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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorChinese University of Hong Kong

About this trial

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.

Eligibility criteria

Qualifiers

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;

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • Theory-based health behaviour change intervention

Treatment groups

160 Participants
are divided into 2 treatment groups

Locations

1
West China Hospital of Sichuan University610000, ChengduSichuan, China

Sponsors and collaborators

Chinese University of Hong Kong

Lead sponsor