NCT01188044

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2010

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 23, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 25, 2010

Completed
7 days until next milestone

Study Start

First participant enrolled

September 1, 2010

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

January 6, 2011

Status Verified

January 1, 2011

Enrollment Period

3 months

First QC Date

August 23, 2010

Last Update Submit

January 5, 2011

Conditions

Motor Activity

Keywords

Motor activityInfantValidation studiesMalawiSub-Saharan Africa

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

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

    First one-hour observation

  • Sensitivity and specificity of the determined cut-off point values

    Second one-hour observation

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

    7-day accelerometer measurement

Study Arms (1)

Study group

Healthy children

Eligibility Criteria

Age16 Months - 18 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Healthy children

You may qualify if:

  • signed informed consent from at least one guardian
  • age 16.00 months to 17.99 months
  • availability during the period of the study

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Malawi, College of Medicine

Mangochi, Malawi

Location

Related Links

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Per Ashorn, MD, PhD

    University of Tampere Medical School

    PRINCIPAL INVESTIGATOR

  • Kenneth Maleta, MBBS, PhD

    Kamuzu University of Health Sciences

    PRINCIPAL INVESTIGATOR

  • Ashorn Ulla, PhD

    University of Tampere Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 23, 2010

First Posted

August 25, 2010

Study Start

September 1, 2010

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

January 6, 2011

Record last verified: 2011-01

Locations

MA(1)