Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06527768
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-04
Brief Title:
Theory-based Health Behaviour Change Intervention in Patients of Metabolic Syndrome With Chronic Kidney Disease
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Effectiveness of a Theory-based Health Behaviour Change Intervention on Waist Circumference and Kidney Function in Patients of Metabolic Syndrome With Chronic Kidney Disease A Pilot Randomised Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
Metabolic syndrome MetS is a worldwide chronic disease mainly due to unhealthy diets and sedentary lifestyles According to the International Diabetes Federation IDF definition of MetS patients must have central obesity defined by waist circumference WC with ethnicity-specific values plus any two of four additional factors namely high triglycerides TG low high-density lipoprotein cholesterol HDL-C high fasting glucose FG and high blood pressure BP
More recent evidence indicates that the MetS could be an independent risk factor for chronic kidney disease CKD CKD is a progressive and incurable condition with high morbidity and mortality which manifests as an estimated glomerular filtration rate eGFR 60 mLmin173 m2 or a urine albumin-to-creatinine ratio UACR 30 mgg for at least three months According to KDIGO 2012 clinical practice guideline CKD is divided into five stages stages 1 2 3a 3b 4 5 which are based on the eGFR test result as the stage progresses kidney function becomes more severe ultimately leading to kidney failure Previous studies have found that individuals with MetS had a higher risk of CKD compared with patients without MetS
Central obesity as the core component of MetS could be one of the most essential pathogenes explaining the association between MetS and CKD Central obesity mainly manifests as excess abdominal adipose tissue which directly leads to the deranged synthesis of various adipose tissue cytokines eg leptin adiponectin resistin and visfatin with nephrotoxic potential to cause sustained damage or structural changes to the kidneys as well as indirectly trigger insulin resistance dyslipidemia and hypertension which are the most substantial risk factors for CKD
Many patients fail to take MetS seriously until they are diagnosed with CKD This is attributed to the additional complications and complex treatments associated with CKD significantly affecting their daily lives Current therapeutic guidelines for MetS suggest that non-pharmacological interventions NPIs with multifactorial lifestyle changes should be the primary treatment including dietary modification physical activity PA counselling or lifestyle modifications Therefore NPIs could be an essential method for reducing WC and preserving kidney function for the target population Hence this proposed study aims to develop an NPI for adults with MetS and CKD on the synthesized scientific evidence and the effects on health-related outcomes will be evaluated using a randomized controlled trial RCT study
Therefore the design of the theory-based behavioural process change intervention is based on the findings of the systematic review SR and the implications of the qualitative study Before the main RCT a pilot RCT will be conducted to examine the feasibility and acceptability of the proposed intervention
More recent evidence indicates that the MetS could be an independent risk factor for chronic kidney disease CKD CKD is a progressive and incurable condition with high morbidity and mortality which manifests as an estimated glomerular filtration rate eGFR 60 mLmin173 m2 or a urine albumin-to-creatinine ratio UACR 30 mgg for at least three months According to KDIGO 2012 clinical practice guideline CKD is divided into five stages stages 1 2 3a 3b 4 5 which are based on the eGFR test result as the stage progresses kidney function becomes more severe ultimately leading to kidney failure Previous studies have found that individuals with MetS had a higher risk of CKD compared with patients without MetS
Central obesity as the core component of MetS could be one of the most essential pathogenes explaining the association between MetS and CKD Central obesity mainly manifests as excess abdominal adipose tissue which directly leads to the deranged synthesis of various adipose tissue cytokines eg leptin adiponectin resistin and visfatin with nephrotoxic potential to cause sustained damage or structural changes to the kidneys as well as indirectly trigger insulin resistance dyslipidemia and hypertension which are the most substantial risk factors for CKD
Many patients fail to take MetS seriously until they are diagnosed with CKD This is attributed to the additional complications and complex treatments associated with CKD significantly affecting their daily lives Current therapeutic guidelines for MetS suggest that non-pharmacological interventions NPIs with multifactorial lifestyle changes should be the primary treatment including dietary modification physical activity PA counselling or lifestyle modifications Therefore NPIs could be an essential method for reducing WC and preserving kidney function for the target population Hence this proposed study aims to develop an NPI for adults with MetS and CKD on the synthesized scientific evidence and the effects on health-related outcomes will be evaluated using a randomized controlled trial RCT study
Therefore the design of the theory-based behavioural process change intervention is based on the findings of the systematic review SR and the implications of the qualitative study Before the main RCT a pilot RCT will be conducted to examine the feasibility and acceptability of the proposed intervention
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None