Healthy Children, Healthy Communities: Effectiveness of a Multilevel Rural Community Engagement Model for Improving Children's Dietary Intake in Family Child Care Homes

NCT ID: NCT07160530

Last Updated: 2025-09-08

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

RECRUITING

Clinical Phase

NA

Total Enrollment

360 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-07

Study Completion Date

2029-05-31

Brief Summary

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The purpose of this study is to find out whether a program called "Healthy Children, Healthy Communities" can help young children in rural areas eat healthier and improve their health. The study focuses on children ages 3 to 5 who attend family childcare homes in rural communities.

The main goal is to see if the program can:

Help children eat healthier foods, like more fruits and vegetables.

Support childcare providers in using positive mealtime practices that encourage healthy eating.

The study will involve about 120 licensed family childcare providers in rural areas who participate in the Child and Adult Care Food Program (CACFP), along with about 240 children they care for.

Childcare providers will be randomly placed into one of two groups:

EAT Family Style Group (Intervention Group):

Complete 7 online training modules over 16 weeks about healthy mealtime practices.

Join 7 individual coaching sessions on Zoom.

Record short videos of their mealtimes to get personalized feedback from a coach.

Work with a coach to set goals and make plans to improve mealtimes.

Receive printed materials and conversation cards to use during meals.

Some providers may join Zoom interviews to share their experiences.

Better Kid Care Group (Comparison Group):

Complete 10 online modules about general childcare topics like child development, oral health, play, and managing a childcare home.

For both groups, the research team will:

Ask providers to fill out online surveys about how mealtimes work in their childcare homes.

Visit the childcare homes to observe and record children's mealtimes on two days at each data collection point.

Measure the height and weight of participating children.

Use a painless skin scanner (Veggie Meter) to check how many fruits and vegetables children have been eating.

Ask providers to complete surveys about the children's eating habits.

The study focuses on rural, low-income communities, where children are at higher risk of having poor diets and obesity compared to children in urban areas. Information will be collected at the start of the study, after 16 weeks, and again after 24 weeks to see if there are lasting changes.

Detailed Description

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The primary objective of this study is to evaluate the effectiveness of a multilevel rural community engagement model in:

1. improving children's dietary intake, and
2. enhancing providers' feeding practices, within rural family childcare homes, using a cluster randomized controlled trial design.

Secondary objectives are to assess within these family childcare homes:

1. child BMI z-scores and skin carotenoid levels (as a biomarker of fruit and vegetable intake), and
2. the mealtime emotional climate.

This cluster randomized controlled trial uses the family childcare home as the unit of randomization (i.e., clusters), with both children and providers nested within each family childcare home.

Conditions

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Childhood Obesity Pevention Diet Quality Feeding Behaviors Health Behavior Change Rural Health

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Arm 2. Better Kid Care

Arm 2: Rural family childcare home providers receive 10 online modules about general childcare topics unrelated to nutrition, including child development, block play, oral health, supervising children, and managing a family childcare home through the Better Kid Care platform.

Group Type ACTIVE_COMPARATOR

Better Kid Care

Intervention Type BEHAVIORAL

Rural family childcare home providers receive 10 online modules about general childcare topics unrelated to nutrition, including child development, block play, oral health, supervising children, and managing a family childcare home through the Better Kid Care platform.

Arm 1: EAT Family Style

Arm 1: Rural family childcare home providers receive 7 online modules on responsive feeding practices over 16 weeks, plus 7 individual coaching sessions via Zoom with Extension agents. Providers record mealtime videos for personalized feedback, engage in goal-setting and action planning, and receive printed materials and conversation cards.

Group Type EXPERIMENTAL

EAT Family Style

Intervention Type BEHAVIORAL

Rural family childcare home providers receive 7 online modules on responsive feeding practices over 16 weeks, plus 7 individual coaching sessions via Zoom with Extension agents. Providers record mealtime videos for personalized feedback, engage in goal-setting and action planning, and receive printed materials and conversation cards.

Interventions

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EAT Family Style

Rural family childcare home providers receive 7 online modules on responsive feeding practices over 16 weeks, plus 7 individual coaching sessions via Zoom with Extension agents. Providers record mealtime videos for personalized feedback, engage in goal-setting and action planning, and receive printed materials and conversation cards.

Intervention Type BEHAVIORAL

Better Kid Care

Rural family childcare home providers receive 10 online modules about general childcare topics unrelated to nutrition, including child development, block play, oral health, supervising children, and managing a family childcare home through the Better Kid Care platform.

Intervention Type BEHAVIORAL

Other Intervention Names

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EAT for Prevention

Eligibility Criteria

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Inclusion Criteria

FCCH Settings:

* Licensed family child care home-based early child care and education settings
* Located in Nebraska (with potential expansion to Iowa, Kansas, South Dakota, Oklahoma, Illinois, and/or Northwest Missouri if needed)
* Participate in the Child and Adult Care Food Program (CACFP)
* Care for at least 2 preschool-aged non-sibling children (3-5 years old) without feeding disorders or developmental delays
* Provide meals and snacks to attending children
* Located in a county designated as nonmetropolitan based on the 2023 Rural-Urban Continuum Codes (RUCC)

FCCH Providers:

* Currently caring for at least two 3-5 year old non-sibling children who do not have dietary restrictions or feeding disorders that impact how they eat
* Present with children during meals and snacks
* Over the age of 19 years
* Have not participated in this study before

Children:

* Between 3 to 5 years old
* No dietary restrictions or feeding disorder that impact how they eat (lactose intolerance, egg/nut allergies, or vegetarian diet are acceptable)
* Typically developing children (no diagnosis of developmental delays as identified by childcare providers)
* Have a parent or guardian 19 years of age or older to consent for them

Exclusion Criteria

FCCH Providers:

* FCCH provider closes the business
* FCCH provider stops serving meals to children
* FCCH provider discontinues participation in CACFP and no longer adheres to CACFP meal pattern requirements
* FCCH provider loses all eligible study children due to children leaving care, developing developmental delays or feeding disorders, or other reasons making them ineligible

Children:

* Diagnosis of dietary restrictions or feeding disorder that impact how they eat (soft diet requirements or difficulty swallowing that impacts how they eat)
* Diagnosis of developmental delays
* A sibling of a participating child (only one 3-5 year old child per family eligible)
Minimum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Nebraska Lincoln

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dipti Dev, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Nebraska Lincoln

Locations

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University of Nebraska Lincoln

Lincoln, Nebraska, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Dipti Dev, PhD

Role: CONTACT

402-472-2605

Other Identifiers

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UNL-00024617

Identifier Type: -

Identifier Source: org_study_id

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