HAPA-based health behavior program for adults with metabolic syndrome and chronic 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 randomized, assessor-blind trial compares a health behavior change program based on the Health Action Process Approach (HAPA) to a control condition in Chinese adults with metabolic syndrome and CKD. Participants will be 18 years or older, with 80 in each arm (total n=160), and will be followed at four time points: baseline, immediately after the intervention, 1 month after, and 6 months after. Outcomes include central obesity (waist circumference), estimated glomerular filtration rate, dietary behavior, physical activity, exercise capacity, and self-efficacy related to diet and activity. Data will be collected via an online platform with assessors blinded to group allocation to minimize bias.

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;
* 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'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)55393204

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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.