Theory-based Health Behaviour Change Intervention in Patients of Metabolic Syndrome With Chronic Kidney Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorChinese University of Hong Kong
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
Theory-based health behaviour change interventio
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.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Theory-based health behaviour change intervention groupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Data will be collected at day 0 and month 3.2
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.
Time frame
Data will be collected at day 0 and month 3.Secondary outcomes
1
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.
Time frame
Data will be collected at day 0 and month 3.2
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.
Time frame
Data will be collected at day 0 and month 3.3
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.
Time frame
Data will be collected at day 0 and month 3.4
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.
Time frame
Data will be collected at day 0 and month 3.Sponsors and contacts
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Source ClinicalTrials.gov