Exploring biorepository donation patterns, experiences, and recommendations: a mixed-methods study among Appalachian adults enrolled in a sugary drink reduction program.

Background: Under-represented subgroups in biomarker research linked to behavioral health trials may impact the promise of precision health. This mixed methods study examines biorepository donations across an Appalachian sample enrolled in a sugary drink reduction intervention trial. Methods: Participants enrolled in the behavioral trial were asked to join an optional biomarker study and were tracked for enrollment and biospecimen returns (stool and/or buccal sample). At 6 months, participants completed a summative interview on decision-making process, experiences collecting samples, and recommendations to encourage biospecimen donation. Return rates were analyzed across demographics (i.e., age, gender, race, education, income, health literacy status, and rurality status) using chi-squares. Qualitative data were content coded with differences compared by biomarker study enrollment and donation choices. Results: Of the 249 invited participants, 171 (61%) enrolled, and 63% (n = 157) returned buccal samples and 49% (n = 122) returned stool samples. Metro residing participants were significantly more likely (56%) to return stool samples compared to non-metro (39%) counterparts [x2(1) = 6.61; p = 0.01]. Buccal sample return had a similar trend, 67 and 57%, respectively for metro vs. non-metro [x2(1) = 2.84; p = 0.09]. An additional trend indicated that older (≥40 years) participants were more likely (55%) to donate stool samples than younger (43%) participants [x2(1) = 3.39; p = 0.07]. No other demographics were significantly associated with biospecimen return. Qualitative data indicated that societal (66-81%) and personal (41-51%) benefits were the most reported reasons for deciding to donate one or both samples, whereas mistrust (3-11%) and negative perceptions of the collection process (44-71%) were cited the most by those who declined one or both samples. Clear instructions (60%) and simple collection kits (73%) were donation facilitators while challenges included difficult stool collection kits (16%) and inconveniently located FedEx centers (16%). Recommendations to encourage future biorepository donation were to clarify benefits to science and others (58%), provide commensurate incentives (25%), explain purpose (19%) and privacy protections (20%), and assure ease in sample collection (19%). Conclusion: Study findings suggest the need for biomarker research awareness campaigns. Researchers planning for future biomarker studies in medically underserved regions, like Appalachia, may be able to apply findings to optimize enrollment.

Kids SIPsmartER reduces sugar-sweetened beverages among Appalachian middle-school students and their caregivers: a cluster randomized controlled trial.

BACKGROUND: High consumption of sugar-sweetened beverages (SSB) is a global health concern. Additionally, sugar-sweetened beverage (SSB) consumption is disproportionately high among adolescents and adults in rural Appalachia. The primary study objective is to determine the intervention effects of Kids SIPsmartER on students' SSB consumption. Secondary objectives focus on caregivers' SSB consumption and secondary student and caregiver outcomes [e.g, body mass index (BMI), quality of life (QOL)]. METHODS: This Type 1 hybrid, cluster randomized controlled trial includes 12 Appalachian middle schools (6 randomized to Kids SIPsmartER and 6 to control). Kids SIPsmartER is a 6-month, 12 lesson, multi-level, school-based, behavior and health literacy program aimed at reducing SSB among 7th grade middle school students. The program also incorporates a two-way text message strategy for caregivers. In this primary prevention intervention, all 7th grade students and their caregivers from participating schools were eligible to participate, regardless of baseline SSB consumption. Validated instruments were used to assess SSB behaviors and QOL. Height and weight were objectively measured in students and self-reported by caregivers. Analyses included modified two-part models with time fixed effects that controlled for relevant demographics and included school cluster robust standard errors. RESULTS: Of the 526 students and 220 caregivers, mean (SD) ages were 12.7 (0.5) and 40.6 (6.7) years, respectively. Students were 55% female. Caregivers were mostly female (95%) and White (93%); 25% had a high school education or less and 33% had an annual household income less than $50,000. Regardless of SSB intake at baseline and relative to control participants, SSB significantly decreased among students [-7.2 ounces/day (95% CI = -10.7, -3.7); p < 0.001, effect size (ES) = 0.35] and caregivers [-6.3 ounces/day (95% CI = -11.3, -1.3); p = 0.014, ES = 0.33]. Among students (42%) and caregivers (28%) who consumed > 24 SSB ounces/day at baseline (i.e., high consumers), the ES increased to 0.45 and 0.95, respectively. There were no significant effects for student or caregiver QOL indicators or objectively measured student BMI; however, caregiver self-reported BMI significantly decreased in the intervention versus control schools (p = 0.001). CONCLUSIONS: Kids SIPsmartER was effective at reducing SSB consumption among students and their caregivers in the rural, medically underserved Appalachian region. Importantly, SSB effects were even stronger among students and caregivers who were high consumers at baseline. TRIAL REGISTRATION: Clincialtrials.gov: NCT03740113. Registered 14 November 2018- Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT03740113 .

