Dataset Information

The Sunscreen for Kindergarteners (SKIN) Study trial protocol.

ABSTRACT:

Background

Exposure to ultraviolet radiation (UVR) is the major modifiable risk factor for skin cancers. The majority of lifetime UVR exposure occurs before age 20, underscoring an important window for risk reduction. Incorporation of skills-based sunscreen education into school health curricula may foster the development of consistent and effective use of sunscreen among children and youth. We describe the study protocol for a first-of-its-kind study that examined the feasibility of bringing skills-based sunscreen education into kindergarten classrooms.

Methods

Participants were 96 kindergarten students across four classrooms in a single elementary school. A single-blind open-label trial design was used to evaluate the feasibility of incorporating a song-based, video-guided intervention for independent application of sunscreen into the kindergarten curriculum. Students first completed a 10-day no-intervention baseline period, followed by a 10-day intervention period, and then a 10-day randomized follow-up period where students were randomly assigned to continue with the intervention or to revert to the no-intervention condition.

Outcomes

Feasibility metrics associated with study process, resources, management, scientific outcomes and safety were gathered. The primary outcome was pre-to-post intervention changes in student engagement in the sunscreen task. The secondary outcome was pre-to-post intervention changes in the proportion of exposed skin to which a student applies sunscreen. Teacher and student perceptions of intervention value and utility were also evaluated.

Discussion

This is the study protocol for a clinical trial designed to determine the feasibility of implementing a skills-based sunscreen curriculum in kindergarten classrooms. Next steps include evaluation of the intervention for efficacy and effectiveness.

Clinical trial registration

NCT03752736.

SUBMITTER: Lee GH

PROVIDER: S-EPMC8585331 | biostudies-literature | 2021 Aug

REPOSITORIES: biostudies-literature

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Publications

The Sunscreen for Kindergarteners (SKIN) Study trial protocol.

Lee Gun Ho GH Bae Gordon H GH Barnes Leandra A LA Pol-Rodriguez Marlyanne M MM Ransohoff Katherine J KJ Nord Kristin M KM Lu Ying Y Cannell Brad B Weitlauf Julie C JC

Contemporary clinical trials 20210611

<h4>Background</h4>Exposure to ultraviolet radiation (UVR) is the major modifiable risk factor for skin cancers. The majority of lifetime UVR exposure occurs before age 20, underscoring an important window for risk reduction. Incorporation of skills-based sunscreen education into school health curricula may foster the development of consistent and effective use of sunscreen among children and youth. We describe the study protocol for a first-of-its-kind study that examined the feasibility of bri ...[more]

PMID: 34126263

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Project description:BackgroundSleep is instrumental for growth and development in children, making it critical to establish healthy sleep habits from the earliest years of life. Many kindergarteners (3-6 years) in China have inadequate and poor sleep, necessitating targeted interventions. This research protocol details the "Healthy Sleep" intervention that was designed to promote healthy sleep among kindergarteners in China.MethodsThe "Healthy Sleep" intervention will be family-based and will support parents as change agents. The development of the intervention is based on evidence regarding correlates of sleep in young children and guided by Bandura's social cognitive theory. A 12-month randomised controlled trial will be conducted to examine the efficacy of the intervention for promoting healthy sleep in Chinese kindergarteners and the intervention's effects on child development outcomes. A targeted sample of 160 kindergarteners and their parents will be recruited through social media. The intervention group (n = 80) will receive monthly webinars for one year that include multiple intervention components - including educational training, goal setting and planning, as well as follow-up support sessions. The control group (n = 80) will receive videos of the recorded educational sessions after the study end. For primary outcomes, child sleep behaviours will be examined using the Child Sleep Health Questionnaire. For secondary outcomes, communication, fine motor, gross motor, personal-social, and problem-solving development will be examined using the Ages and Stages Questionnaire; executive functions will be examined using the Head, Toes, Knees, and Shoulders Revised tasks. Potential intervention mediators and covariates will be measured using a parental questionnaire. Mixed models will be conducted.DiscussionThis intervention targets sleep behaviours among kindergarteners in China. It has the potential to inform programs to support parents in helping their child establish healthy sleep habits from the earliest years of life. The study will provide high-quality experimental evidence on sleep behaviours in relation to development outcomes in kindergarteners. This evidence will inform family-based strategies to optimise early childhood development and inform national and international updates of the sleep recommendations for young children.Trial registrationThe trial was registered prospectively at Chinese Clinical Trial Registry (ID: ChiCTR2300072105) on 2 June 2023.

