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
Phase: NA
Conditions: Chronic Kidney Diseases, Metabolic Syndrome
Sponsor: Chinese University of Hong Kong

 
 
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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 Protocol and Statistical Analysis Plan 
 
 
 
 
Investigator Information 
Investigator Name: Yan Linjia 
Investigator Official Title: Principal Investigator 
Investigator Affiliation: The Chinese University of Hong Kong 
Document Date: July 19, 2024 
 
 
 
 
 
 

 
 
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Introduction 
Metabolic syndrome (MetS) is a worldwide chronic disease mainly due to unhealthy diets 
and sedentary lifestyles (McCracken et al., 2018). 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) (Alberti et al., 2006). IDF's definition differs from 
the other definition in that WC is considered a core component for MetS, which increases the 
specificity of the diagnosis and reduces the likelihood of over-diagnosing individuals who may 
have a clustering of additional risk factors (Zhu et al., 2020). The prevalence of MetS in adults 
has significantly increased since the 90s, with 28.2% (95% confidence interval [CI], 26.7 to 
29.7) worldwide (Noubiap et al., 2022) and 25.6% (95% CI, 23.77 to 27.41) in China (Ma et 
al., 2020).  
More recent evidence indicates that the MetS could be an independent risk factor for 
chronic kidney disease (CKD) (Dobrowolski et al., 2022; Rashidbeygi et al., 2019). CKD is a 
progressive and incurable condition with high morbidity and mortality, which manifested 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 (Delanaye et al., 2019). According 
to the Kidney Disease Improving Global Outcomes Clinical Practice (KDIGO) 2012 
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 

 
 
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leading to kidney failure (Delanaye et al., 2019). CKD is currently estimated to affect 10% of 
adults worldwide (Webster et al., 2017), with the prevalence of CKD in China being extremely 
high at 8.24%  (95%CI: 7.84 to 8.64) (Wang et al., 2023). A recent meta-analysis involving 
413,621 participants of which 93,944 had MetS showed that MetS contributed to higher risks 
of kidney dysfunction (risk ratio [RR] 1.50, 95% CI, 1.39 to 1.61), specifically, rapid decline 
in eGFR (RR 1.31, 95% CI 1.13 to 1.51), new-onset CKD (RR 1.47, 95% CI 1.37 to 1.58), as 
well as end-stage kidney disease (ESKD) (RR 1.55, 95% CI 1.08 to 2.22) compared with 
patients without MetS (Li et al., 2023). Besides, a cross-sectional study (n=383) showed a high 
prevalence of CKD with 25.59 % (95% CI: 21.20 to 29.98) in Chinese patients with MetS (Li 
et al., 2014).  
Many studies have suggested that central obesity, as the core component of MetS (Alberti 
et al., 2006), could be one of the essential pathogenesis explaining the association between 
MetS and CKD (Cao et al., 2015; Tanner et al., 2012). 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 (Nashar & Egan, 2014; Nogueira & Marreiros, 2022; Zhang & Lerman, 2017). 
Besides, central obesity was found to be more prevalent in patients with CKD than those 
without CKD. A population-based study found that central obesity occurred in 29.7%, 45.2%, 
40.6%, 40.2%, and 30.7% of patients with CKD stages 1, 2, 3a, 3b, and 4/5, while the rate of 

 
 
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central obesity in non-CKD patients was 23.4% (Evangelista et al., 2018). A recent study even 
showed that the raw prevalence of central obesity in Chinese adults with CKD was as high as 
35.4%  (Wang et al., 2023). 
Patients with MetS and CKD may not only required to manage symptoms related to MetS 
and CKD, such as lifestyle management, monitoring of blood pressure, blood glucose levels, 
lipid profile and kidney function (Chadban et al., 2020; Grundy, 2016), but also face a higher 
possibility of needing dialysis or kidney transplantation to maintain their life, which could 
significantly decrease their quality of life (Kostro et al., 2016). The development of CKD is 
often a silent and asymptomatic process, making it difficult to detect without physical and 
biochemical examinations. MetS appears to be a readily identifiable target for intervention to 
reduce the incidence and mortality of CKD. By focusing on the core components of MetS, 
particularly central obesity, healthcare professionals can better identify individuals at risk and 
provide targeted interventions to decrease the incidence of CKD and prevent further 
deterioration of kidney function (Prasad, 2014).  However, current limited studies have paid 
attention to the health needs of this population. 
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 (Grundy, 2016). 
Besides, the latest studies showed that certain types of NPIs, such as mobile-based health 
interventions and lifestyle modification, had significantly reduced the prevalence of MetS and 
alleviated the severity of its components, especially in WC (Rahimi et al., 2022; Sequi-

 
 
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Dominguez et al., 2020; van Namen et al., 2019). 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 a theoretical-based NPI for adults with MetS 
and CKD on the synthesised scientific evidence, and the effects on health-related outcomes 
will be evaluated using a randomised controlled trial (RCT) study. Before the main RCT, a 
pilot RCT will be conducted to examine the feasibility and acceptability of the proposed 
intervention. The hypothesis is (1) the theory-based health behaviour change intervention is 
feasible and acceptable among Chinese patients with MetS and CKD; (2) Participants in the 
intervention group will have lower WC, better kidney function, healthier dietary behaviour, 
higher PA, better exercise capacity and higher self-efficacy than those in the control group at 
immediate post-intervention (T1). 
 
