Quality assurance of data collection in the multi-site community randomized trial and prevalence survey of the children’s healthy living program (original) (raw)
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Childhood obesity research demonstration project: cross-site evaluation methods
Childhood obesity (Print), 2015
The Childhood Obesity Research Demonstration (CORD) project links public health and primary care interventions in three projects described in detail in accompanying articles in this issue of Childhood Obesity. This article describes a comprehensive evaluation plan to determine the extent to which the CORD model is associated with changes in behavior, body weight, BMI, quality of life, and healthcare satisfaction in children 2-12 years of age. The CORD Evaluation Center (EC-CORD) will analyze the pooled data from three independent demonstration projects that each integrate public health and primary care childhood obesity interventions. An extensive set of common measures at the family, facility, and community levels were defined by consensus among the CORD projects and EC-CORD. Process evaluation will assess reach, dose delivered, and fidelity of intervention components. Impact evaluation will use a mixed linear models approach to account for heterogeneity among project-site populati...
Review of External Validity Reporting in Childhood Obesity Prevention Research
American Journal of Preventive Medicine, 2008
Background: The translation and dissemination of prevention intervention evidence into practice is needed to address significant public health issues such as childhood obesity. Increased attention to and reporting of external validity information in research publications would allow for better understanding of generalizability issues relevant to successful translation. To demonstrate this potential, recent reports of childhood obesity prevention interventions were evaluated on the extent to which external validity dimensions were reported. Methods: Childhood obesity prevention studies that were controlled, long-term research trials published between 1980 and 2004 that reported a behavioral target of physical activity and/or healthy eating along with at least one anthropometric outcome were identified in 2005. Studies were summarized between 2005 and 2006 using review criteria developed by Green and Glasgow in 2006. Results: Nineteen publications met selection criteria. In general, all studies lacked full reporting on potential generalizability and dissemination elements. Median reporting over all elements was 34.5%; the mode was 0% with a range of 0% to 100%. Most infrequent were reports of setting level selection criteria and representativeness, characteristics regarding intervention staff, implementation of intervention content, costs, and program sustainability. Conclusions: The evidence base for future prevention interventions can be improved by enhancing the reporting of contextual and generalizability elements central to translational research. Such efforts face practical hurdles but could provide additional explanation for variability in intervention outcomes, insights into successful adaptations of interventions, and help guide policy decisions.
BMC Pediatrics
Background: One in three Head Start children is either overweight or obese. We will test the efficacy of an early childhood obesity prevention program, "¡Míranos! Look at Us, We Are Healthy!" (¡Míranos!), which promotes healthy growth and targets multiple energy balance-related behaviors in predominantly Latino children in Head Start. The ¡Míranos! intervention includes center-based (policy changes, staff development, gross motor program, and nutrition education) and home-based (parent engagement/education and home visits) interventions to address key enablers and barriers in obesity prevention in childcare. In partnership with Head Start, we have demonstrated the feasibility and acceptability of the proposed interventions to influence energy balance-related behaviors favorably in Head Start children. Methods: Using a three-arm cluster randomized controlled design, 12 Head Start centers will be randomly assigned in equal number to one of three conditions: 1) a combined center-and home-based intervention, 2) center-based intervention only, or 3) comparison. The interventions will be delivered by trained Head Start staff during the academic year. A total of 444 3-year-old children (52% females; n = 37 per center at baseline) in two cohorts will be enrolled in the study and followed prospectively 1 year post-intervention. Data collection will be conducted at baseline, immediately post-intervention, and at the one-year follow-up and will include height, weight, physical activity (PA) and sedentary behaviors, sleep duration and screen time, gross motor development, dietary intake and food and activity preferences. Information on family background, parental weight, PA-and nutrition-related practices and behaviors, PA and nutrition policy and environment at center and home, intervention program costs, and treatment fidelity will also be collected.
AIMS Public Health, 2016
The US Affiliated Pacific region's childhood obesity prevalence has reached epidemic proportions. To guide program and policy development, a multi-site study was initiated, in collaboration with partners from across the region, to gather comprehensive information on the regional childhood obesity prevalence. The environmental and cultural diversity of the region presented challenges to recruiting for and implementing a shared community-based, public health research program. This paper presents the strategies used to recruit families with young children (n = 5775 for children 2-8 years old) for obesity-related measurement across eleven jurisdictions in the US Affiliated Pacific Region. Data were generated by site teams that provided summaries of their recruitment strategies and lessons learned. Conducting this large multi-site prevalence study required considerable coordination, time and 141 AIMS Public Health Volume 3, Issue 1, 140-157. flexibility. In every location, local staff knowledgeable of the community was hired to lead recruitment, and participant compensation reflected jurisdictional appropriateness (e.g., gift cards, vouchers, or cash). Although recruitment approaches were site-specific, they were predominantly school-based or a combination of school-and community-based. Lessons learned included the importance of organization buy-in; communication, and advance planning; local travel and site peculiarities; and flexibility. Future monitoring of childhood obesity prevalence in the region should consider ways to integrate measurement activities into existing organizational infrastructures for sustainability and costeffectiveness, while meeting programmatic (e.g. study) goals.
