Healthy AgingNCT06100198
The Effect of Nutrition and Exercise Program on the Health of Community-dwelling Older Adults
A study testing nutrition and exercise program in people with Healthy Aging and Nutrition, Healthy, run by Taipei City Hospital at 1 site in Taiwan.
Trial summary
The purpose of this study is to design a nutrition and exercise course for the elderly adults in the community, and to evaluate the effectiveness of this course intervention on the nutritional knowledge, nutritional status, sarcopenia, and health status of the elderly in the community. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Aging, Nutrition, Healthy, Knowledge, Attitudes, Practice
- What is being tested?
- nutrition and exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteTaiwan
- Study dates
- 25 Oct 2023to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Citizens aged 65 and above, residing in communities in Taipei City.
- Clear consciousness and the ability to communicate in Mandarin and Taiwanese.
- Capability to move freely.
Who cannot join
- Individuals with cognitive impairment who are unable to cooperate with the measurements.
- Those unable to walk.
- Individuals with obvious edema of the lower limbs.
- Those with hand disabilities (such as fractures, arthritis, or stroke) preventing the measurement of grip strength.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Huanyu International Culture and Education Foundation Guting Branch
Taipei, 100045
Shi-Cheng Huang, +886-2-2364-1334, gutingfamily@icef.org.tw
About this study
Official title: Evaluation of the Effect of Nutrition and Exercise Program Intervention on the Health of Community-dwelling Older Adults
The purpose of this study is to design a nutrition and exercise course for the elderly adults in the community, and to evaluate the effectiveness of this course intervention on the nutritional knowledge, nutritional status, sarcopenia, and health status of the elderly in the community. This study adopted convenience sampling and targeted 108 community elders over 65 years old in Taipei City. All participants receive 3 nutrition and exercise courses. Each course was separated by one week. Measurements and collections were conducted one week before and one week after the course. BMI (body mass index), muscle mass, calf circumference, grip strength, Mini Nutritional Assessment Form Short Form (MNA-SF), SARC-F scale, Taiwan Short Form 36 Health Scale (SF-36) and nutrition knowledge and attitude and behavioral questionnaires will be collected to evaluate the effectiveness of the course.
Read the detailed description
The elderly population in Taiwan, aged over 65, has exceeded 14%, officially marking the country's transition into an aging society. This demographic shift has brought forth numerous health-related challenges among the elderly, including malnutrition, sarcopenia, and frailty, thereby increasing the risk of falls, cognitive dysfunction, and morbidity rates. This also results in rising disability and mortality rates, ultimately driving up healthcare costs.
The primary aim of this study is to develop a nutrition and exercise program for elderly individuals within the community. This program will be carried out in collaboration with a team of nutrition and exercise professionals. Furthermore, the study seeks to assess the effectiveness of this intervention on the nutritional awareness, nutritional status, sarcopenia, and overall health of elderly community members.
The study employed convenience sampling and included 108 community elders aged over 65 from Taipei City, all of whom were sourced from the community congregated meal stations. Each participant received three nutrition and exercise courses, with each course separated by a week. Measurements for body weight, BMI (body mass index), muscle mass, calf circumference, grip strength, Mini Nutritional Assessment Form Short Form (MNA-SF), SARC-F scale, Taiwan Short Form 36 Health Scale (SF-36), as well as pre- and post-course knowledge, attitude, and behavior assessments were conducted one week before and after the program.
After collecting the questionnaire data, SPSS version 22 (IBM Corp., Armonk, NY, USA) was used for data storage and statistical analysis. A p-value less than 0.05 was considered statistically significant. Descriptive statistical analysis methods, including mean, standard deviation, and percentages, were employed to provide a basic overview of the participant group. To understand differences and correlations between variables, the study utilized Chi-square and Paired Sample T-test methods.
Through this project, the investigators aim to evaluate the impact of the nutrition and exercise course intervention for elderly individuals in Taipei City. This endeavor will empower participants to incorporate nutrition and exercise strategies into daily lives, ultimately fostering better health outcomes for the elderly adults.
- Being tested
- nutrition and exercise program
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nutrition and exercise programOther
Nutrition courses include understanding malnutrition and sarcopenia; understanding the six major food categories and their requirements; and understanding protein-rich food sources. Exercise courses include understanding exercise types, flexibility exercises, and muscle strength training exercises.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | A one-group pretest-posttest design was adopted. Participants participated in 3 nutrition and exercise courses, each lasting 2 hours (including 1 hour nutrition course and 1 hour exercise course) with an interval of 1 week between each course. All subjects underwent anthropometric measurements and completed questionnaires one week before the start of the course and one week after the end of the course. A repeat assessment was conducted 6 months after the course intervention. Receives: Other: nutrition and exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Mass Index
Body Mass Index (BMI) is a person's weight in kilograms divided by the square of height in meters.
Measured: One week before the first class, one week after the third class, and 6 months after the course intervention.
Calf circumference
The widest part of the calf was measured with a non-elastic tape applied flat on the skin and parallel to the floor.
Measured: One week before the first class, one week after the third class, and 6 months after the course intervention.