Findings of Systematic Review 
After conducting a literature review, surprisingly limited studies focus on the 
effectiveness of NPIs among adults of MetS with CKD to reduce WC and preserve kidney 
function or decelerate the development and progression of CKD. Hence, this study expanded 
the search strategy of the population to adults with MetS-only to identify this relevant evidence. 
Previous studies have suggested that certain types of NPIs (e.g., mobile-based health 
interventions, lifestyle modification) had a significant change in the reducing prevalence of 
MetS and alleviating the severity of its components, especially in WC (Rahimi et al., 2022; 
Sequi-Dominguez et al., 2020; van Namen et al., 2019). However, previously published 

 
 
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reviews could not determine the optimal format, type and key components of NPIs for adults 
with MetS in reducing WC. Moreover, limited attention has been paid to the effectiveness of 
NPIs for adults with MetS in preserving kidney function or even decelerating the development 
and progression of CKD. Evidence on the effectiveness of NPIs of adults with MetS on WC 
and kidney function remains scarce. Hence, this systematic review (SR) aimed to examine the 
effectiveness of NPIs in reducing WC and preserving kidney function in adults with MetS. 
Methods 
Nine electronic databases (Embase, PubMed, Scopus, Web of Science, CINAHL, 
PsycINFO, Cochrane, CNKI and Wanfang) were searched from inception to 26 April 2024. 
Randomised controlled trials of adults with MetS receiving NPIs reporting on the outcomes of 
WC, kidney function, MetS-related components and health-related behaviours were included. 
The pooled synthesis of intervention effects was reported as the standardised mean difference 
or mean difference (MD) and its 95% confidence interval (CI). The narrative summary was 
provided if a meta-analysis was not applicable. 
Results 
This review included 15 studies with 1,559 participants (Female: 56.9%). The NPI of 
included studies were categorised into dietary intervention (n=3), physical activity (PA) 
intervention (n=5) and multi-component intervention (n=7) including dietary and PA 
intervention, with psychological strategies. The multi-component intervention with 
psychological strategies showed the largest reduction in WC (MD: -3.45, 95% CI: -5.05 to -
1.86), systolic blood pressure (MD: -4.24, 95% CI: -8.23 to -0.25), fasting glucose (MD: -0.24, 

 
 
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95% CI: -0.48 to -0.00), dietary behaviour and PA (all P<0.05). Besides, the PA intervention 
showed significant improvement in high-density lipoprotein cholesterol (Cohen’s d=1.42 and 
1.82). Only one of the included studies examined intervention effects on kidney function, 
showing that the urine albumin-to-creatinine ratio significantly decreased after the multi-
component intervention compared with baseline (p<0.05).  
Conclusion 
The finding of SR suggested that the multi-component intervention, which includes the 
provision of a low-calorie (negative energy balance of 500 kcal/day) and low-carbohydrate 
(based on a low glycemic index) diet plan or healthy dietary education, PA education and/or 
supervised or unsupervised moderate-intensity PA (dosage: 1 to 2.5h/week), assisted with 
psychological strategies (goal setting, problem-solving, coping skills) in a group or/and 
individual, face-to-face, smartphone, telephone, email or/and booklet format, and provided by 
nurse or researcher with health education background at least three months, had strong 
effectiveness in improving health-related behaviours and MetS-related components, especially 
in reducing WC. Only one study reported the kidney function outcome, which showed that the 
multi-component intervention had no significant change in preserving kidney function in adults 
with MetS. However, the result should not draw a conclusion on the effectiveness of multi-
component intervention due to the limited number of included studies. More rigorous studies 
are needed to confirm the effectiveness and examine a better approach to reduce WC and 
preserve kidney function. 

 
 
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However, limited information on factors influencing these behaviour change interventions 
was reported and identified from this SR, therefore studies are needed to explore the possible 
factors influencing health-related behaviours among Chinese adults of MetS with CKD. 
Besides, only two included studies indicated that the health belief model (Wong et al., 2023) 
and the transtheoretical model (Saboya et al., 2017) were used to guide the design and 
development of the interventions. Hence, the mechanisms behind the intervention and the 
factors influencing health-related behaviours (e.g., healthy dietary and PA) still need more 
investigation. 
 
