ClinicalTrials.gg
RecruitingNCT07160530Updated Sep 1, 2026

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

An interventional study of EAT Family Style and Better Kid Care in Childhood Obesity Pevention, Diet Quality and Feeding Behaviors, sponsored by University of Nebraska Lincoln. Recruiting at 1 site in United States. Open to participants aged 3 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-01.

Sponsored by University of Nebraska Lincoln · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Started Sep 2025; still recruiting 1 year 1 month later.
Phase
Not applicable
Study type
Interventional
Enrollment
360
Allocation
Randomized
Ages
3 Years and older
Sex
All
01

Study 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.

Read the detailed description

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.

02

Conditions studied

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

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Keywords

  • Rural population
  • Feeding Behavior
  • Child Care
  • Child Feeding
  • Carotenoids
  • Body Mass Index
03

In context

Feeding Behavior

985 studies on the registry are indexed under Feeding Behavior; 178 are open to participants now.

This study's planned enrollment of 360 is above the median of 77 across 700 interventional studies indexed under Feeding Behavior.

Browse Feeding Behavior studies →

Lead sponsor

University of Nebraska Lincoln is the lead sponsor of 29 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

FCCH Settings:

  • Licensed family child care home-based early child care and education settings
  • Located in RURAL Nebraska or Kansas
  • Participate in the Child and Adult Care Food Program (CACFP)
  • Care for at least 2 preschool-aged 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.

FCCH Providers:

  • Currently caring for at least two eligible 3-5 year old children who consume at least one meal and one snack in the program for at least two days per week.
  • Present with children during meals and snacks
  • Over the age of 19 years
  • Have not participated in the intervention before

Children:

  • Between 3 to 5 years old
  • Must consume at least one meal and one snack in the program for at least two days per week.
  • 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

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
360 participants (estimated)

Study arms

  • 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.

    Behavioral: Better Kid Care

  • 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.

    Behavioral: EAT Family Style

Interventions

  • BehavioralEAT 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.

    Also known as: EAT for Prevention

  • BehavioralBetter 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.

06

What researchers measure

Primary outcomes

  1. 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 compared to Dietary Guidelines for Americans to determine each child's two-day average intake.

    Time frame: From baseline to 16 weeks post-intervention

  2. 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 compared to Dietary Guidelines for Americans to determine each child's two-day average intake.

    Time frame: From baseline to 24 weeks post-intervention

Secondary outcomes

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

    Children's dietary intake will be assessed by trained research staff observing two 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. Diet quality will be measured with the Healthy Eating Index-2020 (HEI-2020), ranging from 0-100, where higher scores reflect better diet quality. Average HEI-2020 scores will be calculated per child, standardized per 1,000 kcal, and aggregated at the FCCH level.

    Time frame: From baseline to 16 weeks post-intervention

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

    Children's dietary intake will be assessed by trained research staff observing two 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. Diet quality will be measured with the Healthy Eating Index-2020 (HEI-2020), ranging from 0-100, where higher scores reflect better diet quality. Average HEI-2020 scores will be calculated per child, standardized per 1,000 kcal, and aggregated at the FCCH level.

    Time frame: From baseline to 24 weeks follow-up

  3. Change in the observed mealtime emotional climate

    Mealtime emotional climate refers to the quality of interpersonal interactions between the provider and children during mealtime. We will record lunchtime videos during baseline, post and follow-up to assess MEC coded by the Mealtime Emotional Climate in Child Care Observational Scales , which includes two higher-level constructs: positive and negative MEC.

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

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

    Providers' observed responsive feeding practices. The research team will record lunchtime videos before and after the intervention and follow-up; these videos will be coded using the Mealtime Observation in Child Care Checklist. These responsive feeding practices are focused on improving mealtime structure and providing developmentally appropriate support for children's autonomy.

    Time frame: From baseline to 16 weeks post-intervention

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

    Providers' observed feeding practices. The research team will record lunchtime videos before and after the intervention and follow-up; these videos will be coded using the Mealtime Observation in Child Care Checklist. These responsive feeding practices are focused on improving mealtime structure and providing developmentally appropriate support for children's autonomy.

    Time frame: From baseline to 24 weeks follow-up

  6. Change in family childcare home providers' self-reported responsive feeding practices (16 weeks)

    Providers' self-reported feeding practices. All FCCH providers will complete a 30- 45-minute online survey on Qualtrics before, after, and during follow-up data collection to to measure providers' responsive feeding practices. These practices are focused on improving mealtime structure and providing developmentally appropriate support for children's autonomy during mealtimes.

    Time frame: From baseline to 16 weeks post-intervention

  7. Change in family childcare home providers' self-reported responsive feeding practices (24 weeks)

    Providers' self-reported responsive feeding practices. All FCCH providers will complete a 30- 45-minute online survey on Qualtrics before, after, and during follow-up data collection to to measure providers' responsive feeding practices. These practices are focused on improving mealtime structure and providing developmentally appropriate support for children's autonomy during mealtimes.

