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Formative research implications on design of a randomized controlled trial for oral health promotion in children.

ABSTRACT: Background:The COordinated Oral health Promotion (CO-OP) Chicago trial will test the efficacy of a community health worker (CHW) intervention to improve oral health behaviors for children at high risk for early childhood caries. Before implementing the cluster-randomized controlled trial, we conducted a formative assessment to determine the final design. We used qualitative methods to assess the feasibility and acceptability of the proposed recruitment, data collection, and intervention plan. Methods:Key informant interviews (N?=?37) and site observations were conducted at 10 pediatric primary care clinics and 10 Special Supplemental Nutrition Program for Women Infant and Children (WIC) centers to gain insight from providers and administrators at the locations where recruitment and intervention will occur. Eight focus groups (N?=?68) were conducted with caregivers of children to capture the parent perspective. Conceptual coding methods from grounded theory were applied to organize the data into the final themes. Results:Families, clinics, and WIC centers were all very interested in additional supports for oral health and were enthusiastic about CHWs. Challenges included competing family priorities that might interfere in study enrollment and intervention efficacy. Physical space for enrollment and intervention delivery was a major barrier for some sites. Home visits for data collection and intervention delivery would be unacceptable for some families. These challenges and barriers prompted us to make major changes in our trial design. We opened the option for data collection to occur in multiple locations. We eliminated the home-only arm of the trial. Clinics and WIC centers that are randomized to the non-intervention arm will now have CHWs available at the study conclusion. Finally, we aligned the CHW oral health topics to the needs of families. Conclusions:We conducted this comprehensive formative assessment to determine the feasibility and acceptability of the CO-OP Chicago trial. While overall acceptance of the trial was high, the results highlighted specific issues with the proposed trial implementation plan and led to several critical design changes. This type of formative work requires a significant upfront investment but we expect it will translate into savings through better recruitment, retention, intervention implementation and adherence, and result dissemination.

SUBMITTER: Martin MA

PROVIDER: S-EPMC6171134 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature

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Formative research implications on design of a randomized controlled trial for oral health promotion in children.

Martin Molly A MA Lee Helen H HH Landa Jazmin J Minier Mark M Avenetti David D Sandoval Anna A

Pilot and feasibility studies 20181004

<h4>Background</h4>The COordinated Oral health Promotion (CO-OP) Chicago trial will test the efficacy of a community health worker (CHW) intervention to improve oral health behaviors for children at high risk for early childhood caries. Before implementing the cluster-randomized controlled trial, we conducted a formative assessment to determine the final design. We used qualitative methods to assess the feasibility and acceptability of the proposed recruitment, data collection, and intervention ...[more]

PMID: 30305918

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Project description:COordinated Oral health Promotion (CO-OP) Chicago is a two-arm cluster-randomized trial with a wait-list control. The primary aim is to evaluate the efficacy of an oral health community health worker (CHW) intervention to improve oral health behaviors in low-income, urban children under the age of three years. Exploratory aims will determine cost-effectiveness, and if any CHW intervention impact on child tooth brushing behaviors varies when CHWs are based out of a medical clinic compared to a community setting. This paper describes progress toward achieving these aims. Participating families were recruited from community social service centers and pediatric primary care medical clinics in Cook County, Illinois. Sites were cluster-randomized to CHW intervention or usual services (a wait-list control). The intervention is oral health support from CHWs delivered in four visits to individual families over one year. The trial sample consists of 420 child/caregiver dyads enrolled at the 20 participating sites over 11 months. Participant demographics varied across the sites, but primary outcomes values at baseline did not. Data on brushing frequency, plaque, and other oral health behaviors are collected at three timepoints: baseline, 6-, and 12-months. The primary analysis will assess differences in caregiver-reported child brushing frequency and observed plaque score between the two arms at 12-months. The trial is currently in the active intervention phase. The trial's cluster-randomized controlled design takes a real-world approach by integrating into existing health and social service agencies and collecting data in participant homes. Results will address an important child health disparity. ClinicalTrials.gov identifier: NCT03397589. CLINICAL TRIAL REGISTRATION: University of Illinois at Chicago Protocol Record 2017-1090. National Institutes of Dental & Craniofacial Research of the National Institutes of Health (NIDCR) Protocol Number: 17-074-E. NCT03397589.

