Chronic Kidney DiseasesNCT06715735
HAPA-based Intervention in Adults With Metabolic Syndrome and Chronic Kidney Disease
A study testing HAPA-based intervention in people with Chronic Kidney Diseases and Metabolic Syndrome, run by Chinese University of Hong Kong at 1 site in China.
Trial summary
This study will adopt a 2-arm, pretest-posttest, and assessor-blind RCT design to examine the effectiveness of a theory-based health behaviour change intervention on WC (primary outcome), kidney function (eGFR, primary outcome), dietary behaviour, PA, exercise capacity, and self-efficacy of dietary behaviour and PA… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Kidney Diseases, Metabolic Syndrome
- What is being tested?
- HAPA-based intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- 20 Dec 2024to 30 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants are 18 years old and above;
- Participants have both diagnoses of MetS based on IDF clinical diagnostic criteria (WC for Chinese: ≥ 90 cm in men and ≥ 80 cm in women, and fulfils two items of the following: TG ≥ 1.7 mmol/L or treatment for hypertriglycerides, HDL-C<1.03 mmol/L in men or <1.29 mmol/L in women or treatment for low HDL-C, FG ≥5.6 mmol/L or previously diagnosed type 2 diabetes, and BP ≥ 130/85 mmHg or treatment for hypertension), and CKD;
- Participants are capable of understanding and providing informed consent, their cognitive function will be screened by the abbreviated mental test with a score higher than seven;
- Own a smartphone for accessing WeChat;
- Being able to communicate in Chinese.
Who cannot join
- Participants who have medical contraindications to exercise, including walking;
- Participants who have already started dialysis or kidney transplant;
- Current participation in another clinical trial related to health behaviour change or medical trial;
- Participants who have doctor-diagnosed psychiatric illness;
- Adjustment of medication within half a year;
- Participants who have performed regular planned exercise (Defined as at least 150 minutes of moderate-intensity aerobic activity or 75 minutes of high-intensity aerobic activity per week, or a combination of moderate-intensity and high-intensity aerobic activity) within the past month.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
West China Hospital of Sichuan University
Chengdu, Sichuan, 610000
DI FEI DUAN, (86)13880446097, duandifei89@wchscu.cn
About this study
Official title: Effectiveness of a Health Action Process Approach-Based Intervention on Waist Circumference and Kidney Function in Adults With Metabolic Syndrome and Chronic Kidney Disease: A Randomised Controlled Trial
This study will adopt a 2-arm, pretest-posttest, and assessor-blind RCT design to examine the effectiveness of a theory-based health behaviour change intervention on WC (primary outcome), kidney function (eGFR, primary outcome), dietary behaviour, PA, exercise capacity, and self-efficacy of dietary behaviour and PA among Chinese adults with metabolic syndrome and chronic kidney disease.
A total of 160 adults with metabolic syndrome and chronic kidney disease will be recruited, with 80 participants in each group. Data will be collected at 4 time points (baseline, immediate post-intervention, 1-month post-intervention, and 6-month post-intervention) via an online questionnaire survey platform (Qualtrics) by researchers blinded to the group allocation to reduce the detection bias.
Read the detailed description
Metabolic syndrome (MetS) is a worldwide chronic disease mainly due to unhealthy diets and sedentary lifestyles. According to the International Diabetes Federation (IDF) definition of MetS, patients must have central obesity defined by waist circumference (WC) with ethnicity-specific values, plus any two of four additional factors, namely high triglycerides (TG), low high-density lipoprotein cholesterol (HDL-C), high fasting glucose (FG), and high blood pressure (BP).
More recent evidence indicates that the MetS could be an independent risk factor for chronic kidney disease (CKD). CKD is a progressive and incurable condition with high morbidity and mortality, defined by markers of kidney damage or decreased glomerular filtration rate (GFR) persisting for at least three months. According to KDIGO 2012 clinical practice guideline, CKD is divided into five stages (stages 1, 2, 3a, 3b, 4, 5), which are based on the eGFR test result, as the stage progresses, kidney function becomes more severe, ultimately leading to kidney failure. Previous studies have found that individuals with MetS had a higher risk of CKD compared with patients without MetS.
Central obesity, as the core component of MetS, could be one of the most essential pathogenes explaining the association between MetS and CKD. Central obesity mainly manifests as excess abdominal adipose tissue, which directly leads to the deranged synthesis of various adipose tissue cytokines (e.g., leptin, adiponectin, resistin, and visfatin) with nephrotoxic potential to cause sustained damage or structural changes to the kidneys, as well as indirectly trigger insulin resistance, dyslipidemia and hypertension, which are the most substantial risk factors for CKD.
