Effects of mHealth Message on Metabolic Syndrome and Bone Loss of HIV Infected Persons in Taiwan

Hiv Clinical Trial

Official title:

Effects of mHealth Message on Metabolic Syndrome and Bone Loss of HIV Infected Persons in Taiwan

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06022549
• Other study ID #: 202301HM003
• Status: Recruiting
• Start date: October 11, 2023
• Est. completion date: July 31, 2024

Study information

• Verified date: October 2023
• Source: National Taiwan University
• Contact: PIAO-YI CHIOU, doctoral
• Phone: +886-2-23123456
• Email: piaoyi[@]ntu.edu.tw
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

With improved AIDS treatment leading to extended survival, HIV-infected individuals face a higher metabolic syndrome incidence. This study aims to determine the prevalence of Non-AIDS related Comorbidities (NARC) in HIV-infected individuals. Using purposive and snowball sampling, the cross-sectional survey targets 400 HIV-infected individuals aged 40 and above. Data collection includes demographics, physical activity, nutrition, depression, and physiological measurements. Analyzing the data through statistical tests and structural equation modeling, the study aims to provide precise care recommendations for preventive medicine and healthy aging in this population.

Description:

With the success of treatment, the survival period of Acquired immunodeficiency syndrome (AIDS) patients is prolonged. Compared with non-HIV-infected persons of the same age, HIV-infected persons have a relatively higher incidence of metabolic syndrome (MS). The main purpose of this study is to estimate the prevalence of common Non-AIDS related Comorbidities (NARC) among HIV-infected persons This study is a cross-sectional survey, purposive and snowball sampling will be applied. The recruitment information is released through channels such as AIDS case managers, AIDS non-government organizations, and social networks of HIV-infected people all around Taiwan. The expected sample size is 400 HIV-infected persons over the age of 40, after signing a written consent form, a test will be conducted, including the collection of demographic data, questionnaire data collection with physical activity scale, mini-nutrition assessment scale, and depression self-test scale, and measurement of physiological parameters using instruments including a gripper, body composition meter, sphygmomanometer, blood glucose, and lipid monitor, tape measure. The Chi-square test and independent sample T-test are used to compare the differences in the categorical and continuous data of each variable, and the structural equation model is used to conduct path analysis of the research framework. The research results can be used as precise care recommendations for the development of preventive medicine and healthy aging for HIV-infected persons.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: July 31, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• HIV-infected persons over the age of 40 Exclusion Criteria: -

Related Conditions & MeSH terms

• Hiv
• Metabolic Syndrome

Locations

Country	Name	City	State
Taiwan	National Taiwan University, College of Medicine, School of Nursing	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mini Nutritional Assessment	The points of this assessment is from 0 to 30. The points over 23.5 mean normal nutritional status, 17~23.5 points mean at risk of malnutrition, less 7 points mean malnourished.	1 year
Primary	International Physical Activity Questionnaire	It is a self-administered survey used to assess an individual's physical activity levels. It aims to measure the amount of physical activity a person engages in across various domains of life, including work, transportation, household chores, and leisure time.; The IPAQ typically asks participants about the duration and frequency of their physical activities in the past seven days. The MET-minutes per week score is calculated by multiplying the minutes spent in each activity intensity level by the MET value associated with that activity and then summing these values across all activities.; The interpretation of MET-minutes per week is as follows: Low activity: Below 600 MET-minutes per week Moderate activity: 600 to 3000 MET-minutes per week High activity: More than 3000 MET-minutes per week	1 year
Primary	Patient Health Questionnaire-9	The Patient Health Questionnaire-9 (PHQ-9) is a self-report assessment tool commonly used to screen and measure the severity of depression symptoms in individuals. It consists of 9 items or questions, each assessing different aspects of depression such as mood, energy level, and concentration.; The PHQ-9 scores each item on a scale from 0 (not at all) to 3 (nearly every day), with a maximum total score of 27. Higher scores on the PHQ-9 indicate more severe depressive symptoms, while lower scores suggest milder or no depressive symptoms.	1 year