Background Mobile health (mHealth) interventions are prevalent, yet people from marginalized communities are less likely to use digital health technologies to support self-management behaviors. Community engagement can inform health care design to enhance a hypertension self-management mHealth intervention. Objective We applied human-centered design (HCD) to determine appropriate iterations of an existing hypertension intervention. Methods Through an equity-focused, community-centered approach, we strove to optimize an mHealth app. We used validated theories and frameworks as well as an HCD methodology organized into three fundamental design skills: (1) methods to directly observe user experiences, (2) methods to analyze barriers to ideal intervention use, and (3) methods to design future iterations. Results In October 2023, we conducted a series of HCD activities with a community advisory board (n=8) to refine an mHealth intervention for hypertension. Participants tested app prototypes with blood pressure monitors and suggested content modifications to enhance intervention fidelity. Among 6 participants, usability testing scored 67.5 (benchmark 68, “above average”), with all users finding the tool easy to use. Feedback identified critical needs, barriers, and work-arounds for future mHealth iterations. Conclusions This study was a novel use case example of HCD as a patient-centered methodology to improve a hypertension management tool.

Background:Heart failure (HF) is a major public health problem associated with frequent hospitalizations, high mortality, and substantial health care costs. Self-care is fundamental to improving health outcomes; yet, self-care is commonly poor among patients with HF. SMS text messaging interventions may provide a simple, scalable, and accessible strategy to support HF self-care, particularly among older adults who may face barriers to using more complex digital health technologies. However, the efficacy of text messaging as a standalone intervention for patients with HF remains underexplored. Objective:This protocol paper describes the rationale and design of a pilot randomized controlled trial examining the feasibility, acceptability, and preliminary efficacy of an individually Tailored Text Messaging Intervention to Improve Self-Care in Adults with HF (Text4HF). Methods:This study is a single-site, stage I, parallel-group randomized controlled trial. Participants (n=30) are community-dwelling adults aged 50 years or older with stage C HF and suboptimal self-care, defined as a score of 3 or less on at least 2 items of the Self-Care of Heart Failure Index (SCHFI v7.2). Participants are randomized (1:1) to either a 12-week tailored text messaging intervention (Text4HF) plus usual care or usual care alone. Text messages are triggered based on patient responses to validated instruments assessing evidence-based, modifiable behavioral factors of HF self-care. Feasibility (recruitment and retention) and acceptability of the intervention are assessed as key process outcomes. The main exploratory patient-reported outcome is HF self-care (SCHFI v7.2). Other patient-reported outcomes include medication adherence, adherence to a heart-healthy diet, HF knowledge, health-related quality of life, self-efficacy, and health beliefs. Results:This study was funded in June 2022, and participant recruitment began in September 2024. A total of 26 participants have been enrolled and randomized to the intervention (n=13) and control (n=13) groups. Participants have a mean age of 60 (SD 6.6) years, 46% (12/26) are female, and 73% (19/26) identify as non-Hispanic Black. Half of the participants are individuals with reduced ejection fraction. Study completion is anticipated in June 2026. Conclusions:This protocol describes an important step toward evaluating a scalable, low-cost text messaging intervention designed to improve self-care in patients with HF. Study findings will provide critical data on feasibility and acceptability to guide a future fully powered efficacy trial of Text4HF.

Integrated health technologies (IHTs) have emerged as promising tools for improving heart failure (HF) management by facilitating care coordination and enabling timely clinical intervention. This joint scientific statement from the Heart Failure Society of America and the American Association of Heart Failure Nurses summarizes current evidence about the use of IHTs in HF management, including traditional telemonitoring, mobile health-based remote monitoring, and implantable devices. IHT interventions have demonstrated benefits, such as improved quality of life and reduced hospitalization rates, but their effectiveness varies, depending on patients’ adherence, clinical integration, and feedback mechanisms. Challenges to widespread implementation of IHTs include suboptimal patient engagement, disparities in digital literacy and access, lack of interoperability between systems, concerns about data privacy and security, disruptions to clinician workflow, and substantial start-up and maintenance costs. This statement outlines strategies to overcome these challenges, including enhancing patients’ engagement through personalized, actionable feedback; improving digital literacy and access; advancing interoperability; ensuring data security; engaging clinicians during implementation to facilitate seamless integration; and expanding reimbursement. Finally, the statement proposes key priorities for future research, including the use of automation and machine learning to reduce clinician burden, the integration of emerging technologies that reduce patient burden, and the evaluation of cost-effectiveness to support broader implementation.

