Validating Accelerometers to Study Physical Activity of Toddlers

Motor Activity Clinical Trial

Official title:

Validating the Use of Accelerometers for the Study of Physical Activity Among Young Malawian Toddlers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01188044
• Other study ID #: AG Validation Lungwena
• Status: Completed
• Phase: N/A
• First received: August 23, 2010
• Last updated: January 5, 2011
• Start date: September 2010
• Est. completion date: December 2010

Study information

• Verified date: January 2011
• Source: University of Tampere
• Contact: n/a
• Is FDA regulated: No
• Health authority: Malawi: College of Medicine Research and Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 16 Months to 18 Months

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Motor Activity

Locations

Country	Name	City	State
Malawi	University of Malawi, College of Medicine	Mangochi

Sponsors (4)

Lead Sponsor	Collaborator
University of Tampere	Singapore Clinical Research Institute, University of Glasgow, University of Malawi College of Medicine

Country where clinical trial is conducted

Malawi, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility/acceptability	Proportion of participants (%) of wearing the accelerometer device for 4 days, 6 hours per day (defined from the accelerometer output data).	7-day accelerometer measurement	No
Secondary	Cut-off point values for sedentary, light, moderate, and vigorous activity	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.	First one-hour observation	No
Secondary	Sensitivity and specificity of the determined cut-off point values	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.	Second one-hour observation	No
Secondary	Intra- and inter-subject variation in time spent in different activity classes	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.	7-day accelerometer measurement	No

External Links

•   College of Medicine homepage
•   Home page for University of Tampere Medical School, Department of International Health