Project description:BackgroundSkin cancer rates are increasing. Interventions to increase adolescent sunscreen use and skin self-examination (SSE) are required.MethodsQuasi-experimental design; 1 control and 4 intervention group schools in Scotland, UK. Participants were 15-16 year old students on the school register. The intervention was a theoretically-informed (Common-Sense Model and Health Action Process Approach) 50-min presentation, delivered by a skin cancer specialist nurse and young adult skin cancer survivor, to students in a classroom, supplemented by a home-based assignment. Outcome variables were sunscreen use intention, SSE intention/behaviour, planning, illness perceptions and skin cancer communication behaviour, measured 2 weeks pre- and 4 weeks post- intervention using self-completed pen and paper survey. School attendance records were used to record intervention up-take; students self-reported completion of the home-based assignment. Pearson's chi-square test, analysis of variance, and non-parametric Wilcoxon Signed Ranks Test were used to measure outcomes and associations between variables. Focus groups elicited students' (n = 29) views on the intervention. Qualitative data were analysed thematically.ResultsFive of 37 invited schools participated. 639 (81%) students in intervention schools received the intervention; 33.8% completed the home-based assignment. 627 (69.6%) of students on the school register in intervention and control schools completed a questionnaire at baseline; data for 455 (72.6%) students were available at baseline and follow-up. Focus groups identified four themes - personal experiences of skin cancer, distaste for sunscreen, relevance of SSE in adolescence, and skin cancer conversations. Statistically significant (p < 0.05) changes were observed for sunscreen use, SSE, planning, and talk about skin cancer in intervention schools but not the control. Significant associations were found between sunscreen use, planning and 2 illness perceptions (identity and consequence) and between SSE, planning and 3 illness perceptions (timeline, causes, control).ConclusionsIt is feasible to promote sunscreen use and SSE in the context of an adolescent school-based psychoeducation intention. Further research is required to improve study uptake, intervention adherence and effectiveness.Trial registrationISRCTN11141528.

Project description:ImportanceA prior pilot study demonstrated the systemic absorption of 4 sunscreen active ingredients; additional studies are needed to determine the systemic absorption of additional active ingredients and how quickly systemic exposure exceeds 0.5 ng/mL as recommended by the US Food and Drug Administration (FDA).ObjectiveTo assess the systemic absorption and pharmacokinetics of the 6 active ingredients (avobenzone, oxybenzone, octocrylene, homosalate, octisalate, and octinoxate) in 4 sunscreen products under single- and maximal-use conditions.Design, setting, and participantsRandomized clinical trial at a clinical pharmacology unit (West Bend, Wisconsin) was conducted in 48 healthy participants. The study was conducted between January and February 2019.InterventionsParticipants were randomized to 1 of 4 sunscreen products, formulated as lotion (n = 12), aerosol spray (n = 12), nonaerosol spray (n = 12), and pump spray (n = 12). Sunscreen product was applied at 2 mg/cm2 to 75% of body surface area at 0 hours on day 1 and 4 times on day 2 through day 4 at 2-hour intervals, and 34 blood samples were collected over 21 days from each participant.Main outcomes and measuresThe primary outcome was the maximum plasma concentration of avobenzone over days 1 through 21. Secondary outcomes were the maximum plasma concentrations of oxybenzone, octocrylene, homosalate, octisalate, and octinoxate over days 1 through 21.ResultsAmong 48 randomized participants (mean [SD] age, 38.7 [13.2] years; 24 women [50%]; 23 white [48%], 23 African American [48%], 1 Asian [2%], and 1 of unknown race/ethnicity [2%]), 44 (92%) completed the trial. Geometric mean maximum plasma concentrations of all 6 active ingredients were greater than 0.5 ng/mL, and this threshold was surpassed on day 1 after a single application for all active ingredients. For avobenzone, the overall maximum plasma concentrations were 7.1 ng/mL (coefficient of variation [CV], 73.9%) for lotion, 3.5 ng/mL (CV, 70.9%) for aerosol spray, 3.5 ng/mL (CV, 73.0%) for nonaerosol spray, and 3.3 ng/mL (CV, 47.8%) for pump spray. For oxybenzone, the concentrations were 258.1 ng/mL (CV, 53.0%) for lotion and 180.1 ng/mL (CV, 57.3%) for aerosol spray. For octocrylene, the concentrations were 7.8 ng/mL (CV, 87.1%) for lotion, 6.6 ng/mL (CV, 78.1%) for aerosol spray, and 6.6 ng/mL (CV, 103.9%) for nonaerosol spray. For homosalate, concentrations were 23.1 ng/mL (CV, 68.0%) for aerosol spray, 17.9 ng/mL (CV, 61.7%) for nonaerosol spray, and 13.9 ng/mL (CV, 70.2%) for pump spray. For octisalate, concentrations were 5.1 ng/mL (CV, 81.6%) for aerosol spray, 5.8 ng/mL (CV, 77.4%) for nonaerosol spray, and 4.6 ng/mL (CV, 97.6%) for pump spray. For octinoxate, concentrations were 7.9 ng/mL (CV, 86.5%) for nonaerosol spray and 5.2 ng/mL (CV, 68.2%) for pump spray. The most common adverse event was rash, which developed in 14 participants.Conclusions and relevanceIn this study conducted in a clinical pharmacology unit and examining sunscreen application among healthy participants, all 6 of the tested active ingredients administered in 4 different sunscreen formulations were systemically absorbed and had plasma concentrations that surpassed the FDA threshold for potentially waiving some of the additional safety studies for sunscreens. These findings do not indicate that individuals should refrain from the use of sunscreen.Trial registrationClinicalTrials.gov Identifier: NCT03582215.

Project description:BackgroundAdvances in treatment have increased childhood cancer 5-year survival rates to greater than 80%. However, children previously treated with radiation are at significantly increased risk of developing subsequent neoplasms, the most common of which are skin cancers. The National Cancer Institute and Children's Oncology Group have issued recommendations for survivors treated with radiation to perform monthly skin self-examinations and receive a physician skin examination at least annually, as early detection has demonstrated markedly improved outcomes in the diagnosis and treatment of skin cancers. The goal of the present study is to increase rates of skin self-examinations and clinical skin examinations among adult survivors of childhood cancer treated with radiation.Methods/designThis randomized controlled trial uses a 3-group comparative effectiveness design comparing: (1) Patient Activation and Education (PAE) including text messaging, print and web-based tutorials over 12 months; (2) PAE plus physician activation (PAE + MD) adding physician activation/educational materials about survivors' increased skin cancer risk and conducting full-body skin exams; and (3) PAE plus physician activation, plus teledermoscopy (PAE + MD + TD) adding participant receipt of a dermatoscope intended to empower them to photograph suspect moles or lesions for review by the study dermatologist.DiscussionThe current study addresses barriers to screening in this population by providing educational and motivational information for both survivors and physicians regarding the value of periodic skin examinations. It also utilizes innovative mobile health technology to encourage and motivate (that is activate) survivors to conduct skin self-examinations, request physician exams, and obtain treatment when worrisome lesions are found. Finally, as a comparative effectiveness trial, this study isolates the effects of adding specific components to the patient activation intervention to test the most effective intervention for enhancing skin examination vigilance among this high-risk group.Trial registrationClinicaltrials.gov: NCT02046811 ; Registration date: 22 January 2014.

