AzTrials
AzTrials

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.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record

Search all trials

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
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

Other trials in United States

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.

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 groups in NCT07107321
Study groupRoleWhat they receive
WISE WordsExperimentalBundle of deimplementation strategies including training, peer learning collaborative, external facilitation, audit and feedback, environmental reminders, and educational materials
Receives: Behavioral: WISE Words
Standard educational practiceNo interventionUsual 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.

  1. 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.

  1. First posted6 Aug 2025
  2. Study start12 Aug 2025
  3. Primary completion30 Apr 2029 (estimated)
  4. Study completion30 Apr 2029 (estimated)

Resources

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)
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

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in