Physical Activity Clinical Trial
Official title:
Care2bWell: A Worksite Physical Activity & Wellness Program for Child Care Staff
This study will evaluate the efficacy of a 6-month child care-based intervention to improve workers' physical activity and other health-related behaviors compared to an attention control intervention (Healthy Lifestyles vs. Healthy Finances). The study sample will use a cluster randomized design and a sample of 104 child care centers and 416 child care workers (4 workers/center). The intervention arm will receive a 6-month child care-based intervention designed to improve workers' moderate to vigorous physical activity (MVPA) and other health-related behaviors (Healthy Lifestyles). The control arm (attention control) will receive a similarly structured program about financial health (Healthy Finances). The primary outcome is workers' MVPA; and secondary outcomes include workers' dietary intake, weight, smoking, sleep, and stress, as well as the centers' health supportive policies/structures for staff wellness and the overall physical activity environment for children. All primary and secondary outcomes will be assessed at baseline, post-intervention (6 months), and maintenance (18 months).
The proposed study will evaluate the efficacy of a 6-month, child care-based intervention to
increase workers' MVPA and other health-related behaviors (Healthy Lifestyles) compared to an
attention control condition (Healthy Finances). This study will use a two-arm,
cluster-randomized controlled trial (RCT) and a sample of 104 child care centers and 416
workers (4 workers/center). The primary outcome will be workers' MVPA; and secondary outcomes
include workers' weight, dietary intake, smoking status, sleep habits, and emotional health
as well as child care centers' programs, policies and environment around worksite wellness
and teachers' interactions with children around physical activity. All primary and secondary
outcomes will be assessed at baseline, post-intervention (6 months), and maintenance (18
months).
For this study, 104 child care centers will be recruited 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 research study. Direct
recruitment of centers will employ a variety of strategies (e.g., mail, email, telephone,
website, video, in-person contacts). Once a center expresses interest, the center director
will be engaged to recruit their staff (child care workers) to participate as a team.
Outcome Measures:
A series of measurements will be collected on participating child care center directors and
staff at three time points - baseline, follow-up (6 months), and maintenance (18 months).
Primary outcome measures will assess moderate to vigorous physical activity (MVPA) of center
staff. Secondary outcomes measures will assess staff members' behavioral health risk factors
as well as centers' programs, policies and environment around worksite wellness and teachers'
interactions with children around physical activity. These measures will be collected during
a one-day, on-site visit to the child care center, and supplemented with physical health
assessments completed at the kick-off event. Center visits will be conducted by research
assistants who have undergone extensive training and certification on all measurement
procedures and are blinded to study-arm assignment. Similar data collection protocols will be
used at all three time points - baseline, follow-up and maintenance.
Randomization:
Centers will be randomly assigned (1:1) into the intervention or control arm. Randomization
will occur during local kick-off events (each center must attend one event). Each kick-off
event will include a short wellness fair in the morning (including stations to collect
baseline biomedical health assessments). Lunch will be provided, followed by random
assignment into either the intervention or control arm. Timing allows for all of baseline
measures to be complete prior to randomization. Centers in both the intervention and control
arms will immediately start implementation of their respective programs.
Program Details/Intervention:
Healthy Lifestyles Intervention will kick off with an educational workshop and tailored
feedback based on responses to the CHART assessment tool. The educational workshop and
personalized health assessment summary will be delivered during the afternoon of the kick-off
event in a group format with other participating centers. Following this launch, the
intervention will provide 3 campaigns, each of which will include the following components:
center support materials, director webinar, staff magazine, and behavioral goal
setting/monitoring and weekly personalized feedback. The center support materials, director
webinars, and staff magazines will be delivered directly to the center to support the
center-based intervention. The behavioral goal setting/monitoring will be delivered directly
to participating staff. While campaign structure is constant, topics of each campaign will
vary. Campaign 1 focuses on increasing daily physical activity, cutting back on unhealthy
snacking, and switching from sugary and diet drinks to water. Campaign 2 focuses on eating a
diet rich in fruit and vegetables, whole grains, and lean protein, varying daily physical
activity, and increasing strength training. Campaign 3 focuses on maintaining an active
lifestyle, managing stress in a healthy way, and improving sleep habits.
Program Details/Control:
Healthy Finances Intervention will kick-off with an educational workshop and personalized
health assessment snapshot at the kickoff community event. The educational workshop will be
delivered during the afternoon of the kick-off event in a group format with other
participating centers randomized to the Healthy Finances arm. The personalized health
assessment snapshot will be provided during that workshop, but not reviewed in detail. It is
intended to provide only a basic comparison of current behaviors to recommendations.
Following this launch, the intervention will provide 3 campaigns, each of which will include
the following components: director webinar, staff magazine, and a contest focused on quizzing
knowledge gained from the magazines. The director webinars and staff magazines will be
delivered directly to the center to support the center-based program. The contest and
knowledge quizzes will be delivered directly to participating staff. While campaign structure
is constant, topics of each campaign will vary. Campaign 1 focuses on the link between
financial health and personal well-being (physical, mental), record-keeping: logging income
and expenses, and thoughtful spending: creating and sticking to a spending plan. Campaign 2
focuses on creating and making the most of a personal savings account, and benefits of
long-term investing: rules of thumb for picking investments. Campaign 3 focuses on
understanding your credit report and credit score, understanding what good credit can do for
you, and tips and strategies for improving your credit.
Analysis:
Investigators will compare the difference in mean change in MVPA between baseline and post
intervention between Healthy Lifestyle and Healthy Finance arms, controlling for baseline
physical activity. The primary analysis will test the hypothesis under the intent-to-treat
principle using Generalized Linear Mixed Models (GLMM) that will account for the correlation
induced by the clustering of staff within centers. Each GLMM will include a random intercept
for centers (β 0) and fixed effects for the baseline value of the primary outcome (β1) and
the intervention (β2) to test if the difference in mean change in the primary outcome is zero
where β0 is the fixed intercept and e is error.
[Change in Primary Outcome6mo = β0 + β1PrimaryOutcomebaseline + β2Intervention + b0 + e]
Including baseline score as a covariate in an analysis of covariance (ANCOVA), in our case a
GLLM ANCOVA analysis, is a more powerful test than a group comparison of baseline to
post-intervention change. Additionally, ANCOVA is not distorted by regression towards the
mean bias, whereas a change analysis is. To further explore intervention effect,
investigators will fit GLMMs that: 1) adjust for baseline covariates, considered a priori, to
be relevant to change in MVPA; 2) adjust for baseline variables distributed differently
between Healthy Lifestyle and Healthy Finance arms; 3) test interaction terms between
treatment group and other covariates; and 4) examine completers only. While investigators
will make every effort to minimize attrition at the center and participant level; some drop
out is expected. Investigators will explore the potential bias from non-ignorable,
non-response using two methods: 1) compare respondents and non- respondents to see if they
differ systematically on values of non-missing variables; and 2) assess whether data are
missing completely at random (MCAR), or missing at random (MAR) or missing not at random
(MNAR) - non-ignorable. If missing data are ignorable (MAR and/or MCAR), investigators will
consider imputing missing endpoint data using multiple imputation techniques. However, it is
often hard to determine if missing data are ignorable; therefore, investigators will consider
selection models (MNAR models) to assess if data are missing not at random and estimate the
effect of the interventions after removing selection bias. Investigators will also consider
using pattern mixture models to assess the sensitivity of our results to various assumptions
of missing data patterns. Investigators' previous work in child care centers and worksites
demonstrate good retention.
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