NCT03960944

Brief Summary

Poverty is a common experience for many children and families in developing countries. Living in a poor or low-income household has been linked to poor health and increased risk for mental health problems than the general population. Previous studies link psychological well-being with yoga in adolescents and children. This study investigated the effects of a structured yoga program on psychological well-being in low-income school children.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 21, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 21, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 12, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 21, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 23, 2019

Completed
Last Updated

May 23, 2019

Status Verified

May 1, 2019

Enrollment Period

7 months

First QC Date

May 21, 2019

Last Update Submit

May 21, 2019

Conditions

Psychological DisturbanceAnxiety Disorder of Childhood

Outcome Measures

Primary Outcomes (1)

  • Anxiety

    Anxiety score was measured through State and Trait Anxiety Inventory

    Change from baseline to 8 weeks

Secondary Outcomes (2)

  • Depression

    Changes from baseline to 8 weeks

  • Self Esteem

    Changes from baseline to 8 weeks

Study Arms (2)

Yoga in School Group

EXPERIMENTAL

30-mins yoga sessions were conducted in schools for 8-weeks

Other: Yoga

Control Group

NO INTERVENTION

Usual Activities in school

Interventions

YogaOTHER

30 Min Yoga session included of Physical posture, Breathing exercise, Yoga games and Relaxation.

Yoga in School Group

Eligibility Criteria

Age8 Years - 13 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Low income Group
  • Parental consent to participate in study

You may not qualify if:

  • Disabilities
  • Substance abuse
  • Living outside the school areas

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

NMP Medical Research Institute

Mumbai, Maharashtra, India

Location

United Research International

Jaipur, Rajasthan, India

Location

Arsha Vidya Study Centre

Chennai, Tamil Nadu, India

Location

MeSH Terms

Interventions

Yoga

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesExercise Movement TechniquesPhysical Therapy Modalities

Study Officials

  • Buddhatmananda Saraswati

    Arsha Vidya Study Centre, India

    STUDY CHAIR

  • Divya Gaur

    United Research International, India

    STUDY DIRECTOR

  • Rajubhai P Odedra

    NMP Medical Research Institute, India

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 21, 2019

First Posted

May 23, 2019

Study Start

May 21, 2018

Primary Completion

December 21, 2018

Study Completion

March 12, 2019

Last Updated

May 23, 2019

Record last verified: 2019-05

Locations

IN(3)