Student and caregiver acceptability of a school-based intervention to improve sugar-sweetened beverage behaviors: a mixed methods study.

Kids SIPsmartER is a 6-month behavioral and health literacy intervention effective at reducing sugar-sweetened beverage (SSB) intake among middle school students and their caregivers in the rural Appalachian region. This exploratory mixed methods study utilized a convergent parallel design to assess participant acceptability of a school-based curriculum for students and a text messaging program for caregivers. Acceptability was assessed using surveys (873 students and 453 caregivers), five focus groups (34 students) and telephone interviews (22 caregivers). Quantitative data were analyzed descriptively, and qualitative data were content coded. On a 5-point scale, average quantitative survey acceptability ratings ranged from 2.7 to 3.3 among three student-rated questions and 4.1 to 4.2 among four caregiver-rated questions. Qualitative focus group findings suggested that students preferred curricular activities that were hands-on and involved social interaction, while caregiver interview results showed high acceptability of the text messaging program's design, including usability, content messages and personalization. Students and caregivers reported similar program benefits: increased knowledge of SSBs and health risks, increased awareness of SSB behaviors and support to make beverage behavior changes. Results from this study can be used to understand Kids SIPsmartER's effectiveness data, communicate the intervention's acceptability with stakeholders and plan for future implementation studies.

Associations of Body Mass Index with Self-Rated Health and Weight Perceptions Among Rural Appalachian Adolescent Students.

BACKGROUND: Adolescents with overweight or obesity are at greater risk of having physical and psychosocial consequences. With increased disparities and inadequate literature on prevalence of adolescent weight status in rural Appalachia, there is potential for further complications. Unfortunately, adolescent obesity treatment options are often limited, especially in medically underserved regions. METHODS: This cross-sectional study of adolescents at eight rural Appalachian schools examined weight status among and associations between body mass index percentile (BMIp) categories and health-related perceptions and weight-control intentions. Previously validated instruments were utilized. Analyses included independent samples t-tests, ANOVA tests, and chi-squared tests. RESULTS: Of 814 adolescents (ages 11-13; 55.0% girls), BMIp revealed 20.8% overweight, 22.7% obese, and 10.6% severely obese. Adolescents with higher BMIp categories reported poorer self-rated health, inaccurate weight perceptions, and greater weight loss intentions (all p < .05). CONCLUSIONS: Findings, including high prevalence of adolescents with overweight and obesity, emphasize the need for more obesity prevention and treatment options. Schools may be an ideal setting to reach at-risk adolescents and provide obesity prevention and treatment options, especially in medically underserved regions such as rural Appalachia. Opportunities and challenges to apply findings, including school-based obesity programs, are discussed.

Outcomes of a Caregiver-Focused Short Message Service (SMS) Intervention to Reduce Intake of Sugar-Sweetened Beverages in Rural Caregivers and Adolescents.

This study examined enrollment, retention, engagement, and behavior changes from a caregiver short message service (SMS) component of a larger school-based sugar-sweetened beverage (SSB) reduction intervention. Over 22 weeks, caregivers of seventh graders in 10 Appalachian middle schools received a two-way SMS Baseline Assessment and four monthly follow-up assessments to report their and their child's SSB intake and select a personalized strategy topic. Between assessments, caregivers received two weekly one-way messages: one information or infographic message and one strategy message. Of 1873 caregivers, 542 (29%) enrolled by completing the SMS Baseline Assessment. Three-quarters completed Assessments 2-5, with 84% retained at Assessment 5. Reminders, used to encourage adherence, improved completion by 19-40%, with 18-33% completing after the first two reminders. Most caregivers (72-93%) selected a personalized strategy and an average of 28% viewed infographic messages. Between Baseline and Assessment 5, daily SSB intake frequency significantly (p < 0.01) declined for caregivers (-0.32 (0.03), effect size (ES) = 0.51) and children (-0.26 (0.01), ES = 0.53). Effect sizes increased when limited to participants who consumed SSB twice or more per week (caregivers ES = 0.65, children ES = 0.67). Findings indicate that an SMS-delivered intervention is promising for engaging rural caregivers of middle school students and improving SSB behaviors.

Retention and engagement of rural caregivers of adolescents in a short message service intervention to reduce sugar-sweetened beverage intake.

