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

NCT05129163 | Terminated

• 1 other identifier: AS-IRB01-16057
• Study Type: interventional
• Target: 219
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Frailty

Outcome Measures

Primary Outcomes (3)

• Change from baseline in intake frequency (portion per day) on the six food groups at months 3 and 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.

  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.

  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

Secondary Outcomes (2)

• Change from baseline in the score of digit span at months 3 and 6.

  Baseline, Month 3 and Month 6

• Change from baseline in the scores on the Geriatric Depression Scale at months 3 and 6.

  Baseline, Month 3 and Month 6

Study Arms (2)

Exercise

PLACEBO COMPARATOR

The control group received weekly one-hour group exercise training for 3 months.

Behavioral: Exercise

Exercise and nutrition

EXPERIMENTAL

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.

Behavioral: Exercise; Behavioral: Nutrition activities

Interventions

Exercise BEHAVIORAL

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.

Exercise; Exercise and nutrition

Nutrition activities BEHAVIORAL

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.

Exercise and nutrition

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Aged 65 years or older
• Able to walk independently for 14 meters within 1 minute
• Willing to sign the informed consent

You may not qualify if:

• Under dietary control by doctors' instructions
• With mental illness, mental disorders, or unable to communicate
• With severe diseases such as under treatments for cancer

Sponsors & Collaborators

• Academia Sinica, Taiwan: lead

Study Sites (1)

Institute of Biomedical Sciences, Academia Sinica

Taipei, 115, Taiwan

Location

Related Publications (2)

• 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.

  PMID: 31791364 BACKGROUND

• 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.

  PMID: 30272850 BACKGROUND

MeSH Terms

Conditions

Frailty

Interventions

Exercise

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Wen-Harn Pan, PhD

  Academia Sinica, Taiwan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Distinguished Research Fellow

Study Record Dates

• First Submitted: October 28, 2021
• First Posted: November 22, 2021
• Study Start: August 27, 2018
• Primary Completion: December 20, 2019
• Study Completion: December 20, 2019
• Last Updated: January 25, 2022

Record last verified: 2022-01

Locations

TW (1)