Healthy Environments Study (HEROs)

NCT04743531 | Completed

• 1 other identifier: USDA 2015-68001-23240
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 2

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.

Conditions

Health Behavior; Childhood Obesity

Keywords

Early Childhood; Mindful Parenting; Family Intervention; Picky Eating; Motor Development; Diet Quality; Physical Activity

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• Change in child BMI

  Baseline (pre-intervention), Month 2 (post-intervention), Month 4 (follow up)

• Change in caregivers' physical activity levels

  Baseline (pre-intervention), Month 2 (post-intervention), Month 4 (follow up)

• Change in parent-child feeding practices

  Baseline (pre-intervention), Month 2 (post-intervention), Month 4 (follow up)

• Change in physical activity parenting practices

  Baseline (pre-intervention), Month 2 (post-intervention), Month 4 (follow up)

Study Arms (2)

Intervention

EXPERIMENTAL

Families living in rural Colorado will participate in the HEROs intervention in Fall 2019.

Behavioral: HEROs

Staggered Intervention

EXPERIMENTAL

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

Interventions

HEROs BEHAVIORAL

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.

Intervention; Staggered Intervention

Eligibility Criteria

• Age: 3 Years - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Colorado State University: lead
• University of Colorado, Denver: collaborator
• New Mexico State University: collaborator
• Pennington Biomedical Research Center: collaborator
• Cornell University: collaborator

Study Sites (2)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

Colorado State University

Fort Collins, Colorado, 80523, United States

Location

Related Publications (6)

• 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.

  PMID: 26292225 BACKGROUND

• 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.

  PMID: 30508613 BACKGROUND

• 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.

  PMID: 31159810 BACKGROUND

• 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.

  PMID: 29567008 BACKGROUND

• 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.

  PMID: 24428935 BACKGROUND

• 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.

  PMID: 22403917 BACKGROUND

MeSH Terms

Conditions

Health Behavior; Pediatric Obesity; Food Fussiness; Motor Activity

Condition Hierarchy (Ancestors)

Behavior; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Feeding Behavior

Study Officials

• Laura L Bellows, PhD

  Colorado State University

  PRINCIPAL INVESTIGATOR

• Susan L Johnson, PhD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2021
• First Posted: February 8, 2021
• Study Start: September 1, 2019
• Primary Completion: September 30, 2020
• Study Completion: September 30, 2020
• Last Updated: February 8, 2021

Record last verified: 2020-11

Locations

US (2)