Intervention for the Elderly With Malnutrition, Hidden Hunger and Low Skeletal Muscle Mass
13. Dezember 2019 aktualisiert von: Ting Zhao, The First Affiliated Hospital with Nanjing Medical University
Intervention for the Elderly With Malnutrition, Hidden Hunger and Low Skeletal Muscle Mass in Binhu Community Hospital of Nanjing
Background: As the aging of the population aggravating, the ratio of the elderly in empty nest family has reached 50%, particularly in big and medium size cities, it is as high as 70%.
The elderly in those families where no child living inside, elderly living alone, including an individual living alone or living with spouse are known as empty nester.
The diversity of food consumption of empty nester is always poor, with single and simple meals, especially for the consumption of "core food" (fish, meat, egg, milk, vegetables and fruits), and the quantity and variety of consumption is very limited, which make the elderly be prone to be deficient of high quality protein and micronutrient.
In 2005, the World Health Organization (WHO) brought up a new concept for the universally exiting problem of vitamin and trace elements intake deficiency among people, namely Hidden Hunger.
With age increasing, multiple causes such as single eating pattern, empty nest lifestyle and chronic diseases lead to long term intake deficiency of protein and micronutrient of the elderly, which will further result in various symptoms of nutritional deficiency.
Therefore, it is particularly important for the empty nester to have sufficient energy, high quality protein and multiple micronutrients to prevent hidden hunger and sarcopenia, thus avoiding the health problem and life quality decreasing caused by them.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Studientyp
Interventionell
Einschreibung (Tatsächlich)
78
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
-
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Jiangsu
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Nanjing, Jiangsu, China, 210029
- The First Affiliated Hospital with Nanjing Medical University
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
65 Jahre bis 85 Jahre (Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
Inclusion Criteria:
- the one who is or is between 65 to 85 years old, male or female;
- the one with nutritional risk according to MNA-Short Form evaluation (score less than12);
- the one who has low skeletal muscle mass (with bioelectrical impedance analysis report indicating that the skeletal muscle mass is less than 90% of the normal level) and/or the one who has at least 1 type of the micronutrient deficiency symptom (part A < 40 or part A < 85 in the hidden hungry evaluation questionnaire)
Exclusion Criteria:
- long-term bedridden or the one has difficult in taking food orally;
- Liver failure in recent one year;
- Renal insufficiency (serum creatinine is more than 2 times of normal value)
- the one who is allergic to or not applicable to the component in oral dietary supplement;
- the one with parkinsonism, epilepsy and other nervous system disorders;
- malignant tumor patients with chemotherapy and chemotherapy;
- irritable bowel disease and other chronic wasting diseases.
- Taking multi-vitamin&mineral supplements or protein or other oral nutritional supplements
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Experimental: Intervention group
Give the verbal nutrition education and supply Ensure Complete powder that will be the oral nutrition supplement, with the dose of 6 scoops (53.8 grams) twice daily.Duration: 12 weeks
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Supply the Ensure Complete powder that will be the oral nutrition supplement, with the dose of 6 scoops (53.8 grams) twice daily.Duration: 12 weeks
give the verbal nutrition education
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Sonstiges: Control group
just give the verbal nutrition education.
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give the verbal nutrition education
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Mini Nutritional Assessment short-form (MNA®-SF) score
Zeitfenster: 12 weeks
|
MNA®-SF is a validated nutrition screening and assessment tool that can identify geriatric patients age 65 and above who are malnourished or at risk of malnutrition.
The Screening score(max.
14 points) is 12-14 points indicates "Normal nutritional status", 8-11 points indicates "At risk of malnutrition", 0-7 points indicates "Malnourished".
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12 weeks
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Muscle mass--The change of percentage of skeletal muscle mass
Zeitfenster: 12 weeks
|
The skeletal muscle mass of the participants were assessed using a multiple-frequency bioelectrical impedance analysis (BIA) instrument (InBodyS10; InBody, Shanghai, China).
Percentage of skeletal muscle mass (PSM) is the ratio of skeletal muscle mass to ideal skeletal muscle mass which is defined according to the height and the standard BMI of each patient.
Normal PSM standard is defined as values in the range of 90-110%.
We defined low skeletal muscle mass (Sarcopenia) as values <90% of the standard.