Background: Sequential physical activity interventions hold promise in developing effective interventions when adapted to participants' physical activity. Adaptive interventions can be further strengthened by understanding the moderators of their effects on physical activity outcomes. Purpose: To determine whether baseline personal characteristics moderated the impact of adaptive interventions on physical activity in the Working Women Walking trial. Methods: This study analyzed data from a sequential multiple assignment randomized trial (SMART) targeting 18- to 70-year-old women employed at an urban medical center who self-reported low physical activity (N = 301). Four adaptive interventions included combinations of Initial Treatments (Fitbit or Fitbit + Text Messages) and Augmented Treatments for nonresponders (Motivational Calls or Group Meetings). Personal characteristics, including demographics, health status, self-reported physical activity, and neighborhood walkability, were measured at baseline. Moderation of intervention effects was tested across ActiGraph-assessed physical activity at baseline, 9-10 weeks (end of Initial Phase), 35-36 weeks (end of Augmented Phase), and 49-50 weeks (end of Maintenance). Results: There was no evidence that personal characteristics moderated the differential impact of the Initial or Augmented Treatments on device-assessed steps or moderate-to-vigorous physical activity. Independent of the Initial Treatment, Black race, higher baseline body mass index, and higher baseline self-reported moderate-to-vigorous physical activity were associated with lower increases in physical activity (P < .05) during the Initial Phase. Lower neighborhood walkability was associated with relative decreases in physical activity during the Maintenance Phase. Conclusions: Although personal characteristics may have altered the degree to which participants increased their physical activity, they did not alter the differential impact of the adaptive interventions.

BACKGROUND:While mobile health (mHealth) technologies can support individuals' physical activity management, they often present accessibility barriers for blind and low-vision (BLV) users. To address this gap, we developed the Personalised and Conversational Health Agent (PCHA) app for BLV users. METHODS:We conducted a 7-day usability study with six BLV adults. Data were collected on physical activity indicators (daily step counts and walking distance), System Usability Scale (SUS) scores, and qualitative feedback from semi-structured exit interviews. RESULTS:The PCHA app achieved a mean SUS score of 77.1, with ratings ranging from "Okay" to "Excellent." Participants valued the app's streamlined interface and reminder system but expressed mixed preferences for voice versus text-based data input. The AI-based chat feature demonstrated limited engagement, with participants reporting generic responses that reduced its perceived utility. The physical activity data revealed highly variable patterns, influenced by personal and contextual factors, and technical issues such as incomplete data synchronisation. CONCLUSION:Voice interfaces offer important accessibility benefits but should complement screen reader-based interactions. Further improvements should include multi-modal interaction options, improved technical reliability, and adaptive personalisation features that account for individual circumstances and preferences. These findings provide design insights for advancing inclusive mHealth interventions to better support physical activity management among BLV individuals.

Atrial fibrillation (AF) is the most common cardiac arrhythmia, increasing the risk of stroke, heart failure, and healthcare costs. Although patient self-management can improve outcomes, sustaining long-term engagement is often difficult. Mobile health applications may help address this gap, but their quality and clinical alignment have not been systematically assessed using a validated framework. A structured search of the Apple App Store and Google Play Store identified free, English-language apps supporting AF self-management. Eligible apps included features such as symptom tracking, medication reminders, or educational content. App quality was assessed using the Mobile Application Rating Scale (MARS), which evaluates engagement, functionality, aesthetics, and information quality. Of 455 apps identified, five met all inclusion criteria. Common features included symptom tracking and medication logging, but coverage of evidence-based care domains varied. Mean MARS scores ranged from 4.07 to 4.53 out of 5. Higher-performing apps excelled in functionality and information quality but often lacked comprehensive integration of guideline-recommended care, such as stroke risk assessment or personalized feedback. These findings highlight a gap in high-quality, clinically grounded digital tools for AF self-care. Improved co-design processes and clearer frameworks for app evaluation may help guide the development and selection of effective tools to support AF self-management.

