Theory-based Health Behaviour Change Intervention in Individuals of Metabolic Syndrome With Chronic Kidney Disease

Recruiting now · Not applicable

Conditions studied: Chronic Kidney Diseases, Metabolic Syndrome

In brief

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.

Key facts

Study ID

NCT06715735

Run by

Chinese University of Hong Kong

People needed

160

Starts

2024-12-20

Expected to finish

2026-10-30

Last updated by the study team

2026-06-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

• West China Hospital of Sichuan University — Chengdu, Sichuan, China (enrolling)

Full record on ClinicalTrials.gov

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