Pasos Hacia La Salud II: A Superiority RCT Utilizing Technology to Promote Physical Activity in Latinas.

INTRODUCTION: Latinas face an increased risk for chronic diseases associated with insufficient physical activity (PA). The researchers previously showed that a website-based intervention could increase PA among insufficiently active Latinas, yet rates of meeting national PA guidelines were low. The original intervention was enhanced by adding additional features, content, and points of contact, including via text messaging. This study tests the efficacy of the enhanced intervention compared with the original, aimed at maximizing and sustaining PA gains across 24 months. It also examines if increases in PA differed by baseline PA. STUDY DESIGN: The researchers conducted a superiority randomized controlled trial (data collected 2018-2022, analyzed 2023). SETTING/PARTICIPANTS: Participants were 195 Spanish-speaking Latinas ages 18-65 in the Providence, RI area. INTERVENTION: The original intervention is an empirically supported Spanish-language, individually-tailored, website-delivered PA intervention. The enhanced intervention includes text messaging and additional data-driven content and interactive features. MAIN OUTCOME MEASURES: Total weekly minutes of moderate to vigorous PA (MVPA) was measured via accelerometry and self-report at 6, 12, 18, and 24 months. RESULTS: Participants in both groups increased their MVPA over 24 months. There were no significant between-group differences at 6 or 12 months; at 18 months the enhanced intervention group had higher levels of self-reported (mean (sd): 90.35 (43.55) vs 70.18 [9.99]) and accelerometer-measured (66.21 [18.26] vs 60.27 [16.00]) MVPA compared to the original intervention group. They also had higher levels of self-reported (111.17 [23.35] vs 81.44 [1.82]) and accelerometer-measured (63.76 [15.12] vs 54.86 [14.59]) MVPA at 24 months. Baseline PA moderated the intervention effect. CONCLUSIONS: This study demonstrates the potential to enhance the efficacy of website-based PA interventions by utilizing text messaging, and adding more interactive features, content, and phone support. These enhancements may be particularly beneficial in supporting long-term PA maintenance. TRIAL REGISTRATION: This study is registered at www. CLINICALTRIAL: gov (NCT03491592).

Improvements in stress among Latinas participating in a randomized controlled trial of technology-supported physical activity interventions.

High levels of stress and inactivity likely contribute to chronic disease disparities among Latinas in the U.S. and call for intervention. To inform such efforts, the current study examined the relationships among changes (over time) in physical activity, stress, and related cardiometabolic biomarkers among sedentary (mostly) first generation Latinas. Data are taken from a randomized controlled trial (N = 199 Latinas) of two home-based physical activity interventions (Original vs. theory- and technology- Enhanced versions). Physical activity and perceived stress were assessed at baseline and 6 and 12 months. Blood draws occurred at baseline and 6 months in a random subsample (N = 153). The participants were underactive (<60/min week of moderate-to-vigorous physical activity) Mexican American (89%) women with moderate perceived stress scores (M = 21.49, SD = 8.55, range = 0-40) and excess weight (M BMI = 30.6) at baseline. Overall, participants reported decreases in stress after 6 months enroled in the physical activity programs. The odds of a reduction in perceived stress were 11% higher among Enhanced versus Original Intervention participants (OR = 1.11, 95% CI: 1.05-2.27). Those who met physical activity guidelines were significantly more likely to report reductions in perceived stress over 6 months (OR = 1.92, 95% CI: 1.08-4.16). Furthermore, those who reported reductions in perceived stress over 6 months reported significantly more moderate-to-vigorous physical activity at 12 months (+69 min/week, SE = 27.98, p = 0.01) compared to those who did not. Greater reductions in perceived stress over 6 months were associated with greater improvements in cardiometabolic biomarkers (HbA1c, triglycerides, p's < 0.05). These results support a bidirectional relationship between improvements in stress and physical activity among Latinas. Future implications include using physical activity to address stress management and health disparities in this community.

Barriers and Facilitators to Muscle-Strengthening Activity Among Latinas in the U.S.: Results From Formative Research Assessments.

