HivNCT06022549
Effects of mHealth Message on Metabolic Syndrome and Bone Loss of HIV Infected Persons in Taiwan
An observational study of Hiv, run by National Taiwan University at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Hiv
- How many people
- 400 participants
- Where
- 1 siteTaiwan
- Study dates
- 11 Oct 2023to 31 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: HIV-infected persons over the age of 30
Who may be able to join
- HIV-infected persons over the age of 30
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University, College of Medicine, School of Nursing
Taipei
PIAO-YI CHIOU, doctoral, +886-2-23123456 ext. 88427, piaoyi@ntu.edu.tw
About this study
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 30 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.
Read the detailed 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 30, 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.
- Conditions
- Hiv
- Keywords
- HIV-infected persons, Metabolic syndrome
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Metabolic Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
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
Measured: 1 year
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2023
- Study start11 Oct 2023
- Primary completion1 Jan 2025 (estimated)
- Study completion31 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HivStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Piao-Yi Chiou, National Taiwan University
- Investigators
- PIAO-YI CHIOU, doctoral, Study director, National Taiwan University, College of Medicine, School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06022549
- Sponsor's protocol ID
- 202301HM003
- Status last verified
- Jul 2024
- First submitted
- 25 Aug 2023
- Last updated
- 29 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of mHealth Message on Metabolic Syndrome and Bone Loss of HIV Infected Persons in Taiwan
- ClinicalTrials.gov ID
- NCT06022549
- Acronym / sponsor ID
- 202301HM003
- Conditions
- Hiv
- Keywords
- HIV-infected persons, Metabolic syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- National Taiwan UniversityUniversity, hospital or other
- Study start
- 11 Oct 2023 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 31 Jan 2025 (estimated)
- First posted
- 5 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 30 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.
Detailed 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 30, 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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HIV-infected persons over the age of 30
Key inclusion criteria (1 listed)
- HIV-infected persons over the age of 30
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mini Nutritional Assessment
Time frame: 1 year
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.
International Physical Activity Questionnaire
Time frame: 1 year
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
Patient Health Questionnaire-9
Time frame: 1 year
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
PIAO-YI CHIOU, doctoral study director
National Taiwan University, College of Medicine, School of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hiv, run by National Taiwan University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact PIAO-YI CHIOU, doctoral (+886-2-23123456 ext. 88427, piaoyi@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mini Nutritional Assessment (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2024.