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Effectiveness of Self-Management Skills for Metabolic Syndrome Fatty Liver Disease Adults

C

Chang Gung University of Science and Technology

Status

Completed

Conditions

Metabolic Syndrome

Treatments

Behavioral: self-management intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT05472298
MOST 107-2314-B-255-006

Details and patient eligibility

About

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.

Full description

The study is a 2-parallel groups' randomized controlled trial. Participants with metabolic syndrome (three or more risk factors - triglycerides (TG) >150 mg/dL, systolic blood pressure (SBP) ≥130 mm Hg, diastolic blood pressure (DBP) ≥85 mm Hg, or fasting blood glucose≥100 mg/dL; high-density lipoprotein cholesterol<50 mg/dL, or waist circumference ≥80 cm) are enrolled. The four community units are randomized to receive a lifestyle intervention (intervention arm) or an education leaflet (control arm). The parameters are obtained from physical examination and biochemical assessments by well-trained case manager at baseline and each follow visit (6th months and 18th months). All participants complete a structured questionnaire, including basic information, physical activity, and food-frequency.

Enrollment

137 patients

Sex

Female

Ages

50 to 80 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • 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

Exclusion criteria

  • Unconscious
  • Cognitive impairment or dementia

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

137 participants in 2 patient groups

intervention arm
Experimental group
Description:
lifestyle modification, goal setting, coaching and peer support, problem-solving, and self-monitoring
Treatment:
Behavioral: self-management intervention
control arm
No Intervention group
Description:
education leaflet

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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