Backround: Self-care is essential for managing heart failure (HF), yet many patients struggle with adherence to prescribed medications, low sodium diet, and daily self-monitoring of vital signs and symptoms. Commercial mobile health (mHealth) technologies offer unique opportunities for improving HF self-care, but their efficacy is underexplored. Aim: This study aimed to assess the feasibility and preliminary efficacy of a patient-centered intervention (iCardia4HF) that integrates multiple commercial mHealth apps and devices with individually tailored text messages (TM) to promote HF self-care. Methods: We conducted a two-arm, pilot randomized trial (NCT04262544) with allocation concealment and masking of outcome assessors. Eligible patients (adults with Stage C HF) were randomly assigned to either the control or intervention group. The control group (CG) received usual care enhanced with the provision of three consumer mHealth devices: Fitbit activity tracker and Withings Body Cardio scale and blood pressure (BP) monitor. The intervention group (IG) received the iCardia4HF program which synergistically integrates these devices with three commercial mHealth apps (Health Storylines, Withings, and Fitbit) and a program of individually tailored TM promoting HF self-care adherence. The primary outcome was medication adherence (MEMS bottle) and daily weighing adherence (Withings scale) over 12 weeks. Secondary outcomes included daily BP monitoring (Withings BP cuff) and change in self-reported self-care (SCHFI v7.2). Timestamped adherence data were transmitted from the devices to a secure digital health platform. Two-sample t-tests were performed to assess intervention effects. Results: A total of 81 patients completed the 12-week follow up (IG=42, CG=39). Participants’ mean age was 54.7 years (SD=11.0), 81% were African American, 45% were female, 64% had HFrEF, and 85% had NYHA class II or III. There were significant differences between the IG and CG in medication adherence (85% vs 75%; d=0.5, 95% CI: 0.04, 0.96; p=0.03) and daily self-monitoring of weight (72% vs 54%; d=0.6, 95% CI: 0.15, 1.04; p=0.007) and BP (67% vs 50%; d=0.54, 95% CI: 0.08, 1.0; p=0.02) over 12 weeks. There were no significant differences between the two groups in self-reported HF self-care. Conclusion: This pilot study provides preliminary evidence of feasibility and potential efficacy warranting further evaluation of the iCardia4HF intervention in a larger, fully powered trial with longer follow-up.

Background Centre-based cardiac rehabilitation (CBCR) is underused due to low referral rates, accessibility barriers, and socioeconomic constraints. mHealth technologies have the potential to address some of these challenges through remote delivery of home-based cardiac rehabilitation (HBCR). This study aims to assess the effects of mHealth HBCR interventions compared with usual care and CBCR in patients with heart disease. Methods We conducted a systematic review and meta-analysis of randomised controlled trials of mHealth HBCR interventions. Four electronic databases (MEDLINE, CENTRAL, CINAHL, and Embase) were searched from inception to March 31, 2023, with no restrictions on language or publication type. Eligible studies were randomised controlled trials of adult patients (age >= 18 years) with heart disease, comparing mHealth interventions with usual care or CBCR. The primary outcome of interest was aerobic exercise capacity, assessed with VO2 peak or 6-min walk test (6MWT). Quality of evidence was assessed using the GRADE system. This review was registered with PROSPERO, CRD42024544087. Findings Our search yielded 9164 references, of which 135 were retained for full-text review. 13 randomised controlled trials met eligibility criteria and were included in the systematic review, involving 1508 adults with myocardial infarction, angina pectoris, or heart failure, or who had undergone revascularisation. Intervention duration ranged from 6 weeks to 24 weeks. Random-effects meta-analysis showed that, compared with usual care, mHealth HBCR significantly improved 6MWT (mean difference 2474, 95% CI 988-3960; 532 patients) and VO2 peak (177, 119-235; 359 patients). No significant differences were found between mHealth HBCR and CBCR. Quality of evidence ranged from low to very low across outcomes due to risk of bias and imprecision (small sample size). Interpretation mHealth HBCR could improve access and health outcomes in patients who are unable to attend CBCR. Further research is needed to build a robust evidence base on the clinical effectiveness and cost-effectiveness of mHealth HBCR, particularly in comparison with CBCR, to inform clinical practice and policy. Funding None. Copyright (c) 2025 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license.

Introduction:Black Girls Move is a 12-week, race-conscious, multicomponent, mHealth obesity prevention intervention for Black 7th-10th grade daughters and their mothers. The complex experiences of Black female adolescents and adults necessitate tailored recruitment and retention strategies to address structural, programmatic, and interpersonal barriers to participation. We outline culturally responsive recruitment and retention strategies, lessons learned, and their implications. Methods:A review of recruitment literature highlighted trust-building as essential. We utilized guidelines for evaluating recruitment feasibility in pilot studies and the Community-Informed Recruitment Plan template of diverse populations as frameworks to assess and refine our recruitment and retention approach. Results:Key findings included: (1) trust was critical for sustaining participant relationships from screening to baseline, (2) weight eligibility criteria were overly restrictive, (3) recruitment targets needed adjustment to prevent school loss, and (4) competing demands impacted engagement. Refinements involved consulting community leaders and an expert community research consultant, leading to (1) broadening eligibility criteria to include daughters of all weight statuses and 7th-8th graders; (2) increasing incentives to align compensation with time commitments for surveys; and (3) hiring a community health worker to address communication and scheduling issues while fostering trust. Discussion:Strengthening trust, expanding eligibility, and improving incentives enhanced recruitment and participant engagement. We found this culturally tailored, race-conscious approach was valuable in refining recruitment strategies. Future studies should test the guidelines for evaluating the feasibility of recruitment and the Community-Informed Recruitment Plan template of diverse populations in a large-scale randomized control trial.

Importance Hypertension is a leading risk factor for cardiovascular diseases and is often undiagnosed. Emergency department (ED) visits serve as critical access points within health care and present a unique opportunity for hypertension screening and intervention. Objective To evaluate the effectiveness of an Education and mHealth Empowerment (E2) intervention compared with usual care in reducing systolic blood pressure (SBP) among patients with elevated BP discharged from the ED. Design, Setting, and Participants This randomized clinical trial enrolled participants who presented to an urban academic medical center ED for any indication and had elevated blood pressure (>= 140/90 mm Hg and <= 180/110 mm Hg). Eligible participants who were discharged from the ED were enrolled between February 12, 2019, and March 31, 2023, and were randomized to receive either usual care or the intervention with follow-up visits at 3 and 6 months. Interventions Usual care involved standard hypertension discharge instructions with a referral for outpatient follow-up. The E2 intervention involved a 3-prong approach, which included a brief Post-Acute Care Hypertension consultation (PACHT-c) with a clinical pharmacist or an advanced practice nurse, a smartphone-enabled BP monitoring kit (Withings device and mobile app) for daily self-monitoring along with behavior change text messages, and primary care referral. Main Outcomes and Measures The primary outcome was the mean change in SBP (mm Hg) from baseline to 6 months. Results Of the 574 participants enrolled, mean (SD) age was 51.1 (12.5) years, and 323 (56%) were female; 413 were Black (72%), 115 were Hispanic or Latino (20%), 27 were White (5%), and 19 were other race and ethnicity (3%), which included Asian, American Indian, and other racial or ethnic groups. Of the 413 patients with BP data at 6 months, the E2 intervention group (n = 210) showed a greater mean reduction in SBP (mean difference, 4.9 mm Hg; 95% CI, 0.8-9.0 mm Hg; P = .02) compared with the usual-care group (n = 203). A similar proportion of patients achieved BP less than or equal to 140/90 mm Hg at 6 months in the intervention arm (42.9% [90 of 210]) and the control arm (36.9% [75 of 203]; P = .22). Conclusions and Relevance In this single-center randomized clinical trial, a multicomponent intervention directed at patients in the ED who have elevated BP was associated with greater reduction in SBP at 6 months. Identifying patients who present to the ED with hypertension may be a viable strategy to improve BP management. Trial RegistrationClinicalTrials.gov Identifier: NCT03749499