BACKGROUND: Latinas are disproportionately affected by low physical activity (PA) levels and related health conditions (e.g., diabetes, obesity). Few Latinas in the U.S. (17%) meet the National PA Guidelines for both aerobic PA and muscle-strengthening activity (MSA), yet, research to date in this population has focused almost exclusively on aerobic PA. Performing regular MSA is linked with numerous health improvements and reduced mortality; thus, may be key to addressing health disparities in this community. This study examined perspectives on engaging in MSA among Latinas enrolled in two aerobic PA RCTs. METHODS: Brief quantitative surveys were conducted to assess interest in MSA among Latinas (N = 81), along with 19 follow-up in-depth semi-structured interviews on knowledge, barriers, and facilitators for engaging in regular MSA. Interview transcripts were analyzed by two independent bilingual researchers using a directed content analysis approach. RESULTS: Eighty-one Latinas (18-65 years) completed the survey. Most (91%) expressed interest in learning more about MSA and 60% reported not knowing how to do MSA as a substantial MSA barrier. Interview results indicated Latinas were aware of health benefits of MSA and motivated to engage in MSA but reported barriers (e.g., perception that MSA is for men, a taboo topic, and lack of knowledge on how to do MSA). CONCLUSION: This study contributes to a critical gap in PA research among Latinas. Findings will inform future culturally appropriate MSA interventions in this at-risk population. Addressing MSA and aerobic PA together in future interventions will provide a more comprehensive approach to reducing PA-related health disparities in Latinas than aerobic PA alone.

Dietary Barriers Appear to Influence the Effects of a Dyadic Web-Based Lifestyle Intervention on Caloric Intake and Adiposity: A Mediation Analysis of the DUET Trial.

Mechanisms that explain behavior change within web-based lifestyle interventions are not well-studied. This secondary analysis explores whether the effects of the DUET web-based lifestyle intervention on diet, physical activity, and/or adiposity are mediated through changes in self-efficacy, social support, and perceived barriers (key constructs of social cognitive theory). Data on mediators, diet quality, caloric intake, moderate-to-vigorous physical activity (MVPA), weight, and waist circumference (WC) were analyzed from 112 cancer survivors and their partners enrolled in the DUET intervention. Mediation analyses were performed using Mplus to execute regression analyses and determine associations. Mediation analyses supported an effect of the intervention on caloric intake (-3.52, 95% CI [-8.08 to -0.84]), weight (-1.60, CI [-3.84 to -0.47]), and WC (-0.83, CI [-1.77 to -0.18]), interpreting these negative associations as intervention induced reductions in dietary barriers. Higher social support was significantly and positively associated with, but not a mediator for, improvements in self-reported and accelerometry-measured MVPA (b = 0.69, CI [0.19, 1.24]) and (b = 0.55, CI [0.15, 1.00]), respectively. Self-efficacy did not appear to mediate the intervention's effects. Findings suggest that the effects of the DUET intervention on diet and adiposity stem from reducing perceived barriers to a healthful, low-calorie diet.

Impact of the COVID-19 Pandemic on Physical Activity among Mostly Older, Overweight Black Women Living in the Rural Alabama Black Belt.

Despite well-documented global declines in physical activity (PA) during the COVID-19 pandemic, little is known regarding the specific impact among underserved, rural Alabama counties. This is concerning as this region was already disproportionately burdened by inactivity and related chronic diseases and was among the hardest hit by COVID-19. Thus, the current study examined the effect of COVID-19 on PA in four rural Alabama counties. An ancillary survey was administered between March 2020 and August 2021 to the first cohort (N = 171) of participants enrolled in a larger PA trial. Main outcomes of this survey included the perceived impact of COVID-19 on PA, leisure-time PA, and social cognitive theory (SCT) constructs at 3 months. Almost half of the participants reported being less active during the pandemic (49.7%) and endorsed that COVID-19 made PA more difficult (47.4%), citing concerns such as getting sick from exercising outside of the home (70.4%) and discomfort wearing a face mask while exercising (58%). Perceived COVID-19 impact on PA was significantly associated with education, household dependents, and gender (p's < 0.05). More women, parents, and college graduates reported that the COVID-19 pandemic made PA more difficult. Overall, there were no significant associations between PA, SCT constructs, or perceived COVID-19 impact on PA scores at 3 months. While the pandemic made PA difficult for many participants, these barriers were not associated with leisure-time PA levels or related theoretical mechanisms of action, which bodes well for the success of our ongoing intervention efforts and the resiliency of these communities.

Using the TIDieR checklist to describe development and integration of a web-based intervention promoting healthy eating and regular exercise among older cancer survivors.

