Theory-based Health Behaviour Change Intervention in Patients of Metabolic Syndrome With Chronic Kidney Disease

Condition(s) studied

Investigational drug(s) / intervention(s)

Theory-based health behaviour change interventio: The 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.

Study 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.

Eligibility

Primary outcome measure(s)

• Waist circumference — Data will be collected at day 0 and month 3.
  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 — Data will be collected at day 0 and month 3.
  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.

Trial sites (1)

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