BACKGROUND:Black adolescent females are at increased risk for obesity-related morbidity and mortality as adults compared to non-Hispanic White adolescent females. Few interventions to prevent obesity in Black adolescent females have leveraged the relationship of the daughter/mother dyad. Studies that include mothers tend to use theoretical frameworks that do not explicitly build on this important relationship and have not included mothers' active participation. Additionally, these studies do not include girls older than 12 years. In response, we developed Black Girls Move, a school-linked obesity prevention intervention that addresses these limitations in the extant literature. METHOD:This pilot randomized controlled trial examines the feasibility, acceptability, and impact of Black Girls Move (BGM), a 12-week obesity prevention intervention. Within four schools, 96 dyads will be randomized to either BGM or daughters-only comparison condition (DOCC) (12 per condition). All daughter/mother dyads (BGM and DOCC) complete self-report measures (i.e., PA, diet, family theoretical measures, racial identity, daughter/mother relationship, social cognitions) at baseline, post-intervention, and 3-months post-intervention. BGM incorporates content and processes derived from Public Health Critical Race Praxis, Family Systems Theory, and Social Cognitive Theory. Specific aims are to determine the feasibility of BGM compared to DOCC on change in PA and dietary intake, and the impact of BGM compared to daughters-only on racial identity, daughter/mother relationship, and social cognitions. IMPLICATIONS:Our long-term goal is to decrease disparities in obesity and associated co-morbidities in Black women. The findings may inform a Phase III efficacy trial of BGM in Black daughter/mother dyads.

Hypertension is a leading risk factor for cardiovascular diseases and is often undiagnosed. Emergency department (ED) visits serve as critical access points within health care and present a unique opportunity for hypertension screening and intervention. To evaluate the effectiveness of an Education and mHealth Empowerment (E2) intervention compared with usual care in reducing systolic blood pressure (SBP) among patients with elevated BP discharged from the ED. This randomized clinical trial enrolled participants who presented to an urban academic medical center ED for any indication and had elevated blood pressure (≥140/90 mm Hg and ≤180/110 mm Hg). Eligible participants who were discharged from the ED were enrolled between February 12, 2019, and March 31, 2023, and were randomized to receive either usual care or the intervention with follow-up visits at 3 and 6 months. Usual care involved standard hypertension discharge instructions with a referral for outpatient follow-up. The E2 intervention involved a 3-prong approach, which included a brief Post-Acute Care Hypertension consultation (PACHT-c) with a clinical pharmacist or an advanced practice nurse, a smartphone-enabled BP monitoring kit (Withings device and mobile app) for daily self-monitoring along with behavior change text messages, and primary care referral. The primary outcome was the mean change in SBP (mm Hg) from baseline to 6 months. Of the 574 participants enrolled, mean (SD) age was 51.1 (12.5) years, and 323 (56%) were female; 413 were Black (72%), 115 were Hispanic or Latino (20%), 27 were White (5%), and 19 were other race and ethnicity (3%), which included Asian, American Indian, and other racial or ethnic groups. Of the 413 patients with BP data at 6 months, the E2 intervention group (n = 210) showed a greater mean reduction in SBP (mean difference, 4.9 mm Hg; 95% CI, 0.8-9.0 mm Hg; P = .02) compared with the usual-care group (n = 203). A similar proportion of patients achieved BP less than or equal to 140/90 mm Hg at 6 months in the intervention arm (42.9% [90 of 210]) and the control arm (36.9% [75 of 203]; P = .22). In this single-center randomized clinical trial, a multicomponent intervention directed at patients in the ED who have elevated BP was associated with greater reduction in SBP at 6 months. Identifying patients who present to the ED with hypertension may be a viable strategy to improve BP management. ClinicalTrials.gov Identifier: NCT03749499