Findings of Qualitative Study 
Based on the findings and knowledge gaps from the SR, the proposed intervention to 
reduce WC and preserve kidney function among adults with MetS mainly involves the most 
common health-related behaviours, such as regular exercise and healthy dietary (Short & 
Mollborn, 2015). For patients with MetS-only or comorbid with CKD, health-related behaviour 
such as dietary adjustment and increased exercise aimed at controlling the associated 
problematic health conditions (e.g., hypertension, dyslipidaemia, insulin resistance, and 
diabetes) are currently one of the most affordable and life-long effective interventions (Prasad, 
2014).  
Previous studies have shown that self-efficacy (Taha et al., 2022), social support (Kim & 
Park, 2023), perceived barriers and benefits (Wu et al., 2016) could be these factors influencing 
health-related behaviours among adults with MetS. However, few studies focus on factors 

 
 
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influencing health-related behaviours and needs related to these behaviour changes among 
adults with MetS and CKD. A deep understanding of the possible factors influencing the 
identified health-related behaviours (dietary behaviour and PA) from the SR among adults of 
MetS with CKD is critical to engage these health-related behaviours and ultimately improve 
patients’ health management and overall health outcomes.  
The Health Action Process Approach (HAPA) is a commonly used theory in health 
behaviour change research among patients with chronic diseases. The HAPA suggests that 
engagement in healthy behaviour is comprised of two main processes: the motivational phase, 
which involves forming an intention, and the volitional phase, which includes planning to act 
and taking action (Schwarzer, 2016). Such interventions may include behaviour change 
techniques specifically designed to increase an individual’s motivation to change, facilitate the 
translation of intentions into action, or both. Besides, motivation (e.g., self-efficacy, intention) 
and volition (e.g., planning, action control) have been shown to uniquely predict various health 
behaviours including dietary behaviours (Duan et al., 2022; Ranjbaran et al., 2022) and PA 
(Dillon et al., 2022; Rollo & Prapavessis, 2020). The latest study has also shown that HAPA-
based intervention was effective in modifying health behaviours among patients with CKD (Hu 
et al., 2023). 
Based on these considerations, this proposed study aims to explore the factors influencing 
healthy dietary behaviour and PA and needs related to these behaviours changes among the 
Chinese adults of MetS with CKD guided by the HAPA.  
Methods 

 
 
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A total of 36 semi-structured, audio-recorded interviews were conducted with adults with 
MetS, or comorbid with CKD (female: 33.3%, mean age: 39.8 ± 12.5) who volunteered to be 
interviewed from Sichuan Province. A sociodemographic data collection form was used to 
collect the sociodemographic and clinical characteristics. 10 open-ended questions guided by 
HAPA were used to explore patients’ perceived barriers, facilitators, experiences and needs 
among the targeted population. SPSS version 26.0 will be used for quantitative data analyses, 
and content analysis will be used for qualitative data analysis. Besides, credibility, 
transferability, dependability and confirmability were employed to establish the 
trustworthiness of the current study (Anney, 2014). 
Results 
The interview revealed that the vast majority of patients have a positive attitude towards 
managing diseases through healthy dietary behaviour and PA, and believe that the main 
motivation for them to adhere to these health-related behaviours is to stay healthy. secondly, 
the lack of disease-related knowledge and professional guidance on healthy dietary and PA are 
the main obstacles they face. Therefore, the provision of such knowledge is most needed at 
present. However, the reliability and authority of information sources were also emphasized. 
Thirdly, the importance of advice or inspiration from others and the companionship of family 
or friends in maintaining health-related behaviours is also emphasized. Finally, unlike MetS-
only patients, patients with MetS and CKD needed more professional treatment based on their 
health condition, and almost all of these patients chose walking or brisk walking as their daily 
exercise routine. 

 
 
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Conclusions 
Dietary behaviour and PA change intervention is feasible and acceptable to people with 
MetS, or comorbid with CKD in managing health conditions. Interventions could mainly be 
achieved by providing MetS and CKD knowledge, dietary and PA guidance through healthcare 
professionals, dietitians or physicians. Also, using group discussions to increase social support. 
Besides, brisk walking could be an aerobic exercise form for the targeted population as this is 
commonly performed by the study population. 
 
