Validating Accelerometers to Study Physical Activity of Toddlers

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

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.

Study Overview

• Status: Completed
• Conditions: 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.

• Study Type: Observational
• Enrollment (Actual): 56

Contacts and Locations

Study Locations

• Malawi
  • Mangochi, Malawi
    • University of Malawi, College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 1 year (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Healthy children

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Study group; Healthy children

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Tampere University
• Collaborators: Kamuzu University of Health Sciences; University of Glasgow; Singapore Clinical Research Institute
• Investigators: Principal Investigator: Kenneth Maleta, MBBS, PhD, Kamuzu University of Health Sciences; Principal Investigator: Per Ashorn, MD, PhD, University of Tampere Medical School; Principal Investigator: Ashorn Ulla, PhD, University of Tampere Medical School

Publications and helpful links

Helpful Links

• College of Medicine homepage

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): December 1, 2010

Study Registration Dates

• First Submitted: August 23, 2010
• First Submitted That Met QC Criteria: August 24, 2010
• First Posted (Estimate): August 25, 2010

Study Record Updates

• Last Update Posted (Estimate): January 6, 2011
• Last Update Submitted That Met QC Criteria: January 5, 2011
• Last Verified: January 1, 2011

More Information

Terms related to this study

• Keywords: Infant; Sub-Saharan Africa; Motor activity; Malawi; Validation studies
• Other Study ID Numbers: AG Validation Lungwena