Objective: This study investigates a 6-month short message service (SMS) intervention to reduce adolescent sugar-sweetened beverage (SSB) intake. The objectives are to describe caregiver retention and SMS engagement as well as explore differences by caregiver characteristics. Methods: Caregivers completed a baseline survey then messages were sent two times per week. Message types included the following: SSB intake assessments, educational information, infographic URLs, and strategies. Engagement was measured through interaction with these messages and included: assessment completion, reminders needed, number of strategies chosen, and URLs clicked. Results: Caregivers (n = 357) had an average baseline SSB intake of 23.9 (SD = 26.8) oz/day. Of those, 89% were retained. Caregivers with a greater income and education were retained at a higher rate. Average engagement included: 4.1 (SD = 1.3) of 5 assessments completed with few reminders needed [4.1 (SD = 3.7) of 14 possible], 3.2 (SD = 1.1) of 4 strategies selected, and 1.2 (SD = 1.6) of 5 URLs clicked. Overall, average engagement was relatively high, even where disparities were found. Demographic characteristics that were statistically related to lower engagement included younger age, lower income, lower educational attainment, single caregivers, lower health literacy. Furthermore, caregivers with a reduced intention to change SSB behaviors completed fewer assessments and needed more reminders. Higher baseline SSB intake was associated with lower engagement across all indicators except URL clicks. Conclusions: Results can be used to develop targeted retention and engagement strategies (e.g., just-in-time and/or adaptive interventions) in rural SMS interventions for identified demographic subsets. Trial registration: Clincialtrials.gov: NCT03740113.

Feasibility of an Adapted Community-Based Lifestyle Intervention to Prevent Cancer in the Rural South: Healthy Living Partnerships to Prevent Cancer (HELP PC).

Obesity increases risk of cancer onset and promulgates cancer mortality. Healthy Living Partnerships to Prevent Cancer (HELP PC) is an adapted intensive lifestyle intervention that is facilitated by community health workers (CHWs). The primary objective of this one-arm pilot study was to test the feasibility of evaluating HELP PC in a rural community by assessing participant recruitment, retention, and adherence to the intervention. The secondary objectives of this study were to evaluate the feasibility of collecting study measures and analyze intervention effects to inform future studies. Adults of all races and a BMI ≥ 25 kg/m2 who resided in the Dan River Region of Southern Virginia were recruited. Participants received 24 weekly (hour-long) group sessions led by a CHW and two consultations with a registered dietitian (RDN). Seventy-five percent (21/28) of eligible subjects were enrolled (n = 21; mean age = 46 years; 67% African American; 90% female; median BMI = 36.1), and recruitment was completed in 2 weeks. Fifty-two percent (11/21) of participants attended >70% of group sessions (adherence) and 98% of RDN consultations were attended. Eighty-six percent (n=18) of participants completed the 6-month follow-up visit (retention), and showed improvements in moderate physical activity, health literacy, general health, energy, and emotional well-being. Feasibility of HELP PC was established through efficient participant recruitment, modest attendance, high retention, and execution of data collection procedures. Importantly, findings can be applied to advance cancer prevention lifestyle interventions in rural communities.

Comparing two different family-based childhood obesity treatment programmes in a medically underserved region: Effectiveness, engagement and implementation outcomes from a randomized controlled trial.

BACKGROUND: Access to evidence- and family-based childhood obesity (FBCO) treatment interventions is a challenge, especially in underserved regions where childhood obesity disparities persist. OBJECTIVE: Compare two 6-month FBCO treatment interventions, iChoose (high intensity, parent-child dyads) and Family Connections (low intensity, parents only), in one underserved US region. METHODS: This unblinded, RCT reports on effectiveness and implementation outcomes. Eligibility included children ages 5-12 with BMI ≥85th percentile. Analyses included descriptive statistics and intention-to-treat Heckman treatment effect models. RESULTS: Enrolled children (n = 139, mean age 10.1 ± 1.7 years, 30% with overweight, 70% with obesity, 45% black, 63% Medicaid) were randomly assigned to iChoose (n = 70) or Family Connections (n = 69). Retention rates were 63% for iChoose and 84% for Family Connection. Among children, 6-month BMI z-score changes were not statistically significant within iChoose [BMI z-score 0.03 (95% CI = -0.13, 0.19)] or Family Connections [BMI z-score 0.00 (95% CI = -0.16, 0.16)]. Likewise, parents' BMI changes were not statistically significant. No adverse events were reported. Both programmes were delivered with high fidelity (77%-100%). Engagement in core components was 25%-36% for iChoose and 52%-61% for Family Connections. Implementation costs per child with improved BMI z-score were $2841 for iChoose and $955 for Family Connections. CONCLUSIONS: Neither intervention yielded significant improvements in child BMI z-score or parent BMI, yet both were delivered with high fidelity. Relative to iChoose, descriptive data indicated higher retention, better engagement, and lower costs for Family Connections-suggesting that a lower intensity and parent-focused programme may better fit the intended audience's context.