Methodology 
 
Study design 
This pilot study will adopt a 2-arm, pretest-posttest, and assessor-blind RCT design to 
examine the feasibility and acceptability of a theory-based health behaviour change 
intervention and examine its effects on WC (primary outcome), kidney function (eGFR, UACR, 
primary outcome), dietary behaviour, PA, exercise capacity and self-efficacy of diet behaviour 
and PA among Chinese adults with MetS and CKD. 
Settings and participants 
Settings 
This study will be conducted in the ward and outpatient departments of the nephrology 
unit of West China Hospital of Sichuan University, and one community hospital.  
Inclusion criteria and exclusion criteria 

 
 
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Inclusion criteria. (1) Participants are 18 years old and above; (2) 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) (Alberti et al., 2006).  and CKD (eGFR < 
60 mL/min/1.73 m2 or a UACR ≥  30 mg/g for at least three months) (Delanaye et al., 2019); 
(3) No medical contraindications to exercise, including walking; (4) Participants are capable 
of understanding and providing informed consent; (5) Own a smartphone for accessing WeChat; 
(6) Being able to communicate in Chinese; (7) Stay in Chengdu during the study period. 
Exclusion criteria. (1) Participants who cannot perform brisk walking exercise; (2) 
Participants who have already started dialysis or kidney transplant; (3) Current participation in 
another clinical trial related to health behaviour change or medical trial; (4) Participants who 
have doctor-diagnosed psychiatric illness ; (5) Participants who have a cognitive impairment, 
which will be screened by the abbreviated mental test with a score lower than seven (Chan et 
al., 2013); (6) Adjustment of medication within half a year; (7) 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) (Olson et al., 2023) within the past 
month. 
Sample Size Calculation 

 
 
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The sample size for the pilot study is identified according to the general rule of thumb 
(Lancaster et al., 2004), and 40 adults of MetS with CKD will be recruited, each group will 
have 20 participants. The sampling method will adopt the convenience sampling method. 
Randomisation 
Participants will be 1:1 randomised (blocks of random size of 8) to the intervention and 
control group, stratified by stage of CKD. Blinded allocation of the participants will be based 
on computer-generated random numbers with sealed, opaque, sequentially numbered 
allocation envelopes. The envelopes will be opened by the participants after the baseline 
assessment. Assessors for all outcomes were blinded to the group assignment of participants. 
All outcome data remained blinded until the end of the study. 
Theoretical framework 
The Health Action Process Approach (HAPA) will be adopted to guide this study. 
Previous studies with the effectiveness in changing health behaviours guided by the HAPA 
showed that the available dosage of intervention ranged from eight to 12 sessions for each week 
in eight to 12 weeks (Dillon et al., 2022; Duan et al., 2022; Ranjbaran et al., 2022; Rollo & 
Prapavessis, 2020). Figure 1 displays the variables associated with each phase, along with 
hypothesised relationships among the variables.  
Figure 1 
The Health Action Process Approach 

 
 
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Intervention procedures 
Theory-based health behaviour change intervention group  
For the intervention group, participants will be enrolled via WeChat and undergo 8 
intervention sessions over 12 weeks. WeChat is one of the most popular social media platforms 
worldwide, and it has been used on a large scale since its release. The latest statistics show that 
in 2023, there are 827.2 million WeChat users in China, which accounts for 58.9% of the total 
population (China Internet Watch, 2023).  
The 8 intervention sessions contain three parts. The first part will consist of two online 
individual education sessions related to MetS, CKD, healthy dietary and PA, displaying in the 
form of texts and pictures, and online instant conversations via WeChat, two online group (6 
to 8 participants) music-paced brisk walking training, two group discussions (6 to 8 participants) 
related to current health status, recommended and dietary regimens and exercise and personal 
goals, two telephone follow-ups after group discussions to reinforce the predetermined goals 
and the practice of healthy dietary and music-paced brisk walking, and to provide opportunities 

 
 
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for answering any questions related to the practice of healthy dietary and music-paced brisk 
walking. All the education sessions’ contents are based on a well-structured health handbook. 
An overview of the intervention sessions is shown in Table 1. 
Table 1 
Intervention sessions based on the Health Action Process Approach 
Session One: Strengthen understanding of MetS, CKD, health dietary, PA and 
management related to these behaviours 
Format: Individual 
Delivery mode: Online  
Week 
Phase 
Detail 
1 
Motivation 
phase 
a. Briefly self-introduction and study introduction. 
b. Provide knowledge about MetS, CKD, health dietary, PA and 
management related to these behaviours 
c. Introduce music-paced brisk walking 
d. Ask participants if they have any question about the MetS, CKD, 
different types of health dietary and PA and their management. 
e. Ask patients to set goals for a healthy dietary and PA, reflecting 
in waist circumference, weight, exercise time and frequency. 
Session Two: Music-paced brisk walking practice 
Format: Group 
Delivery mode: Online  
Week 
Phase 
Detail 
2 
Motivation 
phase 
a. Perform the group music-paced brisk walking. 
b. Ask participants did they make specific action plans of when, 
where and how to perform healthy dietary and music-paced brisk 
walking. 
Session Three: Get to Know other health-related lifestyle management and self-
monitoring methods 
Format: Individual 
Delivery mode: Online 
Week 
Phase 
Detail 
3 
Motivation 
phase 
a. Provide knowledge about tobacco and alcohol consumption, 
mental health, medicine management and self-monitoring 
methods. 
b. 
Strength 
training, 
flexibility 
and 
balance 
training 
recommendations 
c. Ask participants if they have any question tobacco and alcohol 
consumption, mental health, medicine management and self-
monitoring methods. 
d. Ask participants to evaluate their execution of music-paced brisk 
walking plans and adjust music-paced brisk walking plans if 
necessary. 