Many patients fail to take MetS seriously until they are diagnosed with CKD. This is attributed to the additional complications and complex treatments associated with CKD, significantly affecting their daily lives. Current therapeutic guidelines for MetS suggest that non-pharmacological interventions with multifactorial lifestyle changes should be the primary treatment, including dietary modification, physical activity (PA), counselling or lifestyle modifications.
The Health Action Process Approach (HAPA) offers such a framework by distinguishing processes (risk perception, outcome expectancies and action self-efficacy) from volitional processes (action planning, coping planning, and maintenance and recovery self-efficacy). Application of HAPA is therefore well suited to supporting behavior change under the unique constraints of coexisiting MetS and CKD.
Despite high prevalence and synergistic risks of this dual diagnosis, behavioural intervention research has largely overlooked the population. Existing non-pharmacological programmes typically target MetS or CKD in isolation and do not systematically reconcile their conflicting dietary and lifestyle requirements. This study therefore evaluates the effectiveness of a HAPA-based behaviour change intervention on WC and kidney function in Chinese adults with both MetS and CKD.
- Conditions
- Chronic Kidney Diseases, Metabolic Syndrome
- Being tested
- HAPA-based intervention
- Keywords
- Metabolic Syndrome, Chronic Kidney Disease, Waist Circumference, Estimated Glomerular Filtration Rate, Behaviour Change, Health Action Process Approach, Randomised Controlled Trial
- Medical subject headings
- Renal Insufficiency, Chronic, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HAPA-based interventionBehavioural
Online individual education sessions on MetS, CKD, healthy diet, and physical activity are delivered via WeChat. Group music-paced brisk walking training (5-min warm-up, 30-min walking, 5-min cool-down) and group discussions on health status, diet, exercise, and personal goals are conducted via Tencent Meeting. Follow-up phone calls reinforce goals and address questions. All content is based on a structured health handbook. Participants are required to perform self-paced brisk walking for 30 minutes/day, 5 days/week.
| Study group | Role | What they receive |
|---|---|---|
| HAPA-based intervention group | Experimental | Participants will be enrolled via WeChat and Tencent Meeting and undergo a HAPA-based intervention comprising 8 intervention sessions over 12 weeks. The 8 intervention sessions contain two online individual education sessions, two online group music-paced brisk walking training, two group discussions, and two telephone follow-ups. Besides, participants in the intervention group will be required to perform self-music-paced brisk walking 150 minutes/week for three months. Receives: Behavioral: HAPA-based intervention |
| Control group | No intervention | Usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Waist circumference
WC will be measured at the midpoint between the lower rib and the top of the iliac crest with the relaxed abdomen using a non-stretchable plastic measuring tape with an accuracy of 0.1 cm.
Measured: Data will be collected at baseline, immediate post-intervention, 1-month post-intervention, and 6-month post-intervention.
Estimated glomerular filtration rate
Blood samples will be obtained in the morning after fasting for at least 12 hours, and they will be refrigerated immediately after phlebotomy and centrifuged within 2 hours of collection. Blood samples will be analysed for eGFR. The eGFR will be calculated by the Chronic Kidney Disease Epidemiology Collaboration equation for Chinese individuals.
Measured: Data will be collected at baseline, immediate post-intervention, 1-month post-intervention, and 6-month post-intervention.
Secondary outcomes (9)
Physical activity
The Chinese version of the short form of the International Physical Activity Questionnaire (IPAQ-SF) will be used to evaluate the amount of weekly PA. The IPAQ-SF records PA with nine questions, including vigorous, moderate-intensity, walking, and sitting. The simplified Chinese version of IPAQ-SF records self-reported physical activity in the last seven days, and the responses were converted to Metabolic Equivalent Task minutes per week (MET-min/wk). Total minutes over the last seven days spent on vigorous activity, moderate-intensity activity, and walking were multiplied by 8.0, 4.0, and 3.3, respectively, to create MET scores for each activity level.
Measured: Data will be collected at baseline, immediate post-intervention, 1-month post-intervention, and 6-month post-intervention.