Objective: To facilitate replication and future intervention design of web-based multibehavior lifestyle interventions, we describe the rationale, development, and content of the AiM, Plan, and act on LIFestYles (AMPLIFY) Survivor Health intervention which provides healthy eating and exercise behavior change support for older cancer survivors. The intervention promotes weight loss, improvements in diet quality, and meeting exercise recommendations. Methods: The Template for Intervention Description and Replication (TIDieR) checklist was used to provide a comprehensive description of the AMPLIFY intervention, consistent with CONSORT recommendations. Results: A social cognitive theory web-based intervention founded on the core components of efficacious print and in-person interventions was conceptualized and developed through an iterative collaboration involving cancer survivors, web design experts, and a multidisciplinary investigative team. The intervention includes the AMPLIFY website, text and/or email messaging, and a private Facebook group. The website consists of: (1) Sessions (weekly interactive e-learning tutorials); (2) My Progress (logging current behavior, receiving feedback, setting goals); (3) Tools (additional information and resources); (4) Support (social support resources, frequently asked questions); and (5) Home page. Algorithms were used to generate fresh content daily and weekly, tailor information, and personalize goal recommendations. An a priori rubric was used to facilitate intervention delivery as healthy eating only (24 weeks), exercise only (24 weeks), or both behaviors concurrently over 48 weeks. Conclusions: Our TIDieR-guided AMPLIFY description provides pragmatic information helpful for researchers designing multibehavior web-based interventions and enhances potential opportunities to improve such interventions.

Assessing the built environment, programs, and policies that support physical activity opportunities in the rural Deep South.

Disparities in physical activity (PA) exist in rural regions and prior research suggests environmental features and community resources likely contribute. It is important to identify the opportunities and barriers that influence activity to appropriately inform PA interventions in such areas. Thus, we assessed the built environment, programs and policies related to PA opportunity in six rural Alabama counties that were purposively selected to inform a PA randomized controlled trial. Assessments were conducted August 2020-May 2021 using the Rural Active Living Assessment. Town characteristics and recreational amenities were captured using the Town Wide Assessment (TWA). PA programs and policies were examined with the Program and Policy Assessment. Walkability was evaluated using the Street Segment Assessment (SSA). Using the scoring system (0-100), the overall TWA score was 49.67 (range: 22-73), indicating few schools within walking distance (≤5 miles of the town's center) and town-wide amenities (e.g., trails, water/recreational activities) for PA. The Program and Policy Assessment showed a paucity of programming and guidelines to support activity (overall average score of 24.67, [range: 22-73]). Only one county had a policy requiring walkways/bikeways in new public infrastructure projects. During assessment of 96 street segments, few pedestrian-friendly safety features [sidewalks (32%), crosswalks (19%), crossing signals (2%), and public lighting (21%)] were observed. Limited opportunities for PA (parks and playgrounds) were identified. Barriers such as few policies and safety features (crossing signals, speed bumps) were indicated as factors that should be addressed when developing PA interventions and informing future policy efforts.

Cost effectiveness of a technology-enhanced physical activity intervention for Latinas.

Latinas report low levels of physical activity (PA) and disproportionate risk of lifestyle-related diseases. Enhancements to evidence-based PA interventions may increase efficacy; however, uptake of interventions will likely depend on costs. To describe costs and examine the cost-effectiveness of two interventions for helping Latinas reach national aerobic PA guidelines. Adult Latinas (N = 199) were randomly assigned to an Original theory-based mail-delivered intervention or an Enhanced version with texting and additional calls and materials. Meeting PA guidelines was measured by the 7-Day PA Recall interview at baseline, 6 and 12 months. Intervention costs were estimated from a payer perspective. Incremental cost-effectiveness ratios (ICERs) were calculated as the additional cost per participant meeting guidelines in the Enhanced versus Original intervention. At baseline, no participants met guidelines. After 6 months, 57% and 44% in the Enhanced and Original arms met guidelines, respectively; at 12 months, rates fell to 46% and 36%. Cost per person of the Enhanced and Original interventions were $184 and $173 at 6 months, respectively, and $234 and $203 at 12 months. The primary additional expense in the Enhanced arm was staff time. ICERs were $87 per additional person meeting guidelines at 6 months (per sensitivity analysis, $26 if delivered by volunteers and $114 by medical assistants), and $317 at 12 months (sensitivity analysis: $57 and $434). Incremental costs per person meeting guidelines in the Enhanced arm were modest and could be warranted given the potential health benefits of meeting PA guidelines.

