Design for a cluster randomized controlled trial to evaluate the effects of the CATCH Healthy Smiles school-based oral health promotion intervention among elementary school children

Contemporary Clinical Trials Communications - Tập 30 - Trang 101033 - 2022
Ru-Jye Chuang1, Courtney Byrd-Williams1, Jose-Miguel Yamal1, Kila Johnson2, Steven Kelder1, Suchitra Nelson3, Dania Mofleh1, Shreela V. Sharma1
1Department of Epidemiology, Human Genetics & Environmental Sciences, Michael & Susan Dell Center for Healthy Living, University of Texas Health Science Center at Houston School of Public Health, 1200 Pressler Street, RAS E615, Houston, TX, 77030, USA
2Harris County Public Health, Houston, TX, USA
3Case Western Reserve University, Clinical and Translational Research Department of Community Dentistry, School of Dental Medicine, Cleveland, OH, USA

Tài liệu tham khảo

2000, Oral health in America: a report of the surgeon general, J. Calif. Dent. Assoc., 28, 685 2021 Capurro, 2015, Trends in income-related inequality in untreated caries among children in the United States: findings from NHANES I, NHANES III, and NHANES 1999-2004, Community Dent. Oral Epidemiol., 43, 500, 10.1111/cdoe.12174 Fleming, 2015, Timetable for oral prevention in childhood-a current opinion, Prog. Orthod., 16, 27, 10.1186/s40510-015-0098-5 Lewallen, 2015, The Whole School, Whole Community, Whole Child model: a new approach for improving educational attainment and healthy development for students, J. Sch. Health, 85, 729, 10.1111/josh.12310 Story, 2009, Schools and obesity prevention: creating school environments and policies to promote healthy eating and physical activity, Milbank Q., 87, 71, 10.1111/j.1468-0009.2009.00548.x Shakir, 2021, Effectiveness of school-based behavioural interventions to improve children's oral health by reducing sugar intake and promoting oral hygiene: a rapid review of randomised controlled trials, Community Dent. Health, 38, 275 2013 Bandura, 1971 Bandura, 1986 Nader, 1999, Three-year maintenance of improved diet and physical activity: the CATCH cohort. Child and Adolescent Trial for Cardiovascular Health, Arch. Pediatr. Adolesc. Med., 153, 695, 10.1001/archpedi.153.7.695 Coleman, 2005, Prevention of the epidemic increase in child risk of overweight in low-income schools: the El Paso coordinated approach to child health, Arch. Pediatr. Adolesc. Med., 159, 217, 10.1001/archpedi.159.3.217 Hoelscher, 2010, Changes in the regional prevalence of child obesity in 4th, 8th, and 11th grade students in Texas from 2000-2002 to 2004-2005, Obesity, 18, 1360, 10.1038/oby.2009.305 Hoelscher, 2010, Reductions in child obesity among disadvantaged school children with community involvement: the Travis County CATCH Trial, Obesity, 18, 36, 10.1038/oby.2009.430 Sharma, 2022, Development and feasibility testing of CATCH healthy Smiles, an oral health promotion intervention for prevention of dental caries among elementary school children, J. Sch. Health, 92, 20, 10.1111/josh.13100 Bartholomew, 1998, Intervention mapping: a process for developing theory- and evidence-based health education programs, Health Educ. Behav., 25, 545, 10.1177/109019819802500502 Hoelscher, 2010, Reductions in child obesity among disadvantaged school children with community involvement: the Travis County CATCH Trial, Obesity, 18, 36, 10.1038/oby.2009.430 Luepker, 1996, Outcomes of a field trial to improve children's dietary patterns and physical activity. The Child and Adolescent Trial for Cardiovascular Health. CATCH collaborative group, JAMA, 275, 768, 10.1001/jama.1996.03530340032026 Ekstrand, 2018, The international caries detection and assessment system - ICDAS: a systematic review, Caries Res., 52, 406, 10.1159/000486429 Donner, 2000 Hooper, 2018, Analysis of cluster randomised trials with an assessment of outcome at baseline, BMJ, 360, k1121, 10.1136/bmj.k1121 Marshall, 2020, Long-term impact of a school-based nutrition intervention on home nutrition environment and family fruit and vegetable intake: a two-year follow-up study, Preventive Medicine Reports, 20, 10.1016/j.pmedr.2020.101247 Sharma, 2019, Impact of a pilot school-based nutrition intervention on fruit and vegetable waste at school lunches, J. Nutr. Educ. Behav., 51, 1202, 10.1016/j.jneb.2019.08.002 Sharma, 2019, Impact of the coordinated approach to child health early childhood program for obesity prevention among preschool children: the Texas childhood obesity research demonstration study, Child. Obes., 15, 1, 10.1089/chi.2018.0010 Sharma, 2016, Evaluating a school-based fruit and vegetable co-op in low-income children: a quasi-experimental study, Prev. Med., 91, 8, 10.1016/j.ypmed.2016.07.022 Sharma, 2015, Effectiveness of the Lunch is in the Bag program on communication between the parent, child and child-care provider around fruits, vegetables and whole grain foods: a group-randomized controlled trial, Prev. Med., 81, 1, 10.1016/j.ypmed.2015.07.005 Shivakumar, 2009, International Caries Detection and Assessment System: a new paradigm in detection of dental caries, J. Conserv. Dent., 12, 10, 10.4103/0972-0707.53335 Pahel, 2007, Parental perceptions of children's oral health: the early childhood oral health impact scale (ECOHIS), Health Qual. Life Outcome, 5, 6, 10.1186/1477-7525-5-6 Albino, 2017, The basic research factors questionnaire for studying early childhood caries, BMC Oral Health, 17, 83, 10.1186/s12903-017-0374-5 Finlayson, 2005, Reliability and validity of brief measures of oral health-related knowledge, fatalism, and self-efficacy in mothers of African American children, Pediatr. Dent., 27, 422 Lopez, 2012, Parent support and parent-mediated behaviors are associated with children's sugary beverage consumption, J. Acad. Nutr. Diet., 112, 541, 10.1016/j.jand.2011.11.013 de Silva-Sanigorski, 2013, Parental self-efficacy and oral health-related knowledge are associated with parent and child oral health behaviors and self-reported oral health status, Community Dent. Oral Epidemiol., 41, 345, 10.1111/cdoe.12019 Du, 2019, Oral health behaviours of preschool children with autism spectrum disorders and their barriers to dental care, J. Autism Dev. Disord., 49, 453, 10.1007/s10803-018-3708-5 Broadbent, 2005, For debate: problems with the DMF index pertinent to dental caries data analysis, Community Dent. Oral Epidemiol., 33, 400, 10.1111/j.1600-0528.2005.00259.x Hayes, 2017 Hooper, 2015, Cluster randomised trials with repeated cross sections: alternatives to parallel group designs, BMJ, 350, h2925, 10.1136/bmj.h2925 Kerry, 2001, Unequal cluster sizes for trials in English and Welsh general practice: implications for sample size calculations, Stat. Med., 20, 377, 10.1002/1097-0258(20010215)20:3<377::AID-SIM799>3.0.CO;2-N Cooper, 2013, Primary school-based behavioural interventions for preventing caries, Cochrane Database Syst. Rev., 5 Glanz, 2010, The role of behavioral science theory in development and implementation of public health interventions, Annu. Rev. Publ. Health, 31, 399, 10.1146/annurev.publhealth.012809.103604