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

NCT07160530 | Recruiting DMC

• 1 other identifier: UNL-00024617
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Rural population; Feeding Behavior; Child Care; Child Feeding; Carotenoids; Body Mass Index

Outcome Measures

Primary Outcomes (2)

• Change in children's observed combined fruit and vegetable consumption [16 weeks]

  Children's fruit and vegetable consumption (servings/day) will be assessed by trained research staff observing two consecutive days of meals and snacks in family child care homes (FCCHs), following the Dietary Observation in Child Care (DOCC) protocol, which allows one observer to record intake for up to three children with minimal disruption. Data will be entered into the Nutrition Data System for Research (NDSR) to convert observed foods into nutrient and food group values. Fruit and vegetable intake will be quantified using MyPlate categories and compared to Dietary Guidelines for Americans to determine each child's two-day average intake.

  From baseline to 16 weeks post-intervention

• Change in children's observed combined fruit and vegetable consumption [24 weeks]

  Children's fruit and vegetable consumption (servings/day) will be assessed by trained research staff observing two consecutive days of meals and snacks in family child care homes (FCCHs), following the Dietary Observation in Child Care (DOCC) protocol, which allows one observer to record intake for up to three children with minimal disruption. Data will be entered into the Nutrition Data System for Research (NDSR) to convert observed foods into nutrient and food group values. Fruit and vegetable intake will be quantified using MyPlate categories and compared to Dietary Guidelines for Americans to determine each child's two-day average intake.

  From baseline to 24 weeks post-intervention

Secondary Outcomes (11)

• Change in children's observed diet quality, measured by the Healthy Eating Index-2020 (HEI-2020) (16 weeks)

  From baseline to 16 weeks post-intervention

• Change in children's observed diet quality, measured by the Healthy Eating Index-2020 (HEI-2020) (24 weeks)

  From baseline to 24 weeks follow-up

• Change in the observed mealtime emotional climate

  From baseline to 16 weeks post-intervention and 24-week follow-up

• Change in family childcare home providers observed responsive feeding practices (16 weeks)

  From baseline to 16 weeks post-intervention

• Change in family childcare home providers observed responsive feeding practices (24 weeks)

  From baseline to 24 weeks follow-up

Other Outcomes (4)

• Change in children's skin carotenoids (16 weeks)

  From baseline to 16 weeks post-intervention

• Change in children's skin carotenoids (24 weeks)

  From baseline to 24-week follow-up

• Change in children's measured BMI z-score (16 weeks)

  From baseline to 16 weeks post-intervention

Study Arms (2)

Arm 2. Better Kid Care

ACTIVE COMPARATOR

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.

Behavioral: Better Kid Care

Arm 1: EAT Family Style

EXPERIMENTAL

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.

Behavioral: EAT Family Style

Interventions

EAT Family Style 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.

Also known as: EAT for Prevention

Arm 1: EAT Family Style

Better Kid Care 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 2. Better Kid Care

Eligibility Criteria

• Age: 3 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Nebraska Lincoln: lead

Study Sites (1)

University of Nebraska Lincoln

Lincoln, Nebraska, 68588, United States

RECRUITING

MeSH Terms

Conditions

Feeding Behavior

Interventions

Eating

Condition Hierarchy (Ancestors)

Behavior, Animal; Behavior

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Digestive System Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Study Officials

• Dipti Dev, PhD

  University of Nebraska Lincoln

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dipti Dev, PhD

CONTACT

402-472-2605; unlhealthychildren@unl.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2025
• First Posted: September 8, 2025
• Study Start: September 25, 2025
• Primary Completion (Estimated): December 20, 2028
• Study Completion (Estimated): May 31, 2029
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data will become available as soon as the dataset is cleaned and prior to the time of publication or the end of the funding period, whichever comes first. Data will be permanently archived and maintained through the NICHD DASH repository for long-term access and preservation, following NIH data sharing policies.
• Access Criteria: Access will be provided through NICHD's DASH controlled-access repository to identity-verified researchers for scientifically and ethically appropriate uses. The NICHD DASH Data Access Committee reviews all access requests to ensure proposed use does not conflict with research data use limitations. Requesters must establish a Data Use Agreement outlining expectations for appropriate use of DASH data.

Locations

US (1)