NCT07107321

Brief 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. 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,640

participants targeted

Target at P75+ for not_applicable

Timeline
35mo left

Started Aug 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress23%
Aug 2025Apr 2029

First Submitted

Initial submission to the registry

July 30, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 6, 2025

Completed
6 days until next milestone

Study Start

First participant enrolled

August 12, 2025

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2029

Last Updated

October 2, 2025

Status Verified

September 1, 2025

Enrollment Period

3.7 years

First QC Date

July 30, 2025

Last Update Submit

September 29, 2025

Conditions

Outcome Measures

Primary Outcomes (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.

    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.

Study Arms (2)

WISE Words

EXPERIMENTAL

Bundle of deimplementation strategies including training, peer learning collaborative, external facilitation, audit and feedback, environmental reminders, and educational materials

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.

Interventions

WISE WordsBEHAVIORAL

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.

WISE Words

Eligibility Criteria

Age3 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • We will exclude sites that have participated in intervention studies with our team in the last 3 years.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arkansas Children's Nutrition Center

Little Rock, Arkansas, 72205, United States

Location

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 30, 2025

First Posted

August 6, 2025

Study Start

August 12, 2025

Primary Completion (Estimated)

April 30, 2029

Study Completion (Estimated)

April 30, 2029

Last Updated

October 2, 2025

Record last verified: 2025-09

Locations