 
 
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Session Four: Music-paced brisk walking practice 
Format: Group 
Delivery mode: Online 
Week 
Phase 
Detail 
4 
Motivation 
phase 
a. Re-emphasis on the importance of exercise in MetS and CKD 
management. 
b. Perform the group music-paced brisk walking. 
c. Encourage participants to complete training and achieve their 
goal.  
Session Five: Discuss current health status and personal goal 
Format: Group 
Delivery mode: Online 
Week 
Phase 
Detail 
6 
Volition 
Phase 
a. Briefly introduce this discussion content. 
b. Provide information about the reference standards for various 
indicators and height and weight correspondence table 
c. Guide participants to discuss their health changes and personal 
goals since participating in the study.  
Session Six: How to solve the difficulties and challenges faced during conducting the 
healthy dietary and music-paced brisk walking. 
Format: Group 
Delivery mode: Online 
Week 
Phase 
Detail 
8 
Volition 
Phase 
a. Briefly introduce this discussion content. 
b. Guide participants to discuss their difficulties and challenges 
and how they solve them.  
Session Seven: Telephone follow-ups about current healthy dietary status and music-paced 
brisk walking 
Format: Individual 
Delivery mode: Telephone 
Week 
Phase 
Detail 
10 
Volition 
Phase 
a. Briefly introduce this telephone follow-up. 
b. Guide participants to reinforce the practice of conducting 
healthy dietary and music-paced brisk walking.  
Session Eight: Telephone follow-ups to congratulate participants’ achievements 
Format: Individual 
Delivery mode: Telephone 
Week 
Phase 
Detail 
12 
Volition 
Phase 
a. Celebrating achievements and providing positive reinforcement. 
b. Guide participants to reinforce the practice of conducting 
healthy dietary and music-paced brisk walking.  
Note. PA: physical activity; MetS: metabolic syndrome; CKD: chronic kidney disease. 
Besides, participants in the intervention group will be required to perform moderate-
intensity PA at least 150min/week. Brisk walking (refer as 3000 steps in 30 minutes, or 100 
steps per minute) has been well-reported as a safe moderate-intensity exercise (O’Brien et al., 

 
 
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2018; Tudor-Locke et al., 2020). Walking with appropriate music tempo is one of the simple 
and easy-to-master methods of brisk walking, and it has been shown to be a useful regulatory 
tool to prompt the free-living individual to reach an appropriate stride rate to achieve a walking 
pace that is at least moderate-intensity PA (Faulkner et al., 2021). Previous studies also showed 
that after considering the different heights and weights, the optimal walking tempo for 
synchronisation with music was 100 to 120 beats per minute (bpm) (Etani et al., 2018; Styns 
et al., 2007).  
 Participants can choose nine songs (each song is about three minutes long) suitable for 
themselves from our song list with the music tempo ranging from 100 to 120 beats/minute. 
Participants will be required to perform music-paced brisk walking, including a 5-minute 
warm-up, 30-minute music-paced brisk walking and 5-minute stretching exercises to promote 
cool-down five days per week. Besides, participants will be required to send their daily walking 
record, which can be obtained from WeRun (a mini monitoring program in WeChat) to the 
researcher via WeChat. If the daily walking record of the participants is less than 3000 or has 
not been sent for two consecutive days in a week, the researcher will remind the participants 
separately through WeChat.  
Control group  
The participants in the control group will follow the routine care provided by the hospitals. 
In addition to providing the contact number of the nephrology unit in case they have medical 
needs, any other additional support during the intervention period will not be provided. After 
the 12-week intervention ends, the control group will be provided with the same information 

 
 
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given to the intervention group to raise the awareness of its members regarding the need for 
healthy dietary, daily exercise and disease care after the entire study is completed. 
In order to maximise the retention rate, some reminder strategies will be implemented. For 
example, WeChat messages will be sent to the participants before each intervention session to 
remind them to participate in the intervention or group discussion, and also will be sent to 
participants to confirm the time for telephone follow-up the next day. Besides, exercise 
reminders will also be conducted. 
The feasibility of the intervention will be assessed by the recruitment rates, attrition rates 
and attendance rates for the intervention. In addition, reasons for exclusion, refusal to 
participate, incompletion and dropout will be recorded.  
The acceptability of the intervention will be assessed through semi-structured interviews 
with participants in the intervention group within one week of completion of the intervention. 
The theoretical framework of acceptability is used to identify the interview outline (Sekhon et 
al., 2022). The outline of the semi-structured interview is presented in Appendix I, and the 
principal investigator (PI) will conduct the interviews via Tencent Meeting. All the interviews 
will be audio-recorded, transcribed verbatim and analysed using direct content analysis. 
Content validation  
An expert panel review will be invited to read and provide comments to examine the 
validity and acceptability of the information provided in the intervention using the Content 
Validity Index (CVI) (Almanasreh et al., 2019). The expert panel will be composed of one 

