Clinical trial NCT06527768: Theory-based Health Behaviour Change Intervention in Patients of Metabolic Syndrome With Chronic Kidney Disease
Official title: The Effectiveness of a Theory-based Health Behaviour Change Intervention on Waist Circumference and Kidney Function in Patients of Metabolic Syndrome With Chronic Kidney Disease: A Pilot Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Chronic Kidney Diseases
Metabolic Syndrome
Keywords: Metabolic Syndrome
Chronic Kidney Disease
Waist Circumference
Kidney Function
Behaviour Change Intervention
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2024-07-30
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: Metabolic syndrome (MetS) is a worldwide chronic disease mainly due to unhealthy diets and sedentary lifestyles. According to the International Diabetes Federation (IDF) definition of MetS, patients must have central obesity defined by waist circumference (WC) with ethnicity-specific values, plus any two of four additional factors, namely high triglycerides (TG), low high-density lipoprotein cholesterol (HDL-C), high fasting glucose (FG), and high blood pressure (BP).

More recent evidence indicates that the MetS could be an independent risk factor for chronic kidney disease (CKD). CKD is a progressive and incurable condition with high morbidity and mortality, which manifests as an estimated glomerular filtration rate (eGFR) \< 60 mL/min/1.73 m2 or a urine albumin-to-creatinine ratio (UACR) ≥ 30 mg/g for at least three months. According to KDIGO 2012 clinical practice guideline, CKD is divided into five stages (stages 1, 2, 3a, 3b, 4, 5), which are based on the eGFR test result, as the stage progresses, kidney function becomes more severe, ultimately leading to kidney failure. Previous studies have found that individuals with MetS had a higher risk of CKD compared with patients without MetS.

Central obesity, as the core component of MetS, could be one of the most essential pathogenes explaining the association between MetS and CKD. Central obesity mainly manifests as excess abdominal adipose tissue, which directly leads to the deranged synthesis of various adipose tissue cytokines (e.g., leptin, adiponectin, resistin, and visfatin) with nephrotoxic potential to cause sustained damage or structural changes to the kidneys, as well as indirectly trigger insulin resistance, dyslipidemia and hypertension, which are the most substantial risk factors for CKD.

Many patients fail to take MetS seriously until they are diagnosed with CKD. This is attributed to the additional complications and complex treatments associated with CKD, significantly affecting their daily lives. Current therapeutic guidelines for MetS suggest that non-pharmacological interventions (NPIs) with multifactorial lifestyle changes should be the primary treatment, including dietary modification, physical activity (PA), counselling or lifestyle modifications. Therefore, NPIs could be an essential method for reducing WC and preserving kidney function for the target population. Hence, this proposed study aims to develop an NPI for adults with MetS and CKD on the synthesized scientific evidence, and the effects on health-related outcomes will be evaluated using a randomized controlled trial (RCT) study.

Therefore, the design of the theory-based behavioural process change intervention is based on the findings of the systematic review (SR) and the implications of the qualitative study. Before the main RCT, a pilot RCT will be conducted to examine the feasibility and acceptability of the proposed intervention.

Eligibility criteria: 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 (eGFR \< 60 mL/min/1.73 m2 or a UACR ≥ 30 mg/g for at least three months);
* 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.

Primary outcomes:
measure: Waist circumference
timeFrame: Data will be collected at day 0 and month 3.
measure: Estimated glomerular filtration rate
timeFrame: Data will be collected at day 0 and month 3.
measure: Urine albumin-to-creatinine ratio
timeFrame: Data will be collected at day 0 and month 3.
Secondary outcomes:
measure: Physical activity
timeFrame: Data will be collected at day 0 and month 3.
measure: Exercise capacity
timeFrame: Data will be collected at day 0 and month 3.
measure: Dietary behaviour
timeFrame: Data will be collected at day 0 and month 3.
measure: Dietary behaviour
timeFrame: Data will be collected at day 0 and month 3.
measure: Self-efficacy of dietary behavior and physical activity
timeFrame: Data will be collected at day 0 and month 3.
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
Study officials:
References: