Motor ActivityNCT01188044
Validating Accelerometers to Study Physical Activity of Toddlers
An observational study of Motor Activity, run by Tampere University at 1 site in Malawi.
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. Read more about this study
- Who is it for?
- Ages 16 to 18 monthsHealthy volunteers can take part
- Conditions the study is for
- Motor Activity
- How many people
- 56 participants
- Where
- 1 siteMalawi
- Study dates
- Sep 2010to Dec 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 18 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Healthy children
Who may be able to join
- signed informed consent from at least one guardian
- age 16.00 months to 17.99 months
- availability during the period of the study
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Motor Activity
- Keywords
- Motor activity, Infant, Validation studies, Malawi, Sub-Saharan Africa
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Healthy children |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility/acceptability
Proportion of participants (%) of wearing the accelerometer device for 4 days, 6 hours per day (defined from the accelerometer output data).
Measured: 7-day accelerometer measurement
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 7-day accelerometer measurement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2010 (estimated)
- Study startSep 2010
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Motor ActivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tampere University
- Sponsor type
- University, hospital or other
- Collaborators
- Kamuzu University of Health Sciences, Singapore Clinical Research Institute, University of Glasgow
- Investigators
- Per Ashorn, MD, PhD, Principal investigator, University of Tampere Medical SchoolKenneth Maleta, MBBS, PhD, Principal investigator, Kamuzu University of Health SciencesAshorn Ulla, PhD, Principal investigator, University of Tampere Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01188044
- Sponsor's protocol ID
- AG Validation Lungwena
- Status last verified
- Jan 2011
- First submitted
- 23 Aug 2010
- Last updated
- 6 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validating the Use of Accelerometers for the Study of Physical Activity Among Young Malawian Toddlers
- ClinicalTrials.gov ID
- NCT01188044
- Acronym / sponsor ID
- AG Validation Lungwena
- Conditions
- Motor Activity
- Keywords
- Motor activity, Infant, Validation studies, Malawi, Sub-Saharan Africa
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Tampere UniversityUniversity, hospital or other
- Collaborators
- Kamuzu University of Health Sciences, Singapore Clinical Research Institute, University of Glasgow
- Study start
- Sep 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 25 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | – | –Healthy children |
Who may qualify
- Ages
- 16 to 18 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Healthy children
Key inclusion criteria (3 listed)
- signed informed consent from at least one guardian
- age 16.00 months to 17.99 months
- availability during the period of the study
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
3 secondary outcomes
Cut-off point values for sedentary, light, moderate, and vigorous activity
Time frame: First one-hour observation
Sensitivity and specificity of the determined cut-off point values
Time frame: Second one-hour observation
Intra- and inter-subject variation in time spent in different activity classes
Time frame: 7-day accelerometer measurement
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2011.
- College of Medicine homepageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Per Ashorn, MD, PhD principal investigator
University of Tampere Medical School
Kenneth Maleta, MBBS, PhD principal investigator
Kamuzu University of Health Sciences
Ashorn Ulla, PhD principal investigator
University of Tampere Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Motor Activity, run by Tampere University at 1 site in Malawi.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malawi. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility/acceptability (time frame: 7-day accelerometer measurement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2011.