    Time frame: From baseline to 24-week follow-up

  8. Change in family childcare home providers observed controlling feeding practices (16 weeks)

    Providers' observed controlling feeding practices (e.g. pressure to eat, offering food as reward). The research team will record lunchtime videos before and after the intervention and follow-up; these videos will be coded using the Mealtime Observation in Child Care Checklist.

    Time frame: From baseline to 16 weeks post-intervention

  9. Change in family childcare home providers observed controlling feeding practices (24 weeks)

    Providers' observed controlling feeding practices (e.g. pressure to eat, offering food as reward). The research team will record lunchtime videos before and after the intervention and follow-up; these videos will be coded using the Mealtime Observation in Child Care Checklist.

    Time frame: From baseline to 24 weeks follow-up

  10. Change in family childcare home providers' self-reported controlling feeding practices (16 weeks)

    Providers' self-reported controlling feeding practices (e.g. pressure to eat, offering food as reward). All FCCH providers will complete a 30- 45-minute online survey on Qualtrics before, after, and during follow-up data collection to to measure providers' controlling feeding practices.

    Time frame: From baseline to 16 weeks post-intervention

  11. Change in family childcare home providers' self-reported controlling feeding practices (24 weeks)

    Providers' self-reported controlling feeding practices (e.g. pressure to eat, offering food as reward). All FCCH providers will complete a 30- 45-minute online survey on Qualtrics before, after, and during follow-up data collection to to measure providers' controlling feeding practices.

    Time frame: From baseline to 24 weeks follow-up

Other outcomes

  1. Change in children's skin carotenoids (16 weeks)

    The Veggie Meter device (Longevity Link Corp., Utah)will provide an objective, non-invasive, and quick measure reflecting fruit and vegetable intake at all three study timepoints. The device uses reflection spectroscopy to detect carotenoid levels in human skin, has been validated against dietary intake in diverse groups of adults and children and also assess changes over time.

    Time frame: From baseline to 16 weeks post-intervention

  2. Change in children's skin carotenoids (24 weeks)

    The Veggie Meter device (Longevity Link Corp., Utah)will provide an objective, non-invasive, and quick measure reflecting fruit and vegetable intake at all three study timepoints. The device uses reflection spectroscopy to detect carotenoid levels in human skin, has been validated against dietary intake in diverse groups of adults and children and also assess changes over time.

    Time frame: From baseline to 24-week follow-up

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

    Children's standing height (in meters) will be measured using a portable stadiometer, and weight (in kg) will be measured using a calibrated digital scale in the FCCH setting, following a standard protocol. Height-weight measurements will be aggregated to arrive at BMI z-score (e.g., weight and height will be combined to report BMI in kg/m\^2 and then calculate the BMI z-score).

    Time frame: From baseline to 16 weeks post-intervention

  4. Change in children's measured BMI z-score (24 weeks)

    Children's standing height (in meters) will be measured using a portable stadiometer, and weight (in kg) will be measured using a calibrated digital scale in the FCCH setting, following a standard protocol. Height-weight measurements will be aggregated to arrive at BMI z-score (e.g., weight and height will be combined to report BMI in kg/m\^2 and then calculate the BMI z-score).

    Time frame: From baseline to 24-week follow-up

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Yes — There is a plan to make IPD and related data dictionaries available. All collected individual participant data that underlies results in publications will be shared after being fully de-identified. This includes child dietary intake, anthropometric, skin carotenoid data, provider feeding practices surveys, and demographic information. Data will be available through the NICHD DASH controlled-access repository with proper plans and safeguards for privacy protection.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report

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.

Data sharing details ↗ · dash.nichd.nih.gov

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2025 (actual). Primary completion is estimated for Dec 2028, 38 months after the start.

Of 503 non-industry interventional studies with no phase under Feeding Behavior, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 31. This study's planned 38 months is above that.

Counting every sponsor, half of 515 studies reached it within 14 months; a quarter within 5 and three quarters within 31.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 10, 2025
First posted
Sep 8, 2025
StartActual
Sep 25, 2025
Primary completionEst.
Dec 20, 2028
CompletionEst.
May 31, 2029
Last update
Sep 1, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 1, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07160530
Lead sponsor
University of Nebraska Lincoln
Responsible party
Sponsor
First posted
Sep 8, 2025
Start date
Sep 25, 2025
Primary completion
Dec 20, 2028 (estimated)
Completion
May 31, 2029 (estimated)
Last update
Sep 1, 2026

Study contacts

Dipti Dev, PhD
Contact
unlhealthychildren@unl.edu
402-472-2605
Dipti Dev, PhD
principal investigator · University of Nebraska Lincoln

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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