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Obesity prevention practices in early care and education settings: an adaptive implementation trial.
Swindle, T, Rutledge, JM, Selig, JP, Painter, J, Zhang, D, Martin, J, Johnson, SL, Whiteside-Mansell, L, Almirall, D, Barnett-McElwee, T, et al
Implementation science : IS. 2022;(1):25
Abstract
BACKGROUND Despite the potential for Early Care and Education (ECE) settings to promote healthy habits, a gap exists between current practices and evidence-based practices (EBPs) for obesity prevention in childhood. METHODS We will use an enhanced non-responder trial design to determine the effectiveness and incremental cost-effectiveness of an adaptive implementation strategy for Together, We Inspire Smart Eating (WISE), while examining moderators and mediators of the strategy effect. WISE is a curriculum that aims to increase children's intake of carotenoid-rich fruits and vegetables through four evidence-based practices in the early care and education setting. In this trial, we will randomize sites that do not respond to low-intensity strategies to either (a) continue receiving low-intensity strategies or (b) receive high-intensity strategies. This design will determine the effect of an adaptive implementation strategy that adds high-intensity versus one that continues with low-intensity among non-responder sites. We will also apply explanatory, sequential mixed methods to provide a nuanced understanding of implementation mechanisms, contextual factors, and characteristics of sites that respond to differing intensities of implementation strategies. Finally, we will conduct a cost effectiveness analysis to estimate the incremental effect of augmenting implementation with high-intensity strategies compared to continuing low-intensity strategies on costs, fidelity, and child health outcomes. DISCUSSION We expect our study to contribute to an evidence base for structuring implementation support in real-world ECE contexts, ultimately providing a guide for applying the adaptive implementation strategy in ECE for WISE scale-up. Our work will also provide data to guide implementation decisions of other interventions in ECE. Finally, we will provide the first estimate of relative value for different implementation strategies in this setting. TRIAL REGISTRATION NCT05050539 ; 9/20/21.
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Digital Intervention Strategies for Increasing Physical Activity Among Preschoolers: Systematic Review.
Swindle, T, Poosala, AB, Zeng, N, Børsheim, E, Andres, A, Bellows, LL
Journal of medical Internet research. 2022;24(1):e28230
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Digital strategies to improve the diet and activity of pre-schoolers are increasing due to their accessibility and relatively low cost to set up. This systematic review of 8 studies aimed to determine the quality of the studies that have been performed to date, and to determine the effectiveness of the digital strategies used to increase physical activity. The results showed that the studies reviewed had a small sample size. Only 2 studies showed positive changes in physical activity of pre-schoolers and these approaches were child led, but the studies were low quality. Parent focused interventions did not improve the physical activity of pre-schoolers. It was concluded that digital child-centred activities may be of benefit to physical activity in pre-schoolers, however parent-focused digital interventions may be ineffective. This study could be used by healthcare professionals to understand the importance of using digital strategies which engage children to improve their health.
Abstract
BACKGROUND Digital interventions are increasingly used to improve health behaviors. Improved access and lower costs (relative to in-person interventions) make such interventions appealing. Specifically, digital platforms may be a promising approach for increasing physical activity (PA) in young children. OBJECTIVE The goal of this systematic review was three-pronged: (1) to determine the quality of studies using digital PA intervention strategies with preschool-aged children (ie, 3 to 5 years old); (2) to assess the efficacy of digital interventions and approaches designed to improve PA in preschool-aged children; and (3) to examine theoretical application and implementation outcomes with current approaches to digital PA interventions. METHODS This review identified and summarized studies on digitally supported interventions for promoting PA in preschool-aged children. We generated 3 lists of relevant search terms that included technology-related terms, PA-related terms, and weight-related terms. The search included Ovid MEDLINE(R) and Epub Ahead of Print, In-Process & Other Non-Indexed Citations, and Daily, Ovid EMBASE, Ovid Cochrane Central Register of Controlled Trials, Ovid Cochrane Database of Systematic Reviews, and Scopus. Study selection was led by a single author and verified by a second; the same 2 authors assessed study quality using a standardized tool, and 3 authors completed data extraction on PA outcomes, theory application, and implementation outcomes. RESULTS In total, 601 studies were identified; 8 met the inclusion criteria. For study quality, only 2 studies received an overall rating of strong quality and low risk of bias. All but 1 study had a small sample size (<100). Positive and significant changes in child PA outcomes were reported in only 2 studies with weak overall quality, both of which used child-directed approaches. In total, 5 studies applied a behavioral theory for designing the intervention; no patterns of effectiveness were identified based on the application of theory. Finally, no studies reported on the implementation outcomes of adoption, cost, penetration, or sustainability; 1 study did not assess any implementation outcomes, and no single study reported on more than 2 implementation outcomes. Studies measured the implementation outcome of acceptability most frequently (n=4), and researchers assessed fidelity in 3 studies. CONCLUSIONS The interventions with a significant effect on PA used child-centered activities; parent-directed digital interventions alone were ineffective for improving PA. Future research with rigorous designs, monitoring of implementation outcomes, and testing of the contributions of digital components will advance understanding of the effectiveness of digital interventions for increasing PA in children.
