Intervention for the Elderly With Malnutrition, Hidden Hunger and Low Skeletal Muscle Mass
2019년 12월 13일 업데이트: 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.
연구 개요
연구 유형
중재적
등록 (실제)
78
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Jiangsu
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Nanjing, Jiangsu, 중국, 210029
- The First Affiliated Hospital with Nanjing Medical University
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
65년 (고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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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다른: Control group
just give the verbal nutrition education.
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give the verbal nutrition education
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Mini Nutritional Assessment short-form (MNA®-SF) score
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Muscle mass--The change of percentage of skeletal muscle mass
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Ting Zhao, The First Affiliated Hospital with Nanjing Medical University
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2017년 5월 20일
기본 완료 (실제)
2018년 12월 31일
연구 완료 (실제)
2019년 6월 30일
연구 등록 날짜
최초 제출
2017년 12월 20일
QC 기준을 충족하는 최초 제출
2018년 8월 23일
처음 게시됨 (실제)
2018년 8월 27일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2019년 12월 16일
QC 기준을 충족하는 마지막 업데이트 제출
2019년 12월 13일
마지막으로 확인됨
2019년 12월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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