Study protocol for iSIPsmarter: A randomized-controlled trial to evaluate the efficacy, reach, and engagement of a technology-based behavioral intervention to reduce sugary beverages among rural Appalachian adults.

Sugar-sweetened beverage (SSB) consumption is disproportionately high among rural Appalachian adults, with intakes double the national average and nearly four times the recommended amount. This trial targets this major dietary risk factor and addresses notable gaps in the rural digital health intervention literature. iSIPsmarter is a technology-based behavior and health literacy intervention aimed at improving SSB behaviors. It is comprised of six Internet-delivered, interactive Cores delivered weekly, an integrated short message service (SMS) strategy to engage users in tracking and reporting SSB behaviors, and a cellular-enabled scale for in-home weighing. iSIPsmarter is adapted from an evidence-based intervention and is grounded by the Theory of Planned Behavior and health literacy, numeracy, and media literacy concepts. The RCT is guided by the RE-AIM framework and targets 244 rural Appalachian adults. The goal is to examine the efficacy of iSIPsmarter to reduce SSB in a two-group design [iSIPsmarter vs. static Participant Education website] with four assessment points. Changes in secondary outcomes (e.g., diet quality, weight, quality of life) and maintenance of outcomes will also be evaluated. Additional secondary aims are to examine reach and representativeness, patterns of user engagement, and cost. Two tertiary aims are exploratory mediation analyses and a systems-level, participatory evaluation to understand context for future organizational-level adoption of iSIPsmarter. The long-term goal is to sustain an effective, scalable, and high reach behavioral intervention to reduce SSB-related health inequities and related chronic conditions (i.e., obesity, diabetes, some obesity-related cancers, heart disease, hypertension, dental decay) in rural Appalachia and beyond. ClinicalTrial registry: NCT05030753.

Advancing engagement and capacity for rural cancer control: a mixed-methods case study of a Community-Academic Advisory Board in the Appalachia region of Southwest Virginia.

BACKGROUND: The objectives are to: 1) describe engagement processes used to prioritize and address regional comprehensive cancer control needs among a Community-Academic Advisory Board (CAB) in the medically-underserved, rural Appalachian region, and 2) detail longitudinal CAB evaluation findings. METHODS: This three-year case study (2017-2020) used a convergent parallel, mixed-methods design. The approach was guided by community-based participatory research (CBPR) principles, the Comprehensive Participatory Planning and Evaluation process, and Nine Habits of Successful Comprehensive Cancer Control Coalitions. Meeting artifacts were tracked and evaluated. CAB members completed quantitative surveys at three time points and semi-structured interviews at two time points. Quantitative data were analyzed using analysis of variance tests. Interviews were audio recorded, transcribed, and analyzed via an inductive-deductive process. RESULTS: Through 13 meetings, Prevention and Early Detection Action Teams created causal models and prioritized four cancer control needs: human papillomavirus vaccination, tobacco control, colorectal cancer screening, and lung cancer screening. These sub-groups also began advancing into planning and intervention proposal development phases. As rated by 49 involved CAB members, all habits significantly improved from Time 1 to Time 2 (i.e., communication, priority work plans, roles/accountability, shared decision making, value-added collaboration, empowered leadership, diversified funding, trust, satisfaction; all p < .05), and most remained significantly higher at Time 3. CAB members also identified specific challenges (e.g., fully utilizing member expertise), strengths (e.g., diverse membership), and recommendations across habits. CONCLUSION: This project's equity-based CBPR approach used a CPPE process in conjunction with internal evaluation of cancer coalition best practices to advance CAB efforts to address cancer disparities in rural Appalachia. This approach encouraged CAB buy-in and identified key strengths, weaknesses, and opportunities that will lay the foundation for continued involvement in cancer control projects. These engagement processes may serve as a template for similar coalitions in rural, underserved areas.

There has been notable progress among state and local cancer coalitions in developing and implementing comprehesive cancer control plans. Yet, gaps exist in rural communities and cancer remains a leading cause of death in rural populations. This paper reports on how the involvement of a Community-Academic Advisory Board (CAB) helped to prioritize cancer control and research needs in the medically-underserved, rural Appalachian region. CAB members were asked to participate in meetings and to share their experiences through surveys and interviews. Through this three-year process, four cancer control needs were prioritized: human papillomavirus vaccination, tobacco control, colorectal cancer screening, and lung cancer screening. Also, over the course of the project, CAB members' experiences improved, including: communication, priority work plans, roles/accountability, shared decision making, value-added collaboration, empowered leadership, diversified funding, trust, satisfaction. During the interviews, CAB members identified specific challenges, strengths, and recommendations. The opportunities and barriers at building and sustaining capacity as well as advancing a community-driven research agenda to address cancer disparities in rural Appalachia is discussed.