 
 
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experienced physician, one experienced dietitian, two senior nurses who take care of MetS or 
CKD patients, and one academic professor in nursing. 
Treatment fidelity 
The intervention will be delivered in accordance with a standardised protocol. The PI will 
conduct all the intervention sessions in the daily outpatient clinic and ward rounds to ensure 
the consistency of the intervention. A checklist will be used for audit checking on the 
intervention provision, and the dose of each session will be recorded.  
Outcome measures 
 
Waist circumference  
WC will be measured at the midpoint between the lower rib and the top of the iliac crest 
with the relaxed abdomen with a non-stretchable plastic measuring tape with an accuracy of 
0.1 cm (Ness‐Abramof & Apovian, 2008).  
Kidney function  
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 
(Sun et al., 2016). Blood Samples will be analysed for eGFR. The eGFR will be calculated by 
the Chronic Kidney Disease Epidemiology Collaboration equation for Chinese individuals 
(Kong et al., 2013). Venipuncture will be performed by doctors or nurses in the department of 
clinical laboratory in the hospital or the ward of the nephrology unit. Morning urine samples 
will be collected in the refrigerator immediately to measure the levels of urine albumin and 

 
 
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creatinine; then, the UACR will be calculated. All blood samples and urine samples will be 
sent to the department of clinical laboratory at the research hospital for investigation. 
According to the KDIGO and IDF guidelines of frequent assessment of CKD (KDIGO, 
2012), if the participant has done the eGFR test in the hospital within three months of any data 
collection time point, this blood result will be used. 
PA 
The Chinese version of the short form of the International Physical Activity Questionnaire 
(IPAQ-SF) will be used to evaluate the amount of weekly PA. IPAQ was developed by the 
WHO in 1998 to access PA (Bassett Jr, 2003). The IPAQ-SF records PA with nine questions, 
including vigorous, moderate-intensity, walking, and sitting. The simplified Chinese version 
of IPAQ-SF has shown good internal reliability and test-retest stability (total intraclass 
correlation coefficient [ICC]=0.84, 95%CI 0.76 to 0.89) (Lou & He, 2019). Besides, the IPAQ-
SF records self-reported physical activity in the last seven days, and the responses were 
converted to Metabolic Equivalent Task minutes per week (MET-min/wk). Total minutes over 
the last seven days spent on vigorous activity, moderate-intensity activity, and walking were 
multiplied by 8.0, 4.0, and 3.3, respectively, to create MET scores for each activity level. 
Exercise capacity  
6MWT is an assessment to measure the distance a person is capable of walking on a flat, 
hard surface in 6 minutes, and will be performed according to the American Thoracic Society’s 
guideline (Laboratories, 2002). It has been validated in MetS or CKD population (Heubel et 
al., 2018; Wilkinson et al., 2019). Participants will be asked to walk back and forth in 6 minutes 

 
 
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at their usual speed along a straight 30-meter hospital corridor with marks every 5 meters. 
Throughout the test, patients will be permitted to slow down, pause, or take breaks as needed, 
but also be expected to resume walking when they feel ready. Give encouragement using 
standard phrases from the guide (Holland et al., 2014). Dyspnea and fatigue during the walk 
will be graded by the 10-scale Borg scale (Shariat et al., 2018). Heart rate, oxygen saturation, 
BP and total distance covered will be measured immediately before and after the 6MWT.  
Dietary behaviour 
The diet control subscale of the Chinese version of Chronic Kidney Disease Self-care 
(CKDSC-DC) and the nutrition domain of Health Promoting Lifestyle Profile-II (HPLP-II-N) 
will be used to measure dietary behaviour. The CKDSC scale is a 16-item questionnaire 
designed to measure self-care behaviour for people with CKD with five subscales, one of which 
is diet control (4 items). Based on the Likert scale, responses ranged from 1 (almost never) to 
5 (almost always), and the higher scores indicate better CKD self-care behaviours in diet 
control. A total score of 14 or more is considered healthy dietary behaviour. The overall validity 
and reliability of the Chinese version of CKDSC were satisfactory, with Cronbach's α of 0.83. 
For the diet control subscales, Cronbach's α was 0.83 (Wang et al., 2016).  
HPLP-II has 52 items, covering six domains: health responsibility, physical activity, 
spiritual growth, nutrition, interpersonal relations and stress management. The Chinese version 
of HPLP-II has a good internal consistency with an overall Cronbach’s alpha of 0.95, and the 
Cronbach’s alpha of each domain is: health responsibility (0.81), physical activity (0.83), 
nutrition (0.72), spiritual growth (0.84), interpersonal relations (0.84), stress management 

