Cluster Randomized Controlled Trial of a Multilevel Rural Community Engagement Model for Improving Children's Dietary Intake in Family Child Care Homes

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 3
Healthy Volunteers: t
View:

⁃ 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

Locations
United States
Nebraska
University of Nebraska Lincoln
RECRUITING
Lincoln
Contact Information
Primary
Dipti Dev, PhD
unlhealthychildren@unl.edu
402-472-2605
Time Frame
Start Date: 2025-10-07
Estimated Completion Date: 2029-05-31
Participants
Target number of participants: 360
Treatments
Active_comparator: 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.
Experimental: 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.
Related Therapeutic Areas
Sponsors
Leads: University of Nebraska Lincoln

This content was sourced from clinicaltrials.gov

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