Latinas report low levels of physical activity (PA) and high rates of related diseases. Existing evidence-based interventions for Latinas may need additional enhancements to help this population meet national PA guidelines. Enhancements could both increase the effectiveness and the costs of PA interventions. It is thus important to consider the costs and benefits of the different versions of these interventions, as these may influence whether the interventions are adopted and sustained on a larger scale in the future. This study describes the costs of two versions of a PA intervention (an original and a technology-enhanced version) and examines their cost effectiveness in helping sedentary Latina participants reach national PA guidelines. At the beginning of the study, none of the participants were meeting PA guidelines. More participants in the Enhanced intervention, compared to the Original intervention, were meeting guidelines both at 6 months (57% vs. 44%) and 12 months (46% vs. 36%). Costs were also higher for the Enhanced Intervention both at 6 and 12 months. Each additional person meeting guidelines in the Enhanced (vs. Original) group cost $87 at 6 months and $317 at 12 months. Given potential cost savings in medical care associated with meeting PA guidelines, these interventions could ultimately save money in addition to promoting health.

Results of DUET: A Web-Based Weight Loss Randomized Controlled Feasibility Trial among Cancer Survivors and Their Chosen Partners.

(1) Background: A healthful diet, regular physical activity, and weight management are cornerstones for cancer prevention and control. Yet, adherence is low in cancer survivors and others, calling for innovative solutions. Daughters, dUdes, mothers, and othErs fighting cancer Together (DUET) is a 6-month, online, diet-and-exercise, weight-loss intervention to improve health behaviors and outcomes among cancer survivor-partner dyads. (2) Methods: DUET was tested in 56 dyads (survivors of obesity-related cancers and chosen partners) (n = 112), both with overweight/obesity, sedentary behavior, and suboptimal diets. After baseline assessment, dyads were randomized to DUET intervention or waitlist control arms; data were collected at 3- and 6-months and analyzed using chi-square, t-tests, and mixed linear models (α < 0.05). (3) Results: Retention was 89% and 100% in waitlisted and intervention arms, respectively. Dyad weight loss (primary outcome) averaged -1.1 (waitlist) vs. -2.8 kg (intervention) (p = 0.044/time-by-arm interaction p = 0.033). Caloric intake decreased significantly in DUET survivors versus controls (p = 0.027). Evidence of benefit was observed for physical activity and function, blood glucose, and c-reactive protein. Dyadic terms were significant across outcomes, suggesting that the partner-based approach contributed to intervention-associated improvements. (4) Conclusions: DUET represents a pioneering effort in scalable, multi-behavior weight management interventions to promote cancer prevention and control, calling for studies that are larger in size, scope, and duration.

Targeting Physical Inactivity Using Behavioral Theory in Chronic, Disabling Diseases.

Physical inactivity and comorbidities (e.g., hypertension) result in poor prognoses among persons with chronic, disabling conditions including multiple sclerosis, Parkinson disease, and stroke. Theory can guide the design of behavior change interventions that can be delivered remotely for broad scale implementation. We hypothesize that theory-based behavior change interventions can increase physical activity and reduce comorbidities and associated consequences among persons with chronic, disabling conditions.

Adapting MultiPLe behavior Interventions that eFfectively Improve (AMPLIFI) cancer survivor health: program project protocols for remote lifestyle intervention and assessment in 3 inter-related randomized controlled trials among survivors of obesity-related cancers.

