Purpose: In the behavioral sciences, conducting pilot and/or feasibility studies (PFS) is a key step that provides essential information used to inform the design, conduct, and implementation of larger-scale trials. There are more than 160 published guidelines, reporting checklists, frameworks, and recommendations related to PFS. All offer some form of guidance on PFS, but many focus on one or few topics. The purpose of this study was to develop a consolidated set of considerations for the design, conduct, implementation, and reporting of PFS for interventions conducted in the behavioral sciences.

Methods: To develop this consolidation, we undertook a review of the published guidance on PFS in combination with expert consensus (via a Delphi study) from the authors who wrote such guidance to inform the identified considerations. A total of 161 PFS-related guidelines, checklists, frameworks, and recommendations were identified via a review of recently published behavioral intervention PFS. Authors of all 161 PFS publications were invited to complete a three-round Delphi survey, which was used to guide the creation of a consolidated list of considerations to guide the design, conduct, and reporting of PFS conducted by researchers in the behavioral sciences.

Results: A total of 496 authors were invited to take part in the Delphi survey, 50 (10.1%) of which completed all three rounds, representing 60 (37.3%) of the 161 identified PFS-related guidelines, checklists, frameworks, and recommendations. A set of 20 considerations, categorized into six themes (Intervention Design, Study Design, Conduct of Trial, Implementation of Intervention, Statistical Analysis and Reporting) were generated from a review of the 161 PFS-related publications as well as data synthesis from the three-round Delphi process. These 20 considerations are presented alongside a supporting narrative for each consideration as well as a crosswalk of all 161 publications aligned with each consideration for further reading.

Conclusion: We leveraged expert opinion from researchers who have published PFS-related guidelines, checklists, frameworks, and recommendations on a wide range of topics and distilled this knowledge into a valuable resource for researchers conducting PFS. Researchers may use these considerations alongside the previously published literature to guide decisions about all aspects of PFS.

Purpose: Improving the reach of existing lifestyle interventions focused on health promotion, disease prevention, and self-management delivered in community or clinical settings has the potential to increase the public health impact of these interventions. However, little is known about the overall success of recruitment strategies or the specification of strategy components including how, through which channel and by who the recruitment strategies are enacted.

Methods: We conducted a scoping review with guidance from the latest version of the Joanna Briggs Institute Manual for Evidence Synthesis to address this issue. For transparency and reproducibility, we adhered to the PRISMA reporting guidelines for scoping reviews and searches. Primary inclusion criteria were intervention content focus aligning with the review purpose, provided information to calculate a participation rate, and a description of the recruitment strategy used. Covidence, an online systematic reviewing platform, was used to screen and select studies.

Results: A total of 5,446 articles were initially identified by using combinations of keywords and database subject headings from 18 databases, with Medline serving as the primary database. Ninety-nine of those articles were identified as duplicates and subsequently removed, leaving 5,347 to be screened, of which 5,139 studies were excluded. Full text screenings, conducted by two independent reviewers, resulted in the inclusion of 104 (of 208) eligible studies. Preliminary findings, indicated that the average reach, operationalized as participation rate, was approximately 8% of those exposed to recruitment activities (174,279 enrolled/2,478,465 potential participants). There was a wide variety of recruitment strategies used, with 34% of the studies utilizing more than one recruitment strategy. Recruitment strategy specification based on who delivered the strategy content (74%), the setting (95%), and delivery channel were provided in a large majority of the studies. However, only 57% of studies reported on the temporality of their strategy, 49% specified delivery dosage, and 14% reported on cost.

Conclusions: More transparency is needed when reporting on specific recruitment strategies used in lifestyle interventions. Particularly when it comes to the temporality, dosage, and cost of the recruitment strategies. This increased transparency will greatly aid in the reproducibility and implementation of lifestyle interventions in other populations.

Purpose: Understanding facilitators and barriers to implementing a novel technology is an important area of study that can help close the research to practice gap. However, little research has explored implementation change over time.

