Healthy Environments Study (HEROs)

Health Behavior Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04743531
• Other study ID #: USDA 2015-68001-23240
• Status: Completed
• Phase: N/A
• Start date: September 1, 2019
• Est. completion date: September 30, 2020

Study information

• Verified date: November 2020
• Source: Colorado State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: September 30, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 5 Years

Eligibility

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.

Related Conditions & MeSH terms

• Childhood Obesity
• Health Behavior
• Obesity
• Pediatric Obesity

Intervention

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.

Locations

Country	Name	City	State
United States	University of Colorado Anschutz Medical Campus	Aurora	Colorado
United States	Colorado State University	Fort Collins	Colorado

Sponsors (5)

Lead Sponsor	Collaborator
Colorado State University	Cornell University, New Mexico State University, Pennington Biomedical Research Center, University of Colorado, Denver

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Vähä-Ypyä H, Vasankari T, Husu P, Mänttäri A, Vuorimaa T, Suni J, Sievänen 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)