Physical DisorderNCT03578159
Study of Arsha Vidya Chhatralaya Initiative on Health and Functioning of Disadvantaged Tribal Children
An observational study of Physical Disorder and Mental Health Wellness, run by NMP Medical Research Institute at 1 site in India.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 8 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Disorder, Mental Health Wellness, Social Function Disorder, Childhood or Adolescent
- What is being tested?
- Chhatralaya
- How many people
- 50 participants
- Where
- 1 siteIndia
- Study dates
- 3 Mar 2017to 8 Jun 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children selected from Udaipur tribal areas, Rajasthan, India
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Physical Disorder, Mental Health Wellness, Social Function Disorder, Childhood or Adolescent, Malnutrition
- Being tested
- Chhatralaya
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChhatralayaOther
Chhatralaya, home for children provide living resources along with spiritual practices.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Chhatralaya |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical health and wellbeing
Measured by MacArthur Health and Behavior Questionnaire
Measured: Change from baseline to one year
Mental Health and wellbeing
Measured by MacArthur Health and Behavior Questionnaire
Measured: Change from baseline to one year
Social functioning
Measured by MacArthur Health and Behavior Questionnaire
Measured: Change from baseline to one year
Academic functioning
Measured by MacArthur Health and Behavior Questionnaire
Measured: Change from baseline to one year
Secondary outcomes (2)
Weight
child's weight was measured by using a calibrated electronic weighing scale
Measured: Change from baseline to one year
Prevalence of acute child malnutrition
To calculate WHZ scores the 2006 WHO growth reference was used
Measured: Change from baseline to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2018
- Study start3 Mar 2017
- Primary completion15 May 2018
- Study completion8 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- NMP Medical Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Warwick Research Services, Arsha Vidya Tirtha
- Responsible party
- Sponsor
- Investigators
- Brahmaparananda Saraswati, Study chair, Arsha Vidya TirthaNeha Sharma, PhD, Study director, Warwick Research Servives, UKPuneet Sharma, Principal investigator, NMP Medical Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03578159
- Sponsor's protocol ID
- NMP/10128
- Status last verified
- Jun 2018
- First submitted
- 24 Jun 2018
- Last updated
- 6 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Arsha Vidya Chhatralaya Initiative on Health and Functioning of Disadvantaged Tribal Children
- ClinicalTrials.gov ID
- NCT03578159
- Acronym / sponsor ID
- NMP/10128
- Conditions
- Physical Disorder, Mental Health Wellness, Social Function Disorder, Childhood or Adolescent, Malnutrition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- NMP Medical Research InstituteUniversity, hospital or other
- Collaborators
- Warwick Research Services, Arsha Vidya Tirtha
- Study start
- 3 Mar 2017 (actual)
- Primary completion
- 15 May 2018 (actual)
- Study completion
- 8 Jun 2018 (actual)
- First posted
- 6 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arsha Vidya Chhatralaya | – | Other: ChhatralayaChhatralaya 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. |
Who may qualify
- Ages
- 8 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children selected from Udaipur tribal areas, Rajasthan, India
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ChhatralayaChhatralaya, home for children provide living resources along with spiritual practices. | Other | Arsha Vidya Chhatralaya |
Primary outcome
Physical health and wellbeing
Time frame: Change from baseline to one year
Measured by MacArthur Health and Behavior Questionnaire
Mental Health and wellbeing
Time frame: Change from baseline to one year
Measured by MacArthur Health and Behavior Questionnaire
Social functioning
Time frame: Change from baseline to one year
Measured by MacArthur Health and Behavior Questionnaire
Academic functioning
Time frame: Change from baseline to one year
Measured by MacArthur Health and Behavior Questionnaire
2 secondary outcomes
Weight
Time frame: Change from baseline to one year
Prevalence of acute child malnutrition
Time frame: Change from baseline to one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brahmaparananda Saraswati study chair
Arsha Vidya Tirtha
Neha Sharma, PhD study director
Warwick Research Servives, UK
Puneet Sharma principal investigator
NMP Medical Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Physical Disorder and Mental Health Wellness, run by NMP Medical Research Institute at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical health and wellbeing (time frame: Change from baseline to one year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2018.