Assets and Challenges to Recruiting and Engaging Families in a Childhood Obesity Treatment Research Trial: Insights From Academic Partners, Community Partners, and Study Participants.

Background: There is need for the childhood obesity treatment literature to identify effective recruitment and engagement strategies for rural communities that are more likely to lack supportive infrastructure for healthy lifestyles and clinical research relative to their urban counterparts. This community case study examines recruitment and engagement strategies from a comparative effectiveness research (CER) trial of two family-based childhood obesity (FBCO) treatment interventions conducted in a medically underserved, rural region. Guided by a Community Based Participatory Research (CBPR) and systems-based approach, the primary aim was to analyze interviews from academic partners, community partners, and parent study participants for recruitment and engagement assets, challenges, and lessons learned. Methods: Over the 3-year lifespan of the study, researchers conducted 288 interviews with Community Advisory Board members (n = 14), Parent Advisory Team members (n = 7), and study participants (n = 100). Using an inductive-deductive approach, interviews were broadly coded for recruitment and engagement assets, challenges, and recommendations; analyzed for descriptive sub-coding; and organized into stakeholder/organization and participant level themes. Codes were analyzed aggregately across time and examined for differences among stakeholders and parent study participants. Results: Adherence to CBPR principles and development of strong community partnerships facilitated recruitment and engagement; however, variability in recruitment and engagement success impacted partner confidence, threatened outcome validity, and required additional resources. Specifically, assets and challenges emerged around eight key needs. Three were at the stakeholder/organization level: (1) readiness of stakeholders to conduct CBPR research, (2) development of sustainable referral protocols, and (3) development of participant engagement systems. The remaining five were at the participant level: (1) comfort and trust with research, (2) awareness and understanding of the study, (3) intervention accessibility, (4) intervention acceptability, and (5) target population readiness. Future recommendations included conducting readiness assessments and awareness campaigns, piloting and evaluating recruitment and engagement strategies, identifying participant barriers to engagement and finding a priori solutions, and fostering stakeholder leadership to develop sustainable protocols. Conclusion: Collective findings from multiple perspectives demonstrate the need for multi-leveled approaches focusing on infrastructure supports and strategies to improve stakeholder and participant awareness of, and capacity for, recruiting and engaging medically underserved, rural families in a FBCO CER trial.

Understanding and Advancing Organizational Health Literacy Within a Public Health Setting.

BACKGROUND: Organizational health literacy (OHL) within the public health setting is lacking. OBJECTIVE: The aim of this study was to form a health literacy (HL) improvement team consisting of university researchers and Virginia Department of Health (VDH) district directors and staff to assess and improve OHL practices of VDH staff in four medically underserved health districts in southwest Virginia. METHODS: The Agency for Healthcare Research and Quality Health Literacy Universal Precautions Toolkit guided this mixed-methods needs assessment and improvement plan. VDH staff completed a 44-item survey adapted from this Toolkit and a roundtable discussion to indicate their perceptions of current OHL practices. VDH clients completed a survey including seven items measuring perceptions of staff OHL practices and three items measuring subjective HL. KEY RESULTS: About one-half of VDH staff (n = 252, 88% female, average age 49 ± 12 years, 23% ≤ high school education [HS]) reported "doing well" across all OHL domains. Staff survey and roundtable discussion revealed the need to strengthen the written communication domain. Among 185 VDH clients (82% female, average age 33 ± 14 years, 40% ≤ HS), perceptions of staff OHL practices were high, ranging from 3.07 to 3.64 (scale of 1-4). Client HL status was significantly positively correlated (p < .01-.05) with 5 of 7 OHL practices. Findings aided development and initial implementation of an OHL improvement plan, including e-newsletters and in-person workshops. On average, 60% of staff opened quarterly e-newsletters. Staff ratings of the Clear Communication Index workshop were high in terms of utility and applicability of content. CONCLUSIONS: Results reflected notable strengths and weaknesses in current OHL practices from staff and client perspectives, with the greatest need identified in written communication. E-newsletter series and in-person workshops on the Clear Communication Index helped lay groundwork for additional HL improvement activities for VDH staff. Limitations and future recommendations for public health settings are discussed. [HLRP: Health Literacy Research and Practice. 2021;5(1):e35-e48.] PLAIN LANGUAGE SUMMARY: This study describes use of the Agency for Healthcare Research and Quality Health Literacy Universal Precautions Toolkit to conduct an organizational health literacy needs assessment and improvement plan in a public health setting, the Virginia Department of Health. Assessment of staff and clients revealed strengths and weaknesses in organizational health literacy practices. Feedback guided efforts to improve organizational health literacy capacity.