BACKGROUND: Scalable, multiple behavior change interventions are needed to address poor diet, inactivity, and excess adiposity among the rising number of cancer survivors. Efficacy-tested diet (RENEW) and exercise (BEAT Cancer) programs were adapted for web delivery among middle-aged and older cancer survivors for the AMPLIFI study, a National Cancer Institute-funded, multi-site, program project. METHODS: Throughout the continental U.S., survivors of several obesity-related cancers are being recruited for three interconnected randomized controlled trials (RCTs). Projects 1 and 2 test 6-month diet or exercise interventions versus a wait-list control condition. Upon completion of the 6-month study period, the intervention participants receive the next behavior change sequence (i.e., diet receives exercise, exercise receives diet) and the wait-list control arm initiates a 12-month combined diet and exercise intervention. Project 3 tests the efficacy of the sequential versus simultaneous interventions. Assessments occur at baseline and semi-annually for up to 2-years and include: body mass index, health behaviors (diet quality, accelerometry-assessed physical activity/sleep), waist circumference, D3 creatine-assessed muscle mass, physical performance, potential mediators/moderators of treatment efficacy, biomarkers of inflammation and metabolic regulation, health care utilization, cost, and overall health. Four shared resources support AMPLIFI RCTs: 1) Administrative; 2) Adaptation, Dissemination and Implementation; 3) Recruitment and Retention; and 4) Assessment and Analysis. DISCUSSION: Representing a new generation of RCTs, AMPLIFI will exclusively use remote technologies to recruit, intervene and assess the efficacy of the newly-adapted, web-based diet and exercise interventions and determine whether sequential or combined delivery works best for at-risk (older, rural, racial minority) cancer survivors. TRIAL REGISTRATION: ClinicalTrials.gov , NCT04000880 . Registered 27 June 2019.

Increases in Muscle-Strengthening Activities Among Latinas in Seamos Saludables.

BACKGROUND: Only 17% of Latinas meet national physical activity (PA) guidelines for both moderate-to-vigorous aerobic and muscle-strengthening PA. Additional health benefits are derived from the combination of aerobic and muscle-strengthening PA (vs. aerobic alone), yet there is paucity in research on muscle-strengthening activity in Latinas. The aim of this study was to examine changes in muscle-strengthening activity from baseline to 6 and 12 months in Seamos Saludables, a 12-month PA randomized controlled trial for Latinas. METHODS: A secondary data analysis was conducted among 131 Latinas ages 18-65 years, who were randomized to either a PA Intervention or a Wellness Control. Self-reported muscle-strengthening exercise was measured at baseline, 6 months, and 12 months via adapted muscle-strengthening questions from the Behavioral Risk Factor Surveillance System. RESULTS: There was a 16-minute/week difference in median minute/week of muscle-strengthening activity between Intervention and Wellness at 6 months (SE = 7.91, p = .04) and 45-minute/week difference at 12 months (SE = 25.80, p = .06) adjusting for baseline. Significantly more PA Intervention participants met muscle-strengthening guidelines of 2 or more days/week at 6 months versus Wellness Control participants (odds ratio [OR] = 4.29, 95% confidence interval [CI] = [1.03, 17.84]). CONCLUSION: Results from the current study showed that Latinas engaged in muscle-strengthening activity in an intervention that emphasized primarily aerobic PA outcomes, suggesting they may be interested in engaging in muscle-strengthening activities. Future interventions targeting both aerobic and muscle-strengthening activity could achieve greater health improvements and help more Latinas reach the full national PA guidelines.ClinicalTrials.gov Identifier. NCT01583140.

Web-Based Lifestyle Interventions for Survivors of Cancer: Usability Study.

BACKGROUND: Internet-based lifestyle programs are increasingly being used to deliver health behavior change interventions to survivors of cancer. However, little is known about website use in this population or its association with healthy lifestyle changes. OBJECTIVE: The aim of this study is to describe lifestyle intervention website use (log-ins, time on website, and page views) among survivors of cancer and patterns of use by participant characteristics. In addition, associations were explored between website use and changes in healthy lifestyle knowledge and practice. METHODS: A total of 35 survivors of cancer were recruited between August 2017 and 2018 to participate in a 2-week, single-arm pilot test of the SurvivorSHINE lifestyle intervention website. Knowledge and practices related to healthy diet and physical activity behaviors were measured at baseline and follow-up. Website use (eg, time spent on the website, frequency of log-ins, and page views) were collected from the SurvivorSHINE administrative site during the intervention period. Patterns of use were examined by participants' gender and race. Correlations between website use and changes in healthy lifestyle knowledge, physical activity, diet, and weight were explored. Mann-Whitney U tests were used to compare demographic factors on website use. RESULTS: Participants logged into the SurvivorSHINE intervention website an average of 3.2 (SD 2) times over the 2-week period and spent a total average of 94 (SD 56) minutes viewing the website during the intervention. Examining website activity, 1905 page views were logged. The User Profile (344 page views) and Home sections (301 page views) were the most frequently visited components. No associations were observed between the frequency of log-ins or the total time on the website, improvements in knowledge related to healthy lifestyles, or changes in body weight or dietary intake. However, the total time on the website was positively correlated with improvements in accelerometer-measured physical activity (r=0.74; P=.02) and self-reported physical activity (r=0.35; P=.04). CONCLUSIONS: Survivors of cancer demonstrated clear interest in a diet and exercise intervention website, as evidenced by their frequency of log-ins, page views on numerous features, and total viewing time. Moreover, increased website use was correlated with improvements in physical activity.

