Healthy Environments Study (HEROs)

Status Completed

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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04743531
Study type	Interventional
Source	Colorado State University
Contact
Status	Completed
Phase	N/A
Start date	September 1, 2019
Completion date	September 30, 2020

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.