Capacity Development and Evaluation of a Parent Advisory Team Engaged in Childhood Obesity Research.

Guided by community-based participatory research principles, this mixed-methods process evaluation explored the experience and capacity of a newly formed Parental Advisory Team (PAT) engaged in childhood obesity research in a medically underserved region. Following the successful completion of a 3-month evidence-based childhood obesity treatment program (iChoose), 13 parents/caregivers who completed iChoose consented to participate in the PAT. Between June 2015 and March 2016, the PAT had nine monthly meetings and completed mixed-methods capacity assessments. They engaged in activities related to understanding iChoose outcomes, defining their role and purpose as a partnership, initiating content development, and pilot testing maintenance intervention components for future iChoose efforts. Assessments included a quantitative survey administered at baseline and 9 months, and a qualitative interview completed at 9 months. Results indicated that PAT members' perceptions of the identified capacity dimensions were positive at baseline (3.8-4.3 on a 5-point scale) and remained positive at follow-up (3.9-4.4 on a 5-point scale); changes were not statistically significant. Qualitative data revealed that PAT members were satisfied with group participation and desired to enhance their role in subsequent iChoose research. Understanding and promoting parental engagement in the research process fills an important gap in childhood obesity literature.

SIPsmartER delivered through rural, local health districts: adoption and implementation outcomes.

BACKGROUND: SIPsmartER is a 6-month evidenced-based, multi-component behavioral intervention that targets sugar-sweetened beverages among adults. It consists of three in-person group classes, one teach-back call, and 11 automated phone calls. Given SIPsmartER's previously demonstrated effectiveness, understanding its adoption, implementation, and potential for integration within a system that reaches health disparate communities is important to enhance its public health impact. During this pilot dissemination and implementation trial, SIPsmartER was delivered by trained staff from local health districts (delivery agents) in rural, Appalachian Virginia. SIPsmartER's execution was supported by consultee-centered implementation strategies. METHODS: In this mixed-methods process evaluation, adoption and implementation indicators of the program and its implementation strategy (e.g., fidelity, feasibility, appropriateness, acceptability) were measured using tracking logs, delivery agent surveys and interviews, and fidelity checklists. Quantitative data were analyzed with descriptive statistics. Qualitative data were inductively coded. RESULTS: Delivery agents implemented SIPsmartER to the expected number of cohorts (n = 12), recruited 89% of cohorts, and taught 86% of expected small group classes with > 90% fidelity. The planned implementation strategies were also executed with high fidelity. Delivery agents completing the two-day training, pre-lesson meetings, fidelity checklists, and post-lesson meetings at rates of 86, 75, 100, and 100%, respectively. Additionally, delivery agents completed 5% (n = 3 of 66) and 10% (n = 6 of 59) of teach-back and missed class calls, respectively. On survey items using 6-point scales, delivery agents reported, on average, higher feasibility, appropriateness, and acceptability related to delivering the group classes (range 4.3 to 5.6) than executing missed class and teach-back calls (range 2.6 to 4.6). They also, on average, found the implementation strategy activities to be helpful (range 4.9 to 6.0). Delivery agents identified strengths and weakness related to recruitment, lesson delivery, call completion, and the implementation strategy. CONCLUSIONS: In-person classes and the consultee-centered implementation strategies were viewed as acceptable, appropriate, and feasible and were executed with high fidelity. However, implementation outcomes for teach-back and missed class calls and recruitment were not as strong. Findings will inform the future full-scale dissemination and implementation of SIPsmartER, as well as other evidence-based interventions, into rural health districts as a means to improve population health.

Development and Pilot Testing of Text Messages to Help Reduce Sugar-Sweetened Beverage Intake Among Rural Caregivers and Adolescents: Mixed Methods Study.

