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Validating Accelerometers to Study Physical Activity of Toddlers

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01188044
Enrollment
56
Registered
2010-08-25
Start date
2010-09-30
Completion date
2010-12-31
Last updated
2011-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Motor Activity

Keywords

Motor activity, Infant, Validation studies, Malawi, Sub-Saharan Africa

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.

Interventions

None listed

Sponsors

Kamuzu University of Health Sciences
CollaboratorOTHER
Singapore Clinical Research Institute
CollaboratorOTHER
University of Glasgow
CollaboratorOTHER
Tampere University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
16 Months to 18 Months
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Feasibility/acceptability7-day accelerometer measurementProportion of participants (%) of wearing the accelerometer device for 4 days, 6 hours per day (defined from the accelerometer output data).

Secondary

MeasureTime frameDescription
Cut-off point values for sedentary, light, moderate, and vigorous activityFirst one-hour observationVideotaped 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 valuesSecond one-hour observationActivity 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 classes7-day accelerometer measurementIntra-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.

Countries

Malawi

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026