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Clinical Trials/NCT04743531
NCT04743531CompletedNot Applicable

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

Colorado State University4 sites in 1 country35 target enrollmentStarted: September 1, 2019Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
35
Locations
4
Primary Endpoint
Change in children's physical activity levels

Study Overview

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.
  1. 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 Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
3 Years to 5 Years (Child)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Outcomes

Primary Outcomes

Change in children's physical activity levels

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

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 \[Vaha-Ypya 2015\].

Change in children's diet behaviors

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

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.

Change in children's gross motor skill scores

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

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).

Change in children's willingness to try new foods

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

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 \[Johnson et al 2019\].

Secondary Outcomes

  • Change in child BMI(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 caregivers' physical activity levels(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))

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (4)

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