Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT04189926 |
| Other study ID # |
Pro00069562 |
| Secondary ID |
R01HD091483 |
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
December 5, 2017 |
| Est. completion date |
November 30, 2023 |
Study information
| Verified date |
February 2023 |
| Source |
University of South Carolina |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Leading health organizations have identified prevention of obesity in young children as a
critical public health challenge. Low levels of physical activity and high levels of
sedentary behavior may contribute to the development of excessive fatness in young children,
but these relationships have not been fully explored, and accelerometry rarely has been used
to measure physical activity levels in infants and toddlers. No previous study has used
accelerometry as an objective measure of physical activity in young children as they develop
from infancy to preschool age. Accordingly, little is known about the factors associated with
the development of physical activity behavior in very young children, and little is known
about the influence of physical activity and sedentary behavior, measured objectively, on
development of weight status during the transition from infancy to age 3. The first aim of
this study is to describe physical activity and sedentary behavior in young children as they
develop from infancy to preschool age. The second aim is to describe the longitudinal
associations of weight status with physical activity and sedentary behavior as young children
develop from infancy to preschool age. The proposed investigation will employ a longitudinal,
observational study design. Participants will be 160 children and their biological mothers
living in Columbia, South Carolina. For each participating child, measurements will be taken
at 6, 12, 18, 24, 30, and 36 months of age. At each time point, each child's physical
activity, sedentary behavior, weight status and motor developmental status will be measured
objectively, and each child's mother will complete a survey to assess demographic, social and
physical environmental factors; gross motor milestones; parenting practices related to
physical activity and sedentary behavior; and dietary practices. Childcare center directors
will complete a survey annually to assess center characteristics, and the Environment and
Policy Assessment and Observation (EPAO) will be administered in the child's classroom
annually.
Description:
Subjects and Settings. The proposed research will be conducted in Columbia/Richland County,
South Carolina (SC). Participants will be 160 children and their biological mothers. Children
of all races and ethnic backgrounds will be included. Our recruitment procedures will be
designed to produce a sample with the following approximate race/ethnicity distribution: 38%
non-Hispanic African American, 38% non-Hispanic White, 20% Hispanic, and 4% other. Further,
we anticipate that approximately two-thirds of the participating children be attending formal
childcare centers and one-third will be at home or staying with a family member. Equal
percentages of female and male children will be included. Children will be excluded from the
study if they were born before 37 weeks gestation or have a physical limitation that would
invalidate accelerometry as a measure of physical activity.
Recruitment of Participants. Participants in the study will be 160 mother-child dyads who
will be recruited into the study when the children are between 3 and 6 months of age. They
will be residents of Richland County, South Carolina. Recruitment will take place across a
9-month period and will be designed to recruit two cohorts of 80 children each. Baseline data
collection will occur when each child is within one month of being 6 months of age. The
recruitment process will be coordinated by Richland County First Steps (RCFS), a non-profit
organization founded in 1999 to support provision of quality early childhood education for
children ages 0 to 5 in Richland County.
One-third of participants will be mother-child dyads from families in which the child does
not attend a formal childcare center. Richland County First Steps, in addition to its work
with childcare centers, delivers programs directly to families of young children, including
Latino families.
Cohort Maintenance. Participating mothers and children will be retained in the study across a
30-month period of observation by maintaining excellent communication with the parents and,
for children attending formal childcare centers, the directors and staff of the childcare
centers they attend. The process of maintaining excellent relationships with parents and
center staff will be coordinated by RCFS and managed collaboratively with the
University-based study staff.
Measures
Physical Activity and Sedentary Behavior. Total day physical activity and sedentary behavior
will be measured objectively using an ActiGraph accelerometer (GT3X-BT model, Pensacola, FL).
Accelerometers will be initialized prior to data collection and will be set to begin
collecting data at midnight of the day of distribution. Children will be fitted with the
accelerometer during a data collection visit with the parent and child at his/her childcare
center, home or other appropriate location. Based on preliminary work, we anticipate creating
two variables to define physical activity. The first variable will be based on counts per
minute averaged across 7 days of wear. This expression of the data will be applicable to the
full age range since intensity cutpoints have not been established for non-ambulatory
children. The second expression will use age-specific cutpoints to determine minutes per hour
of total physical activity and sedentary behavior.
Dietary Behavior. We will examine how diet, physical activity and sedentary behavior interact
in influencing developmental trajectories for weight status in children transitioning from
infancy to early childhood. Five instruments will be used in assessing children's dietary
behavior. At baseline data collection (child age = 6 months) the mother will be asked to
complete the Baby Eating Behavior Questionnaire 80, which will provide information on the
child's appetite during the first three months of life, and the ECLS-B Parent Questionnaire
(9-month version),81 which will provide information on the child's current and previous
feeding behavior, including breast-feeding history. At subsequent data collection points
(child age = 12 to 36 months) the mother will complete the ECLS-B Parent Questionnaire
(24-month version), which will provide information on specific dietary behaviors, and the
Multiple Indicator Cluster Survey (MICS) Dietary Intake survey, which will provide
information on foods consumed by the child on the previous day. In addition, at the 18-month
and 36-month data collection points, mothers will complete the Dietary Food Frequency
Self-Administered Questionnaire as developed for use in the National Children's Study.
Sleep characteristics. Sleep behavior will be assessed via actigraphy in children whose
parents consent to participation in this component of the protocol. Due to the substantial
participant burden, participation in this procedure will be optional. All parents
participating in the overall study will be invited to take part, and those who consent will
receive an additional incentive. Participating children will wear an actigraph
(MicroMini-Motionlogger, Ambulatory Monitoring, Inc.) 24 hours per day for seven days, except
during bathing or other water activities.
Weight Status. At each timepoint, data collectors will measure weight and length/height using
standard protocols. Age- and sex-specific weight-for-length percentiles and Z-scores will be
calculated from weight and length according to the World Health Organization (WHO) growth
charts. For children 24 months of age and older, the age- and sex-specific body mass index
(BMI) percentiles and Z-scores will be calculated according to the CDC growth charts.
Demographic Characteristics. At the first measurement point, each child's biological mother
will report her child's date of birth, gender, race/ethnicity, birth weight, length at birth,
and gestational age. The mother will report her own age, race/ethnicity, marital status, and
highest level of education achieved, which will be used as an indicator of socioeconomic
status. The mother will also report information related to her pregnancy with the
participating child.
Social Environmental Factors. At each measurement point, each child's mother will report her
employment status, physical activity behavior, and screen media use. Mothers will report the
number of other children living in the child's home and the age and gender of the children.
Mothers will also report whether there is another adult that lives with the child. Mothers
will also report the amount of time they spend playing with their child and the amount of
time the child spends playing with children of a similar age.
Physical Environmental Factors. Each child's mother will report her child's sleep habits,
outdoor play, television and screen media use, time spent in confining equipment, and care
arrangements during weekdays. Mothers will also report physical activity equipment in the
home. This information will be collected at each of the six time points.
Childcare Center Characteristics. For children attending childcare, we will conduct
assessments of their center once per year. The goal will be to perform a comprehensive
evaluation of the center's policies and practices related to nutrition and physical activity.
Center directors will provide information about their center's characteristics and policies,
and teachers will complete a survey about classroom practices related to physical activity
and nutrition. The director survey will address global policies related to physical activity
and nutrition as well as institutional characteristics. The teacher survey will address
classroom practices, including physical activity, sedentary behavior, meals and snacks, and
teacher behavior and engagement, using the Go NAP SACC self-assessment instrument.91 In
addition, we will conduct observations of the childcare environment using the Environment and
Policy Assessment and Observations (EPAO).92 The EPAO is a standardized instrument that has
been used widely to assess physical activity and nutrition in childcare environments. The
EPAO is completed by a trained observer during a full-day visit to a childcare center, during
which a single classroom is observed. Scores on 8 nutrition and 8 physical activity subscales
will be calculated as well as a total physical activity and total nutrition score for each
center.
Motor Developmental Status. Each child's biological mother will report the age (in months)
when her child first rolled over, sat unassisted, and began walking independently. In
addition, motor developmental status will be assessed using the Peabody Developmental Motor
Scales-2 (PDMS-2).94 Two trained data collectors will administer and score the PDMS-2; data
collection will take place at the participating child's childcare center or other appropriate
community location. The following gross movement subtests will be administered according to
standard age-specific protocols: reflexes, stationary performances, locomotion and object
manipulation. A Gross Motor Quotient will be calculated as the sum of the child's scores on
three subtests. For children less than 1 year of age the sub-tests will be Reflexes,
Stationary and Locomotion. For children ages 1 to 3 years the sub-tests will be Stationary,
Locomotion, and Object Manipulation. Performance is reported as both a raw score and as an
age-specific percentile.
Measurement Logistics. A total of 160 children, organized in two waves of 80 children each,
will be measured. For each participating child, there will be six measurement time points at
6-, 12-, 18-, 24-, 30-, and 36-months of age, with data collection occurring +/- 1 month of
the specified age. The same measurement protocol will be applied at each measurement time
point. Each child will be assessed during two visits at each measurement time point. The
first visit will include anthropometric measures, accelerometer distribution, and parent
survey administration, and the second visit will include the motor development assessment.
The first visit will take place at the child's home, at the childcare center or at another
appropriate community location. The motor development assessment will take place at the
childcare center or other appropriate community location. The motor development assessment
will occur within two weeks of the first visit, but not during the week of accelerometer
wear. All data collection procedures will be administered by trained and experienced research
staff.
For children attending a childcare center, center directors will complete a survey annually
to assess center characteristics. The classroom teacher(s) of participating children will
complete a survey annually. The EPAO will be completed on each classroom serving a
participating child once per year, or as children change to new classrooms. The EPAO will be
completed by trained data collectors. The Measurement Coordinator will download data from the
accelerometers as the monitors are collected, and the data will be scanned by the data
collection staff on a weekly basis. Surveys, anthropometric forms, and observation forms will
be entered into secure databases on a weekly basis. This measurement logistics plan is
similar to the plan that has been used by this research team in two previous studies of
physical activity in preschool children.
All data collected and entered will be reviewed weekly by the Measurement Coordinator for
quality control of data entry and completeness. Quality control and data completeness reports
will be generated monthly and discussed at project meetings. Reliability assessments of
anthropometry and motor development assessments will be conducted at least twice per year for
each data collector. Quality control visits will be conducted at least twice per year to
participating childcare centers for the purpose of observing data collectors.
