Healthy Environments Study (HEROs)

NCT ID: NCT04743531

Last Updated: 2021-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-01

Study Completion Date

2020-09-30

Brief Summary

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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

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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.

Conditions

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Health Behavior Childhood Obesity

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Intervention

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

Group Type EXPERIMENTAL

HEROs

Intervention Type 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.

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.

Group Type EXPERIMENTAL

HEROs

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

3 Years

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Colorado, Denver

OTHER

Sponsor Role collaborator

New Mexico State University

OTHER

Sponsor Role collaborator

Pennington Biomedical Research Center

OTHER

Sponsor Role collaborator

Cornell University

OTHER

Sponsor Role collaborator

Colorado State University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Laura L Bellows, PhD

Role: PRINCIPAL_INVESTIGATOR

Colorado State University

Susan L Johnson, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

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University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States

Site Status

Colorado State University

Fort Collins, Colorado, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 26292225 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30508613 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31159810 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29567008 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24428935 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22403917 (View on PubMed)

Other Identifiers

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USDA 2015-68001-23240

Identifier Type: -

Identifier Source: org_study_id

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