Clinical trial NCT04743531: Healthy Environments Study (HEROs)
Official title: Bridging Home and Preschool Environments to Promote Healthy Eating and Activity Behaviors and Prevent Obesity in Early Childhood
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Behavior
Childhood Obesity
Keywords: Early Childhood
Mindful Parenting
Family Intervention
Picky Eating
Motor Development
Diet Quality
Physical Activity
Lead sponsor: Colorado State University
Sponsor class: OTHER
Collaborators: name: University of Colorado, Denver
name: New Mexico State University
name: Pennington Biomedical Research Center
name: Cornell University
First posted: 2021-02-08
Enrollment: 35
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Obesity is a multi-dimensional problem that has roots in infancy and tracks into adulthood. Obesity is represented disproportionately among children and families from low socioeconomic and minority backgrounds, particularly in rural areas that have limited access to food, activity, and health-related services. There is a need for culturally-tailored, effective interventions that can positively impact the environments (home, preschool, community) in which young children grow and develop their eating and activity behaviors. Developing family interventions, particularly for families with limited resources, requires improving caregivers' health literacy and home food/activity environments, and also requires tailoring to accommodate the realities of stressful and unpredictable family settings. The overall objective of this proposed HEROs Study (HEalthy EnviROnments Study) is to develop a companion, technology-based, interactive family intervention that will promote healthy lifestyles for young children in both Head Start and family settings.

Detailed description: This intervention study will test the impact of the intervention through a quasi-experimental staggered implementation pilot design. The aims will test whether the implementation of a parent-child interaction intervention, focusing on eating and activity behaviors, will improve children's eating behaviors, motor performance and parent-child interactions in these domains. This project seeks to answer the following research questions:

1. Do children participating in the family-based intervention demonstrate enhanced PA and eating behaviors?

   * Hypothesis 1.1: Children receiving the family-based intervention will have higher PA levels and enhanced motor skills compared to children in the control group.
   * Hypothesis 1.2: Children receiving the family-based intervention will demonstrate enhanced eating behaviors compared to children in the control group.
2. Can the home environment be improved by parents' self-monitoring of food availability and electronic devices; and the application of mindful parenting strategies?

   * Hypothesis 2.1: Evaluation of food items in the home and electronic devices in the child's bedroom will demonstrate a more positive home environment of participants receiving the family-based HEROs intervention.
   * Hypothesis 2.2: Parents will report more positive parent-child interactions after receiving the family-based HEROs intervention.

Eligibility criteria: Inclusion Criteria:

* Adults who identify as the primary caregiver of a child enrolled in a Head Start or preschool center ;
* Caregivers who report their child is without disability, illness, or disorder that would significantly affect dietary or activity behaviors (e.g., diabetes, cerebral palsy);
* Participants who communicate in either English or Spanish language.

Exclusion Criteria:

* Caregivers with children who have a disability, illness, or disorder that would significantly affect dietary or activity behaviors.

Primary outcomes:
measure: Change in children's diet behaviors
timeFrame: Baseline (pre-intervention), Month 2 (post-intervention), Month 4 (follow up)
measure: Change in children's gross motor skill scores
timeFrame: Baseline (pre-intervention), Month 2 (post-intervention), Month 4 (follow up)
measure: Change in children's physical activity levels
timeFrame: Baseline (pre-intervention), Month 2 (post-intervention), Month 4 (follow up)
measure: Change in children's willingness to try new foods
timeFrame: Baseline (pre-intervention), Month 2 (post-intervention), Month 4 (follow up)
Secondary outcomes:
measure: Change in child BMI
timeFrame: Baseline (pre-intervention), Month 2 (post-intervention), Month 4 (follow up)
measure: Change in caregivers' physical activity levels
timeFrame: Baseline (pre-intervention), Month 2 (post-intervention), Month 4 (follow up)
measure: Change in parent-child feeding practices
timeFrame: Baseline (pre-intervention), Month 2 (post-intervention), Month 4 (follow up)
measure: Change in physical activity parenting practices
timeFrame: Baseline (pre-intervention), Month 2 (post-intervention), Month 4 (follow up)
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Anschutz Medical Campus
state: Colorado
city: Fort Collins
country: United States
facility: Colorado State University
state: Colorado
Study officials:
affiliation: Colorado State University
name: Laura L Bellows, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Colorado, Denver
name: Susan L Johnson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vaha-Ypya H, Vasankari T, Husu P, Manttari A, Vuorimaa T, Suni J, Sievanen H. Validation of Cut-Points for Evaluating the Intensity of Physical Activity with Accelerometry-Based Mean Amplitude Deviation (MAD). PLoS One. 2015 Aug 20;10(8):e0134813. doi: 10.1371/journal.pone.0134813. eCollection 2015.
citation: Power TG, Johnson SL, Beck AD, Martinez AD, Hughes SO. The Food Parenting Inventory: Factor structure, reliability, and validity in a low-income, Latina sample. Appetite. 2019 Mar 1;134:111-119. doi: 10.1016/j.appet.2018.11.033. Epub 2018 Nov 30.
citation: Johnson SL, Ryan SM, Kroehl M, Moding KJ, Boles RE, Bellows LL. A longitudinal intervention to improve young children's liking and consumption of new foods: findings from the Colorado LEAP study. Int J Behav Nutr Phys Act. 2019 Jun 3;16(1):49. doi: 10.1186/s12966-019-0808-3.
citation: Townsend MS, Shilts MK, Styne DM, Drake C, Lanoue L, Ontai L. An Obesity Risk Assessment Tool for Young Children: Validity With BMI and Nutrient Values. J Nutr Educ Behav. 2018 Jul-Aug;50(7):705-717. doi: 10.1016/j.jneb.2018.01.022. Epub 2018 Mar 19.
citation: O'Connor TM, Cerin E, Hughes SO, Robles J, Thompson DI, Mendoza JA, Baranowski T, Lee RE. Psychometrics of the preschooler physical activity parenting practices instrument among a Latino sample. Int J Behav Nutr Phys Act. 2014 Jan 15;11:3. doi: 10.1186/1479-5868-11-3.
citation: Logan SW, Robinson LE, Getchell N. The comparison of performances of preschool children on two motor assessments. Percept Mot Skills. 2011 Dec;113(3):715-23. doi: 10.2466/03.06.25.PMS.113.6.715-723.