Sviluppo e sperimentazione di strategie di attuazione per la prevenzione dell'obesità basata sull'evidenza nell'assistenza all'infanzia
9 settembre 2026 aggiornato da: University of Arkansas
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).
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Investigators will determine whether the enhanced strategy is feasible, acceptable, and demonstrates improved implementation, fidelity, and sustainability using a Hybrid Type 3 implementation design. Investigators expect that the effectiveness of WISE on child outcomes will vary by the level of implementation fidelity, and a Hybrid 3 design allows for us to explore this hypothesis).
Tipo di studio
Interventistico
Iscrizione (Effettivo)
38
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
-
-
Arkansas
-
Little Rock, Arkansas, Stati Uniti, 72205
- University of Arkansas for Medical Sciences
-
-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
Sì
Sessi ammissibili allo studio
Tutto
Descrizione
Inclusion Criteria:
- Early childhood educators from our partnering Head Start agency
Exclusion Criteria:
- Secondary Outcome Inclusion Criteria:
- Children aged 3-5 years old in our partnering Head Start agency
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Comparatore attivo: Basic WISE strategy
These participants will be asked to implement the basic WISE strategy used in previous studies. |
An enhanced implementation strategy for evidence-based obesity prevention in childcare |
|
Sperimentale: Enhanced WISE strategy
These participants will be asked to implement the enhanced WISE strategy. |
An enhanced implementation strategy for evidence-based obesity prevention in childcare |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
WISE Fidelity Scores for Use of Evidence-Based Obesity Practices
Lasso di tempo: 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 WISE. |
From Baseline Up to 8 months
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Investigatore principale: Taren M Swindle, PhD, University of Arkansas
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
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- Scarmo S, Henebery K, Peracchio H, Cartmel B, Lin H, Ermakov IV, Gellermann W, Bernstein PS, Duffy VB, Mayne ST. Skin carotenoid status measured by resonance Raman spectroscopy as a biomarker of fruit and vegetable intake in preschool children. Eur J Clin Nutr. 2012 May;66(5):555-60. doi: 10.1038/ejcn.2012.31. Epub 2012 Mar 21.
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- Juonala M, Magnussen CG, Berenson GS, Venn A, Burns TL, Sabin MA, Srinivasan SR, Daniels SR, Davis PH, Chen W, Sun C, Cheung M, Viikari JS, Dwyer T, Raitakari OT. Childhood adiposity, adult adiposity, and cardiovascular risk factors. N Engl J Med. 2011 Nov 17;365(20):1876-85. doi: 10.1056/NEJMoa1010112.
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- Johnson SL, Bellows L, Beckstrom L, Anderson J. Evaluation of a social marketing campaign targeting preschool children. Am J Health Behav. 2007 Jan-Feb;31(1):44-55. doi: 10.5555/ajhb.2007.31.1.44.
- Freedman MR, Alvarez KP. Early childhood feeding: assessing knowledge, attitude, and practices of multi-ethnic child-care providers. J Am Diet Assoc. 2010 Mar;110(3):447-51. doi: 10.1016/j.jada.2009.11.018.
- Benjamin SE, Cradock A, Walker EM, Slining M, Gillman MW. Obesity prevention in child care: a review of U.S. state regulations. BMC Public Health. 2008 May 30;8:188. doi: 10.1186/1471-2458-8-188.
- Sigman-Grant M, Christiansen E, Fernandez G, Fletcher J, Johnson SL, Branen L, Price BA. Child care provider training and a supportive feeding environment in child care settings in 4 states, 2003. Prev Chronic Dis. 2011 Sep;8(5):A113. Epub 2011 Aug 15.
- Woolf SH, Johnson RE. The break-even point: when medical advances are less important than improving the fidelity with which they are delivered. Ann Fam Med. 2005 Nov-Dec;3(6):545-52. doi: 10.1370/afm.406.
- Glasgow RE. What types of evidence are most needed to advance behavioral medicine? Ann Behav Med. 2008 Feb;35(1):19-25. doi: 10.1007/s12160-007-9008-5. Epub 2008 Feb 12.
- Clarke AM, Bunting B, Barry MM. Evaluating the implementation of a school-based emotional well-being programme: a cluster randomized controlled trial of Zippy's Friends for children in disadvantaged primary schools. Health Educ Res. 2014 Oct;29(5):786-98. doi: 10.1093/her/cyu047. Epub 2014 Aug 11.
- Atkins MS, Frazier SL, Leathers SJ, Graczyk PA, Talbott E, Jakobsons L, Adil JA, Marinez-Lora A, Demirtas H, Gibbons RB, Bell CC. Teacher key opinion leaders and mental health consultation in low-income urban schools. J Consult Clin Psychol. 2008 Oct;76(5):905-8. doi: 10.1037/a0013036.
- Noell GH, Witt JC, LaFleur LH, Mortenson BP, Ranier DD, LeVelle J. Increasing intervention implementation in general education following consultation: a comparison of two follow-up strategies. J Appl Behav Anal. 2000 Fall;33(3):271-84. doi: 10.1901/jaba.2000.33-271.
- Rabin BA, Glasgow RE, Kerner JF, Klump MP, Brownson RC. Dissemination and implementation research on community-based cancer prevention: a systematic review. Am J Prev Med. 2010 Apr;38(4):443-56. doi: 10.1016/j.amepre.2009.12.035.
- Bell AC, Davies L, Finch M, Wolfenden L, Francis JL, Sutherland R, Wiggers J. An implementation intervention to encourage healthy eating in centre-based child-care services: impact of the Good for Kids Good for Life programme. Public Health Nutr. 2015 Jun;18(9):1610-9. doi: 10.1017/S1368980013003364. Epub 2014 Jan 9.