An Interactive Voice Response System to Increase Physical Activity and Prevent Cancer in the Rural Alabama Black Belt: Design and Usability Study.

BACKGROUND: Increased physical activity (PA) levels are associated with reduced risk and improved survival for several cancers; however, most Americans engage in less than the recommended levels of PA. Using interactive voice response (IVR) systems to provide personalized health education and counseling may represent a high-reach, low-cost strategy for addressing physical inactivity and cancer disparities in disproportionately burdened rural regions. However, there has been a paucity of research conducted in this area to date. OBJECTIVE: The aim of this study is to design, develop, and test the usability of an IVR system aimed at increasing PA levels in the rural Alabama Black Belt. METHODS: A pilot version of the IVR system was used to assess initial feasibility and acceptability. Detailed exit interviews were conducted to elicit participant feedback, which helped inform the development of a substantially upgraded in-house IVR system. This refined IVR system was then subjected to a sequential explanatory mixed methods evaluation. Participating rural county coordinators and research staff (N=10) tested the usability of the IVR system features for 2 weeks and then completed the System Usability Scale and qualitative semistructured interviews. RESULTS: The study sample comprised mostly African American people, women, rural county coordinators, and research staff (N=10). Participants rated the IVR system with a mean score of 81 (SD 5) on the System Usability Scale, implying excellent usability. In total, 5 overarching themes emerged from the qualitative interviews: likes or dislikes of the intervention, barriers to or facilitators of PA, technical difficulties, quality of calls, and suggestions for intervention improvement. Message framing on step feedback, call completion incentives, and incremental goal-setting challenges were areas identified for improvement. The positive areas highlighted in the interviews included the personalized call schedules, flexibility to call in or receive a call, ability to make up for missed calls, narration, and PA tips. CONCLUSIONS: The usability testing and feedback received from the rural county coordinators and research staff helped inform a final round of refinement to the IVR system before use in a large randomized controlled trial. This study stresses the importance of usability testing of all digital health interventions and the benefits it can offer to the intervention.

A Web-based Lifestyle Intervention for Cancer Survivors: Feasibility and Acceptability of SurvivorSHINE.

Assess the feasibility, acceptability, and preliminary efficacy of a healthy lifestyle website, SurvivorSHINE ( www.survivorshine.org ), for cancer survivors using a mixed-methods approach. Formative research included a comprehensive literature review and four focus groups on website preferences with diagnosis-diverse cancer survivors (N = 17). Their feedback informed a web adaptation of a telephone counseling and mailed-print lifestyle intervention previously found effective for cancer survivors. The resulting web-based intervention was examined in a 3-week, single-arm trial among 41 cancer survivors. Assessments of physical activity, diet, body weight, and knowledge related to exercise and diet guidelines for cancer survivors occurred at baseline and 3 weeks later, along with exit interviews. Themes from focus groups indicated cancer survivors' desire for easy-to-use, interactive web-based platforms to access credible diet and exercise information. The study sample was recruited within 12 months, and study retention was high (85.4%). Participants showed significant pre- to post-test improvements in diet and exercise knowledge (t = 5.31, p < .0001) and physical activity (t = 2.40, p = .02). Improvements in body weight and some dietary components (red meat, alcohol) were observed, but did not reach statistical significance. Results support the feasibility and acceptability of SurvivorSHINE. The significant increases in healthy lifestyle knowledge and physical activity found in the current study are promising, but a larger, randomized-controlled trial is needed to determine efficacy.

Developing a virtual assessment protocol for the AMPLIFI Randomized Controlled Trial due to COVID-19: From assessing participants' preference to preparing the team.

