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.
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;
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;
Parallel
Theory-based health behaviour change intervention
BehavioralThe online individual education sessions are related to MetS, CKD, healthy dietary and PA, displayed in the form of texts and pictures, and online instant conversations via WeChat. The online group music-paced brisk walking training includes a 5-minute warm-up, 30-minute music-paced brisk walking, and 5-minute stretching exercises to promote cool-down. The group discussion is related to current health status, recommended dietary regimens, and exercise and personal goals. The telephone follow-up after the group discussion is to reinforce the predetermined goals and the practice of healthy dietary and music-paced brisk walking, and to provide opportunities for answering any questions related to the practice of healthy dietary and music-paced brisk walking. All the education session contents are based on a well-structured health handbook. The self-music-paced brisk walking is required to be performed for 30 minutes/day, 5 days/week.
Waist circumference
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
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.
Physical activity
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. The IPAQ-SF records PA with nine questions, including vigorous, moderate-intensity, walking, and sitting. The simplified Chinese version of 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
The Six-Minute Walk Test (6MWT) will be used to evaluate exercise capacity. Participants will be asked to walk back and forth for six minutes at their usual speed along a straight 30-meter hospital corridor with marks every five meters. Throughout the test, participants will be permitted to slow down, pause, or take breaks as needed, but also be expected to resume walking when they feel ready. Encourage participants to use standard phrases from the guide. The 10-point Borg scale will be used to grade dyspnea and fatigue during the walk, with a higher score indicating a worse situation. The pulse oximeter will be used to measure heart rate and oxygen saturation, and the electronic sphygmomanometer will be used to measure blood pressure before and after the 6MWT. Additionally, the total distance covered will also be recorded.
Dietary behaviour
The diet control subscale of the Chinese version of Chronic Kidney Disease Self-care (CKDSC-DC) will used to measure the dietary behaviour. The CKDSC-DC is a 4-item scale that evaluates CKD-specific dietary self-care, with responses ranging from 1 (almost never) to 5 (almost always). Higher scores indicate better dietary self-management, and a total score of 14 or more is considered healthy.
Dietary behaviour
The nutrition domain of Health Promoting Lifestyle Profile-II (HPLP-II-N) will also be used to measure the dietary behaviour. The HPLP-II-N is a 9-item scale that assesses overall healthy dietary practices, with participants rating items on a 4-point scale from 1 (not at all) to 4 (always). A total HPLP-II-N score of 22.5 or greater is deemed healthy dietary behavior. Using both the CKDSC-DC and HPLP-II-N provides a comprehensive understanding of dietary behaviors among individuals with MetS and CKD. The CKDSC-DC offers a disease-specific measure of dietary self-care in CKD, while the HPLP-II-N evaluates broader aspects of health-promoting nutrition.
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