Obesity, ChildhoodNCT07107321
Deimplementation of Inappropriate Feeding Practices in Early Care and Education Settings
A study testing WISE Words in people with Obesity, Childhood, run by Arkansas Children's Hospital Research Institute at 1 site in United States.
Trial summary
Arkansas and Louisiana have among the highest rates of adult obesity in the United States at 38.7% and 38.6%, respectively. Prevention and intervention efforts are needed to reduce the number of children who will become obese adults and suffer the host of negative health consequences that accompany it. Read more about this study
- Who is it for?
- Ages 3 years and older
- Conditions the study is for
- Obesity, Childhood
- What is being tested?
- WISE Words
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,640 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Aug 2025to 30 Apr 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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Sites within a 100-mile radius of staff offices serving 12+ children ages 3 to 5 years
- Agreeing to participate in data collection
- Sites will serve meals.
- All classrooms at a site will receive the same deimplementation strategies and participate in data collection. We will select one classroom at random per site to participate in the collection of child outcomes (N= 264 classrooms, 15 children per classroom= 1320 children total).
Who cannot join
- We will exclude sites that have participated in intervention studies with our team in the last 3 years.
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
Arkansas Children's Nutrition Center
Little Rock, Arkansas, 72205
About this study
Arkansas and Louisiana have among the highest rates of adult obesity in the United States at 38.7% and 38.6%, respectively. Prevention and intervention efforts are needed to reduce the number of children who will become obese adults and suffer the host of negative health consequences that accompany it. This proposal will develop and test strategies to stop the use of detrimental feeding practices by early childhood educators which promote unhealthy weight trajectories, inappropriate eating behaviors and poor dietary outcomes for children.
Read the detailed description
The long-term goal is to accelerate the implementation of evidence-based feeding practices in ECE settings that support healthy weight trajectories and diets for young children. The overall objective for this application, which is in response to PAR-22-105, is to determine the effectiveness and associated mechanisms of a package of deimplementation strategies to reduce the use of inappropriate feeding practices in ECE. The co-designed package of de-implementation strategies in this project will test includes six complimentary strategies. Three are foundational strategies that all educators will receive: training, a peer learning collaborative, and facilitation; three strategies are tailored to each educator's preferences for support and individual goals: audit and feedback, reminders, and educational resources. These six strategies will simultaneously support the removal of inappropriate practices and the uptake of alternative EBPs. To accomplish this goal, the strategies will target trust as a key mechanism for change, consistent with the Implementation Trust Building Theory of Change.
The rationale for the proposed project is that demonstrating the effectiveness of strategies for reducing inappropriate feeding practices in ECE and determining how the strategies work and for whom will provide new opportunities for their continued development and dissemination. In turn, these strategies will contribute to a strong foundation for lifelong healthy eating habits for children being served in ECE. This project includes a cluster-randomized Hybrid Type III trial with 88 ECE sites serving children ages 3 and 5. The trial will achieve two specific aims:
Aim 1: Determine the effectiveness of a package of deimplementation strategies for reducing the use of inappropriate feeding practices in ECE. The hypothesis is that, compared to usual practice, the deimplementation strategies will be effective at reducing the total number of observed inappropriate feeding practices per meal, our primary deimplementation outcome (N= 88 sites, 528 educators). This project will also identify effects on secondary effectiveness outcome measures including child body mass index, willingness to try new foods, fear of new foods (i.e., neophobia), and dietary intake (N=1320 children).
Aim 2: Identify mechanisms of deimplementation using a mixed methods approach. The hypothesis is that factors specified by the Implementation Trust Building Theory of Change22 will mediate the effect of strategies on deimplementation outcomes. Using an explanatory, sequential design, we will collect qualitative data with purposively selected educators (N = 32) to identify emergent mediators and moderators.
- Conditions
- Obesity, Childhood
- Being tested
- WISE Words
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WISE WordsBehavioural
WISE Words is a co-designed, multicomponent deimplementation strategy package including 6 discrete strategies. Of these, three are delivered in a standard fashion: (1) dynamic training driven by improvisation methods, (2) a peer learning collaborative, and (3) external facilitation. The additional three are tailored to each educator's preferences and goals: (4) reminders, (5) educational materials, and (6) audit and feedback. Educators are supported to set and achieve goals for one feeding practice they want to stop and one they want to start.
| Study group | Role | What they receive |
|---|---|---|
| WISE Words | Experimental | Bundle of deimplementation strategies including training, peer learning collaborative, external facilitation, audit and feedback, environmental reminders, and educational materials Receives: Behavioral: WISE Words |
| Standard educational practice | No intervention | Usual practice in ECE does not require a standard approach to nutrition education, and implementation varies based on the discretion of the site and/or educator. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Table Talk
This observational instrument includes the ability to rate the use of eight inappropriate and six evidence-based feeding practices within a single mealtime (approximately 30 minutes). Trained and field-reliable staff blinded to the study condition will collect fidelity data consistent with published protocols. This tool is not affected by ceiling effects are other measures feeding practices. That is, each discrete use of the 14 target feeding practices is captured. Continuous composite scores for inappropriate and evidence-based feeding practices will be used.
Measured: Five times: (1) baseline in the spring of the year prior to training, (2,3) during winter and spring in the implementation school year, and (4,5) during the fall of the following two school years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2025
- Study start12 Aug 2025
- Primary completion30 Apr 2029 (estimated)
- Study completion30 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, ChildhoodStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 2,640 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arkansas Children's Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Louisiana Tech University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07107321
- Sponsor's protocol ID
- 276116:
- Other IDs
- R01DK138153
- Status last verified
- Oct 2026
- First submitted
- 30 Jul 2025
- Last updated
- 16 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided