- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT05129163
Effects of Community-center Based Dietary Intervention on Frailty Prevention and Regression in the Elderly.
Associations Between Various Geriatric Syndromes and Nutrition Status and Dietary Pattern in Elderly
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
-
Taipei, Taiwan, 115
- Institute of Biomedical Sciences, Academia Sinica
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Aged 65 years or older
- Able to walk independently for 14 meters within 1 minute
- Willing to sign the informed consent
Exclusion Criteria:
- Under dietary control by doctors' instructions
- With mental illness, mental disorders, or unable to communicate
- With severe diseases such as under treatments for cancer
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Placebo-jämförare: Exercise
The control group received weekly one-hour group exercise training for 3 months.
|
The group exercise training was held in each community center.
The group exercise training contained aerobic exercise, complex physical fitness exercise, muscle training, and balance and coordination training.
|
Experimentell: Exercise and nutrition
The intervention group had weekly one-hour group exercise training the same as the control and an additional weekly one-hour group nutrition session for 3 months.
|
The group exercise training was held in each community center.
The group exercise training contained aerobic exercise, complex physical fitness exercise, muscle training, and balance and coordination training.
The intervention programs included: (a) training on-site staffs to use motivational interview techniques to communicate, to estimate participant's energy requirements, and to learn how to provide proper amounts of foods to individual elderlies, (b) nutrition grouped activities on ①know my plate, ②wholegrains, ③ drinking teas with dairy, and nuts, ④novel ways to eat fruit and vegetables, ⑤healthy breakfast ideas.
In the first month, participants were intervened with the activities laid out above; in the second month, participants were intervened with qualitative discussion on elders' dietary changes; in the third month, participants were intervened with designed activities that helped break down barriers in order to establish a long-term change in dietary habits.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Change from baseline in intake frequency (portion per day) on the six food groups at months 3 and 6.
Tidsram: Baseline, Month 3 and Month 6
|
The six food groups include:
|
Baseline, Month 3 and Month 6
|
Change from baseline in the ratios of concentration on urinary nutritional biomarkers at months 3 and 6.
Tidsram: Baseline, Month 3 and Month 6
|
The concentrations of the following urinary nutritional biomarkers were determined: urinary urea nitrogen (mg/dL), urinary calcium (mg/dl), urinary potassium (mmol/L), urinary magnesium (mg/dL), and urinary creatinine (mg/dL). The urinary urea nitrogen to creatinine ratios, urinary calcium to creatinine ratios, urinary potassium to creatinine ratios, and urinary magnesium to creatinine ratios was estimated at baseline, moths 3 and 6. |
Baseline, Month 3 and Month 6
|
Change from baseline in frailty status at months 3 and 6.
Tidsram: Baseline, Month 3 and Month 6
|
Frailty status was defined using modified Linda Fried criteria with cutoff points from the investigators' previous intervention studies. Five frail phenotypes were assigned: (1) unintentional weight loss, (2) self-reported exhaustion, (3) weak grip strength, (4) slow gait speed, and (5) low level of physical activity. To estimate frailty, participants scored 1 point from each phenotype if any of these were satisfied; a maximum score of five was possible. Participants were classified by their point scores as follows: 'robust' for 0 point; 'pre-frail' for 1 or 2 points; and 'frail' for ≥3. |
Baseline, Month 3 and Month 6
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Change from baseline in the score of digit span at months 3 and 6.
Tidsram: Baseline, Month 3 and Month 6
|
A digit span task is used to measure working memory's number storage capacity.
Subjects are read a sequence of numbers and asked to repeat the same sequence back to the examiner in order (forward span) or in reverse order (backward span).
The score is the length of the longest correctly repeated sequence.
The maximum number of digits in a sequence is 9 and the minimum number of digits in a sequence is 2. The higher scores mean a better outcome.
|
Baseline, Month 3 and Month 6
|
Change from baseline in the scores on the Geriatric Depression Scale at months 3 and 6.
Tidsram: Baseline, Month 3 and Month 6
|
The Geriatric Depression Scale (GDS) is a self-report measure of depression in older adults.
Scores of 0-4 are considered normal, depending on age, education, and complaints; 5-8 indicate mild depression; 9-11 indicate moderate depression; and 12-15 indicate severe depression.
|
Baseline, Month 3 and Month 6
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Wen-Harn Pan, PhD, Academia Sinica, Taiwan
Publikationer och användbara länkar
Allmänna publikationer
- Hsieh TJ, Su SC, Chen CW, Kang YW, Hu MH, Hsu LL, Wu SY, Chen L, Chang HY, Chuang SY, Pan WH, Hsu CC. Individualized home-based exercise and nutrition interventions improve frailty in older adults: a randomized controlled trial. Int J Behav Nutr Phys Act. 2019 Dec 2;16(1):119. doi: 10.1186/s12966-019-0855-9. Erratum In: Int J Behav Nutr Phys Act. 2019 Dec 23;16(1):136.
- Wu SY, Hsu LL, Hsu CC, Hsieh TJ, Su SC, Peng YW, Guo TM, Kang YW, Pan WH. Dietary education with customised dishware and food supplements can reduce frailty and improve mental well-being in elderly people: A single-blind randomized controlled study. Asia Pac J Clin Nutr. 2018;27(5):1018-1030. doi: 10.6133/apjcn.032018.02.
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- AS-IRB01-16057
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
Kliniska prövningar på Svaghet
-
Ankara Etlik City HospitalHar inte rekryterat ännu
-
University of Erlangen-Nürnberg Medical SchoolAvslutad
-
University of ValenciaAvslutadFrailty syndromSpanien
-
Sengkang General HospitalOkändSvaghet | Frailty syndromSingapore
-
Charite University, Berlin, GermanyAvslutadFrailty syndromTyskland
-
Instituto Tecnologico y de Estudios Superiores...Har inte rekryterat ännu
-
Xijing HospitalOkänd
-
Region ZealandUniversity of Southern DenmarkAktiv, inte rekryterandeFrailty syndromDanmark
-
Chinese University of Hong KongAvslutad
-
University of PennsylvaniaAvslutad