| CTRI Number |
CTRI/2024/06/069500 [Registered on: 26/06/2024] Trial Registered Prospectively |
| Last Modified On: |
01/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Behavioral |
| Study Design |
Other |
|
Public Title of Study
|
The Health Perspective of the subject family the prevalence and incidence of obesity diabetes cardiovascular disease stroke Tuberculosis Lung Disorders visual impairment cancer and or other significant health problems including cancer identified by the HAPPEN TOOL |
|
Scientific Title of Study
|
A Participatory Action Research Project on One Health and One Planet. |
| Trial Acronym |
HAPPEN |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vijay V Yeldandi |
| Designation |
PRINCIPAL INVESTIGATOR |
| Affiliation |
INTERNATIONAL CENTER HUMAN HEALTH ADVANCEMENT FOUNDATION |
| Address |
6-1-126 & 127/4
Padmarao Nagar
Secunderabad
Plot Number 1278
Road No: 63
Jubilee Hills
Hyderabad 500033
Hyderabad
TELANGANA
500025
India |
| Phone |
9959334797 |
| Fax |
|
| Email |
vvy@ichhaindia.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Vijay V Yeldandi |
| Designation |
PRINCIPAL INVESTIGATOR |
| Affiliation |
INTERNATIONAL CENTER HUMAN HEALTH ADVANCEMENT FOUNDATION |
| Address |
6-1-126 & 127/4
Padmarao Nagar
Secunderabad
Plot No 1278
Road No 63
Jubileehills
Hyerabad 500033
Hyderabad
TELANGANA
500025
India |
| Phone |
9959334797 |
| Fax |
|
| Email |
vvy@ichhaindia.org |
|
Details of Contact Person
Public Query
|
| Name |
Vijay V Yeldandi |
| Designation |
PRINCIPAL INVESTIGATOR |
| Affiliation |
INTERNATIONAL CENTER HUMAN HEALTH ADVANCEMENT FOUNDATION |
| Address |
6-1-126 & 127/4
Padmarao Nagar
Secunderabad
PLOT NUMBER 1278
ROAD NO 63
Jubilee Hills
HYDERABAD
Hyderabad
TELANGANA
500025
India |
| Phone |
9959334797 |
| Fax |
|
| Email |
vvy@ichhaindia.org |
|
|
Source of Monetary or Material Support
|
| International Center Human Health Advancement foundation ICHHA
Plot Number 1278
ROAD NO 63
Jubilee Hills
Hyderabad |
|
|
Primary Sponsor
|
| Name |
International Center Human Health Advancement |
| Address |
Plot Number 1278
Road No 63
Jubilee hills
Hyderabad 500033
Hyderabad -500033 |
| Type of Sponsor |
Other [Non Governmental Organisation] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vijay Yeldandi |
International Center Human Health Advancement |
PLOT NUMBER 1278
ROAD NO 68
JUBILEEHILLS
HYDERABAD
Medak
TELANGANA |
9959334797
vvy@ichha.org |
| Dr Vijay Yeldandi |
International Center Human Health Advancement |
PLOT NUMBER 1278
ROAD NO 63
JUBILEE HILLS
HYDERABAD
Hyderabad
TELANGANA |
9959334797
vvy@ichha.org |
| DrVijay Yeldandi |
International Center Human Health Advancement |
PLOT NUMBER 1278
ROAD NO 63
JUBILEE HILLS
HYDERABAD
Mahbubnagar
TELANGANA |
9959334797
vvy@ichha.org |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| S2J INDEPENDENTETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E00-E89||Endocrine, nutritional and metabolic diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Health Literacy about one health and one planet |
Education about One health one planet health promotion and referral linkage for health Services to appropriate health care provider |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Subjects Willing to participate in the study by giving voluntary informed consent
Age 2-100 years
Residents of the geographic area as defined area for at least six months or more |
|
| ExclusionCriteria |
| Details |
Subjects below the age of 2 years.
Subjects unwilling or unable to provide informed consent/assent. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Attitudes towards health ownership and resilience in a “One Health: One Planet†Framework |
Ten years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Assessment of levels of sanitation
Zoonosis and impact of animals on community health
Assessment of other deficiencies of access to health care
Assessment of deficiencies in the environment that impact on health
Network analysis to explore influencers of health and risk factors for various health conditions
|
Ten years |
|
|
Target Sample Size
|
Total Sample Size="1500"
Sample Size from India="1500"
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)
|
19/07/2024 |
| 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="10"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
A. Introduction of the concept of HAPPEN
in the community through Information, Education, and Communication. (IEC)
B. Screen for the risk of metabolic
syndrome and, where appropriate, help with linkage to health services.
C. Screen for Vision
D. Recruit a subset of subjects for Photovoice.
This is a key tool to understand the perspective and priorities of the
community.
E. Recruit women in the community for
membership of networked empowered peer groups (HAPPEN CLUBS) to catalyze health
advancement.
F. Recruit HAPPEN Champions (Key Opinion
Leaders/Change agents). A. Follow-up visits to encourage healthy
lifestyles addressing the risk of metabolic syndrome reinforcing IEC as well as
adherence to a medical regimen where appropriate, linkage to health services.
|