Our Year of Healthy Living (Formative Research & Intervention)

The purpose of this study is to evaluate the effect of the 7-month social marketing
intervention - Healthy Me, Healthy We (previously called Our Year of Healthy Living) - in
improving preschool children's (3-4 years) diet and physical activity behaviors. The study
will use a two-arm, cluster randomized controlled design and a sample of 90 child care
centers and 810 children (9 parent-child dyads/center).

For this study, the investigators will recruit 90 child care centers from a mix of
urban/suburban and rural areas. Potential child care centers in these counties will be
identified using an online database of licensed child care facilities maintained by the North
Carolina (NC) Division of Child Development and Early Education. State and local community
partners will be engaged to help inform centers in targeted counties about the study. Direct
recruitment of centers will employ a variety of strategies (e.g., mail, email, telephone,
in-person contacts). Once a center expresses interest, the investigators will work with the
center director to recruit nine parent-child dyads and five teachers from the 3- and 4-year
old classrooms.

Outcome Measures:

A series of measurements will be collected on participating children, parents, and child care
providers at two time points - baseline and follow-up. Primary outcomes measures will assess
child physical activity and diet quality. Secondary outcomes measures will assess child
weight, center and home environment. These measures will be collected in large part during
two-day on-site visits to the child care center, and supplemented with self-administered
surveys. Center visits will be conducted by data collectors who have undergone extensive
training and certification on all measurement procedures and are blinded to study-arm
assignment. Identical data collection protocols will be used at baseline and follow-up.

Children's physical activity will be measured using accelerometers. A data collector will fit
each participating child with an accelerometer on a belt during the morning of the first day
of the center visit. The child will wear the accelerometer for seven full days - both at
child care and at home. Once data are downloaded, age-appropriate cut-points will be applied
in order to calculate daily minutes of non-sedentary physical activity.

Children's dietary intakes will be measured using a combination of direct observation and
food diaries. The Dietary Observation for Child Care (DOCC), (Ward et al. 2008) will be used
to assess foods consumed by children while at child care. Each data collector can assess up
to three children at a time; therefore, a team of three data collectors will be assigned to
each center to allow observation of the nine participating children. They will observe
intakes on two consecutive weekdays, recording all foods and beverages consumed by the
children during breakfast/morning snack, lunch, and afternoon snack. Food diaries completed
by parents will be used to assess children's dietary intake outside of child care. Parents
will complete diary records on two weekdays (coinciding with the center visit) and one
weekend day. The diary will prompt parents to record foods consumed, portion size, location,
and time for each meal or snack. Follow-up phone calls will be conducted as needed to fill in
any missing details. The combined DOCC and diary data will be analyzed with the Nutrition
Data System for Research (NDSR) software in order to calculate children's daily intake of
food groups, calories, and nutrients. Healthy Eating Index-2005 (HEI-2010) scores will be
calculated for each child from these data.

Children's height and weight measurements will be collected by trained data collectors during
the center site visit. This data (along with parent-reported child age and sex) will be used
to calculate children's BMI, BMI percentile, and BMI z-score using standards and reference
data provided by the Centers for Disease Control and Prevention (CDC 2010).

The food and physical activity environments of homes and child care centers will be assessed
using the Home Self-administered Tool for Environmental assessment of Activity and Diet
(HomeSTEAD) (Hales 2014) and the Environment and Policy Assessment and Observation (EPAO)
(Ward 2008). HomeSTEAD is a self-administered survey that assesses characteristics of the
home environment that influence children's diet and physical activity behaviors. The EPAO is
an observation protocol that will provide similar data about the food and physical activity
environments at child care centers. EPAO observations will be completed during the center
visit by trained and certified data collectors. Data from HomeSTEAD and EPAO will be used to
calculate scores for home and center nutrition and physical activity environments.

Parents and child care providers will also be asked to complete brief demographic surveys and
health behavior screeners. Demographic surveys will assess standard characteristics like
gender, age, race/ethnicity, marital status, household income, and employment. Center
directors will also complete a demographic survey about the centers' current star rating,
acceptance of child care subsidies, participation in the federally-funded Child and Adult
Care Food Program (CACFP), and numbers, ages, and race/ethnicity of children enrolled. Given
that the intervention targets parents' and child care providers' own health behaviors, the
investigators will also collect self-reported data about provider and parent diet (fruit,
vegetable, sweetened beverage intake), physical activity (frequency, and amounts of time
spent in physical activities), and health status (weight and height), using several health
behavior screeners.

Once all baseline measures are collected, centers will be randomly assigned (1:1) into the
intervention or control arm. Centers in the intervention arm will immediately start
implementation of Healthy Me, Healthy We. Centers in the control arm will receive the same
intervention a year later (delayed).

Program Details/Intervention:

The program will be implemented center-wide (available to all 3-4 year old children and
parents/families in each child care center in the intervention arm, regardless of
participation in measurements). The campaign will begin in October and end in April of the
same school year. At the start of the program center directors will notify parents about the
program and hold a kick-off event. Following kick-off, the center will implement four units
using materials provided by our research team. Each unit will last about six weeks, include a
nutrition and physical activity theme, and incorporate visual cues, educational materials,
and activities to deliver targeted messages.

