Theory-based Health Behaviour Change Intervention in Patients of Metabolic Syndrome With Chronic Kidney Disease
Recruiting · NCT06527768 · Interventional (participants receive a specific treatment) · Lead sponsor: Chinese University of Hong Kong
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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.
Where it is running
1 location listed.
- West China Hospital of Sichuan University - Chengdu, Sichuan, China