Healthy Environments Study (HEROs)

Bridging Home and Preschool Environments to Promote Healthy Eating and Activity Behaviors and Prevent Obesity in Early Childhood

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.

Study Overview

• Status: Completed
• Conditions: Childhood Obesity; Health Behavior
• Intervention / Treatment: Behavioral: HEROs

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.

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Anschutz Medical Campus
    • Fort Collins, Colorado, United States, 80523
      • Colorado State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 5 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Families living in rural Colorado will participate in the HEROs intervention in Fall 2019.	Behavioral: HEROs; Intervention Description: The intervention will consist of a 6-week family workshop series, held one evening per week for six consecutive weeks. The intervention modules will be delivered by trained researchers at two preschool sites in rural Colorado in Fall 2019 and Spring 2020. The primary caregiver and preschool child will be the targets of the study. Each of the workshops will be structured to include joint caregiver-child activities and programming that is tailored for caregivers and children individually. Caregivers will learn about and engage in activities related to healthy eating and picky eating; physical activity and motor development; and parenting strategies. Children will participate in activities focused on healthful eating and physical activity that supports content their parents are learning.
Experimental: Staggered Intervention; Families in the staggered intervention arm will serve as controls for the first intervention arm during Fall 2019. Families the staggered intervention arm will then participate in the HEROs intervention in Spring 2020.	Behavioral: HEROs; Intervention Description: The intervention will consist of a 6-week family workshop series, held one evening per week for six consecutive weeks. The intervention modules will be delivered by trained researchers at two preschool sites in rural Colorado in Fall 2019 and Spring 2020. The primary caregiver and preschool child will be the targets of the study. Each of the workshops will be structured to include joint caregiver-child activities and programming that is tailored for caregivers and children individually. Caregivers will learn about and engage in activities related to healthy eating and picky eating; physical activity and motor development; and parenting strategies. Children will participate in activities focused on healthful eating and physical activity that supports content their parents are learning.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in children's diet behaviors	The Healthy Kids (HK) survey (Townsend et al 2018) examines 23 behaviors in the child's family environment to identify nutrition, activity, and child feeding factors associated with pediatric obesity in low-income populations. Survey responses will be coded using 4 response options per item (4=most healthful; 1=least healthful). Items will be summed into 6 subscales: vegetables, sweetened beverages, activity (screen and physical activity), snacking, energy density, and BMI.	Baseline (pre-intervention), Month 2 (post-intervention), Month 4 (follow up)
Change in children's gross motor skill scores	The Test of Gross Motor Development-2 (TGMD-2) will be used to assess child's motor skill competence. The TGMD-2 assesses 12 skills: run, gallop, hop, leap, horizontal jump, slide (locomotor skills); and striking a stationary ball, stationary dribble, kick, catch, overhand throw, and underhand roll (object control skills). A research team member will demonstrate the proficient technique to the child, then the child will be asked to perform the skill twice. Researchers will score each attempt to perform the skill based on set criteria (Logan et al 2011).	Baseline (pre-intervention), Month 2 (post-intervention), Month 4 (follow up)
Change in children's physical activity levels	Children's physical activity levels will be assessed using the cumulative time in sedentary and moderate and vigorous physical activity (MVPA). Data will be collected using the ActiGraph GT9X accelerometer, which participants will be asked to wear for 7 days during each data collection period (baseline, follow up at month 2, follow up at month 4). Sedentary and MVPA cut points for children will be used to measure of the mean amplitude deviation of acceleration [Vaha-Ypya 2015].	Baseline (pre-intervention), Month 2 (post-intervention), Month 4 (follow up)
Change in children's willingness to try new foods	Children's willingness to try new foods will be conducted using a Tasting Panel, a food preference assessment, with each child. The child will be asked to taste 8 foods in a self-selected order. This panel includes sweet and savory foods, fruits, vegetables, and protein. After tasting a food, children will be asked to place the food in front of one of 3 cartoon faces that best describes how they think the food tasted: a smiling face (yummy), a neutral face (just ok), or a frowning face (yucky). Refusals to taste a food will be recorded [Johnson et al 2019].	Baseline (pre-intervention), Month 2 (post-intervention), Month 4 (follow up)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in child BMI	Children's weight (measured on a digital scale) and height (measured using a portable stadiometer) will be used to determine a BMI using the CDC standardized growth curves.	Baseline (pre-intervention), Month 2 (post-intervention), Month 4 (follow up)
Change in caregivers' physical activity levels	Caregivers' physical activity levels will be assessed using the cumulative time in sedentary and moderate and vigorous physical activity. Data will be collected using the ActiGraph GT9X accelerometer, which participants will be asked to wear for 7 days during each data collection period (baseline, follow up at month 2, follow up at month 4). Sedentary and MVPA cut points for children will be used to measure of the mean amplitude deviation of acceleration [Vaha-Ypya 2015].	Baseline (pre-intervention), Month 2 (post-intervention), Month 4 (follow up)
Change in parent-child feeding practices	The Food Parenting Inventory (FPI) [Power et al 2019] measures food parenting practices and has been validated among diverse populations. We will utilize 5 subscales that link specifically to our HEROs curriculum including: Encourages Exploration of New Foods (3 items), Offers New Foods (3 items), Repeatedly Presents New Foods (3 items), Pressure to Eat (4 items) and Food as Reward (3 items). Response options are a 5-point Likert scale (never to always). The mean score per FPI scale will be calculated for analyses.	Baseline (pre-intervention), Month 2 (post-intervention), Month 4 (follow up)
Change in physical activity parenting practices	The Preschooler's Physical Activity Parenting Practices (PPAPP) instrument [O'Connor et al 2014] has been validated in a large sample of parents of preschoolers. The Engagement/Structure sub-scale (15 items), and 2 single-items (Have outdoor toys; Not enrolled in sports-reverse coded) measures parenting practices that encourage child physical activity. Practices that discourage child physical activity include 4 subscales: Promote Inactivity (3 items), Promote Screen Time (3 items), Psychological Control (5 items), and Restriction for Safety Concerns (4 items). Response options are a 5-point Likert scale (never to always). A mean score per PPAPP scale will be calculated.	Baseline (pre-intervention), Month 2 (post-intervention), Month 4 (follow up)

Collaborators and Investigators

• Sponsor: Colorado State University
• Collaborators: University of Colorado, Denver; Pennington Biomedical Research Center; Cornell University; New Mexico State University
• Investigators: Principal Investigator: Laura L Bellows, PhD, Colorado State University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2019
• Primary Completion (Actual): September 30, 2020
• Study Completion (Actual): September 30, 2020

Study Registration Dates

• First Submitted: February 3, 2021
• First Submitted That Met QC Criteria: February 3, 2021
• First Posted (Actual): February 8, 2021

Study Record Updates

• Last Update Posted (Actual): February 8, 2021
• Last Update Submitted That Met QC Criteria: February 3, 2021
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Physical Activity; Family Intervention; Picky Eating; Early Childhood; Motor Development; Mindful Parenting; Diet Quality
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Pediatric Obesity
• Other Study ID Numbers: USDA 2015-68001-23240

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Data may be available upon request to the Principal Investigator

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No