NET-Works:Community Preschooler Obesity Prevention

1. Trial design overview NET-Works is a two-arm, randomized controlled trial to test the
efficacy of a multi-setting, multi-component intervention approach to preventing obesity
among racially/ethnically diverse preschool age children. The NET-Works intervention
includes four main components: 1) a pediatric primary care brief counseling
intervention; 2) a home-based intervention delivered by NET-Works family connectors to
support parents in making changes in the home environment and parenting practices to
promote healthful eating and activity patterns; 3) community-based parenting classes
designed to parallel the home-based intervention curriculum and provide social support
to participating parents; and 4) linkages to neighborhood and community resources to
support parents in promoting healthful eating and activity patterns for their children.
Five hundred parent/child dyads were randomized to either the NET-Works intervention or
a usual care comparison condition and followed for three years. Participants were
assessed at baseline and annually. The primary hypothesis is that children randomized to
the NET-Works intervention will have lower BMI (body mass index) at two and three years
post-randomization relative to usual care comparison group children. BMI is the primary
outcome across all four Childhood Obesity Prevention and Treatment Research (COPTR)
trials. Recruitment for the trial began in July 2012 and was completed in December 2013,
with the final three year follow-up data collected in December 2016.

2. Study setting and population The target population for NET-Works was racially/ethnically
diverse preschool children and their parent or primary caregiver. To reach the intended
population, NET-Works partnered with 12 primary care clinics and three managed health
care systems that serve diverse populations with respect to race, ethnicity and income.
Over 18 months, 500 families were recruited, enrolled and randomized to the intervention
or to the usual care comparison group. Administrative databases and centralized
electronic scheduling systems at the partner clinics provided data needed to target
recruitment efforts on two-to-four year old children residing in certain zip code areas.
The clinics had data from preventive care visits available for calculation of child body
mass index (BMI) percentile to focus recruitment efforts on children who were
potentially BMI-eligible for the study.

3. Recruitment Administrative databases and centralized electronic scheduling systems at
three partner health care organizations provided data needed to target families of
two-four year old children whose BMI percentile was at or above the 50th percentile for
age and gender. Clinic liaisons obtained approval from each child's pediatrician to send
a study invitation letter to the parent or primary caregiver. A list of
physician-approved potentially eligible children was shared with the NET-Works
recruitment team. NET-Works sent the parent or primary caregiver a study invitation
letter from the pediatrician and researchers. Approximately five working days later,
NET-Works recruitment staff followed up by phone to provide more information, ask
additional screening questions, and assesses parent/primary caregiver's interest in the
study. If the parent/primary caregiver was interested and the child appeared to be
eligible, a home visit for eligibility confirmation, consent, and data collection was
scheduled. The purpose of this initial home visit was to: 1) explain and discuss the
study, and begin to develop rapport with parents; 2) measure the index child's height
and weight to confirm eligibility; 3) obtain informed consent; and 4) begin the process
of collecting baseline data. Based on our pilot study experience, we anticipated the
majority of the participating parent/caregivers would be female and a significant number
of Hispanic families as well as non-Hispanic White, African American, and multi-race
participants would be recruited.

4. Randomization Prior to the start of recruitment and enrollment, the study statistician
created 6 blocked randomization schedules, one for each age group (2, 3, 4) by gender
(M, F) stratum, that would equally allocated children to the NET-Works intervention or
the usual care comparison group in blocks of 10 to ensure equivalent study group size.
Parent-child dyads were randomized to treatment and control conditions after completion
of all baseline measures, including data eligibility requirements established by the
COPTR consortium. Data eligibility requirements included valid height and weight
measurement, a minimum of one weekday and one weekend day NDS-R (nutritional data
survey-revised) previous day dietary recall and four days of valid accelerometry data.
The study coordinator randomly assigned the participant to the condition shown in the
next available slot in the stratum-appropriate pre-defined randomization schedule. The
investigators and all assessment staff remained blinded to experimental assignment until
after the final follow-up assessments were completed.