Campaign components target both the child care center and home, two important spheres of
influence that shape young children's diet and physical activity behaviors (Skouteris et al.
2011; Larsen et al. 2011). Engaging both spheres in a coordinated effort helps ensure that
children receive consistent health messages. Messages will address the promotion and support
of children's healthy diet and physical activity behaviors, while also encouraging child care
staff and parents to adopt similar health behaviors. The messages within each unit will be
informed by our conceptual model and address the following constructs: knowledge of current
recommendations for children and adults, strategies for shaping the physical and social
environment to promote good eating and physical activity habits, strategies for overcoming
common barriers to healthy eating physical activity, and targets for making gradual behavior
changes.

There are three key components to the program. First, is the commitment by the provider, the
parent and the child, called the "Healthy We Promise." The provider, the parent and the child
will each be asked to promise to take a "just try it" approach to healthy food and physical
activity. Each family will receive a copy to sign and keep at home and each provider will be
given a Healthy We Promise Poster to have children sign and display in their classroom.

The second component is classroom activities. A Unit Poster and Activity Cue Cards will be
provided to facilitate these activities. The Unit Poster will be displayed in the classroom
as a visual reminder to children about the overall goals of the current unit. Activity Cue
Cards (about 12-16 cards) that match the Unit Poster will be given to providers. Each week,
providers will select two cards and lead the classroom activities described.

The third component helps connect the classroom and home. A Healthy We Family Guide and
Activity Tracker will go home with each child during the first week of each unit. The Family
Guide has several components 1) introduction to the unit theme, 2) a Unit Guide tailored for
at-home opportunities, 3) at-home versions of activities being completed in the classroom, 4)
two to three recipes to try at home, and 5) expert tips about health and wellness. The
Activity Tracker is designed to be placed on display at the child's home to allow for
tracking of completed take-home activities. Throughout the unit, "Our Turn Tokens" are sent
home whenever the provider completes an Activity Cue Card in the classroom. The Our Turn
Token is intended to trigger parents to try the at-home version of the classroom activity.

At the end of the school year, each center will host a fun-festive gathering to celebrate all
that providers, parents, and children have accomplished over the year. The event will include
healthy food and fun, active games for the entire family.

Analysis:

Intervention impact on children's physical activity (i.e. minutes of non-sedentary physical
activity) and diet quality (i.e. HEI score) will be assessed by comparing differences in mean
changes from pre- to post-intervention between intervention and control arms using two-sided
t-tests adjusted for clustering.

Our primary analyses will involve testing of each of these hypotheses under the
intent-to-treat (ITT) principle (see section on missing data below) using Generalized Linear
Mixed Models (GLMM) that will account for the correlation induced by the clustering of
parents and children within childcare centers. Each GLMM (see below) will include a random
intercept for childcare centers (b0) and fixed effects for the baseline value of the primary
outcome (β1) and the intervention (β2) to test if the differences in mean changes in primary
outcomes is zero, where β0 is the fixed intercept, and e is error.

Change in Primary Outcome9m = β 0 + β1 Primary Outcomebaseline + β2 Intervention + b0 + e

To further explore the effect of the intervention, the investigators will fit GLMMs that: 1)
adjust for baseline covariates of interest, considered a priori, relevant to change in
minutes of non-sedentary activity and HEI score; 2) adjust for baseline variables distributed
differently between intervention groups; 3) test interaction terms between treatment group
and other covariates; and 4) examine completers only.

Similar analyses will be used to examine change in child BMI, healthy weight attainment and
maintenance, and change in scores on HomeSTEAD and EPAO. Demographic and health behavior data
about the child care centers, providers, parents, and children will be analyzed
descriptively, using frequencies, percentages, means, and standard deviations. In addition,
the investigators will include this data as covariates in the GLMM models.

In alignment with RE-AIM (Reach Effectiveness Adoption Implementation Maintenance) (Glasgow
et al. 1999), our process evaluation plan will include assessment of reach, effectiveness,
adoption, implementation, and maintenance. These process measures will allow a fuller
understanding of study results, how the program can be improved, and the potential for
dissemination and sustainability.

Inclusion Criteria:

Child Care Centers:

- Have 7-12 parent-child dyads willing to take part

- Have a Three, Four, or Five Star Rating OR GS110-106

- Serve lunch

- Have 3-4 year old classroom teachers that speak/write in English

Providers

- Teachers must teach in the 3-4 year old classrooms.

- Center directors and teachers must be able to read and speak English.

Parent-Child Dyad:

- Primary caregivers must have at least one 3-4 year old child enrolled in the
participating center.

- Only one parent/primary caregiver will be eligible to participate.

- Can be male or female.

- Primary caregivers must be able to read and speak English.

- Special needs children must not have a chronic health issue that severely impacts
their diet or physical activity.

Exclusion Criteria:

Child Care Centers:

- Serve special needs children exclusively

- Serve only non-English speaking families