Exercise capacity
The Six-Minute Walk Test (6MWT) will be used to evaluate exercise capacity. Participants will be asked to walk back and forth for six minutes at their usual speed along a straight 30-meter hospital corridor with marks every five meters. Throughout the test, participants will be permitted to slow down, pause, or take breaks as needed, but also be expected to resume walking when they feel ready. Encourage participants to use standard phrases from the guide. The 10-point Borg scale will be used to grade dyspnea and fatigue during the walk, with a higher score indicating a worse situation. The pulse oximeter will be used to measure heart rate and oxygen saturation, and the electronic sphygmomanometer will be used to measure blood pressure before and after the 6MWT. Additionally, the total distance covered will also be recorded.
Measured: Data will be collected at baseline, immediate post-intervention, 1-month post-intervention, and 6-month post-intervention.
Dietary behaviour
Dietary behaviour will be assessed using the diet control subscale of the Chinese Chronic Kidney Disease Self-care scale (CKDSC-DC) and the nutrition domain of the Health-Promoting Lifestyle Profile II (HPLP-II-N). The CKDSC-DC is a 4-item measure of CKD-specific dietary self-care, rated from 1 (almost never) to 5 (almost always). Higher scores indicate better dietary self-management, with scores ≥14 considered healthy. The HPLP-II-N comprises 9 items assessing general healthy dietary practices, rated from 1 (not at all) to 4 (always). Higher scores indicate healthier dietary behaviour, with scores ≥22.5 classified as healthy.
Measured: Data will be collected at baseline, immediate post-intervention, 1-month post-intervention, and 6-month post-intervention.
Self-efficacy of dietary behavior and physical activity
The Chinese version of the Health-Related Diet and Exercise Self-Efficacy Scale - Simplified Version (HRDESES) will be used to evaluate the self-efficacy of dietary behavior and physical activity. Response options are rated on a 5-point scale: zero (I'm not sure), one (mostly I cannot), two (I don't know), three (mostly I can), or four (I'm sure I can). The total score of HRDESES ranges from zero to 32, with a higher score indicating higher levels of health-related diet and exercise self-efficacy.
Measured: Data will be collected at baseline, immediate post-intervention, 1-month post-intervention, and 6-month post-intervention.
Blood pressure
An automatic BP monitor will be used to measure the BP, and one of four cuff sizes (small, standard, large, or thigh) will be chosen based on each participant's right arm circumference. Participants were instructed to refrain from smoking, consuming caffeine, or engaging in vigorous PA for at least 30 minutes prior to measurement.
Measured: Data will be collected at baseline, immediate post-intervention, 1-month post-intervention, and 6-month post-intervention.
Triglycerides
Blood samples will be obtained in the morning after fasting for at least 12 hours, and they will be refrigerated immediately after phlebotomy and centrifuged within 2 hours of collection. Blood samples will be analysed for TG by using an Auto Biochemical Analyzer (MODULAR-000GS; Roche, Basel, Switzerland).
Measured: Data will be collected at baseline, immediate post-intervention, 1-month post-intervention, and 6-month post-intervention.
High-density lipoprotein cholesterol
Blood samples will be obtained in the morning after fasting for at least 12 hours, and they will be refrigerated immediately after phlebotomy and centrifuged within 2 hours of collection. Blood samples will be analysed for HDL-C by using an Auto Biochemical Analyzer (MODULAR-000GS; Roche, Basel, Switzerland).
Measured: Data will be collected at baseline, immediate post-intervention, 1-month post-intervention, and 6-month post-intervention.
Fasting glucose
Blood samples will be obtained in the morning after fasting for at least 12 hours, and they will be refrigerated immediately after phlebotomy and centrifuged within 2 hours of collection. Blood samples will be analysed for FG by using an Auto Biochemical Analyzer (MODULAR-000GS; Roche, Basel, Switzerland).
Measured: Data will be collected at baseline, immediate post-intervention, 1-month post-intervention, and 6-month post-intervention.
MetS severity score
The age-sex-ethnicity-specific MetS score model for Chinese adults will be used measure the MetS severity score. The score is based on continuous measures of the five MetS-related components (WC, TG, HDL-C, mean arterial pressure [MAP; calculated as 1/3(SBP - DBP) + DBP], and FG), thereby addressing a key limitation of the traditional dichotomous MetS definition, which fails to capture disease severity or demographic variation. Higher scores reflect greater metabolic severity and increased cardiovascular risk.