5. NET-Works intervention The NET-Works intervention was designed to reach into the home
and family environment to influence parent behaviors and attitudes to support changes in
the home that affect food availability, family meals, television viewing, and active
play. Each intervention component would be situated in community settings where parents
and children already live their lives. The intervention was expected to be effective in
part through taking advantage of the settings that families already inhabit, and through
coordination across settings to reinforce and link the messages, resources and feedback
families receive about healthful food choices, physical activity, and body weight for
their child. We believed the neighborhood-based model would be more likely to enhance
class participation, reduce transportation needs/costs, allow the local community
resources to be accessed more easily, and foster outside-of-class interpersonal
connections among parents for enhanced social support.

5.1. Intervention components implementation overview The intervention curricula across
each component (home visiting, parenting classes, neighborhood environment, pediatric
primary care) was developed and refined during the pilot phase of the COPTR consortium.
The intervention was designed to be implemented by trained research staff including a
family connector who would conduct the home visiting and connector check-in calls and
attend the parenting classes, and a parent educator who would conduct the community
parenting classes that were based on the early childhood parenting class model and was
developed in partnership with ECFE (early childhood and family education) in Minneapolis
and St. Paul. The home visiting and parenting classes shared a common set of underlying
curricula that included skills building around general parenting behaviors and the
specific content behaviors targeted by the intervention (e.g., healthful snacks, family
meals, physical activity). The family connector met parents and children in their own
home, tailoring the intervention messages and strategies to best fit with the resources
and motivations of parents. The family connector provided a one-on-one approach to
synergize with the skills and strategies implemented in a group format in the NET-Works
community parenting classes. Both home visiting and parenting classes directly connected
parents to food and physical activity resources that already exist in their neighborhood
("community links"). Primary care providers bolstered these messages with parents during
annual well-child visits.

5.2. Home visiting The goal of the home visiting was to help parents develop parenting
skills, set goals related to child healthful eating, active play and reduced television
viewing, and provided support for sustaining and building on these behavior and home
environment changes. The dose for the home visiting intervention component was one visit
per month for each of the three years. The family connector built a collaborative,
partnership-based goal setting process for parents to facilitate child behavior change.
Facilitation of the home visits was modeled on Motivational Interviewing, an approach
designed to help individuals explore and resolve ambivalence about behavior change in a
non-confrontational manner. Home visiting included a goal setting process guided by the
family connector, healthful action activities to create norms and skills related to the
targeted behaviors, and resources for links in the community to support healthful
behaviors. Family connectors also checked in with participants to review progress on
goals and provide support in between home visits. Family connector check-in contacts
could be conducted over the telephone or via email. Family connectors had weekly
supervision sessions with a licensed mental health provider with expertise in
Motivational Interviewing to review progress with each participant, problem solve
regarding any challenges that arise, and ensure adherence to the intervention protocol.

5.3. Parenting classes The parenting classes were designed to work synergistically with
the home visiting curriculum. The parenting class and the home visiting curriculum both
included topics that addressed parenting skills development, the home food environment,
healthful eating, family meals, television viewing limits, active play, and goal
setting. The parenting class provided a group format where parents could share their
experiences, gain support from other parents and learn from each other. The curriculum
was research-based and facilitated by a trained parent educator. The dose for the
parenting class component was 12 classes per year for each of the three years. The
curriculum in years 2 and 3 built upon and deepen the topics introduced in year 1, and
addressed parenting and developmental issues as children progress from ages 2-7 years of
age. Parent educators also participated in weekly supervision sessions to ensure
adherence to the intervention protocol.

5.4. Neighborhood and community initiative The purpose of the neighborhood and community
intervention component was to increase access to, and use of, healthful food, physical
activity, and school readiness resources available in the neighborhood communities where
study participants live. Parents were directly linked with resources in their
neighborhood through both the parenting classes and the family connector home visits.
Community initiatives implemented with the family connector included conducting a
walkability assessment of the family's neighborhood. The family connector reviewed
neighborhood food and physical activity resources with the parent at each home visit,
and encouraged them to use these resources to support their home and behavior changes.
The community links included one school readiness community activity (e.g., a library
visit) to promote developmental parenting, sustain parent interest, and provide active
support for whole child development. Four community links were included in the parenting
class and home visiting curriculum each year of the intervention.

