AzTrials
AzTrials

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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

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
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
  • West China Hospital of Sichuan University

    Chengdu, Sichuan, 610000

    DI FEI DUAN, (86)13880446097, duandifei89@wchscu.cn

    Recruiting

Other trials in China

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.

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 groups in NCT06715735
Study groupRoleWhat they receive
HAPA-based intervention groupExperimentalParticipants 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 groupNo interventionUsual care.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

  2. 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)
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  1. First posted4 Dec 2024
  2. Study start20 Dec 2024
  3. Primary completion30 Oct 2026 (estimated)
  4. Study completion30 Oct 2026 (estimated)

Resources

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)
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

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in