Measured: Data will be collected at baseline, immediate post-intervention, 1-month post-intervention, and 6-month post-intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2024
- Study start20 Dec 2024
- Primary completion30 Oct 2026 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yan Linjia, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06715735
- Sponsor's protocol ID
- CREC Ref. No.: 2024.447-T
- Status last verified
- Oct 2026
- First submitted
- 29 Nov 2024
- Last updated
- 9 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Health Action Process Approach-Based Intervention on Waist Circumference and Kidney Function in Adults With Metabolic Syndrome and Chronic Kidney Disease: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06715735
- Acronym / sponsor ID
- CREC Ref. No.: 2024.447-T
- Conditions
- Chronic Kidney Diseases, Metabolic Syndrome
- Keywords
- Metabolic Syndrome, Chronic Kidney Disease, Waist Circumference, Estimated Glomerular Filtration Rate, Behaviour Change, Health Action Process Approach, Randomised Controlled Trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 20 Dec 2024 (actual)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 4 Dec 2024 (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.
This study will adopt a 2-arm, pretest-posttest, and assessor-blind RCT design to examine the effectiveness of a theory-based health behaviour change intervention on WC (primary outcome), kidney function (eGFR, primary outcome), dietary behaviour, PA, exercise capacity, and self-efficacy of dietary behaviour and PA among Chinese adults with metabolic syndrome and chronic kidney disease.
A total of 160 adults with metabolic syndrome and chronic kidney disease will be recruited, with 80 participants in each group. Data will be collected at 4 time points (baseline, immediate post-intervention, 1-month post-intervention, and 6-month post-intervention) via an online questionnaire survey platform (Qualtrics) by researchers blinded to the group allocation to reduce the detection bias.
Detailed description
Metabolic syndrome (MetS) is a worldwide chronic disease mainly due to unhealthy diets and sedentary lifestyles. According to the International Diabetes Federation (IDF) definition of MetS, patients must have central obesity defined by waist circumference (WC) with ethnicity-specific values, plus any two of four additional factors, namely high triglycerides (TG), low high-density lipoprotein cholesterol (HDL-C), high fasting glucose (FG), and high blood pressure (BP).
More recent evidence indicates that the MetS could be an independent risk factor for chronic kidney disease (CKD). CKD is a progressive and incurable condition with high morbidity and mortality, defined by markers of kidney damage or decreased glomerular filtration rate (GFR) persisting for at least three months. According to KDIGO 2012 clinical practice guideline, CKD is divided into five stages (stages 1, 2, 3a, 3b, 4, 5), which are based on the eGFR test result, as the stage progresses, kidney function becomes more severe, ultimately leading to kidney failure. Previous studies have found that individuals with MetS had a higher risk of CKD compared with patients without MetS.
Central obesity, as the core component of MetS, could be one of the most essential pathogenes explaining the association between MetS and CKD. Central obesity mainly manifests as excess abdominal adipose tissue, which directly leads to the deranged synthesis of various adipose tissue cytokines (e.g., leptin, adiponectin, resistin, and visfatin) with nephrotoxic potential to cause sustained damage or structural changes to the kidneys, as well as indirectly trigger insulin resistance, dyslipidemia and hypertension, which are the most substantial risk factors for CKD.
Many patients fail to take MetS seriously until they are diagnosed with CKD. This is attributed to the additional complications and complex treatments associated with CKD, significantly affecting their daily lives. Current therapeutic guidelines for MetS suggest that non-pharmacological interventions with multifactorial lifestyle changes should be the primary treatment, including dietary modification, physical activity (PA), counselling or lifestyle modifications.
The Health Action Process Approach (HAPA) offers such a framework by distinguishing processes (risk perception, outcome expectancies and action self-efficacy) from volitional processes (action planning, coping planning, and maintenance and recovery self-efficacy). Application of HAPA is therefore well suited to supporting behavior change under the unique constraints of coexisiting MetS and CKD.