BACKGROUND: A high consumption of sugar-sweetened beverages (SSBs) poses significant health concerns, particularly for rural adults and adolescents. A manner in which the health of both caregivers and adolescents can be improved is by developing innovative strategies that target caregivers as the agents of change. Sending text messages through mobile phones has been cited as an effective way to improve behavioral outcomes, although little research has been conducted in rural areas, particularly focusing on SSB intake. OBJECTIVE: By targeting rural caregivers, this 2-phase study aimed to (1) understand caregivers' perceptions and language preferences for SSB-related text messages to inform and refine message development and delivery and (2) evaluate the acceptability of text messages for SSB intake behavior change and examine short-term effects on SSB intake behavior. METHODS: A convergent mixed methods design was used to systematically develop and pilot-test text messages with caregivers in Southwest Virginia. In phase 1, 5 focus groups that included a card-sorting activity were conducted to explore advantages/disadvantages, language preferences (ie, tone of voice, audience, and phrase preferences), and perceived use of text messages. In phase 2, caregivers participated in a 5-week text message pilot trial that included weekly educational and personalized strategy messages and SSB intake assessments at baseline and follow-up. Before the focus groups and after completing the pilot trial, caregivers also completed a pre-post survey that assessed SSB intake, SSB home availability, and caregivers' SSB-related practices. Caregivers also completed individual follow-up telephone interviews following the pilot trial. RESULTS: In phase 1, caregivers (N=33) reported that text messages were convenient, accessible, and easy to read. In addition, they preferred messages with empathetic and authoritative tones that provided useful strategies and stayed away from using absolute words (eg, always and never). In the phase 2 pilot trial (N=30), 87% of caregivers completed baseline and 77% completed follow-up assessment, suggesting a high utilization rate. Other ways in which caregivers reported benefiting from the text messages included sharing messages with family members and friends (80%), making mental notes (57%), and looking back at messages as reminders (50%). Caregivers reported significant improvements in home environment, parenting practices, and rulemaking around SSB (P=.003, P=.02, and P=.04, respectively). In addition, the frequency of SSB intake among caregivers and adolescents significantly decreased (P=.003 and P=.005, respectively). CONCLUSIONS: Spending time in the formative phases of text message development helped understand the unique perspectives and language preferences of the target population. Furthermore, delivering an intervention through text messages has the potential to improve caregiver behaviors and reduce SSB intake among rural caregivers and adolescents. Findings from this study were used to develop a larger bank of text messages, which would be used in a future study, testing the effectiveness of a text message intervention targeting SSB intake-related caregiver behaviors.

A comparative effectiveness trial of two family-based childhood obesity treatment programs in a medically underserved region: Rationale, design & methods.

While there is a large body of literature documenting the efficacy of family-based childhood obesity (FBCO) treatment interventions, there is little evidence that these interventions have been systematically translated into regular practice - particularly in health disparate regions. To address this research-practice gap, this project was guided by a community advisory board (CAB) and the RE-AIM planning and evaluation framework within a systems-based and community-based participatory research approach. Families with overweight or obese children between 5 and 12 years old, in the medically-underserved Dan River Region, were randomly assigned to one of two FBCO treatment programs (iChoose vs. Family Connections) delivered by local Parks & Recreation staff. Both programs have previously demonstrated clinically meaningful child BMI z-score reductions, but vary in intensity, structure, and implementation demands. Two clinical CAB partners embedded recruitment methods into their regional healthcare organization, using procedures representative to what could be used if either program was taken to scale. The primary effectiveness outcome is child BMI z-scores at 6-months, with additional assessments at 3-months and at 12-months. Secondary goals are to determine: (1) reach into the intended audience; (2) effectiveness on secondary child and parent outcomes; (3) intervention adoption by organizations and staff; (4) fidelity, cost, and capacity for intervention implementation; and (5) maintenance of individual-level changes and organizational-level sustainability. This research addresses literature gaps related to the features within clinical and community settings that could improve both child weight status and the translation of FBCO interventions into typical practice in medically-underserved communities. IDENTIFIERS: Clincialtrials.gov: NCT03245775.

Kids SIPsmartER, a cluster randomized controlled trial and multi-level intervention to improve sugar-sweetened beverages behaviors among Appalachian middle-school students: Rationale, design & methods.

The intake of sugar-sweetened beverages (SSB) is disproportionately high in Appalachia, including among adolescents whose intake is more than double the national average and more than four times the recommended daily amount. Unfortunately, there is insufficient evidence for effective strategies targeting SSB behaviors among Appalachian youth in real-world settings, including rural schools. Kids SIPsmartER is a 6-month, school-based, behavior and health literacy program aimed at improving SSB behaviors among middle school students. The program also integrates a two-way short message service (SMS) strategy to engage caregivers in SSB role modeling and supporting home SSB environment changes. Kids SIPsmartER is grounded by the Theory of Planned Behavior and health literacy, media literacy, numeracy, and public health literacy concepts. Guided by the RE-AIM framework (reach, effectiveness, adoption, implementation, and maintenance), this type 1 hybrid design and cluster randomized controlled trial targets 12 Appalachian middle schools in southwest Virginia. The primary aim evaluates changes in SSB behaviors at 7-months among 7th grade students at schools receiving Kids SIPsmartER, as compared to control schools. Secondary outcomes include other changes in students (e.g., BMI, quality of life, theory-related variables) and caregivers (e.g., SSB behaviors, home SSB environment), and 19-month maintenance of these outcomes. Reach is assessed, along with mixed-methods strategies (e.g., interviews, surveys, observation) to determine how teachers implement Kids SIPsmartER and the potential for institutionalization within schools. This paper discusses the rationale for implementing and evaluating a type 1 hybrid design and multi-level intervention addressing pervasive SSB behaviors in Appalachia. Clincialtrials.gov: NCT03740113.