Hand grip strength
Grip strength is measured using a hand-held dynamometer (TTM-YD, Tsutsumi Industries, Tokyo, Japan）.
Measured: One week before the first class, one week after the third class, and 6 months after the course intervention.
Muscle mass
Muscle mass is measured using a Inbody H20B Smart Full Body Composition Analyzer Scale.
Measured: One week before the first class, one week after the third class, and 6 months after the course intervention.
Nutritional status
Nutritional status was assessed using the Mini Nutritional Assessment Form Short Form (MNA-SF), a six-item instrument with scores ranging from 0 to 14 points. A total score of MNA-SF <8, 8-11, and >11 indicates malnutrition, risk of malnutrition, and no malnutrition, respectively.
Measured: One week before the first class, one week after the third class, and 6 months after the course intervention.
The risk of sarcopenia
Strength, assistance with walking, rising from a chair, climbing stairs, and falls (SARC-F) questionnaire scores. The SARC-F scores range from 0 (best) to 10 (worst). Patients with a total score ≥4 were considered to be at risk of sarcopenia.
Measured: One week before the first class, one week after the third class, and 6 months after the course intervention.
Taiwan Short 36 Health Scale (SF-36)
The SF-36 is a self-rated scale consisting of 36 items that assess health-related quality of life (HRQoL) in eight health dimensions. This questionnaire consists of 36 questions, focusing on the following two norm-based composite scales: physical component scale (PCS) and mental component scale (MCS). The PCS includes four subscales: physical functioning (PF), role functioning due to limitations in physical problems (RP), bodily pain (BP), and general health (GH). The MCS also includes four subscales: vitality (VT), social functioning (SF), role limitations due to emotional problems (RE), and mental health (MH). The subscales are reported as scores that range from 0 to 100. Higher scores indicate more favourable levels of function.
Measured: One week before the first class, one week after the third class, and 6 months after the course intervention.
Nutritional knowledge, attitudes, and behaviors
Using a self-administered questionnaire to study the relationships among dietary knowledge, attitudes, and behaviors. The scores range from 0 to 20, 0 to 12, 0 to 9 for nutritional knowledge, attitudes, and behaviors respectively. Higher scores mean a better outcome.
Measured: One week before the first class, one week after the third class, and 6 months after the course intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2023
- Study start25 Oct 2023
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei City Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Hui-Ping Chang, Doctor, Principal investigator, Taipei City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06100198
- Sponsor's protocol ID
- TCHIRB-11206012-E
- Status last verified
- Nov 2023
- First submitted
- 17 Oct 2023
- Last updated
- 24 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Nutrition and Exercise Program Intervention on the Health of Community-dwelling Older Adults
- ClinicalTrials.gov ID
- NCT06100198
- Acronym / sponsor ID
- TCHIRB-11206012-E
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Taipei City HospitalOther government
- Study start
- 25 Oct 2023 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 25 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to design a nutrition and exercise course for the elderly adults in the community, and to evaluate the effectiveness of this course intervention on the nutritional knowledge, nutritional status, sarcopenia, and health status of the elderly in the community. This study adopted convenience sampling and targeted 108 community elders over 65 years old in Taipei City. All participants receive 3 nutrition and exercise courses. Each course was separated by one week. Measurements and collections were conducted one week before and one week after the course. BMI (body mass index), muscle mass, calf circumference, grip strength, Mini Nutritional Assessment Form Short Form (MNA-SF), SARC-F scale, Taiwan Short Form 36 Health Scale (SF-36) and nutrition knowledge and attitude and behavioral questionnaires will be collected to evaluate the effectiveness of the course.
Detailed description
The elderly population in Taiwan, aged over 65, has exceeded 14%, officially marking the country's transition into an aging society. This demographic shift has brought forth numerous health-related challenges among the elderly, including malnutrition, sarcopenia, and frailty, thereby increasing the risk of falls, cognitive dysfunction, and morbidity rates. This also results in rising disability and mortality rates, ultimately driving up healthcare costs.
The primary aim of this study is to develop a nutrition and exercise program for elderly individuals within the community. This program will be carried out in collaboration with a team of nutrition and exercise professionals. Furthermore, the study seeks to assess the effectiveness of this intervention on the nutritional awareness, nutritional status, sarcopenia, and overall health of elderly community members.
The study employed convenience sampling and included 108 community elders aged over 65 from Taipei City, all of whom were sourced from the community congregated meal stations. Each participant received three nutrition and exercise courses, with each course separated by a week. Measurements for body weight, BMI (body mass index), muscle mass, calf circumference, grip strength, Mini Nutritional Assessment Form Short Form (MNA-SF), SARC-F scale, Taiwan Short Form 36 Health Scale (SF-36), as well as pre- and post-course knowledge, attitude, and behavior assessments were conducted one week before and after the program.
After collecting the questionnaire data, SPSS version 22 (IBM Corp., Armonk, NY, USA) was used for data storage and statistical analysis. A p-value less than 0.05 was considered statistically significant. Descriptive statistical analysis methods, including mean, standard deviation, and percentages, were employed to provide a basic overview of the participant group. To understand differences and correlations between variables, the study utilized Chi-square and Paired Sample T-test methods.