Methods: Three quasi-experimental trials were conducted as part of the USDA/Tufts Telehealth Intervention Strategies for WIC project. WIC refers to the Special Supplemental Nutrition Program for Women, Infants, and Children program, one of the largest federal nutrition programs in the U.S. Between April-June 2022 (‘early phase implementation’) and April-May 2023 (‘late phase implementation’), semi-structured Zoom interviews were conducted with WIC staff (n=57) involved with implementing telehealth innovations to deliver nutrition education and breastfeeding support services. Interviews were recorded, transcribed and imported into NVivo 12 for coding and analysis. The Consolidated Framework for Implementation Science Research guided the early and late phase interview guides and the deductive analytical approach.

Results: Early phase interviews indicated several key facilitators for innovation implementation, including 'teaming' through additional training for innovation deliverers (WIC staff), effective communication within and across local agencies, supportive work infrastructure (e.g., workplace flexibility for staff), and prioritization (i.e., relative priority) of the telehealth solution by local agencies. In contrast, barriers were the relative advantage of the innovation (e.g., increased time required for appointments), innovation design challenges (e.g., lack of integration with WIC data systems, no chat feature, etc)), limitations in information technology (IT) infrastructure (e.g., difficulty integrating telehealth translation services), and critical incidents (e.g., infant formula recall).
In the late phase, continued ‘teaming’ across innovation deliverers, support from high-level leadership, and tailored strategies (e.g., streamlining the scheduling process) emerged as facilitators. Persistent barriers included ongoing innovation design challenges, IT infrastructure limitations, and issues related to innovation recipients (e.g., multitasking by WIC participants).

Conclusion: Preliminary findings suggest that some facilitators and barriers to implementation change over time while others did not. Consistent telehealth innovation facilitators include teaming between staff and strategic high-level leadership support while critical incidents, innovation design challenges, and infrastructure gaps act as barriers. These findings emphasize the need to track implementation change over time, which can be used to adapt interventions accordingly.

Background: Although family childcare homes (FCCH) present an ideal opportunity to improve children’s healthy dietary intake, their use of mealtime responsive feeding practices is sub-optimal. This study’s purpose was to determine the intervention effectiveness to increase the mealtime practices in Oklahoma FCCHs.

Methods: Happy Healthy Homes, a virtual intervention study included 36 FCCH providers (15=intervention, 21=control) who completed 6 hours of individual and group classes on a variety of topics, including one 20-minute module on responsive mealtime practices. One lunch per participant was recorded and coded using the Mealtime Observation in Child Care (MOCC) tool. Sub-scores for nine mealtime constructs and total scores (0-188.1 points) were assessed at baseline, at 3-months, and at 12-months to evaluate intervention effectiveness.

Results: Compared to baseline (93.8 ± 15.7), overall mealtime environment quality score (intervention group) improved at 3-months (99.0 ± 15.5; Not Significant (NS)) and significantly at 12-months (104 ± 10.8; p=0.035). Compared to baseline (3.3 ± 1.5 out of 20 points), providers scored significantly higher on serving meals family-style at 3-months (5.5 ± 4.3; p=0.048) and remained similar but not significant at 12-months (5.6 ± 2.7; NS). Compared to baseline (6.7 ± 5.2 out of 16.7 points), providers scored higher for sitting with children during mealtimes at 3-months (8.9 ± 4.7; NS), and significantly higher at 12-months (10.3 ± 2.8; p=0.007). Although the scores did not significantly differ between the intervention and the control group at 3-months, at 12 months, the intervention group scored significantly higher than the control group on serving meals family-style (5.6 ± 2.7 vs 3.1 ± 2.1; p=0.013), sitting together (10.3 ± 2.8 vs 6.7 ± 4.8; p=0.042), and allowing children’s self-regulation (8.5 ± 1.4 vs 9.6 ± 0.8; p=0.019).

Conclusion: The virtual intervention was effective in improving aspects of mealtime practices in FCCHs with some changes sustained even at 12 months. Higher intervention dose may be needed to improve other aspects of mealtimes including encouraging verbal communication, sensory exploration, and using less restrictive mealtime practices.

Purpose: The purpose of this study is to describe the impact of the virtually delivered Happy Healthy Homes randomized controlled intervention on Family Child Care Home provider’s (FCCH) nutrition practices, confidence, and knowledge.

Methods: Oklahoma Cooperative Extension Educators delivered a 6-hour zoom intervention over three months, consisting of two, individual 90-minute education sessions and a 3-hour small group cooking class with immediate (3-month) and long-term (12-month) outcomes. Analyses used a mixed model, intent-to-treat paradigm (Nutrition (NUT) n=15; Control (CON) n=21). Clinical trials registration (NCT03560050).