Project description:BackgroundSkin-to-skin care immediately following delivery is a common practice for term infants and has been shown to improve cardiorespiratory stability, facilitate early bonding, and promote breastfeeding. Since 2007, the use of skin-to-skin care has been practiced for preterm infants from 32 weeks of gestation in the delivery room at St. Olav's University Hospital. In the present study we aim to investigate whether skin-to-skin care following delivery is safe, and how it affects early and late outcomes compared to standard care for very preterm infants.Methods/designA randomized controlled trial (RCT) of skin-to-skin care in the delivery room for very preterm infants born at gestational age 280-316 weeks with birth weight >1000 grams. Infants with severe congenital malformations or need of intubation in the delivery room are excluded. A detailed checklist and a flowchart were prepared for the study, and all involved professionals (neonatologists, neonatal nurses, obstetricians, anesthesiologists, midwives) participated in medical simulation training prior to study start on February 1, 2014. A consultant in neonatology and a neonatal nurse are present at all deliveries. Infants with birth weight <1500 grams receive an intravenous line with glucose, amino acids, and caffeine citrate in the delivery room. Infants with gestational age <30 weeks are routinely put on continuous positive airway pressure (CPAP). After initial stabilization, infants are randomized to skin-to-skin care or are transferred to the nursery in an incubator. Primary outcome is cognitive development at 2 years measured with the Bayley Scales of Infant Development, Third Edition. Secondary outcomes are safety defined as hypothermia, respiratory failure, and/or cardiopulmonary resuscitation, physiological stability after birth and motor, language and cognitive development at 1 year for the child, and mental health measured with the State-Trait Anxiety Inventory (STAI) at discharge, and at 3 months and 2 years after expected date of delivery for the mothers.DiscussionThe study may have important implications for the initial care for very preterm infants after delivery and increase our understanding of how early skin-to-skin care affects preterm infants and their mothers.Trial registrationClinicalTrials, NCT02024854 . Registered on 19 December 2013.

Project description:ImportanceThe US Food and Drug Administration (FDA) has provided guidance that sunscreen active ingredients with systemic absorption greater than 0.5 ng/mL or with safety concerns should undergo nonclinical toxicology assessment including systemic carcinogenicity and additional developmental and reproductive studies.ObjectiveTo determine whether the active ingredients (avobenzone, oxybenzone, octocrylene, and ecamsule) of 4 commercially available sunscreens are absorbed into systemic circulation.Design, setting, and participantsRandomized clinical trial conducted at a phase 1 clinical pharmacology unit in the United States and enrolling 24 healthy volunteers. Enrollment started in July 2018 and ended in August 2018.InterventionsParticipants were randomized to 1 of 4 sunscreens: spray 1 (n = 6 participants), spray 2 (n = 6), a lotion (n = 6), and a cream (n = 6). Two milligrams of sunscreen per 1 cm2 was applied to 75% of body surface area 4 times per day for 4 days, and 30 blood samples were collected over 7 days from each participant.Main outcomes and measuresThe primary outcome was the maximum plasma concentration of avobenzone. Secondary outcomes were the maximum plasma concentrations of oxybenzone, octocrylene, and ecamsule.ResultsAmong 24 participants randomized (mean age, 35.5 [SD, 1.5] years; 12 (50%] women; 14 [58%] black or African American; 14 [58%]), 23 (96%) completed the trial. For avobenzone, geometric mean maximum plasma concentrations were 4.0 ng/mL (coefficient of variation, 6.9%) for spray 1; 3.4 ng/mL (coefficient of variation, 77.3%) for spray 2; 4.3 ng/mL (coefficient of variation, 46.1%) for lotion; and 1.8 ng/mL (coefficient of variation, 32.1%). For oxybenzone, the corresponding values were 209.6 ng/mL (66.8%) for spray 1, 194.9 ng/mL (52.4%) for spray 2, and 169.3 ng/mL (44.5%) for lotion; for octocrylene, 2.9 ng/mL (102%) for spray 1, 7.8 ng/mL (113.3%) for spray 2, 5.7 ng/mL (66.3%) for lotion, and 5.7 ng/mL (47.1%) for cream; and for ecamsule, 1.5 ng/mL (166.1%) for cream. Systemic concentrations greater than 0.5 ng/mL were reached for all 4 products after 4 applications on day 1. The most common adverse event was rash, which developed in 1 participant with each sunscreen.Conclusions and relevanceIn this preliminary study involving healthy volunteers, application of 4 commercially available sunscreens under maximal use conditions resulted in plasma concentrations that exceeded the threshold established by the FDA for potentially waiving some nonclinical toxicology studies for sunscreens. The systemic absorption of sunscreen ingredients supports the need for further studies to determine the clinical significance of these findings. These results do not indicate that individuals should refrain from the use of sunscreen.Trial registrationClinicalTrials.gov Identifier: NCT03582215.

Dataset Information

The Sunscreen for Kindergarteners (SKIN) Study trial protocol.

Background

Methods

Outcomes

Discussion

Clinical trial registration

Publications

The Sunscreen for Kindergarteners (SKIN) Study trial protocol.

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