Through this project, the investigators aim to evaluate the impact of the nutrition and exercise course intervention for elderly individuals in Taipei City. This endeavor will empower participants to incorporate nutrition and exercise strategies into daily lives, ultimately fostering better health outcomes for the elderly adults.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: nutrition and exercise programA one-group pretest-posttest design was adopted. Participants participated in 3 nutrition and exercise courses, each lasting 2 hours (including 1 hour nutrition course and 1 hour exercise course) with an interval of 1 week between each course. All subjects underwent anthropometric measurements and completed questionnaires one week before the start of the course and one week after the end of the course. A repeat assessment was conducted 6 months after the course intervention. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Citizens aged 65 and above, residing in communities in Taipei City.
- Clear consciousness and the ability to communicate in Mandarin and Taiwanese.
- Capability to move freely.
Key exclusion criteria (4 listed)
- Individuals with cognitive impairment who are unable to cooperate with the measurements.
- Those unable to walk.
- Individuals with obvious edema of the lower limbs.
- Those with hand disabilities (such as fractures, arthritis, or stroke) preventing the measurement of grip strength.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nutrition and exercise programNutrition courses include understanding malnutrition and sarcopenia; understanding the six major food categories and their requirements; and understanding protein-rich food sources. Exercise courses include understanding exercise types, flexibility exercises, and muscle strength training exercises. | Other | Intervention group |
Primary outcome
Body Mass Index
Time frame: One week before the first class, one week after the third class, and 6 months after the course intervention.
Body Mass Index (BMI) is a person's weight in kilograms divided by the square of height in meters.
Calf circumference
Time frame: One week before the first class, one week after the third class, and 6 months after the course intervention.
The widest part of the calf was measured with a non-elastic tape applied flat on the skin and parallel to the floor.
Hand grip strength
Time frame: One week before the first class, one week after the third class, and 6 months after the course intervention.
Grip strength is measured using a hand-held dynamometer (TTM-YD, Tsutsumi Industries, Tokyo, Japan）.
Muscle mass
Time frame: One week before the first class, one week after the third class, and 6 months after the course intervention.
Muscle mass is measured using a Inbody H20B Smart Full Body Composition Analyzer Scale.
Nutritional status
Time frame: One week before the first class, one week after the third class, and 6 months after the course intervention.
Nutritional status was assessed using the Mini Nutritional Assessment Form Short Form (MNA-SF), a six-item instrument with scores ranging from 0 to 14 points. A total score of MNA-SF <8, 8-11, and >11 indicates malnutrition, risk of malnutrition, and no malnutrition, respectively.
The risk of sarcopenia
Time frame: One week before the first class, one week after the third class, and 6 months after the course intervention.
Strength, assistance with walking, rising from a chair, climbing stairs, and falls (SARC-F) questionnaire scores. The SARC-F scores range from 0 (best) to 10 (worst). Patients with a total score ≥4 were considered to be at risk of sarcopenia.
Taiwan Short 36 Health Scale (SF-36)
Time frame: One week before the first class, one week after the third class, and 6 months after the course intervention.
The SF-36 is a self-rated scale consisting of 36 items that assess health-related quality of life (HRQoL) in eight health dimensions. This questionnaire consists of 36 questions, focusing on the following two norm-based composite scales: physical component scale (PCS) and mental component scale (MCS). The PCS includes four subscales: physical functioning (PF), role functioning due to limitations in physical problems (RP), bodily pain (BP), and general health (GH). The MCS also includes four subscales: vitality (VT), social functioning (SF), role limitations due to emotional problems (RE), and mental health (MH). The subscales are reported as scores that range from 0 to 100. Higher scores indicate more favourable levels of function.
Nutritional knowledge, attitudes, and behaviors
Time frame: One week before the first class, one week after the third class, and 6 months after the course intervention.
Using a self-administered questionnaire to study the relationships among dietary knowledge, attitudes, and behaviors. The scores range from 0 to 20, 0 to 12, 0 to 9 for nutritional knowledge, attitudes, and behaviors respectively. Higher scores mean a better outcome.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2023.
- Individual participant dataSharing planned: No
Related trials for Healthy Aging
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Recruiting
Study Evaluating the Effect of Humiome® Post LB on Stress, Anxiety, and Cognition in Aging Adults
Healthy Aging
Recruiting
Effects of Breathing Exercises on Cognition in Older Adults
Older Adults (65 Years and Older), Cognition
Not yet recruiting
Eccentric Exercise in Community-dwelling Older Adults
Ageing Well
Recruiting
Aquatic Power Training Dosing Strategies and Creatine Supplementation in Older Adults
Aging, Supplementation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hui-Ping Chang, Doctor principal investigator
Taipei City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nutrition and exercise program in people with Healthy Aging and Nutrition, Healthy, run by Taipei City Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hui-Ping Chang, Doctor (+886-2-25553000 ext. 2770, A0239@tpech.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Mass Index (time frame: One week before the first class, one week after the third class, and 6 months after the course intervention.). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2023.