Theory-based Health Behaviour Change Intervention in Patients of Metabolic Syndrome With Chronic Kidney Disease
NCT Number: NCT06527768
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Chronic Kidney Diseases|Metabolic Syndrome
Interventions: BEHAVIORAL: Theory-based health behaviour change interventio
Sponsor: Chinese University of Hong Kong
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2024-07-31
Completion Date: 2026-05-30

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.

Primary 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 using a non-stretchable plastic measuring tape with an accuracy of 0.1 cm., Data will be collected at day 0 and month 3.|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., Data will be collected at day 0 and month 3.|Urine albumin-to-creatinine ratio, Morning urine samples will be collected and refrigerated immediately to measure the levels of urine albumin and creatinine; then, the UACR will be calculated., Data will be collected at day 0 and month 3.
Secondary Outcome Measures: 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., Data will be collected at day 0 and month 3.|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., Data will be collected at day 0 and month 3.|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., Data will be collected at day 0 and month 3.|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., Data will be collected at day 0 and month 3.|Self-efficacy of dietary behavior and physical activity, The Chinese version of the Health-Related Diet and Exercise Self-Efficacy Scale - Simplified Version (HRDESES) will be used to evaluate the self-efficacy of dietary behavior and physical activity. Response options are rated on a 5-point scale: zero (I'm not sure), one (mostly I cannot), two (I don't know), three (mostly I can), or four (I'm sure I can). The total score of HRDESES ranges from zero to 32, with a higher score indicating higher levels of health-related diet and exercise self-efficacy., Data will be collected at day 0 and month 3.