- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01510483
Clinician Promotion of Healthy Diet and Activity to Reduce Obesity Among Adolescents: HEALTHY SMILES (HS)
16 aprile 2018 aggiornato da: Melbourne Hovell, San Diego State University
Clinician Promotion of Healthy Diet and Activity to Reduce Obesity Among Adolescents
This study will test an 18-month intervention designed to increase physical activity, reduce sedentary practices and promote healthy diets or reduce tobacco use and exposure among preteens who obtain orthodontic care.
Relevance: If successful, this study may inform policies that would promote all specialists (orthodontists, physicians, general dentists) to deliver brief counseling for diet, physical activity, and tobacco prevention.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
This study will test a 18-month multi-component intervention designed to increase physical activity, reduce sedentary practices and promote healthy diets among preteens who obtain orthodontic care.
The intervention is based on the Behavioral Ecological Model (BEM), where interacting physiological, environmental, and cultural contingencies select behavior.
This study will require five years to recruit 40 orthodontist offices, and 1700 youth, and implement an office-wide intervention for promoting healthy diet and physical activity among 8-14 yr old youth.
Our primary aims are to detect a differential change in diet, physical activity and BMI in our experimental group compared to the tobacco prevention control group; to observe differential effects of the intervention between low vs. high SES; and similarly for males vs. females; to validate our primary outcome variables by contrasting them with a "gold standard"; and determine the degree to which family and peer encouragement for sedentary and high caloric diet at baseline increases the relative effect of the orthodontist intervention.
Offices will be assigned at random to condition producing a 2 (experimental group) by 2 strata (low vs. high SES) by 2 strata (male vs. female) by 4 (repeated measures) experimental design.
Those in the experimental condition will be exposed to the office-wide intervention for diet and activity; those in the control condition will be exposed to an office-wide intervention for tobacco prevention.
The intervention will consist of training of orthodontists and office staff to provide appropriate social prompts, reinforcement and counseling, and modification of the offices to provide supportive physical and social resources for their patients and parents.
Measures of diet, physical activity, body composition, tobacco use, fitness and family and peer encouragement will occur at baseline, 12, 18, and 24 months.
Differential change over time will be analyzed using Random Effects Multivariate modeling.
Analyses will include control for office cluster effects and multivariate models will include analyses of hypothetical main effects, experimental group by time interactions, and moderating effects by inclusion of interaction terms for susceptibility by experimental condition and other possible moderators.
Relevance: If successful, this study may inform policies that would promote all specialists (physicians, general dentists) to deliver brief counseling for diet and physical activity.
Doing so might yield the cumulative exposure necessary to effect and sustain change in a large proportion of the preteen population.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
693
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
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California
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San Diego, California, Stati Uniti, 92123
- SDSU-Center for Behavioral Epidemiology & Community Health
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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
Da 8 anni a 14 anni (Bambino)
Accetta volontari sani
Sì
Sessi ammissibili allo studio
Tutto
Descrizione
Inclusion Criteria:
- 8-14 years old
- receiving orthodontic care at a participating orthodontic office
- at least 1 year left in braces
Exclusion Criteria:
- participating in 9 or more months of structured
- organized sports for 3 or more days a week, youth who have serious conditions that preclude physical activity or make the child incapable of managing his/her own care will not qualify for this study
- individuals who report anorexia, bulimia or severe, diagnosed depression will not be eligible
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: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: Obesity prevention
Orthodontist promotion of physical activity and healthy diet
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Those in the experimental, obesity prevention, condition will be exposed to the office-wide intervention for diet and activity.
The intervention will consist of training of orthodontists and office staff to provide appropriate social prompts, reinforcement and counseling, and modification of the offices to provide supportive physical and social resources for their patients and parents.
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Comparatore attivo: Tobacco prevention
Orthodontist promotion of tobacco and second hand smoke avoidance
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Those in the control, tobacco prevention, condition will be exposed to the office-wide intervention for avoidance of tobacco and second hand smoke.
The intervention will consist of training of orthodontists and office staff to provide appropriate social prompts, reinforcement and counseling, and modification of the offices to provide supportive physical and social resources for their patients and parents.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Change in Body Mass Index
Lasso di tempo: Baseline, 2, 4, 6, 8, 10, 12, 14, 16, 18, 24 months
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Body Mass Index assessed at Baseline, 12 month, 18 months and 24 months; and every 6-8 weeks during intervention period.
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Baseline, 2, 4, 6, 8, 10, 12, 14, 16, 18, 24 months
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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
---|---|
Change in physical and sedentary activity
Lasso di tempo: Baseline, 12, 18 and 24 months
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Baseline, 12, 18 and 24 months
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Change in dietary intake
Lasso di tempo: Baseline, 12, 18 and 24 months
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Baseline, 12, 18 and 24 months
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Change in tobacco use and exposure
Lasso di tempo: Baseline, 12, 18 and 24 months
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Baseline, 12, 18 and 24 months
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Investigatore principale: Melbourne F Hovell, PhD, MPH, SDSU/GSPH
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
- Slymen DJ, Hovell MF. Cluster versus individual randomization in adolescent tobacco and alcohol studies: illustrations for design decisions. Int J Epidemiol. 1997 Aug;26(4):765-71. doi: 10.1093/ije/26.4.765.
