Validating Accelerometers to Study Physical Activity of Toddlers

Completed

• Conditions: Motor Activity

• Registration Number: NCT01188044
• Lead Sponsor: 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.

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.

Study Timeline

• Study First Submitted: 2010-08-23
• Study First Submitted QC: 2010-08-24
• Study First Posted: 2010-08-25
• Study Start: 2010-09
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2011-01
• Last Update Submitted: 2011-01-05
• Last Update Posted: 2011-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Feasibility/acceptability	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

Name	Time	Method
Cut-off point values for sedentary, light, moderate, and vigorous activity	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.
Sensitivity and specificity of the determined cut-off point values	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.
Intra- and inter-subject variation in time spent in different activity classes	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.

Trial Locations

Locations (1)

University of Malawi, College of Medicine; 🇲🇼 Mangochi, Malawi