Healthy Children, Strong Families: American Indian Communities Preventing Obesity

Intervention

The Healthy Children, Strong Families-2 (HCSF-2) intervention consists of monthly mailed
healthy lifestyle lessons (13 lessons) which will be dose enhanced with social networking
support (cell-phone coaching with instant text messages and Facebook connections), as well as
new intervention elements-stress and sleep. Social networking was chosen due to its
widespread and ease of use, adaptability and potential for sustainability in the community.

HCSF-2 is based on our hypothesis that working with children and their primary
caregivers/parent to assist them in making healthy lifestyle changes is necessary to prevent
excessive weight gain and risk of later lifestyle related chronic disease. Investigators will
work with families at a critical time in their young child's physical and emotional
development to encourage appropriate healthy lifestyle behaviors.

This study will expand on our previous research to test the HCSF-2 intervention in a larger,
more geographically and socially diverse sample of AI communities. The study also enhances
the prior methodology through the inclusion of a social networking component. This research
will address four key gaps in obesity prevention studies: families with preschool age
children, social networking support, stress and sleep. Moreover, to our knowledge, this study
will be the first family-based obesity intervention project for both rural and urban AI
families. The potential impact of this study is high; if successful, this study will not only
provide quantitative evidence of the effectiveness of the intervention but it will also give
other investigators validated tools and procedures to collaboratively engage AI communities
in health behavior change.

Year 1, families will be randomized to start in the HCSF-2 intervention or an active control
(mailed child safety newsletters). Then, in Year 2, intervention change will occur, such that
HCSF-2 intervention families will receive the control safety lessons plus continued HCSF-2
social networking, while control families will now receive the full HCSF-2 intervention.

For example, families will be randomly assigned to begin in one of the two arms - denoted
here as the HCSF-2 intervention (Phase A) or Child Safety intervention (Phase B).

During the HCSF-2 intervention (Phase A) families will receive a monthly mailing with
information about nutrition and physical activity, screen time, sleep and stress management.
Families will also be invited to participate in a private Facebook group and will begin
receiving wellness coaching text messages from the study.

During the Child Safety intervention (Phase B) families will receive a monthly mailing with
information about safety topics such as car safety, water safety, poisoning and home safety.

After one year, families will flip into the second phase until the two year study period is
complete. Families who began in Phase A will continue to receive wellness coaching text
messages and have access to the private Facebook group. Families who began in Phase B will
not receive wellness coaching text messages or have access to the private Facebook group
until the flip into Phase A at the start of year two.

This staggered enrollment design, chosen in conjunction with the participating communities,
maximizes the contribution of each participating family, avoids the negative attitudes that
would occur with a wait-list only control and ensures all families receive the intervention
as desired by the participating tribal sites.

This is a multi-site trial with up to six possible participating communities. Two sites will
become active at the beginning of the intervention with remaining sites becoming active (and
being added to the IRB protocol) at roughly 1 year intervals.

A local site coordinator will be hired at each participating site. The local site coordinator
will be responsible for recruiting participants, and conducting data collection visits. Site
coordinators may also send wellness coaching text messages and post content to the private
Facebook group.

The UW program coordinator will be responsible for screening participants for eligibility,
administering 24-hour dietary recalls by phone, mailing HCSF-2 curriculum materials and Child
Safety materials, managing the entry and storage of study data, sending results letters to
participants and supporting the community site coordinators.

Methods

Investigators will partner with 6 diverse rural and urban AI communities nationally to
conduct a 2-arm staggered-enrollment randomized trial of an enhanced version of the HCSF
intervention (HCSF-2) vs. active control (Child Safety intervention) in a 2-year design with
outcomes measured at 0, 6, 12, 18 and 24 months. At the end of year 1, control families will
receive HCSF-2, and HCSF-2 families will receive the control intervention with continued
HCSF-2 social network support. Communities will work with us to enhance the family-focused
HCSF-2 intervention to include novel methods of delivery (mailed lessons with social
networking/cell phone text coaching) and two less-studied obesity determinants—sleep and
stress—to increase impact and sustainability.

Outcomes

Primary outcomes will be body fat as assessed by child Body Mass Index z-score (zBMI) and
adult Body Mass Index (BMI). Secondary outcomes include adult and child waist circumference,
fruit/vegetable (FV) and added sugar intake, TV/screen time, activity, sleep, home
environment changes, adult psychosocial factors (stress/depression) and social network use.

Investigators will also identify key mediators of the effect of HCSF-2 on obesity and health
behaviors. We hypothesize that modifiable behavior changes in children and caregivers, adult
self-efficacy, social support and home environment changes are important mediators of the
effect of the intervention on obesity and other outcomes. Investigators will develop and test
exploratory mixed-effects regression models to investigate mediation on the path from HCSF-2
to weight reduction.

Inclusion Criteria:

- Adult caregiver with a 2-5 year old child

- 2-5 year old child with a caregiver

- Caregiver has a working cell phone and is willing to receive regular text messages as
part of study participation

- Caregiver lives within feasible travel distance of data collection site and willing to
come for data collection visits at 0, 6 months, 12 months, 18 months and 24 months

- Willingness to be randomized to one of two groups with the understanding that all
participants will receive all components of the intervention, randomization simply
determines the order in which materials are received

- Valid mailing address where participant can receive mail and packages

- Basic English fluency and literacy sufficient for understanding the intervention
materials and completing questionnaires

Exclusion Criteria:

- Adults with no children or whose only children are younger than 2 or older than 5

- Children younger than 2 or older than 5 years of age

- No cell phone or unwilling to receive regular text messages as part of study
participation

- Lives beyond feasible travel distance of data collection sites AND/OR planning on
moving out of the area within a two year period

- Child has major physical or behavioral disorder (e.g. failure to thrive, severe
autism) that would seriously impact study participation

- No valid mailing address

- Unwillingness to accept random allocation to study arm

- Spouse/partner of another caregiver-child pair who is living in same home & who has
already enrolled (e.g. only one adult-child pair per household may be enrolled)