Background During the COVID-19 pandemic, in-person research assessments needed to be adapted to ensure safety of participants and staff. Participants' willingness to participate in research activities, how to prepare assessors to ensure data integrity, and the feasibility of modified protocols, were unknown. Within the AMPLIFI randomized clinical trial (RCT) for cancer survivors, we elicited participants' preferences and willingness to participate in Clinic, Home, or Virtual assessments, prepared assessors for, and implemented virtual assessments. Methods 1) We conducted phone surveys of potential AMPLIFI participants; 2) Based on survey results, we modified assessments from in-person to virtual visits (VV) by videoconference. Assessors were trained and certified, i.e., assessors recorded 3 assessments that were reviewed and scored by 2 investigators. The modified protocol was proposed to 62 participants: we report numbers of those who agreed to attend VV. Results 1) Survey results: Among 74 survey respondents, 44.6% preferred, 75.7% were willing to attend Clinic Visits; 32.4% preferred, 83.8% were willing to do VV; 23% preferred, 77% were willing to do Home Visits. Survivors 70+ were less likely than 50-69 years old to be willing to do VV: no other differences were noted by gender, race, rural status or education. 2) Assessment uptake: 66.1% agreed to attend VV, and of them 75.6% completed them. Conclusion Diverse research participants adapted to protocols that prioritize their safety, although older participants may be reluctant to do virtual assessments. Virtual assessments are feasible and research teams can rigorously prepare to collect quality data through them.

Design and Rationale for the Deep South Interactive Voice Response System-Supported Active Lifestyle Study: Protocol for a Randomized Controlled Trial.

BACKGROUND: The rates of physical inactivity and related cancer incidence and mortality are disproportionately high in the Deep South region in the United States, a rural, medically underserved region with a large African American population compared with the rest of the nation. Given this region's lower rates of literacy and internet access, interactive voice response (IVR) system-automated telephone-based interventions have the potential to help overcome physical activity intervention barriers (literacy, internet access, costs, and transportation) but have yet to be extended to rural, underserved populations, such as in the Deep South. Thus, extensive formative research is being conducted to develop and beta test the Deep South IVR System-Supported Active Lifestyle intervention in preparation for dissemination in rural Alabama counties. OBJECTIVE: This paper aims to describe the design and rationale of an ongoing efficacy trial of the Deep South IVR System-Supported Active Lifestyle intervention. METHODS: A two-arm randomized controlled trial will be conducted to compare a 12-month physical activity intervention versus a wait-list control condition in 240 underactive adults from 6 rural Alabama counties. The Deep South IVR System-Supported Active Lifestyle intervention is based on the Social Cognitive Theory and includes IVR-automated physical activity-related phone counseling (daily in months 0-3, twice weekly in months 4-6, and weekly in months 7-12) and support from local rural county coordinators with the University of Alabama O'Neal Comprehensive Cancer Center Community Outreach and Engagement Office. The primary outcome is weekly minutes of moderate- to vigorous-intensity physical activity (7-day physical activity recall; accelerometry) at baseline, 6 months, 12 months, and 18 months. Rural Active Living Assessments will be conducted in each rural county to assess walkability, assess recreational amenities, and inform future environment and policy efforts. RESULTS: This study was funded in March 2019 and approved by the institutional review board of the University of Alabama at Birmingham in April 2019. As of February 2020, start-up activities (hiring and training staff and purchasing supplies) were completed. Study recruitment and assessments began in September 2020 and are ongoing. As of February 2021, a total of 43 participants have been enrolled in Dallas County, 42 in Sumter County, and 51 in Greene County. CONCLUSIONS: IVR-supported phone counseling has great potential for addressing physical activity barriers (eg, culture, literacy, cost, or transportation) and reducing related rural health disparities in this region. TRIAL REGISTRATION: ClinicalTrials.gov NCT03903874; https://clinicaltrials.gov/ct2/show/NCT03903874. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/29245.

Long-term physical activity outcomes in the Seamos Activas II trial.

