| CTRI Number |
CTRI/2025/12/098702 [Registered on: 09/12/2025] Trial Registered Prospectively |
| Last Modified On: |
09/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Community based experimental study combining two different research types to know whether involving Local Women’s Self-Help Groups can increase testing for Diabetes and Hypertension by Rural Women in Jodhpur |
|
Scientific Title of Study
|
Engaging Women Self-Help Group in Uptake of Screening for Diabetes and Hypertension among Women of Rural Jodhpur: A Community-Based Quasi-Experimental Study using Mixed Methods Design |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Monika Khichi |
| Designation |
Junior Resident |
| Affiliation |
AIIMS Jodhpur |
| Address |
C210, Department of Community Medicine and Family Medicine, Second Floor, Medical College Building, All India Institute of Medical Sciences, Jodhpur, Basni Phase 2, Jodhpur, Rajasthan, 342005
C210, Department of Community Medicine and Family Medicine, Second Floor, Medical College Building, All India Institute of Medical Sciences, Jodhpur,
Jodhpur
RAJASTHAN
342005
India |
| Phone |
8209995664 |
| Fax |
|
| Email |
drmonika98in@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prasanna Thirunavukkarasu |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences, Jodhpur |
| Address |
C215, Department of Community Medicine and Family Medicine, Second Floor, Medical College Building, All India Institute of Medical Sciences, Jodhpur, Basni Phase 2, Jodhpur, Rajasthan, 342005
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9843172412 |
| Fax |
|
| Email |
drprasanmail@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prasanna Thirunavukkarasu |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences, Jodhpur |
| Address |
C215, Department of Community Medicine and Family Medicine, Second Floor, Medical College Building, All India Institute of Medical Sciences, Jodhpur, Basni Phase 2, Jodhpur, Rajasthan, 342005
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9843172412 |
| Fax |
|
| Email |
drprasanmail@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Prasanna Thirunavukkarasu |
| Address |
C215, Dept of CMFM, 2nd Floor, College Building, AIIMS Jodhpur Rajasthan India 3425 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Prasanna Thirunavukkarasu |
All India Institute of Medical Sciences |
C215,Department of Community Medicine and Family Medicine, All India Institute of Medical Sciences, Jodhpur, Basni Phase 2, Jodhpur, Rajasthan, 342005
Jodhpur
RAJASTHAN |
09843172412
drprasanmail@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, All India Institute of Medical Sciences, Jodhpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Diabetes and Hypertension |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control |
"Existing Programmatic Initiative"
They will follow the existing protocol as per the NP-NCD |
| Intervention |
Intervention |
Engagement of SHGs and promotion of awareness and facilitation of uptake of Screening by the SHGs
Training session using power point slide show and
educational flipcharts and booklets regarding knowledge about diabetes and hypertension risk factors, symptoms, treatment, complication, screening, and prevention. Participants will be divided into groups of 10-15 women to conduct the sessions Each session took 45-60 minute.Endline assessment at three months of follow-up period would be evaluated for the intervention and control groups. To determine the effect of intervention the endline assessment in the intervention group would be compared with the control group. Endline assessment at three months of follow-up period would be evaluated for the intervention and control groups. To determine the effect of intervention the endline assessment in the intervention group would be compared with the control group. Endline assessment at three months of follow-up period would be evaluated for the intervention and control groups. To determine the effect of intervention the endline assessment in the intervention group would be compared with the control group. Endline assessment at three months of follow-up period would be evaluated for the intervention and control groups. To determine the effect of intervention the endline assessment in the intervention group would be compared with the control group. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Female |
| Details |
Women of Self Help Group |
|
| ExclusionCriteria |
| Details |
Women ever diagnosed with diabetes and hypertension.
Pregnant and Lactating women
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Uptake of Screening for Diabetes & Hypertension
|
At 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Knowledge, Perception
regarding Screening for Diabetes & Hypertension
Access to, Usage Patterns of Screening; Barriers, Enablers
Acceptability/ Willingness to get screened for Diabetes & Hypertension
|
At 6 months |
|
|
Target Sample Size
|
Total Sample Size="128"
Sample Size from India="128"
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)
|
20/12/2025 |
| 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
|
Years="1"
Months="6"
Days="0" |
|
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [drprasanmail@gmail.com].
- For how long will this data be available start date provided 01-10-2028 and end date provided 31-12-2030?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Non-communicable
diseases (NCDs) are significant public health concerns in India. However, the
uptake of screening for diabetes and hypertension is low, especially among
rural and also women. Women Self-Help Groups (SHGs) are an important community
mobilisation structure in rural areas in India. The national program for NCDs
suggests involvement of SHGs amongst other similar community participation to
be strengthened and established as a platform for community awareness and
promotive and preventive care activities.
Primary Objective:
To assess the effectiveness
of engaging women self-help groups in promoting the uptake of screening for
diabetes and hypertension among women in rural Jodhpur.
Secondary Objectives:
To study the current level
of knowledge and practice regarding diabetes and hypertension prevention and
screening among women
To identify barriers and
facilitators to the uptake of screening for diabetes and hypertension among
women in rural Jodhpur.
To assess the feasibility of
engaging women self-help groups in facilitating the promotion of the uptake of
diabetes and hypertension screening.
Study
design: Community-Based Quasi-Experimental study with Mixed Methods
Study
settings: Rural Jodhpur
Study
participant:
Inclusion
criteria: Women residing in Rural
Jodhpur, aged >30yrs
Exclusion
criteria: Women ever diagnosed with
diabetes and hypertension;
Pregnant and
Lactating Women
A minimum of 64
in each group, a total of 128 women would be included in the study
Intervention:
Engagement of SHGs and promotion of awareness and facilitation of uptake of
Screening by the SHGs
Comparator /
Control: Existing Programmatic Initiative
Outcome:
Change
in screening uptake of diabetes and hypertension
Knowledge / Attitude regarding &
screening of diabetes and hypertension | |