- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03578159
Study of Arsha Vidya Chhatralaya Initiative on Health and Functioning of Disadvantaged Tribal Children
June 24, 2018 updated by: NMP Medical Research Institute
India's poor tribal communities have far worse health and social indicators than the general population.
Most tribal people live in remote forested or desert areas where illiteracy, trying physical environments, malnutrition, inadequate access to potable water, and lack of personal hygiene and sanitation make them more vulnerable to disease.The aim of Chhatralaya initiatives taken by Arsha Vidya, Jaipur was to address the exclusion of the socially and economically disadvantaged children of the tribes and to provide a fair opportunity to all.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
50
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Rajasthan
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Jaipur, Rajasthan, India, 302019
- Arsha Vidya Chhatralaya,
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
8 years to 16 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Children selected from Udaipur tribal areas, Rajasthan, India
Description
Inclusion Criteria:
- Children selected from Udaipur tribal areas as lacking parental care and basic services;
- Children living in Udaipur tribal areas;
- Children from 8 years to 16 years of age
Exclusion Criteria:
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Arsha Vidya Chhatralaya
Chhatralaya is residential setting for children 8 to 16 years old.
It provides residence,food and education opportunities along with regular practice of Yoga, Spiritual sessions and vedic practices to learn and follow.
|
Chhatralaya, home for children provide living resources along with spiritual practices.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Physical health and wellbeing
Time Frame: Change from baseline to one year
|
Measured by MacArthur Health and Behavior Questionnaire
|
Change from baseline to one year
|
Mental Health and wellbeing
Time Frame: Change from baseline to one year
|
Measured by MacArthur Health and Behavior Questionnaire
|
Change from baseline to one year
|
Social functioning
Time Frame: Change from baseline to one year
|
Measured by MacArthur Health and Behavior Questionnaire
|
Change from baseline to one year
|
Academic functioning
Time Frame: Change from baseline to one year
|
Measured by MacArthur Health and Behavior Questionnaire
|
Change from baseline to one year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Weight
Time Frame: Change from baseline to one year
|
child's weight was measured by using a calibrated electronic weighing scale
|
Change from baseline to one year
|
Prevalence of acute child malnutrition
Time Frame: Change from baseline to one year
|
To calculate WHZ scores the 2006 WHO growth reference was used
|
Change from baseline to one year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Brahmaparananda Saraswati, Arsha Vidya Tirtha
- Study Director: Neha Sharma, PhD, Warwick Research Servives, UK
- Principal Investigator: Puneet Sharma, NMP Medical Research Institute
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 3, 2017
Primary Completion (Actual)
May 15, 2018
Study Completion (Actual)
June 8, 2018
Study Registration Dates
First Submitted
June 24, 2018
First Submitted That Met QC Criteria
June 24, 2018
First Posted (Actual)
July 6, 2018
Study Record Updates
Last Update Posted (Actual)
July 6, 2018
Last Update Submitted That Met QC Criteria
June 24, 2018
Last Verified
June 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NMP/10128
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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