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OpenTrials
Completed

NCT Number: NCT05472298

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

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.

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Key information

Age range

50 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Taoyuan

Taoyuan, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Self-management Intervention

Behavioral

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

Primary outcomes

  1. metabolic syndrome

    Time frame: 6 month, and 18-month follow up

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

Secondary outcomes

  1. body weight

    Time frame: 6 months, and 18 months follow up

    weight in kilograms

  2. BMI

    Time frame: 6 months, and 18 months follow up

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

Other outcomes

  1. leisure-time physical activity

    Time frame: 6 months, and 18 months follow up

    moderate-vigorous leisure-time physical activity at least 150 minutes a week

  2. dietary behaviors

    Time frame: 6 months, and 18 months follow up

    intake rate of whole grains, vegetables, fruits, proteins, dairy products, and nuts.

Sponsors and collaborators

Lead sponsor

Chang Gung University of Science and Technology

Other

Collaborators

  • Chang Gung Memorial Hospital

Registry information

Official study title

The Effectiveness of Self-Management Skills and Technology in Individuals Who Have Both Metabolic Syndrome in Community

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jul 25, 2022
Registry last updated
Jul 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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