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

• Sponsor: Chang Gung University of Science and Technology (Other)
• Overall Status: Completed
• CT.gov ID: NCT05472298
• Collaborator: Chang Gung Memorial Hospital (Other)
• Enrollment: 137
• Location: 1
• Arms: 2
• Actual Duration (Months): 24
• Patients Per Site Per Month: 5.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Metabolic Syndrome	Behavioral: self-management intervention	N/A

Detailed 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 137 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Prevention
• Official Title: The Effectiveness of Self-Management Skills and Technology in Individuals Who Have Both Metabolic Syndrome in Community
• Actual Study Start Date: Aug 1, 2017
• Actual Primary Completion Date: Jul 31, 2019
• Actual Study Completion Date: Jul 31, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. metabolic syndrome [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 Outcome Measures

1. body weight [6 months, and 18 months follow up]

   weight in kilograms

2. BMI [6 months, and 18 months follow up]

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

Other Outcome Measures

1. leisure-time physical activity [6 months, and 18 months follow up]

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

2. dietary behaviors [6 months, and 18 months follow up]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years to 80 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Taoyuan	Taoyuan		Taiwan

Sponsors and Collaborators

• Chang Gung University of Science and Technology
• Chang Gung Memorial Hospital

Investigators

• Principal Investigator: Shu-Hung Chang, Ph. D, Chang Gung University of Science and Technology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Shu-Hung Chang, Professor, Chang Gung University of Science and Technology
• ClinicalTrials.gov Identifier: NCT05472298
• Other Study ID Numbers: MOST 107-2314-B-255-006
• First Posted: Jul 25, 2022
• Last Update Posted: Jul 25, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Shu-Hung Chang, Professor, Chang Gung University of Science and Technology: self-management intervention; metabolic syndrome; women
• Additional relevant MeSH terms: Metabolic Syndrome; Syndrome

Study Results

No Results Posted as of Jul 25, 2022