Last reviewed · How we verify

NCT03075085

Developing and Testing Implementation Strategies for Evidence-Based Obesity Prevention in Childcare

Completed NA Results posted Last updated 5 September 2021
What this trial tests

NA trial testing WISE (We Inspire Smart Eating) in Obesity in 696 participants. Completed in 15 December 2019.

Timeline
26 January 2018
Primary endpoint
15 December 2019
15 December 2019

Quick facts

Lead sponsorUniversity of Arkansas
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposeprevention
Enrollment696
Start date26 January 2018
Primary completion15 December 2019
Estimated completion15 December 2019
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of Arkansas

Who can join

18 and older, any sex, with Obesity. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Educators' Observed Implementation Fidelity Scores for Use of Evidence-Based Obesity Practices Primary · From Baseline Up to 8 months

The WISE fidelity measure will be used across the school year. The WISE fidelity instrument is rated on a 1 to 4 scale with 4 representing the highest level of fidelity. Each core component is assessed with 2 items. Average fidelity scores above 3 are considered to reflect adequate fidelity on a component. That is, the 2 items on each fidelity component were averaged; an average of above 3 was considered as having achieved fidelity. We are reporting on the total number of classrooms that achieved fidelity in each condition at the spring (final assessment) for the evidence-based practices of WI

Role Modeling
GroupValue95% CI
Basic WISE Strategy4
Enhanced WISE Strategy10
Use of Mascot
GroupValue95% CI
Basic WISE Strategy2
Enhanced WISE Strategy4
Hands On Exposure
GroupValue95% CI
Basic WISE Strategy1
Enhanced WISE Strategy6

Sponsor's own description

Investigators will pilot test the impact of an enhanced implementation strategy on implementation and child health outcomes using continuous formative evaluation. Investigators will test the hypothesis that better fidelity to the implementation strategy (WISE) is positively related to child outcomes (e.g., child fruit and vegetable intake, BMI).

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Strategies to improve the implementation of healthy eating, physical activity and obesity prevention policies, practices or programmes within childcare services.
    Wolfenden L, Barnes C, Jones J, Finch M, et al · · 2020 · cited 126× · PMID 32036618 · DOI 10.1002/14651858.cd011779.pub3
  2. Caregiver involvement in interventions for improving children's dietary intake and physical activity behaviors.
    Morgan EH, Schoonees A, Sriram U, Faure M, et al · · 2020 · cited 54× · PMID 31902132 · DOI 10.1002/14651858.cd012547.pub2
  3. A mixed methods protocol for developing and testing implementation strategies for evidence-based obesity prevention in childcare: a cluster randomized hybrid type III trial.
    Swindle T, Johnson SL, Whiteside-Mansell L, Curran GM. · · 2017 · cited 27× · PMID 28720140 · DOI 10.1186/s13012-017-0624-6
  4. Fidelity monitoring in complex interventions: a case study of the WISE intervention.
    Swindle T, Selig JP, Rutledge JM, Whiteside-Mansell L, et al · · 2018 · cited 24× · PMID 30181874 · DOI 10.1186/s13690-018-0292-2
  5. Stakeholder selected strategies for obesity prevention in childcare: results from a small-scale cluster randomized hybrid type III trial.
    Swindle T, McBride NM, Selig JP, Johnson SL, et al · · 2021 · cited 17× · PMID 33933130 · DOI 10.1186/s13012-021-01119-x
  6. Interventions to prevent obesity in children aged 2 to 4 years old.
    Phillips SM, Spiga F, Moore TH, Dawson S, et al · · 2025 · cited 3× · PMID 40494564 · DOI 10.1002/14651858.cd015326.pub2
  7. Proceedings of the Fifth Biennial Conference of the Society for Implementation Research Collaboration (SIRC) 2019: where the rubber meets the road: the intersection of research, policy, and practice - part 2 : Seattle, WA, USA. 12-14 September 2019.
    · 2020 · PMID 32998745 · DOI 10.1186/s13012-020-01033-8

Verify or expand the search:

Other recruiting trials for Obesity

Currently open trials in the same condition.

Other University of Arkansas trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03075085.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing