Validating Accelerometers to Study Physical Activity of Toddlers

NCT ID: NCT01188044

Last Updated: 2011-01-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

56 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-09-30

Study Completion Date

2010-12-31

Brief Summary

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One way to assess impacts of nutrition supplements to health is to measure physical activity. Physical activity can be measured with small devices called "accelerometers". Before they can be used, the devices need to be validated in the population in question. Objectives of this study are to test accelerometers in field conditions and validate their use in 16-18 months old Malawian toddlers. This study does not have a pre-set hypothesis.

Detailed Description

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Accelerometers have not been validated in children under 2 years of age. In this study 50 toddlers from Lungwena will be recruited. The participants will wear an ActiGraph GT3X+ -accelerometer fitted on their waist with an elastic belt for 7 days. During the measuring, they will have two videotaped one-hour activity observations while wearing and additional accelerometer device fitted on their ankle. The output from the two devices will be compared to observed activity classified with CPAF-method.

Conditions

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Motor Activity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Study group

Healthy children

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* signed informed consent from at least one guardian
* age 16.00 months to 17.99 months
* availability during the period of the study

Exclusion Criteria

* any guardian reported or observed illness that limits child's physical activity
* a condition reported by the guardian that limits child's activity co-operate in the study
* wasting (weight-for-height \< 2 SD)
* concurrent participation in any clinical trial with an intervention
Minimum Eligible Age

16 Months

Maximum Eligible Age

18 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Kamuzu University of Health Sciences

OTHER

Sponsor Role collaborator

Singapore Clinical Research Institute

OTHER

Sponsor Role collaborator

University of Glasgow

OTHER

Sponsor Role collaborator

Tampere University

OTHER

Sponsor Role lead

Responsible Party

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University of Tampere

Principal Investigators

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Per Ashorn, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Tampere Medical School

Kenneth Maleta, MBBS, PhD

Role: PRINCIPAL_INVESTIGATOR

Kamuzu University of Health Sciences

Ashorn Ulla, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Tampere Medical School

Locations

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University of Malawi, College of Medicine

Mangochi, , Malawi

Site Status

Countries

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Malawi

Related Links

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http://www.medcol.mw/

College of Medicine homepage

Other Identifiers

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AG Validation Lungwena

Identifier Type: -

Identifier Source: org_study_id

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