5.5. Primary care The primary care provider is an influential connection for parents. In
NET-Works, the primary care provider delivered key messages around parent behaviors for
shaping, reinforcing and sustaining healthful child eating and physical activity
behaviors and body weight. To support providers in delivering key messages to parents
during well child visits, a brochure was developed in partnership with the participating
clinic systems. The brochure was used by the primary care provider to converse about
child BMI percentile and strategies parents could use to promote their child's healthful
eating and activity patterns. The NET-Works family connector will also provided
information about progress on intervention goals to the primary care provider on an
annual basis to reinforce continuity and integration of intervention messages. The
primary care intervention linked with the community parenting classes and home visiting
to deliver consistent intervention messages over a sustained time period.

6. Intervention component integration Linkages across the intervention components were
created in several ways with the family connector playing a key role in this
connectivity. Specifically, in addition to conducting home visits, family connectors
facilitated participant entry into parenting classes and also attended parenting
classes. Attending parenting classes allowed the family connector to be knowledgeable
about the parenting class content and the experience their assigned participants were
having during class. This information informed the goal setting that family connectors
and parents worked on during home visits. Family connectors also served as the liaison
between parents and primary care providers. The home visits and parenting classes also
incorporated connections to community resources for physical activity and healthy eating
as described above.

7. Usual care comparison group The usual care comparison group received the primary care
provider component described above, and quarterly newsletters with information about
their child's general health and wellness and school readiness.

8. Participant timeline, assessments, and measures Data collection took place in the home
setting at baseline, 12, 24, and 36 months by trained and certified, bilingual English
and Spanish research specialists, blinded to experimental assignment. At 6, 18, and 30
months, a brief telephone survey was conducted. Participants receive a total of $50 in
gift cards for each set of measurement visits (baseline and each subsequent annual
assessment) and a $5 gift card for each brief telephone survey. Data collectors were
trained by the investigators and, for COPTR consortium common measures, by the Research
Coordinating Unit (RCU) according to standardized protocols. COPTR used a
train-the-trainer model. "Master Trainers" who participated in a central training
organized by the RCU were responsible for training and certifying the data collection
staff at their field center. Data collectors were required to demonstrate high inter-
and intra-rater reliability prior to data collection.

9. Statistical analyses The primary efficacy analysis was designed to test whether two to
four year old children who were randomized to the NET-Works program have statistically
and clinically lower BMI at 24 and 36 months post randomization relative to usual care
comparison group children with age at randomization (2, 3, 4), sex (F, M) and BMI at
baseline used as covariates. According to the study protocol, all covariates in the
primary analysis would be measured at baseline prior to randomization and therefore
available for observed and unobserved BMI values.

10. Data monitoring and participant safety The data safety and monitoring plan included
assessing adverse events systematically at each data collection visit with direct
queries for all injuries, illnesses or other medical problems requiring a visit to a
medical care provider and related to participation in the study. Serious Adverse Events
(SAEs) were specifically monitored. Adverse events were also be recorded and evaluated
when they came to the attention of study staff between the data collection visits. An
independent Data and Safety Monitoring Board was selected to review study protocols and
provide oversight of recruitment and study progress, data quality and completeness, and
participant safety.

Inclusion Criteria:

- A child and his or her parent(s) will be eligible for the study if:

- the two to four year old child is scheduled to receive or eligible for (based on
an upcoming birthday) a recommended well child visit conducted by a pediatric or
family practice care provider;

- the child has no medical problems that would preclude study participation as
determined by the physician conducting the well child visit (e.g. serious disease
that would make following guidelines for parent encouragement of healthy diet and
physical activity infeasible);

- the child's BMI is greater than or equal to the 50th percentile according to CDC
age and sex reference standards
http://www.cdc.gov/nchs/data/nhanes/growthcharts/bmiage.txt;

- the child's parent/guardian agrees to participation in the study and is not
planning to move out of the state in the next three years

- the primary caregiver is willing and able to complete the evaluation measures and
participate in intervention activities if assigned to the active intervention
group.

- the parent speaks either English or Spanish.

Exclusion Criteria:

- A child will be excluded if she or he does not meet the above eligibility criteria