NCT06527768Recruiting
Theory-based Health Behaviour Change Intervention in Patients of Metabolic Syndrome With Chronic Kidney Disease
The Effectiveness of a Theory-based Health Behaviour Change Intervention on Waist Circumference and Kidney Function in Patients of Metabolic Syndrome With Chronic Kidney Disease: A Pilot Randomised Controlled Trial
Source: ClinicalTrials.gov · Last updated 11 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 4 Jul 2024
- Start date
- 31 Jul 2024
- Primary completion date
- 31 Jul 2026
- Lead sponsor
- Chinese University of Hong Kong
- Diseases
- Chronic kidney disease
- NCT number
- NCT06527768
What you commit to
- Study type: Interventional
- Planned participants: 40
- From 31 Jul 2024 to the primary completion date, 31 Jul 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participants who have already started dialysis or kidney transplant;
- Adjustment of medication within half a year;
Other illness
- 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;
Other
- Participants who cannot perform brisk walking exercise;
- Current participation in another clinical trial related to health behaviour change or medical trial;
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| West China Hospital of Sichuan University Coordinator of this site? Confirm its status | Chengdu | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.