Theory-based Health Behaviour Change Intervention in Patients 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
The pilot study will adopt a 2-arm, pretest-posttest, and assessor-blind randomized controlled trial design to examine the feasibility and acceptability of a theory-based health behaviour change intervention and examine its effects on waist circumference (primary outcome), kidney function (estimated glomerular filtration rate, urine albumin-to-creatinine ratio, primary outcome), dietary behaviour, physical activity, exercise capacity and self-efficacy of diet behaviour and physical activity among Chinese adults with metabolic syndrome and chronic kidney disease.
Researchers will compare the theory-based health behaviour change intervention to usual care to see if the theory-based health behaviour change intervention can reduce waist circumference and preserve kidney function over three months.
A total of 40 adults with metabolic syndrome and chronic kidney disease will be recruited, with 20 participants in each group. Data will be collected at two-time points (baseline and immediate 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;
No medical contraindications to exercise, including walking;
Participants are capable of understanding and providing informed consent;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Theory-based health behaviour change interventio
Treatment groups
40 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov