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

NCT06527768 | Active Not Recruiting

• 1 other identifier: CERC Ref. No.: 2024.23.6
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Kidney Diseases; Metabolic Syndrome

Keywords

Metabolic Syndrome; Chronic Kidney Disease; Waist Circumference; Kidney Function; Behaviour Change Intervention

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• Physical activity

  Data will be collected at day 0 and month 3.

• Exercise capacity

  Data will be collected at day 0 and month 3.

• Dietary behaviour

  Data will be collected at day 0 and month 3.

• Dietary behaviour

  Data will be collected at day 0 and month 3.

• Self-efficacy of dietary behavior and physical activity

  Data will be collected at day 0 and month 3.

Study Arms (2)

Theory-based health behaviour change intervention group

EXPERIMENTAL

Participants will be enrolled via WeChat and undergo 8 intervention sessions over 12 weeks. The 8 intervention sessions contain two online individual education sessions, two online group music-paced brisk walking training, two group discussions, and two telephone follow-ups. Besides, participants in the intervention group will be required to perform self-music-paced brisk walking 150 minutes/week for three months.

Behavioral: Theory-based health behaviour change interventio

Control group

NO INTERVENTION

Usual care.

Interventions

Theory-based health behaviour change interventio BEHAVIORAL

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.

Theory-based health behaviour change intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 (eGFR \< 60 mL/min/1.73 m2 or a UACR ≥ 30 mg/g for at least three months);
• No medical contraindications to exercise, including walking;
• Participants are capable of understanding and providing informed consent;
• Own a smartphone for accessing WeChat;
• Being able to communicate in Chinese;
• Stay in Chengdu during the study period.

You may not qualify if:

• 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;
• Participants who have a cognitive impairment, which will be screened by the abbreviated mental test with a score lower than seven;
• Adjustment of medication within half a year;
• Participants who have performed regular planned exercise (Defined as at least 150 minutes of moderate-intensity aerobic activity or 75 minutes of high-intensity aerobic activity per week, or a combination of moderate-intensity and high-intensity aerobic activity) within the past month.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

West China Hospital of Sichuan University

Chengdu, Sichuan, 610000, China

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Metabolic Syndrome

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 4, 2024
• First Posted: July 30, 2024
• Study Start: July 31, 2024
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): May 30, 2026
• Last Updated: December 2, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)