A pilot study to assess physical activity and heart ratevariability in Indian Children using the LifeInsightâ?¢BioTelemetry Platform

GlaxoSmithKline Consumer Healthcare GSKCH0 sites12 target enrollmentTBD

Overview

No summary available.

Registry

who.int

Start Date

TBD

End Date

September 26, 2016

Last Updated

4 years ago

Study Type

Interventional

Sponsor

GlaxoSmithKline Consumer Healthcare GSKCH

•1 Demonstrates understanding of the study and willingness to participate.
•2\. Good general and mental health and no clinically significant and relevant abnormalities in medical history or upon physical examination.
•3\. Absence of any condition that would impact on the participantâ??s safety or wellbeing
•4\.Participant and participantâ??s parents/LAR understand and are willing, able and likely to comply with all study procedures and restrictions.
•5\. Able to read and comprehend one of the languages used for study visits and assessments.

•1\.A child cared for by foster parents or living in a care home or institution.
•2\.Concurrent Medication/ Medical History Use of concomitant medication that, in the opinion of the Principal Investigator, might interfere with the outcome of the study.
•3\.Allergy/ Intolerance Known or suspected intolerance or hypersensitivity to the study materials.
•4\.Participation in another clinical study within 30 days of the screening visit.
•5\.Previous participation in this study.
•6\.Recent history (within the last one year) of alcohol or other substance abuse.
•7\.An employee of the sponsor or the study site or members of their immediate family/ OR Sibling of child already part of this study.
•8\.Current or relevant history of any serious, severe or unstable physical or psychiatric illness or any medical disorder that would make the participant unlikely to fully complete the study.