Participatory development and pilot testing of iChoose: an adaptation of an evidence-based paediatric weight management program for community implementation.

BACKGROUND: To describe the identification, adaptation, and testing of an evidence-based pediatric weight management program for a health disparate community. METHODS: A community advisory board (CAB) of decision-makers and staff from local health care, public health, and recreation organizations engaged with academic partners to select an evidence-based program (EBP) for local implementation. Three EBPs were identified (Traffic Light, Bright Bodies, Golan and colleagues Home Environmental Model) and each EBP was rated on program characteristics, implementation and adaptation, and adoptability. Following selection of the EBP that was rated highest, the POPS-CAB made adaptations based on the program principles described in peer-reviewed publications. The adapted intervention, iChoose, was then pilot tested in 3 iterative phases delivered initially by research partners, then co-delivered by research and community partners, then delivered by community partners. The RE-AIM framework was used to plan and evaluate the iChoose intervention across all waves with assessments at baseline, post program (3 months), and follow-up (6 months). RESULTS: Bright Bodies rated highest on program characteristics and adoptability (p's < 0.05), while Home Environmental Model rated highest on implementation factors (p < 0.05). Qualitatively, the selection focused on important program characteristics and on matching those characteristics to the potential to fit within the community partner services. The adapted program-iChoose-had 18% reach and with participants that were representative of the target population on age, gender, ethnicity, and race. Effectiveness was demonstrated by modest, but significant reductions in BMI z-scores at post-program compared to baseline (MΔ = - 0.047; t = - 2.11, p = 0.046). This decrease returned to values similar to baseline 3 months (MΔ = 0.009) after the program was completed. Implementation fidelity was high and implementation fidelity did not differ between community or research delivery agents. CONCLUSION: The process to help organizations identify and select evidence-based programs appropriate for their community led to consensus on a single EBP. While iChoose was successful in initiating changes in BMI z-scores, could be implemented in a low resource community with fidelity, it was insufficient to lead to sustained child BMI z-scores. In response to these data, maintenance of program effects and delivery are the current focus of the CBPR team.

Building and Sustaining Community Capacity to Address Childhood Obesity: A 3-Year Mixed-Methods Case Study of a Community-Academic Advisory Board.

Guided by a community-based participatory research and systems-based approach, this 3-year mixed-methods case study describes the experiences and capacity development of a Community-Academic Advisory Board (CAB) formed to adapt, implement, and evaluate an evidence-based childhood obesity treatment program in a medically underserved region. The CAB included community, public health, and clinical (n = 9) and academic partners (n = 9). CAB members completed capacity evaluations at 4 points. Partners identified best practices that attributed to the successful execution and continued advancement of project goals. The methodological framework and findings can inform capacity development and sustainability of emergent community-academic collaborations.

One-Year Mixed-Methods Case Study of a Community-Academic Advisory Board Addressing Childhood Obesity.

OBJECTIVE: Using a community-based participatory research and systems-based approach, the purpose of this community case study is to describe the planning process and first-year experiences of community-academic advisory board (CAB) partners involved with the development of an evidence-based childhood obesity treatment program in a medically underserved region. METHOD: Regional community partners ( n = 9; Pittsylvania/Danville Health District, Children's Healthcare Center, Danville Parks & Recreation, and Danville Boys & Girls Club) and academic partners ( n = 9) met monthly to select and adapt an evidence-based childhood obesity program, develop evaluation and recruitment protocols, and plan for program implementation. In the first 3 months, members developed a mixed-methods capacity evaluation, administered at 3 and 11 months following the first CAB meeting. RESULTS: Most capacity dimensions were rated highly and demonstrated no significant change over time. However, perceptions of trust approached a significant increase ( p = .055), the ability to resolve conflicts significantly increased ( p = .018), and participation and influ-ence perceptions significantly decreased ( p = .001). Qualitative analysis elucidated members' experiences and key facilitator and barrier themes emerged. CONCLUSIONS: Similarities and differences between community and academic members' experiences allowed synthesis of best practices and lessons learned. The methodological framework and best practices can inform the capacity development for new community-academic collaborations.