Childhood Obesity PeventionNCT07160530
Healthy Children, Healthy Communities: Effectiveness of a Multilevel Rural Community Engagement Model for Improving Children's Dietary Intake in Family Child Care Homes
A study testing EAT Family Style and Better Kid Care in people with Childhood Obesity Pevention and Diet Quality, run by University of Nebraska Lincoln at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 years and olderHealthy volunteers can take part
- Conditions the study is for
- Childhood Obesity Pevention, Diet Quality, Feeding Behaviors
- What is being tested?
- EAT Family Style and Better Kid Care
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Sep 2025to 31 May 2029
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Show all 18Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Nebraska Lincoln
Lincoln, Nebraska, 68588
About this study
Official title: Cluster Randomized Controlled Trial of a Multilevel Rural Community Engagement Model for Improving Children's Dietary Intake in Family Child Care Homes
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:
Read more
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:
- improving children's dietary intake, and
- 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:
- child BMI z-scores and skin carotenoid levels (as a biomarker of fruit and vegetable intake), and
- 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
- Childhood Obesity Pevention, Diet Quality, Feeding Behaviors, Health Behavior Change, Rural Health
- Being tested
- EAT Family Style, Better Kid Care
- Keywords
- Rural population, Feeding Behavior, Child Care, Child Feeding, Carotenoids, Body Mass Index
- Medical subject headings
- Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EAT Family StyleBehavioural
Also called EAT for Prevention
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.
Better Kid CareBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: EAT Family Style |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 compared to Dietary Guidelines for Americans to determine each child's two-day average intake.
Measured: 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)
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.
Measured: 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)
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.
Measured: From baseline to 24 weeks follow-up
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.
Measured: From baseline to 16 weeks post-intervention and 24-week follow-up
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.
Measured: From baseline to 16 weeks post-intervention
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.
Measured: From baseline to 24 weeks follow-up
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.
Measured: From baseline to 16 weeks post-intervention
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.
Measured: From baseline to 24-week follow-up
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.
Measured: From baseline to 16 weeks post-intervention
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.
Measured: From baseline to 24 weeks follow-up
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.
Measured: From baseline to 16 weeks post-intervention
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.
Measured: From baseline to 24 weeks follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study start25 Sep 2025
- Primary completion20 Dec 2028 (estimated)
- Study completion31 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood Obesity PeventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nebraska Lincoln
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dipti Dev, PhD, Principal investigator, University of Nebraska Lincoln
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07160530
- Sponsor's protocol ID
- UNL-00024617
- Status last verified
- Aug 2026
- First submitted
- 10 Jul 2025
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.