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Stakeholder selected strategies for obesity prevention in childcare: results from a small-scale cluster randomized hybrid type III trial.
Swindle, T, McBride, NM, Selig, JP, Johnson, SL, Whiteside-Mansell, L, Martin, J, Staley, A, Curran, GM
Implementation science : IS. 2021;(1):48
Abstract
BACKGROUND Together, We Inspire Smart Eating (WISE) is an intervention for the early care and education setting to support children's exposure to and intake of fruits and vegetables. WISE emphasizes 4 evidence-based practices (EBPs): (1) use of a mascot; (2) educators' role modeling; (3) positive feeding practices; and (4) hands-on exposures. The current study reports on a small-scale implementation trial aimed at improving the use of WISE EBPs by teachers. METHODS A Hybrid Type III Cluster Randomized Design compared a Basic and Enhanced implementation strategy. The Basic Strategy included training and reminders only; the Enhanced strategy was a multi-faceted package of stakeholder-selected strategies including a leadership commitment, an implementation blueprint, a local champion, an environmental reminder of the EBPs, facilitation, and tailored educational resources and incentives. All study sites were Head Starts. Sites were randomized using a balancing technique that considered site characteristics; 4 sites (20 classrooms, 39 educators, 305 children) received Enhanced support; 5 sites (18 classrooms, 36 educators, 316 children) received Basic support. RE-AIM guided the evaluation, and implementation fidelity was the primary outcome. Strategies were assessed using examination of data distributions and unadjusted comparisons (t tests) as well as general linear and mixed effects models controlling for covariates. RESULTS For the primary outcome of fidelity, the Enhanced group had significantly higher means for 3 of 4 EBPs. Multivariate models explained a significant portion of variance for both mascot use and hands-on exposure with a significant positive effect observed for treatment condition. The Enhanced group also had higher rates of Appropriateness and Organizational Readiness for Implementing Change (as indicators of implementation and adoption, respectively). There was no significant difference between groups for indicators of Reach, Effectiveness or Maintenance. Formative interviews indicated key targets for iteration and potential mechanisms. Key events were catalogued to provide context for interpretation (e.g., 61% of classrooms with turnover). CONCLUSIONS Findings were mixed but suggested promise for the Enhanced strategy, especially considering key events of the study. Implementation fidelity improvements occurred mainly in the last 3 months of the school year; additional time may be needed to translate to improvements in child outcomes. TRIAL REGISTRATION NCT03075085 Registered 20 February 2017.
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The Families and Schools for Health Project: A Longitudinal Cluster Randomized Controlled Trial Targeting Children with Overweight and Obesity.
Topham, GL, Washburn, IJ, Hubbs-Tait, L, Kennedy, TS, Rutledge, JM, Page, MC, Swindle, T, Shriver, LH, Harrist, AW
International journal of environmental research and public health. 2021;(16)
Abstract
This cluster randomized controlled trial aimed at overweight and obese children compared three treatments. Two psychoeducation interventions for parents and children were conducted: Family Lifestyle (FL) focused on food and physical activity; Family Dynamics (FD) added parenting and healthy emotion management. A third Peer Group (PG) intervention taught social acceptance to children. Crossing interventions yielded four conditions: FL, FL + PG, FL + FD, and FL + FD + PG-compared with the control. Longitudinal BMI data were collected to determine if family- and peer-based psychosocial components enhanced the Family Lifestyle approach. Participants were 1st graders with BMI%ile >75 (n = 538: 278 boys, 260 girls). Schools were randomly assigned to condition after stratifying for community size and percent American Indian. Anthropometric data were collected pre- and post-intervention in 1st grade and annually through 4th grade. Using a two-level random intercept growth model, intervention status predicted differences in growth in BMI or BMI-M% over three years. Children with obesity who received the FL + FD + PG intervention had lower BMI gains compared to controls for both raw BMI (B = -0.05) and BMI-M% (B = -2.36). Interventions to simultaneously improve parent, child, and peer-group behaviors related to physical and socioemotional health offer promise for long-term positive impact on child obesity.