Despite high prevalence and synergistic risks of this dual diagnosis, behavioural intervention research has largely overlooked the population. Existing non-pharmacological programmes typically target MetS or CKD in isolation and do not systematically reconcile their conflicting dietary and lifestyle requirements. This study therefore evaluates the effectiveness of a HAPA-based behaviour change intervention on WC and kidney function in Chinese adults with both MetS and CKD.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HAPA-based intervention group | Experimental | Behavioral: HAPA-based interventionParticipants will be enrolled via WeChat and Tencent Meeting and undergo a HAPA-based intervention comprising 8 intervention sessions over 12 weeks. The 8 intervention sessions contain two online individual education sessions, two online group music-paced brisk walking training, two group discussions, and two telephone follow-ups. Besides, participants in the intervention group will be required to perform self-music-paced brisk walking 150 minutes/week for three months. |
| Control group | No intervention | –Usual care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participants are 18 years old and above;
- Participants have both diagnoses of MetS based on IDF clinical diagnostic criteria (WC for Chinese: ≥ 90 cm in men and ≥ 80 cm in women, and fulfils two items of the following: TG ≥ 1.7 mmol/L or treatment for hypertriglycerides, HDL-C<1.03 mmol/L in men or <1.29 mmol/L in women or treatment for low HDL-C, FG ≥5.6 mmol/L or previously diagnosed type 2 diabetes, and BP ≥ 130/85 mmHg or treatment for hypertension), and CKD;
- Participants are capable of understanding and providing informed consent, their cognitive function will be screened by the abbreviated mental test with a score higher than seven;
- Own a smartphone for accessing WeChat;
- Being able to communicate in Chinese.
Key exclusion criteria (6 listed)
- Participants who have medical contraindications to exercise, including walking;
- Participants who have already started dialysis or kidney transplant;
- Current participation in another clinical trial related to health behaviour change or medical trial;
- Participants who have doctor-diagnosed psychiatric illness;
- Adjustment of medication within half a year;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HAPA-based interventionOnline individual education sessions on MetS, CKD, healthy diet, and physical activity are delivered via WeChat. Group music-paced brisk walking training (5-min warm-up, 30-min walking, 5-min cool-down) and group discussions on health status, diet, exercise, and personal goals are conducted via Tencent Meeting. Follow-up phone calls reinforce goals and address questions. All content is based on a structured health handbook. Participants are required to perform self-paced brisk walking for 30 minutes/day, 5 days/week. | Behavioural | HAPA-based intervention group |
Primary outcome
Waist circumference
Time frame: Data will be collected at baseline, immediate post-intervention, 1-month post-intervention, and 6-month post-intervention.
WC will be measured at the midpoint between the lower rib and the top of the iliac crest with the relaxed abdomen using a non-stretchable plastic measuring tape with an accuracy of 0.1 cm.
Estimated glomerular filtration rate
Time frame: Data will be collected at baseline, immediate post-intervention, 1-month post-intervention, and 6-month post-intervention.
Blood samples will be obtained in the morning after fasting for at least 12 hours, and they will be refrigerated immediately after phlebotomy and centrifuged within 2 hours of collection. Blood samples will be analysed for eGFR. The eGFR will be calculated by the Chronic Kidney Disease Epidemiology Collaboration equation for Chinese individuals.
9 secondary outcomes
Physical activity
Time frame: Data will be collected at baseline, immediate post-intervention, 1-month post-intervention, and 6-month post-intervention.
Exercise capacity
Time frame: Data will be collected at baseline, immediate post-intervention, 1-month post-intervention, and 6-month post-intervention.
Dietary behaviour
Time frame: Data will be collected at baseline, immediate post-intervention, 1-month post-intervention, and 6-month post-intervention.
Self-efficacy of dietary behavior and physical activity
Time frame: Data will be collected at baseline, immediate post-intervention, 1-month post-intervention, and 6-month post-intervention.
Blood pressure
Time frame: Data will be collected at baseline, immediate post-intervention, 1-month post-intervention, and 6-month post-intervention.
Triglycerides
Time frame: Data will be collected at baseline, immediate post-intervention, 1-month post-intervention, and 6-month post-intervention.
High-density lipoprotein cholesterol
Time frame: Data will be collected at baseline, immediate post-intervention, 1-month post-intervention, and 6-month post-intervention.
Fasting glucose
Time frame: Data will be collected at baseline, immediate post-intervention, 1-month post-intervention, and 6-month post-intervention.
MetS severity score
Time frame: Data will be collected at baseline, immediate post-intervention, 1-month post-intervention, and 6-month post-intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HAPA-based intervention in people with Chronic Kidney Diseases and Metabolic Syndrome, run by Chinese University of Hong Kong at 1 site in China.
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 5 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 9 Oct 2026. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact LIN JIA YAN ((852)55393204, 1155185244@link.cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Waist circumference (time frame: Data will be collected at baseline, immediate post-intervention, 1-month post-intervention, and 6-month post-intervention.). The study lists 2 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 9 Oct 2026.