Theory-based Health Behaviour Change Intervention in Individuals of Metabolic Syndrome With Chronic Kidney Disease
Recruiting · NCT06715735 · 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
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 3-time points (baseline, immediate post-intervention and 1-month 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;
- 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.
Exclusion criteria
- 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.
Where it is running
1 location listed.
- West China Hospital of Sichuan University - Chengdu, Sichuan, China