Effects of Community-center Based Dietary Intervention on Frailty Prevention and Regression in the Elderly.
10 gennaio 2022 aggiornato da: Wen-Harn Pan, Academia Sinica, Taiwan
Associations Between Various Geriatric Syndromes and Nutrition Status and Dietary Pattern in Elderly
Recent interventional studies have shown that frailty can be improved by modifying dietary quality.
In this study, a set of nutrition-centric health promotion activities was developed in accordance with the Taiwanese Daily Food Guide for elderly participants of the community centers to improve their nutrition in everyday practice and examined the efficacy of these activities on slowing down the development or regression of frailty.
The study was a cluster-randomized controlled trial.
Recruited community centers were randomly assigned into either the control or the intervention group.
The intervention period lasted for 3 months.
Both the control and intervention groups received weekly one-hour group exercise training.
The intervention group had an additional weekly one-hour group nutrition session.
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, ③drinking 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 discussions on 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.
Improvement in nutritional status was the primary outcome.
Secondary outcomes included frailty scores, physical performance, and mental health.
The measurements were performed at baseline, 3 months, and 6 months.
Panoramica dello studio
Stato
Terminato
Condizioni
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Effettivo)
219
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Taipei, Taiwan, 115
- Institute of Biomedical Sciences, Academia Sinica
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
65 anni e precedenti (Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Comparatore placebo: Exercise
The control group received weekly one-hour group exercise training for 3 months.
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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.
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Sperimentale: 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.
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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.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change from baseline in intake frequency (portion per day) on the six food groups at months 3 and 6.
Lasso di tempo: Baseline, Month 3 and Month 6
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The six food groups include:
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Baseline, Month 3 and Month 6
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Change from baseline in the ratios of concentration on urinary nutritional biomarkers at months 3 and 6.
Lasso di tempo: Baseline, Month 3 and Month 6
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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
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Change from baseline in frailty status at months 3 and 6.
Lasso di tempo: Baseline, Month 3 and Month 6
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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
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change from baseline in the score of digit span at months 3 and 6.
Lasso di tempo: Baseline, Month 3 and Month 6
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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.
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Baseline, Month 3 and Month 6
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Change from baseline in the scores on the Geriatric Depression Scale at months 3 and 6.
Lasso di tempo: Baseline, Month 3 and Month 6
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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.
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Baseline, Month 3 and Month 6
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Investigatore principale: Wen-Harn Pan, PhD, Academia Sinica, Taiwan
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- 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.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
27 agosto 2018
Completamento primario (Effettivo)
20 dicembre 2019
Completamento dello studio (Effettivo)
20 dicembre 2019
Date di iscrizione allo studio
Primo inviato
28 ottobre 2021
Primo inviato che soddisfa i criteri di controllo qualità
10 novembre 2021
Primo Inserito (Effettivo)
22 novembre 2021
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
25 gennaio 2022
Ultimo aggiornamento inviato che soddisfa i criteri QC
10 gennaio 2022
Ultimo verificato
1 gennaio 2022
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- AS-IRB01-16057
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .