NCT05476536

Brief Summary

The lifestyle program intervention program focusing on healthy dietary habit and exercise effectively prevents metabolic syndrome, sarcopenia or frailty. Thus, the purpose of this study was to assess the efficacy of intervention program on metabolic syndrome subjects in Taiwan.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 19, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 27, 2022

Completed
7 months until next milestone

Study Start

First participant enrolled

February 15, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2023

Completed
Last Updated

February 8, 2023

Status Verified

February 1, 2023

Enrollment Period

6 months

First QC Date

July 19, 2022

Last Update Submit

February 7, 2023

Conditions

Keywords

self-health managementmetabolic diseasessarcopeniafrailtyintervention

Outcome Measures

Primary Outcomes (4)

  • metabolic syndrome

    changes in triglycerides, high-density lipoprotein cholesterol, systolic blood pressure, diastolic blood pressure, fasting blood glucose, waist circumference

    4 month follow up

  • body weight

    weight in kilograms

    4 month follow up

  • BMI

    weight and height will be combined to report BMI in kg/m\^2

    4 month follow up

  • Frailty

    measurement used study of osteoporotic fracture index (SOF).

    4 month follow up

Secondary Outcomes (4)

  • short physical performance battery

    4 month follow up

  • upper limb muscle strength

    4 month follow up

  • static balance ability

    4 month follow up

  • physical agility and dynamic balance ability

    4 month follow up

Other Outcomes (2)

  • Physical activity

    4 month follow up

  • dietary behaviors

    4 month follow up

Study Arms (2)

experimental arm

EXPERIMENTAL

self-management skills and healthy technology APP

Behavioral: self-management skills and healthy technology APP

control group

NO INTERVENTION

Health education leaflet

Interventions

self-management skills and healthy technology APP

experimental arm

Eligibility Criteria

Age40 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • older adult with age ≥ 40 years
  • community-dwelling
  • no hearing and visual acuity difficulties

You may not qualify if:

  • Unconscious
  • Cognitive impairment or dementia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taoyuan

Taoyuan District, Taiwan

RECRUITING

MeSH Terms

Conditions

Metabolic DiseasesSarcopeniaFrailty

Condition Hierarchy (Ancestors)

Nutritional and Metabolic DiseasesMuscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and SymptomsPathologic Processes

Study Officials

  • Shu-Hung Chang, Ph.D

    Chang Gung University of Science and Technology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shu-Hung Chang, Ph.D

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 19, 2022

First Posted

July 27, 2022

Study Start

February 15, 2023

Primary Completion

July 31, 2023

Study Completion

July 31, 2023

Last Updated

February 8, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations