ClinicalTrials.gg
RecruitingNCT06022549Updated Jul 29, 2024

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

An observational study in Hiv, sponsored by National Taiwan University. Recruiting at 1 site in Taiwan. Open to participants aged 30 Years and older. Per ClinicalTrials.gov, last updated 2024-07-29.

Primary conditionMetabolic SyndromeRegistry: Acquired Immunodeficiency SyndromeReclassifiedWhy we changed it
Registry
Acquired Immunodeficiency Syndrome — the first condition term the registry derived for this study.
ClinicalTrials.gg
Metabolic Syndrome
Why
  1. The registry often attaches Acquired Immunodeficiency Syndrome to studies about something else, and this study's title and listed conditions do not name it.
  2. The study's title name Metabolic Syndrome.
Confidence
High: the new condition is named in the study's own title. Of 46 hand-checked studies reclassified this way, 72% were exactly right and 89% in the right disease family; the registry's first term was right for 4% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by National Taiwan University · Observational

From the registry’s dates

  • Primary completion was expected by Jan 2025, 1 year 10 months ago, but the record still lists the study as recruiting.
  • Started Oct 2023; still recruiting 3 years 1 month later.
Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
400
Ages
30 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Hiv

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Keywords

  • HIV-infected persons
  • Metabolic syndrome
03

In context

Metabolic Syndrome Reclassified

2,116 studies on the registry are indexed under Metabolic Syndrome; 347 are open to participants now.

This study's planned enrollment of 400 is above the median of 197 across 496 observational studies indexed under Metabolic Syndrome.

Browse Metabolic Syndrome studies →

Lead sponsor

National Taiwan University is the lead sponsor of 22 studies on the registry; 7 are open to participants now.

Compared within Metabolic Syndrome, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Acquired Immunodeficiency Syndrome. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
30 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

HIV-infected persons over the age of 30

Inclusion criteria

  • -infected persons over the age of 30

Exclusion criteria

Exclusion Criteria:

-

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

05

Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
400 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 year

  2. 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

    Time frame: 1 year

  3. 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.

    Time frame: 1 year

07

Study locations

1 of 1 sites recruiting
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Oct 2023 (actual). Primary completion is estimated for Jan 2025, 14 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 25, 2023
First posted
Sep 5, 2023
StartActual
Oct 11, 2023
Primary completionEst.
Jan 1, 2025
CompletionEst.
Jan 31, 2025
Last update
Jul 29, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 29, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06022549
Lead sponsor
National Taiwan University
Responsible party
Piao-Yi Chiou (Associate Professor, National Taiwan University) — Principal investigator
First posted
Sep 5, 2023
Start date
Oct 11, 2023
Primary completion
Jan 1, 2025 (estimated)
Completion
Jan 31, 2025 (estimated)
Last update
Jul 29, 2024

Study contacts

PIAO-YI CHIOU, doctoral
Contact
piaoyi@ntu.edu.tw
+886-2-23123456 ext. 88427
PIAO-YI CHIOU, doctoral
study director · National Taiwan University, College of Medicine, School of Nursing

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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