 
 
22 
(0.80). In this study, only the domain of nutrition will be used, and the participants will be 
required to rate on a 4-point Likert scale from 1 (not at all) to 4 (always). A total score of 22.5 
or greater is considered healthy dietary behaviour (Zhou et al., 2022).  
The CKDSC-DC provides a disease-specific measure of dietary behaviour in the context 
of CKD (Wang et al., 2016). While, the HPLP-II-N evaluates various aspects of healthy dietary 
practices, such as consuming a balanced diet, limiting unhealthy food choices, and following 
dietary recommendations. It provides a broader perspective on overall health-promoting 
behaviour, including nutrition, among individuals with Mets or CKD (Zhou et al., 2022). 
Therefore, combining the CKDSC-DC and HPLP-II-N allows for a more comprehensive 
understanding of disease-specific dietary behaviours and general health-promoting dietary 
behaviours among patients with MetS and CKD. 
Self-efficacy of dietary behavior and physical activity 
The Chinese version of Health-Related Diet and Exercise Self-Efficacy Scale - simplified 
version (HRDESES) included 8 items under 2 dimensions: diet subscale and exercise subscale. 
Response options are rated on a 5-point scale: 0 (I’m not sure), 1 (mostly I cannot), 2 (don’t 
know), 3 (mostly I can), or 4 (I’m sure I can). The total score ranges from 0 to 32, with a higher 
score indicating higher levels of health-related diet and exercise self-efficacy. HRDESES 
showed good internal consistency with a Cronbach's α of 0.87 for the total scale, 0.86 for the 
diet subscale and 0.91 for the exercise subscale (Mao et al., 2022). 
Data collection procedures 

 
 
23 
The PI and one trained RA will recruit potential participants previously diagnosed with 
MetS and CKD in the nephrology unit. If the patients meet the inclusion criteria for recruitment, 
they will be given an information sheet to explain the study. If they agree to participate, written 
informed consent will be obtained. After completing baseline questionnaires, eligible 
participants will be randomly assigned to the intervention or control groups. Besides, the 
researchers will add participants' WeChat accounts for the coming intervention. The participant 
recruitment flow is shown in Figure 2. 
Figure 2  
Participant recruitment flow 
 
 
 
 
 
Data will be collected at two time points (baseline, T0 and immediate post-intervention, 
T1) via an online questionnaire survey platform (Qualtrics) by two trained RAs blinded to the 
group allocation to reduce the detection bias.  Before data collection, the intraclass correlation 
coefficient will assess inter-rater reliability, with a value greater than 0.75 indicating good 
inter-rater reliability (Koo & Li, 2016). The schedule of data collection is shown in Table 2.  
Table 2  
Schedule of data collection 

 
 
24 
Outcomes 
Measurements 
T0 
T1 
Sociodemographic characteristics  
Self-reported questionnaire 
✓ 
 
WC 
Anthropometric measure 
✓ 
✓ 
Kidney function 
Biochemical measures 
✓ 
✓ 
PA 
IPAQ-SF 
✓ 
✓ 
Exercise capacity 
6MWT 
✓ 
✓ 
Dietary behaviour 
CKDSC-DC, HPLP-II-N 
✓ 
✓ 
Self-efficacy of dietary behaviour and PA HRDESES 
✓ 
✓ 
Note. T0: baseline; T1: immediate post-intervention; T2: one-month post-intervention; WC: waist circumference; 
PA: physical activity; IPAQ-SF: the simplified Chinese version of the short form of the International Physical 
Activity Questionnaire; 6MWT: Six-Minute Walk Test; CKDSC-DC: the diet control subscale of the Chinese 
version of Chronic Kidney Disease Self-care Scale; HPLP-II-N: the nutrition domain of Health Promoting 
Lifestyle Profile-II; HRDESES: the Chinese version of Health-Related Diet and Exercise Self-Efficacy Scale - 
simplified version 
Data analysis 
Descriptive statistics such as frequency, percentage, mean and SD (normal data), median 
and interquartile range (non-normal data) will be used to summarise the outcomes and other 
variables. The data distribution will be examined for normality using skewness and kurtosis 
statistics. Two-sample independent T-test, Mann-Whitney U test (continuous variables with or 
without normal distribution), Pearson's Chi-Square (categorical variables) and Fisher's exact 
test (if the minimum expected frequency in the contingency table is less than 5) will be used to 
compare outcome variables between the two groups. The data will be analysed under the 

 
 
