Effects of Community-center Based Dietary Intervention on Frailty Prevention and Regression in the Elderly.
Primary Purpose
Frailty
Status
Terminated
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Exercise
Nutrition activities
Sponsored by
About this trial
This is an interventional treatment trial for Frailty
Eligibility Criteria
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
Sites / Locations
- Institute of Biomedical Sciences, Academia Sinica
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Exercise
Exercise and nutrition
Arm Description
The control group received weekly one-hour group exercise training for 3 months.
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.
Outcomes
Primary Outcome Measures
Change from baseline in intake frequency (portion per day) on the six food groups at months 3 and 6.
The six food groups include:
Whole grains and starchy vegetables
Protein foods: soy beans, fish, eggs, and meat
Vegetables
Fruits
Dairy
Oils, nuts and seeds
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.
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.
Secondary Outcome Measures
Change from baseline in the score of digit span at months 3 and 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.
Change from baseline in the scores on the Geriatric Depression Scale at months 3 and 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.
Full Information
NCT ID
NCT05129163
First Posted
October 28, 2021
Last Updated
January 10, 2022
Sponsor
Academia Sinica, Taiwan
1. Study Identification
Unique Protocol Identification Number
NCT05129163
Brief Title
Effects of Community-center Based Dietary Intervention on Frailty Prevention and Regression in the Elderly.
Official Title
Associations Between Various Geriatric Syndromes and Nutrition Status and Dietary Pattern in Elderly
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Terminated
Why Stopped
Due to the impacts of COVID-19, the study had to terminate.
Study Start Date
August 27, 2018 (Actual)
Primary Completion Date
December 20, 2019 (Actual)
Study Completion Date
December 20, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Academia Sinica, Taiwan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frailty
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
219 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exercise
Arm Type
Placebo Comparator
Arm Description
The control group received weekly one-hour group exercise training for 3 months.
Arm Title
Exercise and nutrition
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Nutrition activities
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline in intake frequency (portion per day) on the six food groups at months 3 and 6.
Description
The six food groups include:
Whole grains and starchy vegetables
Protein foods: soy beans, fish, eggs, and meat
Vegetables
Fruits
Dairy
Oils, nuts and seeds
Time Frame
Baseline, Month 3 and Month 6
Title
Change from baseline in the ratios of concentration on urinary nutritional biomarkers at months 3 and 6.
Description
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.
Time Frame
Baseline, Month 3 and Month 6
Title
Change from baseline in frailty status at months 3 and 6.
Description
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.
Time Frame
Baseline, Month 3 and Month 6
Secondary Outcome Measure Information:
Title
Change from baseline in the score of digit span at months 3 and 6.
Description
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.
Time Frame
Baseline, Month 3 and Month 6
Title
Change from baseline in the scores on the Geriatric Depression Scale at months 3 and 6.
Description
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.
Time Frame
Baseline, Month 3 and Month 6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wen-Harn Pan, PhD
Organizational Affiliation
Academia Sinica, Taiwan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Biomedical Sciences, Academia Sinica
City
Taipei
ZIP/Postal Code
115
Country
Taiwan
12. IPD Sharing Statement
Citations:
PubMed Identifier
31791364
Citation
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.
Results Reference
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PubMed Identifier
30272850
Citation
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.
Results Reference
background
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Effects of Community-center Based Dietary Intervention on Frailty Prevention and Regression in the Elderly.
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