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12 weeks
|
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The change of BMI
Zeitfenster: 12 weeks
|
Weight in kilograms was measured during the study.
Height in meters was measured at the baseline.
Weight and height will be combined to report BMI in kg/m^2.
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12 weeks
|
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Muscle strength--The change of Calf circumference
Zeitfenster: 12 weeks
|
Calf circumference(CCF) was measured with a soft tape, the measurement standard is divided into less than 31 cm and 31 cm or greater.
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12 weeks
|
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Muscle strength--The change of Grip strength
Zeitfenster: 12 weeks
|
Grip strength with a calibrated grip force meter to measure the grip strength of the dominant hand.
The cut-off of grip strength is 26 kg for men and 18 kg for women.
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12 weeks
|
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Muscle strength--6 meters gait speed
Zeitfenster: 12 weeks
|
A standard stopwatch is used to measure the subject's 6 meters gait speed for 3 times, and the average pace is then calculated.
The intercept value of step speed is 0.8m/s.
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12 weeks
|
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Hidden Hunger Assessment Scale
Zeitfenster: 12 weeks
|
There are two parts in Hidden Hunger Assessment Scale.
Part A includes the options for 10 dietary behaviors, giving 3 behavioral frequency choices (> 3 times per week, 5 points; 1 to 3 times per week, 3 points; never, 0 points), score ranges from 0 to 50 which are evaluated and classified into three categories.
Part B includes 17 options on the manifestation of micronutrient deficiencies, giving three frequencies of occurrence to score (consecutive, 0 points; occasionally, 3 points; never, 5 points).
The result ranges from 0 to 85, while different ranges were evaluated and defined differently.
The scores of Part A and B of the participants were summed up and separated into three definition: <70 as "obvious hunger requesting immediate intervention", 70-123 as "existing hidden hunger requesting improvement", and > 123 as "no hidden hunger ".
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12 weeks
|
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Dietary Nutrients
Zeitfenster: 12 weeks
|
Average daily intake of dietary nutrients
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12 weeks
|
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The change of DETERMINE score
Zeitfenster: 12 weeks
|
The DETERMINE is checklist to find out if someone you know is at nutritional risk. The checklist is based on warning signs described. DETERMINE is the first letter of all warning signs: Disease, Eating poorly, Tooth loss/month pain, Economic hardship, Reduced social contact, Multiple medicines, Involuntary weight loss/gain, Needs assistance in self care, Elder years above age 80. The total score is 21. 0-2 scores means good, recheck your nutritional scores in 6 months. 3-5 scores you are at moderate nutrition risk. Recheck your nutritional scores in 3 months. 6 or more scores means you are at high nutrition risk. Bring this checklist the next time you see your doctor, dietitian or other qualified health or social service professional. Talk with them about any problem you may have. Ask for help to improve your nutritional health. |
12 weeks
|
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Questionnaire--Healthy lifestyle questionnaire
Zeitfenster: 12 weeks
|
Healthy lifestyle questionnaire be designed by investigator.
24 questions cover healthy lifestyle, that are about disease, fallen, infection, allergy, drink alcohol, smoke, eating habit, activity intensity/frequency, sleep quality, emotion etc.
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12 weeks
|
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Questionnaire--Self-satisfaction questionnaire
Zeitfenster: 12 weeks
|
The self-satisfaction questionnaire be completed by subject.
The questionnaires be used to evaluate self-rate satisfaction for stool pattern, sleep, health status, quality of life, energy level, vitality level, daily activities.
There are some questions to get the state of the stool pattern and sleep.
Others are evaluated in the percentage.
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12 weeks
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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Ermittler
- Hauptermittler: Ting Zhao, The First Affiliated Hospital with Nanjing Medical University
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
20. Mai 2017
Primärer Abschluss (Tatsächlich)
31. Dezember 2018
Studienabschluss (Tatsächlich)
30. Juni 2019
Studienanmeldedaten
Zuerst eingereicht
20. Dezember 2017
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
23. August 2018
Zuerst gepostet (Tatsächlich)
27. August 2018
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
16. Dezember 2019
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
13. Dezember 2019
Zuletzt verifiziert
1. Dezember 2019
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- JYX201603
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
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