BackgroundHeart failure (HF) is one of the most common causes of hospital readmission in the United States. These hospitalizations are often driven by insufficient self-care. Commercial mobile health (mHealth) technologies, such as consumer-grade apps and wearable devices, offer opportunities for improving HF self-care, but their efficacy remains largely underexplored. ObjectiveThe objective of this study was to examine the feasibility, acceptability, safety, and preliminary efficacy of a patient-centered mHealth intervention (iCardia4HF) that integrates 3 consumer mHealth apps and devices (Heart Failure Health Storylines, Fitbit, and Withings) with a program of individually tailored SMS text messages to improve HF self-care. MethodsWe conducted a phase 1 randomized controlled trial. Eligible patients had stage C HF, were aged ≥40 years, and had New York Heart Association (NYHA) class I, II, or III HF. Patients were randomly assigned to either iCardia4HF plus usual care or to usual care only and were observed for 8 weeks. Key feasibility measures were recruitment and retention rates. The primary efficacy outcome was change in HF self-care subscale scores (maintenance, symptom perception, and self-care management) at 8 weeks, assessed with the Self-Care Heart Failure Index (SCHFI; version 7.2). Key secondary outcomes were modifiable behaviors targeted by the intervention (health beliefs, self-efficacy, and HF knowledge), health status, and adherence to daily self-monitoring of 2 core vital signs (body weight and blood pressure). ResultsA total of 27 patients were enrolled in the study and randomly assigned to iCardia4HF (n=13, 48%) or usual care (n=14, 52%). Of these 27 patients, 11 (41%) in the intervention group (iCardia4HF) and 14 (52%) in the usual care group started their assigned care and were included in the full analysis. Patients’ mean age was 56 (SD 8.3) years, 44% (11/25) were female, 92% (23/25) self-reported race as Black, 76% (19/25) had NYHA class II or III HF, and 60% (15/25) had HF with reduced left ventricular ejection fraction. Participant retention, completion of study visits, and adherence to using the mHealth apps and devices for daily self-monitoring were high (>80%). At 8 weeks, the mean group differences in changes in the SCHFI subscale scores favored the intervention over the control group: maintenance (Cohen d=0.19, 95% CI –0.65 to 1.02), symptom perception (Cohen d=0.33, 95% CI –0.51 to 1.17), and self-care management (Cohen d=0.25, 95% CI –0.55 to 1.04). The greatest improvements in terms of effect size were observed in self-efficacy (Cohen d=0.68) and health beliefs about medication adherence (Cohen d=0.63) and self-monitoring adherence (Cohen d=0.94). There were no adverse events due to the intervention. ConclusionsiCardia4HF was found to be feasible, acceptable, and safe. A larger trial with a longer follow-up duration is warranted to examine its efficacy among patients with HF. Trial RegistrationClinicalTrials.gov NCT03642275; https://clinicaltrials.gov/study/NCT03642275

