Clinical trial NCT01188044: Validating Accelerometers to Study Physical Activity of Toddlers
Official title: Validating the Use of Accelerometers for the Study of Physical Activity Among Young Malawian Toddlers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Motor Activity
Keywords: Motor activity
Infant
Validation studies
Malawi
Sub-Saharan Africa
Lead sponsor: Tampere University
Sponsor class: OTHER
Collaborators: name: Kamuzu University of Health Sciences
name: Singapore Clinical Research Institute
name: University of Glasgow
First posted: 2010-08-25
Enrollment: 56
Sex: ALL
Minimum age (years): 16
Maximum age (years): 18
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy children

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.

Eligibility 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

Primary outcomes:
measure: Feasibility/acceptability
timeFrame: 7-day accelerometer measurement
Secondary outcomes:
measure: Cut-off point values for sedentary, light, moderate, and vigorous activity
timeFrame: First one-hour observation
measure: Sensitivity and specificity of the determined cut-off point values
timeFrame: Second one-hour observation
measure: Intra- and inter-subject variation in time spent in different activity classes
timeFrame: 7-day accelerometer measurement
Other outcomes:
Locations:
city: Mangochi
country: Malawi
facility: University of Malawi, College of Medicine
Study officials:
affiliation: University of Tampere Medical School
name: Per Ashorn, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kamuzu University of Health Sciences
name: Kenneth Maleta, MBBS, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Tampere Medical School
name: Ashorn Ulla, PhD
role: PRINCIPAL_INVESTIGATOR
References: