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Trial record 49 of 110 for:    test | ( Map: Malawi )

Validating Accelerometers to Study Physical Activity of Toddlers

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ClinicalTrials.gov Identifier: NCT01188044
Recruitment Status : Completed
First Posted : August 25, 2010
Last Update Posted : January 6, 2011
Sponsor:
Collaborators:
University of Malawi College of Medicine
Singapore Clinical Research Institute
University of Glasgow
Information provided by:
Tampere University

Brief Summary:
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.

Condition or disease
Motor Activity

Detailed Description:
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.

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Study Type : Observational
Actual Enrollment : 56 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Validating the Use of Accelerometers for the Study of Physical Activity Among Young Malawian Toddlers
Study Start Date : September 2010
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Group/Cohort
Study group
Healthy children



Primary Outcome Measures :
  1. Feasibility/acceptability [ Time Frame: 7-day accelerometer measurement ]
    Proportion of participants (%) of wearing the accelerometer device for 4 days, 6 hours per day (defined from the accelerometer output data).


Secondary Outcome Measures :
  1. Cut-off point values for sedentary, light, moderate, and vigorous activity [ Time Frame: First one-hour observation ]
    Videotaped observation of physical activity is classified by CPAF-method. Vector magnitude of the ActiGraph device attached to hip is compared to this gold standard and cut-off point values are determined by ROC curve analysis. Values are presented in counts/15 seconds. Sensitivity and specificity of the determined cut-point values in predicting the right activity class are also calculated.

  2. Sensitivity and specificity of the determined cut-off point values [ Time Frame: Second one-hour observation ]
    Activity count cut-off points derived from the first one-hour observation are cross-validated by determining their sensitivity and specificity in predicting the right activity class during the second one-hour observation.

  3. Intra- and inter-subject variation in time spent in different activity classes [ Time Frame: 7-day accelerometer measurement ]
    Intra-subject variation in time (%) spent in different activity classes between different days and inter-subject variation in time spent in different activity classes are determined.



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Ages Eligible for Study:   16 Months to 18 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy children
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01188044


Locations
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Malawi
University of Malawi, College of Medicine
Mangochi, Malawi
Sponsors and Collaborators
Tampere University
University of Malawi College of Medicine
Singapore Clinical Research Institute
University of Glasgow
Investigators
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Principal Investigator: Per Ashorn, MD, PhD University of Tampere Medical School
Principal Investigator: Kenneth Maleta, MBBS, PhD University of Malawi College of Medicine
Principal Investigator: Ashorn Ulla, PhD University of Tampere Medical School

Additional Information:
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Responsible Party: Per Ashorn / Professor of International Health, University of Tampere
ClinicalTrials.gov Identifier: NCT01188044     History of Changes
Other Study ID Numbers: AG Validation Lungwena
First Posted: August 25, 2010    Key Record Dates
Last Update Posted: January 6, 2011
Last Verified: January 2011

Keywords provided by Tampere University:
Motor activity
Infant
Validation studies
Malawi
Sub-Saharan Africa