Project description:BackgroundThe top two oral diseases (tooth decay and gum disease) are preventable, yet dental caries is the most common childhood disease with 68% of children entering kindergarten having tooth decay. CATCH Healthy Smiles is a coordinated school health program to prevent cavities for students in kindergarten, 1st, and 2nd grade, and is based on the framework of Coordinated Approach to Child Health (CATCH), an evidence-based coordinated school health program. CATCH has undergone several cluster-randomized controlled trials (CRCT) demonstrating sustainable long-term effectiveness in incorporating the factors surrounding children, in improving eating and physical activity behaviors, and reductions in obesity prevalence among low-income, ethnically diverse children. The aim of this paper is to describe the design of the CATCH Healthy Smiles CRCT to determine the effectiveness of an oral health school-based behavioral intervention in reducing incidence of dental caries among children.MethodsIn this CRCT, 30 schools serving low-income, ethnically-diverse children in greater Houston area are recruited and randomized into intervention and comparison groups. From which, 1020 kindergarten children (n = 510 children from 15 schools for each group) will be recruited and followed through 2nd grade. The intervention consists of four components (classroom curriculum, toothbrushing routine, family outreach, and schoolwide coordinated activities) will be implemented for three years in the intervention schools, whereas the control schools will be offered free trainings and materials to implement a sun safety curriculum in the meantime. Outcome evaluation will be conducted at four time points throughout the study period, each consists of three components: dental assessment, child anthropometric measures, and parent survey. The dental assessment will use International Caries Detection and Assessment System (ICDAS) to measures the primary outcome of this study: incidence of dental caries in primary teeth as measured at the tooth surface level (dfs). The parent self-report survey measures secondary outcomes of this study, such as oral health related behavioral and psychosocial factors. A modified crude caries increment (mCCI) will be used to calculate the primary outcome of the CATCH Healthy Smiles CRCT, and a two-tailed test of the null hypothesis will be conducted to evaluate the intervention effect, while considering between- and within-cluster variances through computing the weighted-average of the mCCI ratios by cluster.ConclusionIf found to be effective, a platform for scalability, sustainability and dissemination of CATCH already exists, and opens a new line of research in school oral health.Clinical trials identifierAt ClinicalTrials.gov - NCT04632667.

Project description:The authors tested the effectiveness of a community-based, tribally delivered oral health promotion (OHP) intervention (INT) at reducing caries increment in Navajo children attending Head Start. In a 3-y cluster-randomized trial, we developed an OHP INT with Navajo input that was delivered by trained Navajo lay health workers to children attending 52 Navajo Head Start classrooms (26 INT, 26 usual care [UC]). The INT was designed as a highly personalized set of oral health-focused interactions (5 for children and 4 for parents), along with 4 fluoride varnish applications delivered in Head Start during academic years of 2011 to 2012 and 2012 to 2013. The authors evaluated INT impact on decayed, missing, and filled tooth surfaces (dmfs) increment compared with UC. Other outcomes included caries prevalence and caregiver oral health-related knowledge and behaviors. Modified intention-to-treat and per-protocol analyses were conducted. The authors enrolled 1,016 caregiver-child dyads. Baseline mean dmfs/caries prevalence equaled 19.9/86.5% for the INT group and 22.8/90.1% for the UC group, respectively. INT adherence was 53% (i.e., ≥3 child OHP events, ≥1 caregiver OHP events, and ≥3 fluoride varnish). After 3 y, dmfs increased in both groups (+12.9 INT vs. +10.8 UC; P = 0.216), as did caries prevalence (86.5% to 96.6% INT vs. 90.1% to 98.2% UC; P = 0.808) in a modified intention-to-treat analysis of 897 caregiver-child dyads receiving 1 y of INT. Caregiver oral health knowledge scores improved in both groups (75.1% to 81.2% INT vs. 73.6% to 79.5% UC; P = 0.369). Caregiver oral health behavior scores improved more rapidly in the INT group versus the UC group (P = 0.006). The dmfs increment was smaller among adherent INT children (+8.9) than among UC children (+10.8; P = 0.028) in a per-protocol analysis. In conclusion, the severity of dental disease in Navajo Head Start children is extreme and difficult to improve. The authors argue that successful approaches to prevention may require even more highly personalized approaches shaped by cultural perspectives and attentive to the social determinants of oral health (ClinicalTrials.gov NCT01116739).

