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CTRI Number  CTRI/2025/03/083234 [Registered on: 24/03/2025] Trial Registered Prospectively
Last Modified On: 25/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Health Promotion]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of Nurse-Guided Health Interventions on Patients with Metabolic Syndrome in Rural Areas of Anand District 
Scientific Title of Study   Effect of Tailored Nursing Intervention on Participants Suffering from Metabolic Syndrome in The Selected Rural Areas of Anand District Of Gujarat State: A Randomized Control Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Chirag Jain 
Designation  PhD Scholar 
Affiliation  Maniakaka Topawala Institute of Nursing 
Address  Room No. 201 Manikaka Topawala Institute of Nursing Charusat University Changa, Dist- Anand GUJARAT 388421 India Anand GUJARAT 387001 India
Room No. 201 Manikaka Topawala Institute of Nursing Charusat University Changa, Dist- Anand GUJARAT 388421 India
Anand
GUJARAT
387001
India 
Phone  8758616455  
Fax    
Email  chiragjain.nur@charusat.ac.in  
 
Details of Contact Person
Scientific Query  
Name  Chirag Jain 
Designation  PhD Scholar 
Affiliation  Maniakaka Topawala Institute of Nursing 
Address  Room No. 201 Manikaka Topawala Institute of Nursing Charusat University Changa, Dist- Anand GUJARAT 388421 India Anand GUJARAT 387001 India
Room No. 201 Manikaka Topawala Institute of Nursing Charusat University Changa, Dist- Anand GUJARAT 388421 India
Anand
GUJARAT
387001
India 
Phone  8758616455  
Fax    
Email  chiragjain.nur@charusat.ac.in  
 
Details of Contact Person
Public Query  
Name  Chirag Jain 
Designation  PhD Scholar 
Affiliation  Maniakaka Topawala Institute of Nursing 
Address  Room No. 201 Manikaka Topawala Institute of Nursing Charusat University Changa, Dist- Anand GUJARAT 388421 India Anand GUJARAT 387001 India
Room No. 201 Manikaka Topawala Institute of Nursing Charusat University Changa, Dist- Anand GUJARAT 388421 India
Anand
GUJARAT
387001
India 
Phone  8758616455  
Fax    
Email  chiragjain.nur@charusat.ac.in  
 
Source of Monetary or Material Support  
1. Primary Health Centre, Changa 2. Community Health Centre, Mahelav 3. Primary Health Centre, Bandhani 
 
Primary Sponsor  
Name  Mr Chirag Jain  
Address  Chirag Jain 86 Sankalp Residency Near Pastoral Center Nadiad District Kheda Gujarat India 387002 
Type of Sponsor  Other [] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Jhanvi Sanjay Kumar Shah  01-Primary Health Center  Primary Health Center, Changa, Ta- Petlad
Anand
GUJARAT 		 7567870140

phcchanga.health.anand@gmail.com 
Dr Jhanvi Sanjay Kumar Shah  02-PHC, Bandhani  Primary Health Center, Bandhani. Ta- Petlad.
Anand
GUJARAT 		 07567870140

phcbandhani.health.anand@gmail.com 
Dr Rajeev Contractor  03-Community health center  Community health center Mehlav, Ta-Petlad
Anand
GUJARAT 		 7621989654

chcmehlav.health.anand@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 4  
Name of Committee  Approval Status 
Community health centre Mehlav   No Objection Certificate 
Intitutional Ethics Committe CHARUSAT (IEC CHARUSAT)  Approved 
Primary health centre Bandhani  No Objection Certificate 
Primary health centre Changa  No Objection Certificate 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E889||Metabolic disorder, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nurse Tailored Intervention  Nurse Tailored Intervention Includes the Following 1 Health teaching about basic information on metabolic syndrome and the prevention of complications including the benefits of exercise and diet 2 Early morning and evening walk for thirty minutes 3 Metabolic diet plan for a week 4 Follow up will be conducted through a daily diary maintained by participants 5 Text message reminders 6 Telephonic follow up every fortnight 
Comparator Agent  Nurse tailored intervention (post test)  The control group will also receive the tailored nursing intervention after completion of data collection 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Participants who meet at least three out of five high-risk metabolic criteria including Elevated Fasting Plasma Glucose Central Obesity Elevated Triglycerides Reduced High-Density Lipoprotein (HDL)Elevated Blood Pressure

Participants who are available at the time of the study.

 
 
ExclusionCriteria 
Details  Those participants having physical deformity. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Significant change in biological parameter of metabolic syndrome
1. Waist Circumference.
2. Fasting blood sugar.
3. Blood Pressure.
4. HDL
5. LDL 		 Time point is a specific time at which outcome will be assessed after 8 weeks only 
 
Secondary Outcome  
Outcome  TimePoints 
"Improvement in knowledge and self-care practices related to metabolic syndrome management."

 		 8 weeks/2 month 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   07/04/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial
Modification(s)  		 Years="0"
Months="0"
Days="28" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  
  • problem statement:- “Effect of Tailored Nursing Intervention on Participants Suffering from Metabolic Syndrome in the Selected Rural Areas of Anand District of Gujarat State: A Randomized Control Trial.”Institutional Permissions: Approval from the Head of Manikaka Topawala Institute of Nursing will be obtained.
    • Ethical Clearance: Ethical approval secured from the institutional ethics committee, and further ethical permission also obtained from the concerned PHC and CHC of Anand District.

    Study Design and Participant Allocation

    • In  this  phase participants will be recruited using a block randomization procedure, based on the prevalence rate determined in Phase I.
    • A single-blinding technique will be employed, where participants will be randomly assigned to either the experimental group or the control group.
    • Allocation Concealment:
      • Participants will be selected from the study setting and randomly allocated to the experimental or control group using computer-generated block randomization.
      • The experimental group will receive a nurse-tailored intervention, while the control group will receive the nurse talored intervention after the completion of data collection.

    Nurse tailored intervention

    • Informed Consent: The researcher will introduce himself to participants during home visits, explain the study’s purpose, and obtain written informed consent.
    • Nurse-Tailored Intervention (28 Days) for the Experimental Group:
      1. Individualized Health Education:
        • Face-to-face health teaching sessions during home visits.
      2. Dietary Modifications:
        • A metabolic diet plan chart will be provided to participants.
      3. Physical Activity Component:
        • Encouragement of 30-minute morning and evening walks.
        • Participants will receive text message reminders in the morning and evening.
      4. Follow-Up and Support:
        • The researcher will monitor participants’ diet and exercise adherence via telephonic follow-ups (twice a month).
      5. Self-Monitoring:
        • Each participant will maintain a self-diary to track their diet, exercise, and adherence throughout the intervention period.
    • Health teaching on metabolic syndrome.
    • Metabolic Diet .
    • physical activity.
    • followup and support

    Post-Intervention Assessment

    • After the 28-day intervention period, a post-test evaluation will be conducted to assess the effectiveness of the nurse-tailored intervention.
    • The researcher will express gratitude to all participants for their involvement.



     
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