25 
intention-to-treat principle (Hollis & Campbell, 1999). The missing data imputation will be 
performed based on the observed data and the assumed missing data mechanism. The between-
group intervention effects across time were examined using the generalised estimation 
equations model (Zeger & Liang, 1986). The two-sided level of significance will be set at 0.05 
(Lann, 1959), and IBM SPSS 26.0 will be used for statistical analysis.  
Ethical consideration 
Participation in the study will be voluntary, and all potential participants will be assured 
that they have the right to refuse or withdraw from the study at any time without penalty. A 
trained researcher will solicit written informed consent from each participant after the 
eligibility assessment. No any form of incentives will be provided to the participants. Although 
there will be no unexpected risks in this study, participants will still be encouraged to seek 
medical support or any other additional support for their medical needs.  
All data will be coded by study identification numbers with no identifying personal 
information, and will remain confidential and stored on a password-protected computer for six 
years. In order to protect participants’ privacy, the personal information of participants will be 
collected only once during baseline data collection and then deidentified with participant code 
(instead of name). Since there are WeChat group discussions in the intervention, relevant 
principles (e.g., using pseudonyms and hiding personal information) will be informed when 
establishing WeChat groups to avoid the leakage e of participants’ personal information. All 
collected data will be destroyed after the six-year storage period.  

 
 
26 
Ethics approval will be obtained from the Joint Chinese University of Hong Kong – New 
Territories East Cluster Clinical Research Ethics Committee and West China Hospital Sichuan 
University Ethics Committee. The study protocol conforms to the ethical guidelines of the 
Declaration of Helsinki and will be registered at www.ClinicalTrials.gov. 
Fundings 
None. 
Conflicts of interest 
None declared. 
Significance of the study 
To the best of my knowledge, this is the first study to develop a prospective, single-blinded, 
two-arm RCT design with repeated measures to evaluate the effectiveness of a theoretical-
based dietary and PA behaviour change intervention in WC and kidney function among adults 
of MetS with CKD in Chinese population. From a scientific perspective, the results will also 
help increase the knowledge base for applying a dietary and PA behaviour change intervention 
to reduce WC and preserve kidney function among the target population. 

 
 
27 
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Appendix I 
Intervention Acceptability Interview 
The entire interview involved a total of 8 topics and lasted 20 minutes. You can refuse to 
answer if any of the questions make you uncomfortable. The entire interview will be recorded 
for later verbatim transcription and analysis. 
 
1. Let’s start with “How you feel about the intervention”. 
• 
Did you like or dislike this multi-component behaviour change intervention? From 1 to 5, 
“1” is “Strongly dislike”, “3” is “No opinion”, while “5” is “Strongly like”. What number 
do you choose? Can you tell me why? 
 
2. The second topic is related to “The amount of effort required for you to participate in the 
intervention”. 
• 
How much effort did it take to engage with this multi-component behaviour change 
intervention? From 1 to 5, “1” is “No effort at all”, “3” is “No opinion”, while “5” is “Huge 
effort”. What number do you choose? Can you tell me why? 
 
3. The third topic is related to “The extent to which the intervention has a good fit with your 
value system”. 

 
 
38 
• 
Are there moral or ethical consequences to engage with this multi-component behaviour 
change intervention? From 1 to 5, “1” is “Strongly disagree”, “3” is “No opinion”, while 
“5” is “Strongly agree”. What number do you choose? Can you tell me why? 
 
4. The fourth topic is related to “The extent to which the intervention has achieved its intended 
purpose”. 
• 
Has this multi-component behaviour change intervention improved your health-related 
behaviours and clinical condition? From 1 to 5, “1” is “Strongly disagree”, “3” is “No 
opinion”, while “5” is “Strongly agree”. What number do you choose? Can you tell me 
why? 
 
5. The fifth topic is related to “The extent to which you understand the intervention works”. 
• 
Is it clear to you how this multi-component behaviour change intervention will help 
improve your health-related behaviours and clinical condition? From 1 to 5, “1” is 
“Strongly disagree”, “3” is “No opinion”, while “5” is “Strongly agree”. What number do 
you choose? Can you tell me why? 
 
6. The sixth topic is related to “Your confidence that you can perform behaviours required to 
participate in the intervention”. 

 
 
39 
• 
How confident did you feel about engaging with this multi-component behaviour change 
intervention? From 1 to 5, “1” is “Very unconfident”, “3” is “No opinion”, while “5” is 
“Very confident”. What number do you choose? Can you tell me why? 
 
7. The seventh topic is related to “The benefits, profits or values that were given up to engage 
in the intervention”. 
• 
Did engaging in this multi-component behaviour change intervention interfere with your 
other priorities? From 1 to 5, “1” is “Strongly disagree”, “3” is “No opinion”, while “5” is 
“Strongly agree”. What number do you choose? Can you tell me why? 
 
8. The last topic is related to “The general acceptability of the intervention”. 
• 
How acceptable was this multi-component behaviour change intervention to you? From 1 
to 5, “1” is “Completely unacceptable”, “3” is “No opinion”, while “5” is “Completely 
acceptable”. What number do you choose? Can you tell me why?