| CTRI Number |
CTRI/2018/12/016810 [Registered on: 31/12/2018] Trial Registered Prospectively |
| Last Modified On: |
24/05/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study on measuring the Effectiveness of program:"Kuposhan Mukt Gujarat Maha-Abhiyan" in Vadodara district |
|
Scientific Title of Study
|
A study on Evaluation and Implementation of "Kuposhan Mukt Gujarat Maha-Abhiyan" in Vadodara district, Gujarat |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Arpita Patel |
| Designation |
Post Graduate Student, Prasanna School of Public Health |
| Affiliation |
Prasanna School of Public Health, MAHE |
| Address |
Prasanna School of Public Health, Manipal Academy of Higher Education(MAHE), Manipal.
Udupi
KARNATAKA
576104
India |
| Phone |
9426333339 |
| Fax |
|
| Email |
arpipatel18@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kumar Sumit |
| Designation |
Assistant Professor, Prasanna School of Public Health |
| Affiliation |
Prasanna School of Public Health, MAHE |
| Address |
Prasanna School of Public Health, Manipal Academy of Higher Education(MAHE), Manipal.
Udupi
KARNATAKA
576104
India |
| Phone |
8867620088 |
| Fax |
|
| Email |
sumitsharma315@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jay Patel |
| Designation |
Project Officer-Nutrition, Government of Gujarat |
| Affiliation |
Gujarat Government |
| Address |
3, Shiv park society, Kamana road, Visanagar, Mehsana.
Mahesana
GUJARAT
384315
India |
| Phone |
8980293893 |
| Fax |
|
| Email |
jaypatel9753@gmail.com |
|
|
Source of Monetary or Material Support
|
| DrArpita Patel
Prasanna School of Public Helath, Manipal Academy of Higher Education,
Manipal, Udupi, Karnataka-576104 |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 |
| DrArpita Patel |
Multi centric within Vadodara district |
District Program Management Unit, District Helath society, District Panchayat, Vadodara
Vadodara
GUJARAT |
9426333339
arpipatel18@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasutrba hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
This study involves interviews of program stakeholders and parents of beneficiaries. The program which is going to be evaluated is for the management of stunting condition of under 5 children. |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion criteria for this study is stakeholders or health care provider who are involved in the Kuposhan Mukt Gujarat Maha-Abhiyan and the parents of beneficiaries(here the beneficiaries are stunted under 5 children) |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the implementation of “Kuposhan Mukt Gujarat Maha-Abhiyan†in Vadodara District. |
Outcomes will be analyzed by April 2019 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the implementation of the program from beneficiaries and providers’ perspective and to determine the achievement and perceived barriers in utilization of the services provided, by the community.
|
Outcomes will be Analyzed by April 2019 |
|
|
Target Sample Size
|
Total Sample Size="55"
Sample Size from India="55"
Final Enrollment numbers achieved (Total)= "42"
Final Enrollment numbers achieved (India)="42" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/01/2019 |
| Date of Study Completion (India) |
13/03/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Severe mal nutrition is one of the major cause of Under 5 mortality, even though very less number of children face medical complication which needs institutional care, and rest can be treated with supplementation and continuous monitoring. Gujarat is one of the high performing state in India, but in case of child health it is still lacking behind. Kuposhan Mukt Gujarat Maha-Abhiyan is a newer initiative taken by the Gujarat government which was started in 2015 to address severe acute malnutrition at community level. This study will help in assessing the strength and weaknesses of the program initiatives taken to treat severe acute mal-nutrition by providing supplements and medical care at community level and will also help in determining the challenges faced, from the Provider’s and beneficiaries’ point of view. Therefore this study is being carried out to assess the effectiveness and impact of the community based management of wasted children. |