Latinas report disproportionately low physical activity (PA) levels and related health conditions. Reducing chronic disease in Latinas requires interventions to increase and maintain health-enhancing PA levels; yet limited intervention studies have examined PA maintenance among Latinas. The present study evaluated the efficacy during the maintenance phase (months 6-12) of the Enhanced PA intervention for Latina adults in Seamos Activas II compared to the Original PA Intervention. Seamos Activas II was conducted in San Diego, California from 2015 to 2020. Underactive adult Latina women (N = 199), mainly of Mexican descent (89%) were randomized to the original intervention or a theory- and technology-enhanced intervention. Their PA was measured objectively (via accelerometers) and via self-report at baseline, 6, and 12 months. Quantile regression models assessed treatment effects on min/week of moderate to vigorous PA (MVPA) at 12 months. Generalized linear models examined treatment effects on indicators of meeting 2008 National PA Guidelines. Both groups maintained the significant gains in MVPA they had made during the first 6 months of the intervention, neither increasing nor decreasing their MVPA over the maintenance period, with no significant between-group differences. At 12 months, 46.3% of Enhanced Intervention participants were meeting self-reported PA guidelines (vs 35.6 % of the Original PA Intervention arm, p = .02). Even with minimal contact throughout the maintenance phase, participants maintained their MVPA, which underscores the importance of continued use of evidence-based behavior change tools and techniques to reinforce newly established habits. Theoretical and technological enhancements may help Latinas to continue meeting PA guidelines during maintenance periods.

Psychosocial mediators of physical activity change in a web-based intervention for Latinas.

Objective: To determine whether psychosocial constructs targeted in an online physical activity intervention for Latinas mediated changes in moderate-to-vigorous physical activity (MVPA). Method: Data were taken from a randomized trial of a web-based MVPA intervention for Latina women age 18-65 (N = 205) based on social cognitive theory and the transtheoretical model. Baseline and 6-month measures included minutes/week of MVPA (ActiGraph GT3X + accelerometers and 7-Day Physical Activity Recall Interview) and theorized mediators (self-efficacy, behavioral processes, cognitive processes, social support, enjoyment). A multiple mediation model adjusting for baseline MVPA was fit using a products of coefficients method, simultaneously testing all hypothesized mediators. Results: MVPA increased more in the intervention group than controls by 50 min/week (self-report) and 31 min/week (accelerometers). For the self-reported MVPA model, there was an intervention effect (a-path coefficient) on self-efficacy (b = 0.43, p < .01), cognitive processes (b = 0.64, p < .01), behavioral processes (b = 0.54, p < .01), and enjoyment (b = 9.91, p = .01). Changes in self-efficacy (b = 24.54, p = .03), social support from friends (b = 2.36, p = .04), and enjoyment (a = 0.74, p = .08) were associated with changes in MVPA (b-path coefficient). However, only changes in self-efficacy (b = 10.49, 95% CI [2.46, 24.54]) and enjoyment (b = 7.30, 95% CI [0.92, 21.78]) mediated the intervention effect on MVPA (ab-path coefficient). For the accelerometer-measured MVPA model, intervention effects were significant for self-efficacy (b = 0.48, p < .01), cognitive processes (b = 0.62, p < .01), and behavioral processes (b = 0.61, p < .01), yet only self-efficacy was associated with changes in MVPA (b = 4.43, p = .03), and mediated intervention effects on MVPA (b = 12.15, 95% CI [11.25, 16.34]). Conclusions: Future MVPA interventions with Latinas should target self-efficacy and enjoyment to maximize efficacy. (PsycInfo Database Record (c) 2020 APA, all rights reserved).

Narrative Review of Web-based Healthy Lifestyle Interventions for Cancer Survivors.

This narrative review of web-delivered weight management, diet quality, and physical activity interventions for cancer survivors relies on a systematic search of PubMed, Psych Info, and EBSCOhost which identified 19 unique web-delivered lifestyle interventions for cancer survivors. The sample sizes for these studies ranged from 11-492. Intervention duration ranged from 1-12 months; however, most interventions were 6-12 weeks in length. Ten studies were randomized controlled trials (RCTs), two were two-arm quasi RCTs, and seven employed a single-arm pre/post-test design. Many (N= 15) of the interventions were well-grounded in behavioral theory, which may have led to favorable behavior change. Most studies (15-of-19) targeted and reported increases in physical activity, while only a few targeted and reported improvements in diet quality (36.9% and 15.8%, respectively) and weight management (26.3% and 10.5%, respectively). A notable limitation was that most studies were conducted among populations that were primarily White and female. Future directions for Internet-based lifestyle interventions for cancer survivors include increasing: (a) focus on multiple behavior change, (b) representation of male and minority populations to improve generalizability of findings, (c) extended intervention duration and follow-up to evaluate long-term efficacy of web-based lifestyle interventions, and (d) sample size to allow for adequate statistical power.