Background:With the advancements in mobile health (mHealth) technologies, sighted individuals can benefit from mobile apps and wearable devices to more easily manage their physical activity (PA) and wellness data through intuitive touch gestures and effective data visualizations. However, for blind and low-vision (BLV) individuals, these conventional interaction methods are often challenging, not only limiting their ability to use these technologies but also potentially diminishing their motivation to adopt them to support health-promoting behaviors. We aimed to develop a health monitoring application called Personalized and Conversational Health Agent (PCHA) that supports BLV individuals with self-monitoring and management of their PA and wellness data (e.g., step count, exercise duration, calories burned, heart rate). Methods:Drawing on social cognitive theory and insights from prior needs assessment research, five key design goals were established to guide the development of the app's core features and functionalities. PCHA leverages a large language model (LLM) to enable a conversational health agent that can be installed on iPhone and Apple Watch devices. This conversational interface is designed to ensure accessibility and inclusivity, offering PA management tools through a voice user interface (VUI) that minimizes the navigation challenges often associated with traditional touchscreen-based systems. To ensure evidence-based PA guidance, a thorough review of scientific literature and published PA guidelines was conducted. Finally, two blind accessibility experts conducted the accessibility testing. Results:Accessible user interface (UI) designs, featuring high color contrast, large buttons, and a simple layout, were created using Figma. The main features and functionalities include: (I) a voice health interview to assess users' basic health information; (II) PA recommendations to guide users toward achieving their PA goals; (III) a chat feature enabling human-like conversations with the app; (IV) a PA scheduling and reminder feature with haptic feedback on the Apple Watch; and (V) an in-exercise mode that provides audible updates on heart rate, PA duration, and walking speed. The app's mobile accessibility was found to be satisfactory. Conclusions:A follow-up study involving BLV research participants will be conducted to improve the app's accessibility and usability, and to update its features and functionalities. More research is needed to fully harness the potential of LLMs in the new mHealth system to motivate PA behaviors for BLV populations. To deliver truly personalized PA feedback for BLV individuals, mHealth app developer should incorporate PA and wellness data specific to the BLV population, along with their unique personal and contextual factors that influence PA behaviors.

Background : Different interventions have shown efficacy in improving physical activity in women. This study aimed to determine the most effective adaptive intervention combining 4 efficacious treatments (Fitbit, text messages, personal calls, and group meetings) for improving physical activity. Methods : The Working Women Walking program used a Sequential Multiple Assignment Randomized Trial (SMART) design with 3 phases: initial (weeks 1–8), augmented (weeks 9–34), and maintenance (weeks 35–50). Low-active women aged 18–70 working at an academic medical center were recruited. In the initial phase, participants were randomized to Fitbit or Fitbit + text messages. After 8 weeks, nonresponders were rerandomized to an augmented treatment (personal calls or group meetings). The primary outcomes (steps/day and minutes of moderate/vigorous physical activity [MVPA]/day via ActiGraph) were assessed at baseline and 8, 34, and 50 weeks. Results : The study had 301 women (age: 45.1 [11.6] y). During the initial phase, there were no differences by initial treatment for change in steps ( P = .78) or MVPA ( P = .60). During the augmented phase, there were no differences by augmented treatment among nonresponders for change in steps ( P = .95) or MVPA ( P = .78). A significant overall increase was seen in steps (752/d; P < .001, d = 0.56) and MVPA at 8 weeks (4.1 min/d; P < .001, d = 0.48), and this was sustained at 34 and 50 weeks. Conclusions : Text messages, personal calls, and group meetings did not lead to increased physical activity. Using Fitbit and goal setting (a constant) appeared to have some benefit for many of the women in improving physical activity.

