- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04628897
Physical Activity and the Home Environment in Preschool-aged Children in Urban Bangladesh
Risk Factors for Low Physical Activity Levels in Preschool-aged Children in a Densely Populated Urban Community in Bangladesh
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Rationale
As the double burden of nutrition emerges in Bangladesh and other low- to middle-income countries, it is imperative to develop strategies to mitigate the adverse effects associated with both undernutrition and obesity. Identifying levels of physical activity among children is a requisite step to developing and targeting interventions to promote physical activity among young populations. Furthermore, exploring the risk factors associated with physical activity levels in young children can help better inform policy makers surrounding a public health intervention.
Goals The overall goal of the research is to generate new knowledge regarding the nutritional and environmental determinants of physical activity in young children living in a densely populated urban community in Bangladesh.
Primary Objectives
The specific objectives of this study are to:
- Describe physical activity levels in a sample of preschool-aged children in an inner-city community in Dhaka, Bangladesh,
- Estimate the associations between characteristics of the physical environment of the home (total area of available floor space inside of the home, number and presence of physical hazards, and the number of gross motor activity-oriented items present) and the physical activity levels of preschoolers in Dhaka, and
- Estimate the associations between hemoglobin concentration (Hb) and preschooler physical activity level.
- Describe sleep quantity and quality in the sample of preschool-aged children in urban Bangladesh
The investigators conducted a cross-sectional observational study of preschool-aged children between 34-38 months of age (n=60) selected from the ongoing Maternal Vitamin D for Infant Growth (MDIG) trial cohort (NCT01924013) in Dhaka, Bangladesh. The investigators planned to enrol a minimum of 60 participants with complete data sets, with recruitment up to 90 participants until this enrolment target was reached.
Study Procedures
- Accelerometry
- Home built environment audit
- Anthropometry
- hemoglobin concentration
- Maternal perception of the home environment and household food security
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5G 1X8
- The Hospital for Sick Children
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Child is 34-38 months of age;
- Child and primary caregiver reside in Dhaka or urban environs;
- Parent/guardian provides written informed consent for study procedures.
Exclusion Criteria:
- Child requires mobility assistance and/or has been diagnosed with a major neurological or orthopedic condition or disorder affecting physical activity (e.g., cerebral palsy, club foot, etc.).
- Major physician-diagnosed chronic respiratory or cardiac disease that limits physical activity (e.g., severe asthma, currently taking medication for symptomatic congenital heart disease, etc.).
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Moderate-to-Vigorous Physical Activity
Time Frame: 3-14 days
|
Objectively measured accelerometry data, a continuous variable reflecting mean daily PA during the study period, expressed as mean counts per 15 seconds (cp15s).
This summary measure was generated by first calculating mean daily PA, then averaging the daily means across collection days, including data between the time the child woke up until the time the child went to sleep, as reported by the caregiver on all days that met criteria for inclusion (i.e., at least 10 hours of wear time)
|
3-14 days
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1000057061
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Anemia
-
Hospital Universitario Dr. Jose E. GonzalezCompletedPernicious Anemia | Megaloblastic Anemia NosMexico
-
Assistance Publique - Hôpitaux de ParisNot yet recruitingSevere Aplastic Anemia | Idiopathic Aplastic Anemia | Moderate Aplastic Anemia Requiring Transfusions
-
SanofiActive, not recruitingWarm Autoimmune Hemolytic Anemia (wAIHA)United States, Austria, China, Denmark, Germany, Italy, Spain, United Kingdom, Hungary
-
SanofiTerminatedWarm Autoimmune Hemolytic Anemia (wAIHA)Netherlands, Germany, Italy, United Kingdom, United States, France
-
China Immunotech (Beijing) Biotechnology Co., Ltd.Not yet recruitingAutoimmune Hemolytic AnemiaChina
-
Peking Union Medical College HospitalNot yet recruiting
-
Institute of Hematology & Blood Diseases Hospital...Not yet recruitingSevere Aplastic Anemia | Refractory Aplastic Anemia | Newly Diagnosed Aplastic Anemia
-
Chinese PLA General HospitalBeijing Friendship Hospital; Beijing 302 Hospital; The University of Hong Kong-Shenzhen... and other collaboratorsEnrolling by invitationSevere Aplastic Anemia | Severe Aplastic Anemia (SAA) | Severe Aplastic Anemia, RefractoryChina
-
Incyte CorporationTerminatedWarm Autoimmune Hemolytic Anemia (wAIHA)Spain, United States, Austria, Canada, France, Germany, Israel, Italy, Japan, Netherlands, Poland, United Kingdom, Belgium
-
Chen MiaoNot yet recruiting
Clinical Trials on Exposures
-
Centre des Sciences du Goût et de l'AlimentationEuropean Community; Regional Council of BurgundyCompletedConditioning of Caloric Adjustment and Liking in ChildrenFrance
-
Peking University Third HospitalEnrolling by invitationFemoroacetabular ImpingementChina
-
Boston UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsRecruitingCOVID-19 | Influenza | SARS-COV-2 Infection | Infant Morbidity | Perinatal Morbidity | Other Respiratory VirusesUnited States, India
-
Johns Hopkins UniversityCompletedPancreatic Cancer | Neoplastic Cells, Circulating | Biological MarkersUnited States
-
Hospices Civils de LyonCompletedInterstitial Lung Disease | Occupational ExposureFrance
-
National Institute of Allergy and Infectious Diseases...RecruitingInflammatory | AllergicUnited States
-
Inova MedicalMerck Sharp & Dohme LLCRecruitingPost-Acute COVID-19 SyndromeBrazil
-
Bispebjerg HospitalRecruitingMalnutrition | Geriatric | Length of StayDenmark
-
University Hospital, Strasbourg, FranceRecruitingSleep Disorders | Neurological Pathologies | Psychiatric Pathologies | Ophthalmological PathologiesFrance