| CTRI Number |
CTRI/2023/04/051334 [Registered on: 06/04/2023] Trial Registered Prospectively |
| Last Modified On: |
03/04/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Screening |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to assess the effectiveness of self management
program on Metabolic Syndrome risk reduction among middle and old-aged adults of
the selected villages of Rajpura, Punjab. |
|
Scientific Title of Study
|
A Randomized Control Trial to assess the effectiveness of selfmanagement
program on Metabolic Syndrome risk reduction among middle and old-aged adults of
the selected villages of Rajpura, Punjab. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Navdeep Kaur |
| Designation |
Associate Professor |
| Affiliation |
College of Nursing, Chitkara University, Himachal Pradesh |
| Address |
Nightingale block, Vice-principal cum associate professor (room), 1st floor, College of Nursing, Chitkara University, Baddi, Himachal Pradesh
Solan
HIMACHAL PRADESH
174103
India |
| Phone |
9257400000 |
| Fax |
|
| Email |
navdeep.kaur@chitkarauniversity.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Navdeep Kaur |
| Designation |
Associate Professor |
| Affiliation |
College of Nursing, Chitkara University, Himachal Pradesh |
| Address |
Nightingale Block, Vice- Principal cum associate Professor (Room), 1st floor, College of Nursing, Chitkara University, Baddi, Himachal Pradesh
Jujhar Singh Nagar, St no -4, h.no- 20062 A2, Bathinda, Punjab, India
Solan
HIMACHAL PRADESH
174103
India |
| Phone |
9257400000 |
| Fax |
|
| Email |
navdeep.kaur@chitkarauniversity.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Navdeep Kaur |
| Designation |
Associate Professor |
| Affiliation |
College of Nursing, Chitkara University, Himachal Pradesh |
| Address |
Nightingale Block, Vice-principal cum associate Professor (room), 1st floor, College of Nursing, Chitkara University, Baddi, Himachal Pradesh
Jujhar Singh Nagar, St no -4, h.no- 20062 A2, Bathinda, Punjab, India
Solan
HIMACHAL PRADESH
174103
India |
| Phone |
9257400000 |
| Fax |
|
| Email |
navdeep.kaur@chitkarauniversity.edu.in |
|
|
Source of Monetary or Material Support
|
| Chitkara University, Distt Rajpura, Punjab (Phd Programme) |
|
|
Primary Sponsor
|
| Name |
Chitkara University, Punjab |
| Address |
Chitkara University, Punjab |
| Type of Sponsor |
Other [private university] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Harmeet kaur Guide |
Chitkara University, Punjab |
| Dr JS Thakur Co guide |
Professor, Community Medicine, School of Public Health, PGIMER, Chandigarh |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Gaurav Kholi |
Villages Thua, Sham duon, Kehri Gurna, Sham duon camp of Tehsil Rajpura, Punjab |
Tehsil Rajpura, Punjab
Patiala
PUNJAB |
9778898245
gaurav.kohli@chitkara.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Chitkara University |
Approved |
| Community health centre |
No Objection Certificate |
| village sarpanch |
No Objection Certificate |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
volunteers who will be found have metabolic syndrome after screening as per modified NCEP ATP III criteria. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Self Management Programme |
Intervention: Self Management Programme
Intervention consists of self management through behavior change communication in which individuals with metabolic syndrome takes responsibility of own health and become ‘Principle Caregiver’ in partnership with the investigator (ND). Duration of this intervention is 6 month.
Self Management Program involves delivering Behavior Change Communication (BCC). BCC has 5 phases:
S.No Phase Time Details
1 Pre- intervention Zero Month • Collection of data lifestyle/behavioral factors, Self efficacy level and stress level of a participant of experimental group.
• Tools - WHO STEPS Surveillance, PSS-10, GSE
• Duration is 10 minutes
2 Intervention • BCC via Interpersonal communication to make participant aware about existing and desired health behavior based on information collected in pre- intervention phase, identifying barriers, setting, setting achievable and measureable health goals
• BCC tools i.e health dairies and step counter to measure and record health behavior change
• Duration is 20 minutes
3 Maintenance/ reinforcement of Behavior 2 week,
2,4,5 month • Semi- structured telephone calls at 2 week, 2 , 4 , 5 month
• Paying visits at 1, 3 month reinforce and monitor the behavior change
4 Evaluation of compliance with self management
1, 3 month • Anthropometric measurements - Waist circumference, blood pressure at 1, 3 month
5 Post intervention 6 month • Effects of Self-management program will be assessed by recollecting data using tools:
• Biochemical Physiological Parameters, WHO STEPS Surveillance, PSS-10, GES
|
| Comparator Agent |
Standard care |
participants will be asked to follow healthy health beaviour and will be made aware about their metabolic syndrome. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
64.00 Year(s) |
| Gender |
Both |
| Details |
1. Participants who are willing to enroll in the study
2. Adults who will be found to have metabolic syndrome after screening
3. Participants who have access to mobile phone
|
|
| ExclusionCriteria |
| Details |
1. Already diagnosed with diabetes mellitus (other than gestational diabetes), heart diseases and stroke, cancer.
2. Presently on weight loss diet.
3. Enrolled in any other physical activity program.
4. Enrolled in any other nutritional program.
5. Unable to exercise due to an orthopedic problem.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| reduction in number of risk factors of metabolic syndrome either physiological risk factors (Waist circumference, Blood pressure) and biochemical risk factors (FBS, TG, HDL level) in intervention group than baseline. |
time points: baseline, 4 weeks, 3 months, 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| decrease in behavioural risk factors (physical activity, adequate diet intake, tobacco & alcohol intake) in intervention group. |
total duration of intervention is 6 months.
so after getting enrolled into intervention group, positive changes in ill- health behaviour are expected |
|
|
Target Sample Size
|
Total Sample Size="154"
Sample Size from India="154"
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
|
N/A |
|
Date of First Enrollment (India)
|
15/04/2023 |
| 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
|
Years="0"
Months="6"
Days="10" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
this study has been undertaken to for metabolic syndrome risk reduction in adults of selected villages. Geographically stratified sampling procedure was used to select villages, two for intervention group and 2 for control group to prevent contamination.
After receiving CTRI number, participants will recruited to both the groups with the help of ASHA workers of selected villages via door to door survey and as per inclusive and exclusive criteria Intervention that is self management program will be delived to intervention group and standard care to control group.
Total duration of intervention will be 6 months and at 6 months data will collected from both the groups to compare with baseline data. |