- Jones J, Wolfenden L, Wyse R, Finch M, Yoong SL, Dodds P, Pond N, Gillham K, Freund M, McElduff P, Wye P, Wiggers J. A randomised controlled trial of an intervention to facilitate the implementation of healthy eating and physical activity policies and practices in childcare services. BMJ Open. 2014 Apr 17;4(4):e005312. doi: 10.1136/bmjopen-2014-005312.
- Khoo HE, Prasad KN, Kong KW, Jiang Y, Ismail A. Carotenoids and their isomers: color pigments in fruits and vegetables. Molecules. 2011 Feb 18;16(2):1710-38. doi: 10.3390/molecules16021710.
- Darvin ME, Fluhr JW, Caspers P, van der Pool A, Richter H, Patzelt A, Sterry W, Lademann J. In vivo distribution of carotenoids in different anatomical locations of human skin: comparative assessment with two different Raman spectroscopy methods. Exp Dermatol. 2009 Dec;18(12):1060-3. doi: 10.1111/j.1600-0625.2009.00946.x.
- Blume-Peytavi U, Rolland A, Darvin ME, Constable A, Pineau I, Voit C, Zappel K, Schafer-Hesterberg G, Meinke M, Clavez RL, Sterry W, Lademann J. Cutaneous lycopene and beta-carotene levels measured by resonance Raman spectroscopy: high reliability and sensitivity to oral lactolycopene deprivation and supplementation. Eur J Pharm Biopharm. 2009 Sep;73(1):187-94. doi: 10.1016/j.ejpb.2009.04.017. Epub 2009 May 13.
- Meinke MC, Darvin ME, Vollert H, Lademann J. Bioavailability of natural carotenoids in human skin compared to blood. Eur J Pharm Biopharm. 2010 Oct;76(2):269-74. doi: 10.1016/j.ejpb.2010.06.004. Epub 2010 Jun 15.
- Levi J, Segal L, St. Laurent R, Rayburn J. The state of obesity: Better policies for a healthier America. Princeton (NJ): Robert Wood Johnson Foundation and Trust for America's Health; 2014 Sept. Available from: http://www.rwjf.org/en/library/research/2014/09/the-state-of-obesity.html
- Segal LM, Rayburn J, Martin A. Adult Obesity in the United States. Princeton (NJ): Robert Wood Johnson Foundation and Trust for America's Health; 2015. Available from: http://stateofobesity.org/adult-obesity/
- Frisvold DE, Lumeng JC. Expanding exposure: Can increasing the daily duration of head start reduce childhood obesity? The Journal of Human Resources 46(2): 373-402, 2011.
- Faith MS, Pietrobelli A, Heo M, Johnson SL, Keller KL, Heymsfield SB, Allison DB. A twin study of self-regulatory eating in early childhood: estimates of genetic and environmental influence, and measurement considerations. Int J Obes (Lond). 2012 Jul;36(7):931-7. doi: 10.1038/ijo.2011.258. Epub 2012 Jan 17.
- Thomsen MR, Nayga RM, Alviola PA, Rouse HL. The effect of food deserts on the body mass index of elementary school children. American Journal of Agricultural Economics 98(1): 1-18, 2015.
- Dev DA, Speirs KE, McBride BA, Donovan SM, Chapman-Novakofski K. Head Start and child care providers' motivators, barriers and facilitators to practicing family-style meal service. Early Childhood Research Quarterly 29(4): 649-659, 2014.
- Child Care Aware of America. Child care in America: 2012 state fact sheets; 2012. Available from: http://usa.childcareaware.org/advocacy-public-policy/resources/reports-and-research/
- Whiteside-Mansell L, Bradley R, Conners N, Bokony P. The family map: Structured family interview to identify risks and strength in Head Start families. NHSA Dialog 10(3-4): 189-209, 2007.
- Darvin ME, Sterry W, Lademann J, Vergou T. The role of carotenoids in human skin. Molecules 16(12): 10491-10506, 2011.
- Darvin ME, Gersonde I, Meinke M, Sterry W, Lademann J. Non-invasive in vivo determination of the carotenoids beta-carotene and lycopene concentrations in the human skin using the Raman spectroscopic method. Journal of Physics D: Applied Physics 38(15): 2696, 2005.
- Swindle T, McBride NM, Selig JP, Johnson SL, Whiteside-Mansell L, Martin J, Staley A, Curran GM. Stakeholder selected strategies for obesity prevention in childcare: results from a small-scale cluster randomized hybrid type III trial. Implement Sci. 2021 May 1;16(1):48. doi: 10.1186/s13012-021-01119-x.
- Swindle T, Selig JP, Rutledge JM, Whiteside-Mansell L, Curran G. Fidelity monitoring in complex interventions: a case study of the WISE intervention. Arch Public Health. 2018 Aug 29;76:53. doi: 10.1186/s13690-018-0292-2. eCollection 2018.
- Swindle T, Johnson SL, Whiteside-Mansell L, Curran GM. A mixed methods protocol for developing and testing implementation strategies for evidence-based obesity prevention in childcare: a cluster randomized hybrid type III trial. Implement Sci. 2017 Jul 18;12(1):90. doi: 10.1186/s13012-017-0624-6.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
26 gennaio 2018
Completamento primario (Effettivo)
15 dicembre 2019
Completamento dello studio (Effettivo)
15 marzo 2020
Date di iscrizione allo studio
Primo inviato
20 febbraio 2017
Primo inviato che soddisfa i criteri di controllo qualità
3 marzo 2017
Primo Inserito (Effettivo)
9 marzo 2017
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
1 ottobre 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
9 settembre 2026
Ultimo verificato
1 settembre 2026
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 205335
- K01DK110141-01 (Sovvenzione/contratto NIH degli Stati Uniti)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .