NCT06527768 Theory-based Health Behaviour Change Intervention in Patients of Metabolic Syndrome With Chronic Kidney Disease
| NCT ID | NCT06527768 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Chinese University of Hong Kong |
| Condition | Chronic Kidney Diseases |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2024-07-31 |
| Primary Completion | 2026-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2024-07-31 with a primary completion date of 2026-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The pilot study will adopt a 2-arm, pretest-posttest, and assessor-blind randomized controlled trial design to examine the feasibility and acceptability of a theory-based health behaviour change intervention and examine its effects on waist circumference (primary outcome), kidney function (estimated glomerular filtration rate, urine albumin-to-creatinine ratio, primary outcome), dietary behaviour, physical activity, exercise capacity and self-efficacy of diet behaviour and physical activity among Chinese adults with metabolic syndrome and chronic kidney disease. Researchers will compare the theory-based health behaviour change intervention to usual care to see if the theory-based health behaviour change intervention can reduce waist circumference and preserve kidney function over three months. A total of 40 adults with metabolic syndrome and chronic kidney disease will be recruited, with 20 participants in each group. Data will be collected at two-time points (baseline and immediate post-intervention) via an online questionnaire survey platform (Qualtrics) by researchers blinded to the group allocation to reduce the detection bias.
Eligibility Criteria
Inclusion Criteria: * 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; * No medical contraindications to exercise, including walking; * Participants are capable of understanding and providing informed consent; * Own a smartphone for accessing WeChat; * Being able to communicate in Chinese; * Stay in Chengdu during the study period. Exclusion Criteria: * Participants who cannot perform brisk walking exercise; * 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; * Participants who have a cognitive impairment, which will be screened by the abbreviated mental test with a score lower than seven; * 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06527768 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Kidney Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06527768 currently recruiting?
Yes, NCT06527768 is actively recruiting participants. Contact the research team at 1155185244@link.cuhk.edu.hk for enrollment information.
Where is the NCT06527768 trial being conducted?
This trial is being conducted at Chengdu, China.
Who is sponsoring the NCT06527768 clinical trial?
NCT06527768 is sponsored by Chinese University of Hong Kong. The trial plans to enroll 40 participants.
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