Project description:BackgroundThe Cholera-Hospital-Based-Intervention-for-7-Days (CHoBI7) is a handwashing with soap and water treatment intervention program delivered by a health promoter bedside in a health facility and through home visits to diarrhea patients and their household members during the 7?days after admission to a health facility. In a randomized controlled trial among cholera patient households in Bangladesh, the 7-day CHoBI7 program resulted in a significant reduction in cholera among household members of cholera patients and sustained improvements in drinking water quality and handwashing with soap practices 12 months post-intervention. In an effort to take this intervention to scale across Bangladesh in partnership with the Bangladesh Ministry of Health and Family Welfare, this study evaluates the feasibility and acceptability of mobile health (mHealth) programs as a low-cost, scalable approach for CHoBI7 program delivery.MethodsFormative research for the development of the CHoBI7 mHealth intervention included 40 semi-structured interviews, 4 mHealth workshops, 2 group discussions, and a pilot study of 52 households to assess the feasibility and acceptability of the developed mHealth program. Thematic analysis of the interviews and group discussions was conducted by two individuals separately based on emergent themes, and then themes were compared and discussed.ResultsA theory- and evidence-based approach using qualitative research methods was implemented to design the CHoBI7 mHealth program. Semi-structured interviews with government stakeholders identified perceptions and preferences for scaling the CHoBI7 mHealth program. Group discussions and semi-structured interviews with diarrhea patients and their family members identified beneficiary perceptions of mHealth and preferences for CHoBI7 mHealth program delivery. mHealth workshops were conducted as an interactive approach to draft and refine mobile message content based on stakeholder preferences. The pilot findings indicate that the CHoBI7 mHealth program has high user acceptability and is feasible to deliver to diarrhea patients that present at health facilities for treatment in Bangladesh. Both text and voice messages were recommended for program delivery. Dr. Chobi, the sender of mHealth messages, was viewed as a credible source of information that could be shared with others.ConclusionThis study presents a theory- and evidence-based approach that can be implemented for the development of future water, sanitation, and hygiene mHealth programs in low-resource settings.

Project description:BackgroundThis study aimed to design a gamified smartphone application (app) and assess its efficacy for education of mothers regarding oral healthcare of their children.MethodsIn this pretest-posttest controlled clinical trial, a simple app and a gamified version of it were designed to enhance the oral health knowledge and practice of mothers. The app contains information about early childhood caries, health diet, sugars, baby-oral hygiene, fluoride effect, fluoride toothpaste, tooth-brushing training video and regular dental visits. The opinion of experts and 3 mothers were obtained and both apps were revised accordingly. The intervention was implemented on mothers of preschoolers referring to the specialty dental clinic of Tehran School of Dentistry in 2019. The mothers were randomly allocated to the simple app or gamified app group. Before the intervention, all mothers filled out a questionnaire regarding oral health knowledge and practice, and their demographics were collected. The plaque index (PI) of children was also measured. The mothers filled out the same questionnaire 1 month after the intervention, and the PI of children was measured again. Paired t test and linear regression model were used for statistical analysis of the data.ResultsTotally, 58 mother and child pairs entered the study; 40% of children were boys. The mean age of children was 4.7 ± 1.2 years. The mean knowledge score of mothers in the pretest was 10.5 and 11.3 in simple app and gamified app group, respectively, which changed to 13.1 and 14.3, respectively in the posttest. The mean practice score of mothers was 4.4 and 4.8 in simple app and gamified app groups, respectively in the pretest, which changed to 8.5 and 8, respectively in the posttest. The mean dental plaque index of children in the pretest was 0.8 and 1 in simple app and gamified app groups, respectively, which changed to 0.5 and 0.5, respectively in the posttest. Children had better Plaque control in gamified app group (P < 0.05).ConclusionAfter 1 month, both apps effectively improved the oral-health knowledge and practice of mothers while oral hygiene as a result of plaque control was superior in children of mothers using the gamified app. Trial registration IRCT, IRCT20131102015238N2. Registered 24 February 2019-Retrospectively registered, https://fa.irct.ir/trial/36600 .

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Formative research implications on design of a randomized controlled trial for oral health promotion in children.

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Formative research implications on design of a randomized controlled trial for oral health promotion in children.

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