Intervention for the Elderly With Malnutrition, Hidden Hunger and Low Skeletal Muscle Mass
13. prosince 2019 aktualizováno: 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.
Přehled studie
Postavení
Dokončeno
Podmínky
Intervence / Léčba
Typ studie
Intervenční
Zápis (Aktuální)
78
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Jiangsu
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Nanjing, Jiangsu, Čína, 210029
- The First Affiliated Hospital with Nanjing Medical University
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
65 let až 85 let (Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Popis
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
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: 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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Jiný: Control group
just give the verbal nutrition education.
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give the verbal nutrition education
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Mini Nutritional Assessment short-form (MNA®-SF) score
Časové okno: 12 weeks
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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
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Muscle mass--The change of percentage of skeletal muscle mass
Časové okno: 12 weeks
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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
Časové okno: 12 weeks
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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
Časové okno: 12 weeks
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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
Časové okno: 12 weeks
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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
Časové okno: 12 weeks
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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
Časové okno: 12 weeks
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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
Časové okno: 12 weeks
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Average daily intake of dietary nutrients
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12 weeks
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The change of DETERMINE score
Časové okno: 12 weeks
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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
Časové okno: 12 weeks
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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
Časové okno: 12 weeks
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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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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Vyšetřovatelé
- Vrchní vyšetřovatel: Ting Zhao, The First Affiliated Hospital with Nanjing Medical University
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
20. května 2017
Primární dokončení (Aktuální)
31. prosince 2018
Dokončení studie (Aktuální)
30. června 2019
Termíny zápisu do studia
První předloženo
20. prosince 2017
První předloženo, které splnilo kritéria kontroly kvality
23. srpna 2018
První zveřejněno (Aktuální)
27. srpna 2018
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
16. prosince 2019
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
13. prosince 2019
Naposledy ověřeno
1. prosince 2019
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- JYX201603
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