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Effects of Community-center Based Dietary Intervention on Frailty Prevention and Regression in the Elderly.

10 januari 2022 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Studietyp

Interventionell

Inskrivning (Faktisk)

219

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

      • Taipei, Taiwan, 115
        • Institute of Biomedical Sciences, Academia Sinica

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

65 år och äldre (Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

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:

  1. Whole grains and starchy vegetables
  2. Protein foods: soy beans, fish, eggs, and meat
  3. Vegetables
  4. Fruits
  5. Dairy
  6. Oils, nuts and seeds
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

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Utredare

  • Huvudutredare: Wen-Harn Pan, PhD, Academia Sinica, Taiwan

Publikationer och användbara länkar

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Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

27 augusti 2018

Primärt slutförande (Faktisk)

20 december 2019

Avslutad studie (Faktisk)

20 december 2019

Studieregistreringsdatum

Först inskickad

28 oktober 2021

Först inskickad som uppfyllde QC-kriterierna

10 november 2021

Första postat (Faktisk)

22 november 2021

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

25 januari 2022

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

10 januari 2022

Senast verifierad

1 januari 2022

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • AS-IRB01-16057

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