Results: FCCH providers were 100% women, mean age 43.6 ± 9.8 years. In the nutrition intervention group, average nutrition practices score (max 4) increased from 3.15 ± 0.27 to 3.20 ± 0.28 at 3 months (p=0.05). Nutrition practice sub-scores (max 4) for beverages provided (3.30 ± 0.28, 3.47 ± 0.38, 3.39 ± 0.42) and feeding environment (2.70 ± 0.38, 3.02 ± 0.41, 2.84 ± 0.43) improved in the NUT group at 3 months (p≤0.05), but not at 12. The number of foods-provided best practices (max 13) increased in the NUT group from baseline (6.9 ± 1.5) to 12 months (8.67 ± 1.6, p=0.02). Nutrition confidence was relatively high at baseline for both NUT (14.3 ± 2.8 out of 18) and CON (16.0 ± 2.0), but higher for CON (p=0.04). By 3 months, this difference had diminished however by 12 months it had returned indicating short-term intervention impact. Nutrition barriers were relatively low (range 20-60 where lower=fewer barriers) at baseline for both NUT (35.3 ± 6.3) and CON (34.6 ± 7.3). There was no change by group or over time. The general nutrition knowledge score indicated 67% accuracy with no change at 3 or 12 months. Food program knowledge was low (55% accuracy). By 12 months, the NUT group demonstrated improved knowledge on serving more whole grains and less fried foods.

Conclusions: The virtual intervention delivery yielded modest short-term improvements in nutrition practices, specifically beverages and foods provided and the feeding environment, and in nutrition confidence, and CACFP knowledge. Some changes were maintained at 12 months while others indicated the likely need for follow-up content exposure.

Purpose: To examine the physical (i.e., diet, physical activity, health status), mental (i.e., stress), and professional (i.e., burnout, retention) wellbeing of Early Care and Education (ECE) educators.

Methods: The StayWell ECE Survey (110 items) was distributed electronically via REDCap to New York licensed ECE educators in spring 2023. Physical wellbeing included diet (Rapid Eating Assessment for Participants), physical activity (Behavioral Risk Factor Surveillance System), and health status (e.g., Body Mass Index (BMI)). Mental wellbeing included a stress measure (Perceived Stress Scale). Professional wellbeing included the Maslach Burnout Inventory (emotional exhaustion, depersonalization, and personal accomplishment) and plans for retention (assessing likelihood to leave). Multiple linear regressions tested associations between physical, mental, and professional wellbeing, controlling for income, age, and ECE setting. Analyses were performed using R (v4.3.2, 2023); α< 0.05.

Results: Respondents (n=1,423) worked in a variety of ECE settings- Head Start (21%), large centers/public schools (17%), or small centers/ after school programs (17%); 44% were low-income, 36% were food insecure, and 74% had moderate/high levels of stress. A majority (71%) were overweight/obese; 74% consumed <2 daily servings of whole grains, vegetables, and/or fruit; and 28% did not exercise. For burnout, 54% had medium/high emotional exhaustion, 38% had medium/high depersonalization, and 79% experienced low/medium levels of personal accomplishment. Within the next year, 22% planned to leave their position, center, or the ECE profession. Lower personal accomplishment (high burnout) was positively associated with higher BMI (β=0.08, p=0.02), stress (β=0.53, p=0.00), and likelihood to leave (β=0.07, p=0.00). Higher depersonalization (D) and emotional exhaustion (EE; high burnout) were both positively associated with BMI (D: β=0.06, p=0.00; EE: β=0.18, p=0.00), stress (D: β=0.32, p=0.00; EE: β=1.09, p=0.00), and likelihood to leave (D: β=0.17, p=0.00; EE: β=0.08, p=0.00). Stress was also positively associated with likelihood to leave (β=0.10, p=0.00).

Conclusion: ECE educators experienced high levels of stress and burnout, had poor health behaviors and overall health. Higher burnout related to lower professional retention plans, and higher stress and BMI. Different dimensions of wellbeing were closely linked; these findings have implications towards the development of wellbeing interventions for ECE educators.

Funding Source: USDA-NIFA NYC-199404; NICHD 2T32HD087137-06