HAPA-based Intervention in Adults With Metabolic Syndrome and Chronic Kidney Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorChinese University of Hong Kong
About this trial
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 4 time points (baseline, immediate post-intervention, 1-month post-intervention, and 6-month 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;
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;
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
HAPA-based intervention
BehavioralOnline individual education sessions on MetS, CKD, healthy diet, and physical activity are delivered via WeChat. Group music-paced brisk walking training (5-min warm-up, 30-min walking, 5-min cool-down) and group discussions on health status, diet, exercise, and personal goals are conducted via Tencent Meeting. Follow-up phone calls reinforce goals and address questions. All content is based on a structured health handbook. Participants are required to perform self-paced brisk walking for 30 minutes/day, 5 days/week.
Treatment groups
160 Participants
are divided into 2 treatment groupsGroup A: HAPA-based 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 baseline, immediate post-intervention, 1-month post-intervention, and 6-month post-intervention.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 baseline, immediate post-intervention, 1-month post-intervention, and 6-month post-intervention.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 baseline, immediate post-intervention, 1-month post-intervention, and 6-month post-intervention.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 baseline, immediate post-intervention, 1-month post-intervention, and 6-month post-intervention.3
Dietary behaviour
Dietary behaviour will be assessed using the diet control subscale of the Chinese Chronic Kidney Disease Self-care scale (CKDSC-DC) and the nutrition domain of the Health-Promoting Lifestyle Profile II (HPLP-II-N). The CKDSC-DC is a 4-item measure of CKD-specific dietary self-care, rated from 1 (almost never) to 5 (almost always). Higher scores indicate better dietary self-management, with scores ≥14 considered healthy. The HPLP-II-N comprises 9 items assessing general healthy dietary practices, rated from 1 (not at all) to 4 (always). Higher scores indicate healthier dietary behaviour, with scores ≥22.5 classified as healthy.
Time frame
Data will be collected at baseline, immediate post-intervention, 1-month post-intervention, and 6-month post-intervention.4
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.
Time frame
Data will be collected at baseline, immediate post-intervention, 1-month post-intervention, and 6-month post-intervention.Sponsors and contacts
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Source ClinicalTrials.gov