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Completed

NCT Number: NCT01188044

Validating Accelerometers to Study Physical Activity of 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.

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Key information

Conditions

Motor Activity Behavior

Age range

16 month–18 month

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Malawi, College of Medicine

Mangochi, Malawi

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Feasibility/acceptability

    Time frame: 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 outcomes

  1. Cut-off point values for sedentary, light, moderate, and vigorous activity

    Time frame: 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.

  2. Sensitivity and specificity of the determined cut-off point values

    Time frame: 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.

  3. Intra- and inter-subject variation in time spent in different activity classes

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Tampere University

Other

Collaborators

  • Kamuzu University of Health Sciences
  • Singapore Clinical Research Institute
  • University of Glasgow

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Aug 25, 2010
Registry last updated
Jan 6, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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