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Communities for healthy living (CHL) - A family-centered childhood obesity prevention program integrated into Head Start services: Study protocol for a pragmatic cluster randomized trial.

ABSTRACT: BACKGROUND:Childhood obesity is highly prevalent and carries substantial health consequences. Childhood obesity interventions have had mixed results, which may be partially explained by the absence of theory that incorporates broader family context and methods that address implementation challenges in low-resource settings. Communities for Healthy Living (CHL) is an obesity prevention program for Head Start preschools designed with careful focus on theory and implementation. This protocol paper outlines the design, content, implementation, and evaluation of CHL. METHODS/DESIGN:CHL integrates a parenting program co-led by Head Start staff and parents, enhanced nutrition support, and a media campaign. CHL content and implementation are informed by the Family Ecological Model, Psychological Empowerment Theory, and Organizational Empowerment Theory. The intervention is directed by community-based participatory research and implementation science principles, such as co?leadership with parents and staff, and implementation in a real world context. CHL is evaluated in a three-year pragmatic cluster-randomized trial with a stepped wedge design. The primary outcome is change in child Body Mass Index z-score. Secondary outcomes include children's weight-related behaviors (i.e., diet, physical activity, screen use, and sleep), parenting practices targeted at these behaviors (e.g., food parenting), and parent empowerment. The evaluation capitalizes on routine health data collected by Head Start (e.g., child height and weight, diet) coupled with parent surveys completed by subsamples of families. DISCUSSION:CHL is an innovative childhood obesity prevention program grounded in theory and implementation science principles. If successful, CHL is positioned for sustained implementation and nationwide Head Start scale-up.

SUBMITTER: Beckerman JP

PROVIDER: S-EPMC6487308 | biostudies-literature | 2019 Mar

REPOSITORIES: biostudies-literature

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Communities for healthy living (CHL) - A family-centered childhood obesity prevention program integrated into Head Start services: Study protocol for a pragmatic cluster randomized trial.

Beckerman Jacob P JP Aftosmes-Tobio Alyssa A Kitos Nicole N Jurkowski Janine M JM Lansburg Kindra K Kazik Crystal C Gavarkovs Adam A Vigilante Adrienne A Kalyoncu Begum B Figueroa Roger R Klabunde Rachel R Barouch Rachel R Haneuse Sebastien S Taveras Elsie E Davison Kirsten K KK

Contemporary clinical trials 20190107

<h4>Background</h4>Childhood obesity is highly prevalent and carries substantial health consequences. Childhood obesity interventions have had mixed results, which may be partially explained by the absence of theory that incorporates broader family context and methods that address implementation challenges in low-resource settings. Communities for Healthy Living (CHL) is an obesity prevention program for Head Start preschools designed with careful focus on theory and implementation. This protoco ...[more]

PMID: 30630109

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Project description:BackgroundProcess evaluation can illuminate barriers and facilitators to intervention implementation as well as the drivers of intervention outcomes. However, few obesity intervention studies have documented process evaluation methods and results. Community-based participatory research (CBPR) requires that process evaluation methods be developed to (a) prioritize community members' power to adapt the program to local needs over strict adherence to intervention protocols, (b) share process evaluation data with implementers to maximize benefit to participants, and (c) ensure partner organizations are not overburdened. Co-designed with low-income parents using CBPR, Communities for Healthy Living (CHL) is a family-centered intervention implemented within Head Start to prevent childhood obesity and promote family well-being. We are currently undertaking a randomized controlled trial to test the effectiveness of CHL in 23 Head Start centers in the greater Boston area. In this protocol paper, we outline an embedded process evaluation designed to monitor intervention adherence and adaptation, support ongoing quality improvement, and examine contextual factors that may moderate intervention implementation and/or effectiveness.MethodsThis mixed methods process evaluation was developed using the Pérez et al. framework for evaluating adaptive interventions and is reported following guidelines outlined by Grant et al. Trained research assistants will conduct structured observations of intervention sessions. Intervention facilitators and recipients, along with Head Start staff, will complete surveys and semi-structured interviews. De-identified data for all eligible children and families will be extracted from Head Start administrative records. Qualitative data will be analyzed thematically. Quantitative and qualitative data will be integrated using triangulation methods to assess intervention adherence, monitor adaptations, and identify moderators of intervention implementation and effectiveness.DiscussionA diverse set of quantitative and qualitative data sources are employed to fully characterize CHL implementation. Simultaneously, CHL's process evaluation will provide a case study on strategies to address the challenges of process evaluation for CBPR interventions. Results from this process evaluation will help to explain variation in intervention implementation and outcomes across Head Start programs, support CHL sustainability and future scale-up, and provide guidance for future complex interventions developed using CBPR.Trial registrationClinicalTrials.gov, NCT03334669 . Registered on October 10, 2017.