BMC Public Health, 2013
Background: Although surveillance data are limited in the US Affiliated Pacific, Alaska, and Hawaii, existing data suggest that the prevalence of childhood obesity is similar to or in excess of other minority groups in the contiguous US. Strategies for addressing the childhood obesity epidemic in the region support the use of community-based, environmentally targeted interventions. The Children's Healthy Living Program is a partnership formed across institutions in the US Affiliated Pacific, Alaska, and Hawaii to design a community randomized environmental intervention trial and a prevalence survey to address childhood obesity in the region through affecting the food and physical activity environment. Methods/Design: The Children's Healthy Living Program community randomized trial is an environmental intervention trial in four matched-pair communities in American Samoa, the Commonwealth of the Northern Mariana Islands, Guam, and Hawaii and two matched-pair communities in Alaska. A cross-sectional sample of children (goal n = 180) in each of the intervention trial communities is being assessed for outcomes at baseline and at 24 months (18 months post-intervention). In addition to the collection of the participant-based measures of anthropometry, diet, physical activity, sleep and acanthosis nigricans, community assessments are also being conducted in intervention trial communities. The Freely Associated States of Micronesia (Federated States of Micronesia, and Republics of Marshall Islands and Palau) is only conducting elements of the Children's Healthy Living Program sampling framework and similar measurements to provide prevalence data. In addition, anthropometry information will be collected for two additional communities in each of the 5 intervention jurisdictions to be included in the prevalence survey. The effectiveness of the environmental intervention trial is being assessed based on the RE-AIM (reach, effectiveness, adoption, implementation, maintenance) framework. Discussion: The Children's Healthy Living Program environmental trial is designed to focus on capacity building and to maximize the likelihood of sustainable impact on childhood obesity-related behaviors and outcomes. The multiple measures at the individual, community, and environment levels are designed to maximize the likelihood of detecting change. This approach enhances the likelihood for identifying and promoting the best methods to promote health and well-being of the children in the underserved US Affiliated Pacific Region.
Implementation Science, 2017
Background: Despite the potential to reach at-risk children in childcare, there is a significant gap between current practices and evidence-based obesity prevention in this setting. There are few investigations of the impact of implementation strategies on the uptake of evidence-based practices (EBPs) for obesity prevention and nutrition promotion. This study protocol describes a three-phase approach to developing and testing implementation strategies to support uptake of EBPs for obesity prevention practices in childcare (i.e., key components of the WISE intervention). Methods: Informed by the i-PARIHS framework, we will use a stakeholder-driven evidence-based quality improvement (EBQI) process to apply information gathered in qualitative interviews on barriers and facilitators to practice to inform the design of implementation strategies. Then, a Hybrid Type III cluster randomized trial will compare a basic implementation strategy (i.e., intervention as usual) with an enhanced implementation strategy informed by stakeholders. All Head Start centers (N = 12) within one agency in an urban area in a southern state in the USA will be randomized to receive the basic or enhanced implementation with approximately 20 classrooms per group (40 educators, 400 children per group). The educators involved in the study, the data collectors, and the biostastician will be blinded to the study condition. The basic and enhanced implementation strategies will be compared on outcomes specified by the RE-AIM model (e.g., Reach to families, Effectiveness of impact on child diet and health indicators, Adoption commitment of agency, Implementation fidelity and acceptability, and Maintenance after 6 months). Principles of formative evaluation will be used throughout the hybrid trial. Discussion: This study will test a stakeholder-driven approach to improve implementation, fidelity, and maintenance of EBPs for obesity prevention in childcare. Further, this study provides an example of a systematic process to develop and test a tailored, enhanced implementation strategy.
The Childhood Obesity Declines Project: Implications for Research and Evaluation Approaches
Childhood obesity (Print), 2018
Childhood obesity remains prevalent and is increasing in some disadvantaged populations. Numerous research, policy and community initiatives are undertaken to impact this pandemic. Understudied are natural experiments. The need to learn from these efforts is paramount. Resulting evidence may not be readily available to inform future research, community initiatives, and policy development/implementation. We discuss the implications of using an adaptation of the Systematic Screening and Assessment (SSA) method to evaluate the Childhood Obesity Declines (COBD) project. The project examined successful initiatives, programs and policies in four diverse communities which were concurrent with significant declines in child obesity. In the context of other research designs and evaluation schemas, rationale for use of SSA is presented. Evidence generated by this method is highlighted and guidance suggested for evaluation of future studies of community-based childhood obesity prevention initia...
Background: Existing systematic reviews aimed at comparing effectiveness of childhood obesity treatment interventions are limited by a lack of quality in the conduct and reporting of trials in this area. This study aimed to identify the number and types of primary and secondary outcomes used within trials of childhood obesity treatments and to determine the degree to which these trials correctly report their use of outcome measures. A systematic literature review was conducted to identify phase II (i.e. pilot and feasibility studies) and phase III (e.g. determining effectiveness) trials of childhood obesity treatments across 11 databases. Data were extracted from eligible manuscripts pertaining to the number and type of outcome measures used, in addition to details of citations provided for these measures. Results: 145 different outcome measures were reported to be used within 200 identified eligible trial manuscripts. Citations were provided to indicate the provenance for 417 measures, but only 13% of these were correctly linked to papers describing the development and/or evaluation of measures. Conclusions: This study identified inconsistencies and inaccuracies in the use and reporting of outcome measures used by eligible trials. Researchers in this area are urged to consider guidelines such as CONSORT and the National Obesity Observatory Standard Evaluation Framework in the design and reporting of future trials.