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

NCT06715735 | Active Not Recruiting

• 1 other identifier: CREC Ref. No.: 2024.447-T
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

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 3-time points (baseline, immediate post-intervention and 1-month 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; Health Action Process Approach

Outcome Measures

Primary Outcomes (2)

• 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, month 3 and month 4.

• 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, month 3 and month 4.

Secondary Outcomes (5)

• Physical activity

  Data will be collected at day 0, month 3 and month 4.

• Exercise capacity

  Data will be collected at day 0, month 3 and month 4.

• Dietary behaviour

  Data will be collected at day 0, month 3 and month 4.

• Dietary behaviour

  Data will be collected at day 0, month 3 and month 4.

• Self-efficacy of dietary behavior and physical activity

  Data will be collected at day 0, month 3 and month 4.

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 intervention

Control group

NO INTERVENTION

Usual care.

Interventions

Theory-based health behaviour change intervention 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);
• 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;
• Being able to communicate in Chinese.

You may not qualify if:

• 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;
• 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: November 29, 2024
• First Posted: December 4, 2024
• Study Start: December 20, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: September 3, 2025

Record last verified: 2025-09

Locations

CN (1)