NCT03578159

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 3, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2018

Completed
24 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 8, 2018

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

June 24, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 6, 2018

Completed
Last Updated

July 6, 2018

Status Verified

June 1, 2018

Enrollment Period

1.2 years

First QC Date

June 24, 2018

Last Update Submit

June 24, 2018

Conditions

Outcome Measures

Primary Outcomes (4)

  • Physical health and wellbeing

    Measured by MacArthur Health and Behavior Questionnaire

    Change from baseline to one year

  • Mental Health and wellbeing

    Measured by MacArthur Health and Behavior Questionnaire

    Change from baseline to one year

  • Social functioning

    Measured by MacArthur Health and Behavior Questionnaire

    Change from baseline to one year

  • Academic functioning

    Measured by MacArthur Health and Behavior Questionnaire

    Change from baseline to one year

Secondary Outcomes (2)

  • Weight

    Change from baseline to one year

  • Prevalence of acute child malnutrition

    Change from baseline to one year

Study Arms (1)

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.

Other: Chhatralaya

Interventions

Chhatralaya, home for children provide living resources along with spiritual practices.

Arsha Vidya Chhatralaya

Eligibility Criteria

Age8 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children selected from Udaipur tribal areas, Rajasthan, India

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arsha Vidya Chhatralaya,

Jaipur, Rajasthan, 302019, India

Location

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Brahmaparananda Saraswati

    Arsha Vidya Tirtha

    STUDY CHAIR
  • Neha Sharma, PhD

    Warwick Research Servives, UK

    STUDY DIRECTOR
  • Puneet Sharma

    NMP Medical Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 24, 2018

First Posted

July 6, 2018

Study Start

March 3, 2017

Primary Completion

May 15, 2018

Study Completion

June 8, 2018

Last Updated

July 6, 2018

Record last verified: 2018-06

Locations