Project description:ImportanceSun safety attitudes developed in early childhood can reduce lifetime UV radiation exposure and the risk of skin cancer.ObjectiveTo assess the current policies, practices, and attitudes among caregivers regarding sun protection in children aged 2 to 6 years.Design, setting, and participantsA survey of 202 administrators or managers and teachers of Illinois Head Start/Early Head Start (HS/EHS) and day care centers was conducted from July 3 through 21, 2017. Organizations were randomly selected from 4 lists of urban, suburban, town, and rural locations and stratified to ensure population-based proportional representation of the Illinois population vulnerable to UV exposure. Program administrators or managers participated in a 5- to 10-minute telephone interview that assessed importance of health and sun protection behaviors, program practices, and demographic characteristics. Data analysis was conducted August 2, 2017.Main outcomes and measuresOutcomes included attitudes toward the importance of health behaviors in comparison with sun protective behaviors, reported use of sun protection (seeking shade, scheduling outdoor activities, sun protective clothing, and sunscreen practices), and sunburn prevalence.ResultsRespondents (from 102 HS/EHS programs with 52% boys overall and a mean [SD] child age of 2.5 [0.5] y and 100 day care programs with 49% boys and age of 2.3 [0.4] y) stated that the 3 most important habits were good nutrition (66 [64.7%] HS/EHS, 71 [71.0%] day care), adequate exercise (41 [40.2%] HS/EHS, 55 [55.0%] day care), and brushing teeth (35 [34.3%] HS/EHS, 38 [38.0 %] day care). Scheduling outdoor activities to avoid peak sun intensity was performed less by HS/EHS programs (46 [45.1%]) in comparison with day care programs (71 [71.0%]; P < .001). Sunscreen was provided for students in 109 programs, but 84 (77.1%) did not allow children to apply sunscreen themselves. Half of the programs (100 of 202 [50.0%]) used spray sunscreen to avoid unnecessarily touching children. Most programs did not report any children having sunburns (129 [63.9%]) and followed heat index guidelines (114 [56.4%]).Conclusions and relevanceAdministrators and teachers did not identify sun safety as one of the most important health habits. While spray sunscreen was used frequently, avoiding spraying sunscreen directly on a child's face, which may get it into the child's eyes, was not done. The heat index was widely used to determine outdoor playtime. Adopting UV index policies could help prevent sunburns in early spring when the heat index is low but UV index is high. Dermatologists may assume responsibility for educating the administrators about the danger of spraying sunscreen into a child's face and the advantage of using the UV index to determine when sun protection is needed.

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:BackgroundPatients discharged home after stroke face significant challenges managing residual neurological deficits, secondary prevention, and pre-existing chronic conditions. Post-discharge care is often fragmented leading to increased healthcare costs, readmissions, and sub-optimal utilization of rehabilitation and community services. The COMprehensive Post-Acute Stroke Services (COMPASS) Study is an ongoing cluster-randomized pragmatic trial to assess the effectiveness of a comprehensive, evidence-based, post-acute care model on patient-centered outcomes.MethodsForty-one hospitals in North Carolina were randomized (as 40 units) to either implement the COMPASS care model or continue their usual care. The recruitment goal is 6000 patients (3000 per arm). Hospital staff ascertain and enroll patients discharged home with a clinical diagnosis of stroke or transient ischemic attack. Patients discharged from intervention hospitals receive 2-day telephone follow-up; a comprehensive clinic visit within 2 weeks that includes a neurological evaluation, assessments of social and functional determinants of health, and an individualized COMPASS Care Plan™ integrated with a community-specific resource database; and additional follow-up calls at 30 and 60 days post-stroke discharge. This model is consistent with the Centers for Medicare and Medicaid Services transitional care management services provided by physicians or advanced practice providers with support from a nurse to conduct patient assessments and coordinate follow-up services. Patients discharged from usual care hospitals represent the control group and receive the standard of care in place at that hospital. Patient-centered outcomes are collected from telephone surveys administered at 90 days. The primary endpoint is patient-reported functional status as measured by the Stroke Impact Scale 16. Secondary outcomes are: caregiver strain, all-cause readmissions, mortality, healthcare utilization, and medication adherence. The study engages patients, caregivers, and other stakeholders (including policymakers, advocacy groups, payers, and local community coalitions) to advise and support the design, implementation, and sustainability of the COMPASS care model.DiscussionGiven the high societal and economic burden of stroke, identifying a care model to improve recovery, independence, and quality of life is critical for stroke survivors and their caregivers. The pragmatic trial design provides a real-world assessment of the COMPASS care model effectiveness and will facilitate rapid implementation into clinical practice if successful.Trial registrationClinicaltrials.gov: NCT02588664 ; October 23, 2015.

Dataset Information

Communities for healthy living (CHL) - A family-centered childhood obesity prevention program integrated into Head Start services: Study protocol for a pragmatic cluster randomized trial.

Publications

Communities for healthy living (CHL) - A family-centered childhood obesity prevention program integrated into Head Start services: Study protocol for a pragmatic cluster randomized trial.

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