. 2016 Oct;35(5):1008-14. doi: 10.1016/j.clnu.2015.12.013. Epub 2015 Dec 29.
- Vigitel Brazil 2019:surveillance of risk and protect.factors for chronic dis.by telephone survey: estimates of frequency and sociodemographic distribution of risk and protect.factors for chronic dis.in the capitals in 2019Link provided by the sponsor.
- World Health Organization. (2020). WHO guidelines on physical activity and sedentary behaviour: at a glance. World Health Organization. https://apps.who.int/iris/handle/10665/337001Link provided by the sponsor.
- World Health Organization. (2002, april). Active Ageing - A Policy Framework. A contribution of the World Health Organization to the Second United Nations World Assembly on Ageing. p.4. \[Accessed on August 22, 2020\]Link provided by the sponsor.
- Gonçalves, TJM e col. BRASPEN. Brazilian Society of Parenteral and Enteral Nutrition. Guideline on nutrition therapy in aging. J 2019; 34 (Supl 3):2-58)Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. we will available the study protocol, educational instruments applied in the intervention group (educational and video brochure) and the results of the statistical analysis
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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.
Ana P Lottenberg principal investigator
Hospital Israelita Albert Einstein
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing educational intervention in people with Old Age; Cachexia and Dietary Habits, run by Hospital Israelita Albert Einstein at 1 site in Brazil.
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 6 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: finished, as of the sponsor's last update on 16 Aug 2022. 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 Brazil. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total energy and protein needs and intakes from dietary and oral nutritional supplements during hospitalization, according to the study group (time frame: three days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05502445, which also lists 38 linked publications.
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 16 Aug 2022.