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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Waist circumference
研究概览
简要总结
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.
详细描述
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, defined by markers of kidney damage or decreased glomerular filtration rate (GFR) persisting for more than 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Control group
Usual care.
Theory-based health behaviour change intervention group
Participants will be enrolled via WeChat and undergo 8 intervention sessions over 12 weeks. The 8 intervention sessions contain two online individual education sessions, two online group music-paced brisk walking training, two group discussions, and two telephone follow-ups. Besides, participants in the intervention group will be required to perform self-music-paced brisk walking 150 minutes/week for three months.
干预措施: Theory-based health behaviour change interventio (Behavioral)
结局指标
主要结局
Waist circumference
时间窗: Data will be collected at day 0 and month 3.
WC will be measured at the midpoint between the lower rib and the top of the iliac crest with the relaxed abdomen using a non-stretchable plastic measuring tape with an accuracy of 0.1 cm.
Estimated glomerular filtration rate
时间窗: Data will be collected at day 0 and month 3.
Blood samples will be obtained in the morning after fasting for at least 12 hours, and they will be refrigerated immediately after phlebotomy and centrifuged within 2 hours of collection. Blood samples will be analysed for eGFR. The eGFR will be calculated by the Chronic Kidney Disease Epidemiology Collaboration equation for Chinese individuals.
Urine albumin-to-creatinine ratio
时间窗: Data will be collected at day 0 and month 3.
Morning urine samples will be collected and refrigerated immediately to measure the levels of urine albumin and creatinine; then, the UACR will be calculated.
次要结局
- Exercise capacity(Data will be collected at day 0 and month 3.)
- Self-efficacy of dietary behavior and physical activity(Data will be collected at day 0 and month 3.)
- Physical activity(Data will be collected at day 0 and month 3.)
- Dietary behaviour(Data will be collected at day 0 and month 3.)
研究者
Yan Linjia
Principal Investigator
Chinese University of Hong Kong