Health behavior change plan for adults with metabolic syndrome and kidney disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot study uses a two-arm, randomized design to compare a theory-based health behavior change intervention with usual care. Participants are adults with metabolic syndrome and chronic kidney disease, recruited in Chengdu, China. The primary outcome is change in waist circumference and kidney function (estimated GFR and urine albumin-to-creatinine ratio) over three months, with secondary measures including dietary behavior, physical activity, exercise capacity, and self-efficacy. Assessors are blinded to group assignment, and data are collected at baseline and after the intervention. A total of 40 participants (20 per arm) will be enrolled to assess feasibility and acceptability in addition to preliminary effectiveness.

Why it matters

Who can join: the full rules

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's running

• West China Hospital of Sichuan University
  Chengdu, Sichuan, China Recruiting

Study contacts

• Study coordinator: Lin Jia Yan
• Email: 1155185244@link.cuhk.edu.hk
• Phone: (852)5539 3204

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.