- Hovell MF, Slymen DJ, Keating KJ, Jones JA, Burkham-Kreitner S, Hofstetter CR, Noel D, Rubin B. Tobacco use prevalence and correlates among adolescents in a clinician initiated tobacco prevention trial in California, USA. J Epidemiol Community Health. 1996 Jun;50(3):340-6. doi: 10.1136/jech.50.3.340.
- Hovell MF, Slymen DJ, Jones JA, Hofstetter CR, Burkham-Kreitner S, Conway TL, Rubin B, Noel D. An adolescent tobacco-use prevention trial in orthodontic offices. Am J Public Health. 1996 Dec;86(12):1760-6. doi: 10.2105/ajph.86.12.1760.
- Wahlgren DR, Hovell MF, Slymen DJ, Conway TL, Hofstetter CR, Jones JA. Predictors of tobacco use initiation in adolescents: a two-year prospective study and theoretical discussion. Tob Control. 1997 Summer;6(2):95-103. doi: 10.1136/tc.6.2.95.
- Hovell MF, Nichols JF, Irvin VL, Schmitz KE, Rock CL, Hofstetter CR, Keating K, Stark LJ. Parent/Child training to increase preteens' calcium, physical activity, and bone density: a controlled trial. Am J Health Promot. 2009 Nov-Dec;24(2):118-28. doi: 10.4278/ajhp.08021111.
- Zakarian JM, Hovell MF, Conway TL, Hofstetter CR, Slymen DJ. Tobacco use and other risk behaviors: cross-sectional and predictive relationships for adolescent orthodontic patients. Nicotine Tob Res. 2000 May;2(2):179-86. doi: 10.1080/713688132.
- Russos S, Hovell MF, Keating K, Jones JA, Burkham SM, Slymen DJ, Hofstetter CR, Rubin B. Clinician compliance with primary prevention of tobacco use: the impact of social contingencies. Prev Med. 1997 Jan-Feb;26(1):44-52. doi: 10.1006/pmed.1996.9994.
- Hovell MF, Russos S, Beckhelm MK, Jones JA, Burkham-Kreitner SM, Slymen DJ, Hofstetter CR, Rubin B. Compliance with primary prevention in private practice: creating a tobacco-free environment. Am J Prev Med. 1995 Sep-Oct;11(5):288-93.
- Russos S, Keating K, Hovell MF, Jones JA, Slymen DJ, Hofstetter CR, Rubin B, Morrison T. Counseling youth in tobacco-use prevention: determinants of clinician compliance. Prev Med. 1999 Jul;29(1):13-21. doi: 10.1006/pmed.1999.0495.
- Hovell MF, Jones JA, Adams MA. The feasibility and efficacy of tobacco use prevention in orthodontics. J Dent Educ. 2001 Apr;65(4):348-53.
- Morrison TC, Wahlgren DR, Hovell MF, Zakarian J, Burkham-Kreitner S, Hofstetter CR, Slymen DJ, Keating K, Russos S, Jones JA. Tracking and follow-up of 16,915 adolescents: minimizing attrition bias. Control Clin Trials. 1997 Oct;18(5):383-96. doi: 10.1016/s0197-2456(97)00025-1.
- Keating KJ, Russos S, Hovell MF, Jones JA, Wahlgren D. Creating tobacco-free environments in clinicians' offices: Do patients notice? J Health Educ 2000;31(1):37-41.
- Cisse-Egbuonye N, Liles S, Schmitz KE, Kassem N, Irvin VL, Hovell MF. Availability of Vending Machines and School Stores in California Schools. J Sch Health. 2016 Jan;86(1):48-53. doi: 10.1111/josh.12349.
- Hovell MF, Schmitz KE, Liles S, Robusto K, Hofstetter CR, Nichols JF, Rock CL, Irvin V, Parker MS, Surillo SA, Noel D. A randomized controlled trial of orthodontist-based brief advice to prevent child obesity. Contemp Clin Trials. 2018 Jul;70:53-61. doi: 10.1016/j.cct.2018.05.003. Epub 2018 May 7.
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
1 gennaio 2010
Completamento primario (Effettivo)
1 gennaio 2015
Completamento dello studio (Effettivo)
1 gennaio 2015
Date di iscrizione allo studio
Primo inviato
14 novembre 2011
Primo inviato che soddisfa i criteri di controllo qualità
11 gennaio 2012
Primo Inserito (Stima)
16 gennaio 2012
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
17 aprile 2018
Ultimo aggiornamento inviato che soddisfa i criteri QC
16 aprile 2018
Ultimo verificato
1 aprile 2018
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 5R01CA138192 (Sovvenzione/contratto NIH degli Stati Uniti)
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 .
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