Obesity, ChildhoodNCT04628897
Physical Activity and the Home Environment in Preschool-aged Children in Urban Bangladesh
An observational study of Obesity, Childhood and Malnutrition, run by The Hospital for Sick Children at 1 site in Canada.
Trial summary
The overall goal of this study 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. Read more about this study
- Who is it for?
- Ages 34 to 38 monthsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Childhood, Malnutrition, Anemia
- What is being tested?
- Exposures
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 65 participants
- Where
- 1 siteCanada
- Study dates
- 17 Sep 2017to 9 Dec 2017
- 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 34 to 38 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Participants within the Maternal Vitamin D for Infant Growth (MDIG) trial (NCT01924013) cohort registry who have a) expressed interest in participating in future sub-studies, and b) have children within the target age range, will be contacted. Participants will be contacted prior to their anticipated study visit. A contact list will be updated each week to prospectively recruit participants in advance or during the age window in which children are eligible for enrolment. Each list will begin with the eldest children to reduce the number of missed opportunities to enroll children before they exit the eligible age window. The catchment area will include the following neighbourhoods in urban Dhaka: Kamrangir char, Azimpur, Lalbag, and Hazariba
Who may be able to join
- 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.
Who cannot join
- 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.).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Risk Factors for Low Physical Activity Levels in Preschool-aged Children in a Densely Populated Urban Community in Bangladesh
The overall goal of this study 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. The investigators hypothesize that low levels of preschooler physical activity are associated with a lack of play-oriented physical attributes (i.e., total area of indoor floor space, presence and count of unsafe physical hazards, and presence and count of stationary and portable gross motor activity-oriented items) within the homes in urban Bangladesh. The investigators also hypothesized that low Hb may be associated with low physical activity levels in this population.
Read the 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
- Conditions
- Obesity, Childhood, Malnutrition, Anemia
- Being tested
- Exposures
- Keywords
- Obesity, Home Environment, Malnutrition
- Medical subject headings
- Pediatric Obesity, Malnutrition, Anemia, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExposuresBehavioural
- Total area of available floor space inside the home (m2)
- Frequency that child plays outdoors
- Total number of physical hazards in the home (presence of open stairwells, stove height)
- Total number of fine-motor activity items available to the child
- Presence of gross-motor activity items available to the child across each category (e.g., fixed, portable: ball equipment, push/pull equipment, riding equipment, rocking and twisting equipment)
- Hemoglobin concentration (g/L).
What is being measured
The primary outcome is the main question the study is designed to answer.
Moderate-to-Vigorous Physical Activity
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)
Measured: 3-14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2020
- Study start17 Sep 2017
- Primary completion9 Dec 2017
- Study completion9 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, ChildhoodStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe sponsor's other registered studies.
- 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
- Cross-sectional
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Collaborators
- International Centre for Diarrhoeal Disease Research, Bangladesh, University of Toronto
- Responsible party
- Principal investigator, Daniel Roth, The Hospital for Sick Children
- Investigators
- Daniel Roth, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04628897
- Sponsor's protocol ID
- 1000057061
- Status last verified
- Nov 2020
- First submitted
- 9 Nov 2020
- Last updated
- 17 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Details of the data sharing plan are still to be determined.
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors for Low Physical Activity Levels in Preschool-aged Children in a Densely Populated Urban Community in Bangladesh
- ClinicalTrials.gov ID
- NCT04628897
- Acronym / sponsor ID
- 1000057061
- Conditions
- Obesity, Childhood, Malnutrition, Anemia
- Keywords
- Obesity, Home Environment, Malnutrition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Collaborators
- International Centre for Diarrhoeal Disease Research, Bangladesh, University of Toronto
- Study start
- 17 Sep 2017 (actual)
- Primary completion
- 9 Dec 2017 (actual)
- Study completion
- 9 Dec 2017 (actual)
- First posted
- 16 Nov 2020 (actual)
- 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.
The overall goal of this study 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. The investigators hypothesize that low levels of preschooler physical activity are associated with a lack of play-oriented physical attributes (i.e., total area of indoor floor space, presence and count of unsafe physical hazards, and presence and count of stationary and portable gross motor activity-oriented items) within the homes in urban Bangladesh. The investigators also hypothesized that low Hb may be associated with low physical activity levels in this population.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 34 to 38 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Participants within the Maternal Vitamin D for Infant Growth (MDIG) trial (NCT01924013) cohort registry who have a) expressed interest in participating in future sub-studies, and b) have children within the target age range, will be contacted. Participants will be contacted prior to their anticipated study visit. A contact list will be updated each week to prospectively recruit participants in advance or during the age window in which children are eligible for enrolment. Each list will begin with the eldest children to reduce the number of missed opportunities to enroll children before they exit the eligible age window. The catchment area will include the following neighbourhoods in urban Dhaka: Kamrangir char, Azimpur, Lalbag, and Hazariba
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exposures1. Total area of available floor space inside the home (m2) 2. Frequency that child plays outdoors 3. Total number of physical hazards in the home (presence of open stairwells, stove height) 4. Total number of fine-motor activity items available to the child 5. Presence of gross-motor activity items available to the child across each category (e.g., fixed, portable: ball equipment, push/pull equipment, riding equipment, rocking and twisting equipment) 6. Hemoglobin concentration (g/L). | Behavioural | – |
Primary outcome
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)
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 17 Nov 2020.
- Individual participant dataSharing planned: Yes. Details of the data sharing plan are still to be determined.
Related trials for Obesity, Childhood
Not yet recruiting
Effectiveness of a 10-week Multicomponent Intervention Combined With Parent Education on Binge Eating Behavior in Children and Adolescents
Binge Eating Disorder, Binge Eating
Recruiting
National Childhood Obesity Prevention Programme BE FIT 24
Childhood Obesity
RecruitingPhase 2
Oxytocin for Weight Loss in Adolescents
Obesity, Adolescent, Oxytocin
Not yet recruitingObservational study
Brain and Obesity Longitudinal Development: Neurobiological Mechanisms of Semaglutide Treatment of Adolescent Obesity
Pediatric Obesity, Obesity
RecruitingObservational study
Early Tracking of Childhood Health Determinants (ETCHED) Study
Diabetes Mellitus, Obesity
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.
Daniel Roth principal investigator
The Hospital for Sick Children
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 Obesity, Childhood and Malnutrition, run by The Hospital for Sick Children at 1 site in Canada.
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 2 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 17 Nov 2020. 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 Canada. 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?
Moderate-to-Vigorous Physical Activity (time frame: 3-14 days). 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 17 Nov 2020.