The Effect of Nutrition and Exercise Program on the Health of Community-dwelling Older Adults

NCT06100198 | Unknown

• 1 other identifier: TCHIRB-11206012-E
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Aging; Nutrition, Healthy; Knowledge, Attitudes, Practice

Outcome Measures

Primary Outcomes (8)

• Body Mass Index

  Body Mass Index (BMI) is a person's weight in kilograms divided by the square of height in meters.

  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.

  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）.

  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.

  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.

  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.

  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.

  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.

  One week before the first class, one week after the third class, and 6 months after the course intervention.

Study Arms (1)

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.

Other: nutrition and exercise program

Interventions

nutrition and exercise program OTHER

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.

Intervention group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Taipei City Hospital: lead

Study Sites (1)

Huanyu International Culture and Education Foundation Guting Branch

Taipei, 100045, Taiwan

RECRUITING

MeSH Terms

Conditions

Behavior

Interventions

Nutritional Status

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Health Status; Demography; Population Characteristics

Study Officials

• Hui-Ping Chang, Doctor

  Taipei City Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hui-Ping Chang, Doctor

CONTACT

+886-2-25553000; A0239@tpech.gov.tw

Ying-Chun Chen, Bachelor

CONTACT

+886-2-25553000; T1130@tpech.gov.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2023
• First Posted: October 25, 2023
• Study Start: October 25, 2023
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: November 24, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)