BackgroundBlack women experience a higher prevalence of poor asthma outcomes and physical inactivity than their White counterparts. Black women comprise a particularly vulnerable group of patients with asthma, with some of the highest rates of asthma in adults, high health care use (emergency department visits and hospitalizations), and the highest crude asthma mortality rate of all race or ethnicity groups. Despite recommendations to engage in regular physical activity, fewer than 15% of Black women meet the 2008 National Physical Activity Guidelines, the lowest of all racial subgroups of adults. Given the connection between physical inactivity and poor asthma outcomes, addressing physical activity among Black women with asthma is imperative. ObjectiveThis 2-arm randomized controlled trial aims to (1) determine the efficacy of a lifestyle walking intervention on asthma control compared to an education (control) group over 24 weeks, (2) examine the maintenance effects of the lifestyle walking intervention on asthma control at 48 weeks, (3) explore the behavioral mediators (eg, self-efficacy, social support, self-regulation, and daily physical activity levels) and contextual moderators (eg, baseline asthma severity, neighborhood environment, comorbid conditions, and social determinants of health) that contribute to treatment responsiveness, and (4) assess the reach and implementation potential of the intervention. MethodsThe proposed study (ACTION [A Lifestyle Physical Activity Intervention for Minority Women with Asthma]) delivers a 24-week lifestyle walking intervention designed for and by urban Black women with asthma. Participants (n=224) will be recruited through 2 urban health care systems that care for a diverse Black population. Patients will be randomized to one of two groups: (1) ACTION intervention (group sessions, physical activity self-monitoring—Fitbit, and text-based support for step goal setting) or (2) education control (an individual asthma education session and SMS text messages related to asthma education). Outcome assessments will take place at baseline, 12, 24, and 48 weeks. The primary outcome is a change in asthma control from baseline to week 24 as assessed by the asthma control questionnaire-6 (ACQ-6). Secondary outcomes include asthma-related quality of life, health care use, and asthma exacerbations and behavioral outcomes such as self-efficacy, self-regulation, social support, and physical activity. ResultsThis study was funded by the National Institute of Minority Health Disparities in August 2022. We pilot-tested our recruitment and intervention procedures and began recruitment in April 2023, with the enrollment of our first participant in May 2023. The anticipated completion of the study is April 2027. ConclusionsThis study will deliver a new approach to physical activity interventions in Black women with asthma and help to provide guidance for addressing physical activity within this subgroup. This study will also provide a potential framework for future studies in minoritized populations with other disease conditions associated with low levels of physical activity. Trial RegistrationClinicalTrials.gov NCT05726487; https://clinicaltrials.gov/study/NCT05726487 International Registered Report Identifier (IRRID)DERR1-10.2196/55700

Background Exercise interventions often improve moderate to vigorous physical activity, but simultaneously increase sedentary time due to a compensatory resting response. A higher level of sedentary time is associated with a lower level of executive function, while increased moderate to vigorous physical activity is associated with improved global cognition and working memory among Latino adults. Latino adults are the fastest-growing minority group in the United States and are at high risk for cognitive decline, spend more time sedentary compared to non-Hispanic populations, and engage in low levels of physical activity. Interventions that are culturally appropriate for Latino adults to replace sedentary time with physical activity are critically needed. Objective This study aims to develop and test the feasibility and acceptability of an ecological momentary intervention (EMI; delivered in real time) that is individually designed to replace sedentary time with physical activity in Latino adults. Methods This pilot study randomized 39 (n=26, 67% female; mean age 61, SD 5.8 years) community-dwelling, Spanish-speaking Latino adults (1:1 allocation) to either a 6-week EMI program designed to replace sitting time with physical activity (20/39, 51%) or physical activity guidelines education (19/39, 49%). The program was conducted on the web and in Spanish. The intervention was individualized based on individual interview responses. The intervention included the use of a Fitbit activity monitor, weekly didactic phone meetings, interactive tools (SMS text messages), and coach-delivered feedback. Feasibility and acceptability were assessed via study satisfaction (Likert scales), motivation (ecological momentary assessment), retention, and compliance. Sedentary time and physical activity were assessed via 7-day actigraphy. Cognitive performance was assessed via the trail making test part A and B (part B=executive function) and via the National Institutes of Health Toolbox remote cognitive assessment. Statistical analysis included a linear model on change score from baseline, adjusting for age, sex, and education, emphasizing effect size. Results Participant satisfaction with EMI was high (9.4/10), with a high degree of motivation to replace sitting time with physical activity (9.8/10). The intervention compliance rate was 79% with low difficulty using the Fitbit (1.7/10). Weekly step count increased in the intervention group by 5543 steps (group difference: d=0.54; P=.05) and sedentary time decreased by a mean 348 (SD 485) minutes (group difference: d=0.47; P=.24) compared to controls, with moderately strong effect sizes. The trail making test part B improved in the intervention group (mean –35.26, SD 60.35 seconds), compared to the control group (mean 7.19, SD 46 seconds; group difference: d=0.74; P=.01). No group differences were observed in other cognitive measures. Conclusions An individualized EMI designed for midlife and older Latino adults has the potential to replace sitting time with physical activity and improve executive functioning. The intervention was feasible and well received with a high degree of satisfaction. Trial Registration ClinicalTrials.gov NCT04507464; https://tinyurl.com/44c4thk5