Clinical trial NCT06100198: The Effect of Nutrition and Exercise Program on the Health of Community-dwelling Older Adults
Official title: Evaluation of the Effect of Nutrition and Exercise Program Intervention on the Health of Community-dwelling Older Adults
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy Aging
Nutrition, Healthy
Knowledge, Attitudes, Practice
Lead sponsor: Taipei City Hospital
Sponsor class: OTHER_GOV
First posted: 2023-10-25
Enrollment: 108
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

1. Citizens aged 65 and above, residing in communities in Taipei City.
2. Clear consciousness and the ability to communicate in Mandarin and Taiwanese.
3. Capability to move freely.

Exclusion Criteria:

1. Individuals with cognitive impairment who are unable to cooperate with the measurements.
2. Those unable to walk.
3. Individuals with obvious edema of the lower limbs.
4. Those with hand disabilities (such as fractures, arthritis, or stroke) preventing the measurement of grip strength.

Primary outcomes:
measure: Body Mass Index
timeFrame: One week before the first class, one week after the third class, and 6 months after the course intervention.
measure: Calf circumference
timeFrame: One week before the first class, one week after the third class, and 6 months after the course intervention.
measure: Hand grip strength
timeFrame: One week before the first class, one week after the third class, and 6 months after the course intervention.
measure: Muscle mass
timeFrame: One week before the first class, one week after the third class, and 6 months after the course intervention.
measure: Nutritional status
timeFrame: One week before the first class, one week after the third class, and 6 months after the course intervention.
measure: The risk of sarcopenia
timeFrame: One week before the first class, one week after the third class, and 6 months after the course intervention.
measure: Taiwan Short 36 Health Scale (SF-36)
timeFrame: One week before the first class, one week after the third class, and 6 months after the course intervention.
measure: Nutritional knowledge, attitudes, and behaviors
timeFrame: One week before the first class, one week after the third class, and 6 months after the course intervention.
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei City
country: Taiwan
facility: Huanyu International Culture and Education Foundation Guting Branch
Study officials:
affiliation: Taipei City Hospital
name: Hui-Ping Chang, Doctor
role: PRINCIPAL_INVESTIGATOR
References: