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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01188044
Other study ID # AG Validation Lungwena
Secondary ID
Status Completed
Phase N/A
First received August 23, 2010
Last updated January 5, 2011
Start date September 2010
Est. completion date December 2010

Study information

Verified date January 2011
Source University of Tampere
Contact n/a
Is FDA regulated No
Health authority Malawi: College of Medicine Research and Ethics Committee
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 56
Est. completion date December 2010
Est. primary completion date December 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 16 Months to 18 Months
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Malawi University of Malawi, College of Medicine Mangochi

Sponsors (4)

Lead Sponsor Collaborator
University of Tampere Singapore Clinical Research Institute, University of Glasgow, University of Malawi College of Medicine

Country where clinical trial is conducted

Malawi, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary 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 No
Secondary 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 No
Secondary 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 No
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