NCT05472298

Brief Summary

The multidimensional self-management intervention program focusing on healthy dietary habit and exercise effectively prevents metabolic syndrome. Thus, the purpose of this study was to assess the efficacy of multidimensional self-management intervention program on metabolic syndrome subjects in Taiwan.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
137

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2019

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

July 19, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 25, 2022

Completed
Last Updated

July 25, 2022

Status Verified

July 1, 2022

Enrollment Period

2 years

First QC Date

July 19, 2022

Last Update Submit

July 22, 2022

Conditions

Metabolic Syndrome

Keywords

self-management interventionmetabolic syndromewomen

Outcome Measures

Primary Outcomes (1)

  • metabolic syndrome

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

    6 month, and 18-month follow up

Secondary Outcomes (2)

  • body weight

    6 months, and 18 months follow up

  • BMI

    6 months, and 18 months follow up

Other Outcomes (2)

  • leisure-time physical activity

    6 months, and 18 months follow up

  • dietary behaviors

    6 months, and 18 months follow up

Study Arms (2)

intervention arm

EXPERIMENTAL

lifestyle modification, goal setting, coaching and peer support, problem-solving, and self-monitoring

Behavioral: self-management intervention

control arm

NO INTERVENTION

education leaflet

Interventions

self-management interventionBEHAVIORAL

lifestyle modification, goal setting, coaching and peer support, problem-solving

intervention arm

Eligibility Criteria

Age50 Years - 80 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsadult women with age ≥ 50 years, low education, defined as having less than 6 years of education or being primary school graduates
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adult women with age ≥ 50 years
  • low education, defined as having less than 6 years of education or being primary school graduates
  • presence of metabolic syndrome
  • 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

Location

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Shu-Hung Chang, Ph. D

    Chang Gung University of Science and Technology

    PRINCIPAL INVESTIGATOR

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 25, 2022

Study Start

August 1, 2017

Primary Completion

July 31, 2019

Study Completion

July 31, 2019

Last Updated

July 25, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)