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Adaptation of an exercise intervention for pregnant women to community-based delivery: a study protocol.
Swindle, T, Martinez, A, Børsheim, E, Andres, A
BMJ open. 2020;(9):e038582
Abstract
INTRODUCTION Despite well-established guidelines and benefits to exercise, the majority of pregnant women in the USA fail to meet recommended activity levels. Studies need to determine feasible ways to translate clinical interventions to community settings by engaging pregnant women in widely accessible locations to ensure benefits to more women. The aim of this study is to adapt and determine feasibility, acceptability and fidelity of the research clinic-based Expecting intervention (NCT02125149) with pregnant women with obesity in community settings. METHODS AND ANALYSIS We will use the Replicating Effective Programs (REP) to guide the adaptation and implementation of the research clinic-based intervention into the community. REP provides a four-phase process for implementing evidence-based interventions including collection of feedback from community stakeholders, iterative piloting of the intervention in the community and a process for standardising the intervention across community settings. Following adaptation, the updated intervention will be piloted. The pilot study will include 60 expecting women. We will randomise half to receive the community-adapted Expecting intervention (intervention, N=30) and half to receive standard of care (control, N=30). Feasibility and Acceptability of Intervention Measures are primary outcomes as key indicators of feasibility. Secondary outcomes will include the number of intervention sessions completed, the change in the number of minutes of physical activity as measured by accelerometer, as well as change in health indicators from enrolment to time of delivery and 6 months post-delivery (ie, body mass index, blood pressure and total cholesterol). ETHICS AND DISSEMINATION This study has been approved by the Institutional Review Board (#260132). Findings will be shared with study participants and stakeholder advisors through written summaries and in-person presentations; results will also be shared through presentations at scientific conferences and publications in peer-reviewed journals. TRIAL REGISTRATION NUMBER NCT04298125; Pre-results.
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Identifying opportunities to develop the science of implementation for community-based non-communicable disease prevention: A review of implementation trials.
Wolfenden, L, Reilly, K, Kingsland, M, Grady, A, Williams, CM, Nathan, N, Sutherland, R, Wiggers, J, Jones, J, Hodder, R, et al
Preventive medicine. 2019;:279-285
Abstract
Implementation of interventions in community organisations such as schools, childcare centres, and sporting clubs are recommended to target a range of modifiable risks of non-communicable diseases. Poor implementation, however, is common and has contributed to the failure of non-communicable disease interventions globally. This study aimed to characterise experimental research regarding strategies to improve implementation of chronic disease prevention programs in community settings. The review used data collected in three comprehensive systematic reviews undertaken between August 2015 and July 2017. Randomised controlled trials, including cluster design, and non-randomised trials with a parallel control group were included. The data were extracted to describe trial characteristics, implementation strategies employed, implementation outcomes and study quality. Of the 40 implementation trials included in the study, unhealthy diet was the most common risk factor targeted (n = 20). The most commonly reported implementation strategies were educational meetings (n = 38, 95%), educational materials (n = 36, 90%) and educational outreach visits (n = 29, 73%). Few trials were conducted 'at-scale' (n = 8, 20%) or reported adverse effects (n = 5, 13%). The reporting of implementation related outcomes; intervention adoption (n = 13, 33%); appropriateness (n = 11, 28%); acceptability (n = 8, 20%); feasibility (n = 8, 20%); cost (n = 3, 8%); and sustainability (n = 2, 5%); was limited. For the majority of trials, risk of bias was high for blinding of study personnel/participants and outcome assessors. Testing of strategies to improve implementation of non-communicable disease prevention strategies in community settings, delivered 'at-scale', utilising implementation frameworks, including a comprehensive range of implementation outcomes should be priority areas for future research in implementation science.
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A mixed methods protocol for developing and testing implementation strategies for evidence-based obesity prevention in childcare: a cluster randomized hybrid type III trial.
Swindle, T, Johnson, SL, Whiteside-Mansell, L, Curran, GM
Implementation science : IS. 2017;(1):90
Abstract
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. TRIAL REGISTRATION ClinicalTrials.gov, NCT03075085.
