Manju Daniel

Background: Equitable participation in clinical trials is essential for ensuring that research evidence is scientifically robust, ethically just and representative of the populations it is intended to serve. In Australia, culturally and linguistically diverse (CALD) populations remain underrepresented in clinical trials despite increasing national policy attention to equity and inclusion. This review synthesized empirical evidence and Australian policy and practice documents to examine factors influencing CALD participation in clinical trials. Objectives: To synthesize evidence on CALD attitudes, perceptions and factors influencing clinical trial participation in Australia; examine reported barriers and facilitators; describe how CALD populations have been conceptualized across the literature; and identify implications for research, practice and policy. Methods: A scoping review was conducted in accordance with Joanna Briggs Institute guidance and reported using PRISMA‑ScR. Five electronic databases were searched for English‑language primary studies published between 2006 and June 2025. Eligible studies examined CALD adults' perceptions, experiences or participation in Australian clinical trials. A targeted synthesis of Australian grey literature was undertaken to contextualize empirical findings within the national policy and practice landscape. Data were charted and synthesized narratively. Results: Eight empirical studies and seven Australian policy and practice documents were included. Five themes emerged from the empirical literature: (1) willingness to participate exists but opportunity is structurally constrained; (2) language and health literacy are pervasive barriers; (3) cultural values, family involvement and trust shape participation decision‐making; (4) system‐level practices limit equity monitoring and inclusion; and (5) inconsistent implementation of feasible facilitators. Policy documents increasingly recognized these same structural determinants and proposed system‐level strategies to improve equitable participation; however, nationally consistent implementation and accountability mechanisms remain limited. Conclusion: Clinical trial participation among CALD populations should be understood as a dynamic, multi‐level decision‐making process rather than a single recruitment or informed consent event. Although Australia's policy landscape increasingly recognizes the structural determinants of equitable participation, implementation remains fragmented. Future efforts should prioritize culturally responsive, evidence‐informed and measurable approaches that support equitable participation throughout the clinical trial pathway. Patient or Public Contribution: This scoping review synthesized published literature and did not involve the direct collection of data from patients or members of the public. The analysis, interpretation and framing of the findings were directly informed by patient and community perspectives reported in the included studies, many of which involved CALD consumers, carers and community members. The review was designed to amplify these perspectives and identify system‑level changes to improve equity in clinical trial participation.

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. Clinical Trial Registration Number: ClinicalTrials.gov identifier: NCT03558828.

Background: Cardiovascular disease is the leading cause of death in South Asian Indian immigrant women in the United States. Targeting culturally relevant physical activity interventions in South Asian Indian immigrant women is essential for reducing the risk of cardiovascular disease. Objective: The purpose of this qualitative study was to develop a virtual, 12-week, culturally relevant physical activity program with input from community stakeholders for first-generation South Asian Indian immigrant women. Methods: Focus groups were conducted with 2 expert panels (dance, spouse/partner meetings), including South Asian Indian immigrant community stakeholders from faith and non-faith-based organizations. The focus group conversations were digitally recorded, transcribed verbatim, and de-identified prior to analysis. Themes were finalized to develop the program. Results: A 2-part, 12-week virtual physical activity program was developed. The first part of the program included Bollywood-style South Asian Indian cultural group dance for physical activity (weekly 60-minute dance sessions). The second part of the program included spousal/partner dyad group meetings to address social support for physical activity (60-minute meetings every 2 weeks in Hindi language). Conclusion: A culturally tailored intervention developed with input from community stakeholders will be instrumental for nurses in promoting its uptake among at-risk, first-generation South Asian Indian immigrant women.

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.

Background: Young Arab American women are at risk for cardiovascular disease, but there is limited data on their physical activity (PA) engagement. Objectives: The aim of this study was to examine the relationship between PA and its correlates in young Arab American women. The objectives of this study were to: (1) describe self-reported lifestyle PA behaviors of young Arab American women and (2) examine the relationship between their self-reported lifestyle PA, device-measured lifestyle PA (combined moderate /vigorous and steps), and potentially associated factors (demographics, physical measures, individual factors, and behavior cognition factors). Methods: This cross-sectional study was conducted with women 18 to 35 years of age and Arab American (n = 50) in the Midwest Region of the United States. Participants wore ActiGraph GT3X-BT monitors for 7 days; self-report measures included the International Physical Activity Questionnaire, demographics, acculturation, discrimination, religiosity, self-efficacy, and social support. Results: The mean age of participants was 25.5 years ( SD: 5.5; range: 18-35). Per ActiGraph, the average daily steps were 5946 ( SD: 2783); only 24% met the moderate-intensity PA guidelines. Self-efficacy was significantly associated with increased moderate-to-vigorous PA ( B = 0.37; P = .012). Conclusion: The average daily steps for the young Arab American women in this study were of low active classification. More than 75% of the women failed to meet the recommended weekly moderate /vigorous PA guidelines. Our study supports the importance of targeting and tailoring PA interventions on young Arab American women who have low self-efficacy for overcoming barriers to lifestyle PA.

Collaboration between Doctor of Nursing Practice (DNP) scholars and Doctor of Philosophy (PhD) scholars is crucial to efficiently advance and disseminate nursing science. Also, DNP-PhD collaboration can help achieve priorities outlined in the recent National Institute of Nursing Research (NINR) Strategic Plan. The purpose of this series of case studies is to describe exemplars of ongoing DNP-PhD collaborations across three NINR-funded trials (1 completed, 2 ongoing) testing physical activity interventions for women at risk for cardiovascular disease. In our three physical activity intervention trials for women, we categorized examples of DNP-PhD collaboration by the four phases of the team-based research model (development, conceptualization, implementation, and translation). Across all three trials, DNP and PhD scholars contributed successfully to all phases of research in an iterative manner. Future work should focus on expanding DNP-PhD collaboration in behavioral trials, which can inform adapted, contemporary models of iterative DNP-PhD collaboration.

This review systematically examines the characteristics and effectiveness of randomized controlled trials with aerobic physical activity (PA) interventions tailored to South Asian Indians (SAIs). PubMed/MEDLINE, Scopus, Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials, CINAHL, and Google Scholar were searched. The search yielded 1,842 studies; 11 met the criteria. The Center for Evidence-Based Medicine’s critical appraisal tool was used to assess the quality of studies. Studies that used supervised structured PA sessions, educational material in SAI languages, motivational strategies, and positive reinforcement for goal setting, reported significant improvement in PA ( p < .05; Cohen’s d ≤ 0.3 to >0.8). Future PA studies in India featuring SAIs would benefit from clinic-based one-on-one structured aerobic PA interventions. In contrast, SAI immigrants in Western countries would benefit from community-based structured aerobic PA interventions that are offered in groups and culturally adapted.

The global pandemic of coronavirus disease 2019 (COVID‐19) affected many aspects of randomized controlled trials, including recruiting and screening participants. The purpose of this paper is to (a) describe adjustments to recruitment and screening due to COVID‐19, (b) compare the proportional recruitment outcomes (not completed, ineligible, and eligible) at three screening stages (telephone, health assessment, and physical activity assessment) pre‐ and post‐COVID‐19 onset, and (c) compare baseline demographic characteristics pre‐ and post‐COVID‐19 onset in the Working Women Walking program. The design is a cross‐sectional descriptive analysis of recruitment and screening data from a 52‐week sequential multiple assignment randomized trial (SMART). Participants were women 18–70 years employed at a large urban medical center. Recruitment strategies shifted from in‐person and electronic to electronic only post‐COVID‐19 onset. In‐person eligibility screening for health and physical activity assessments continued post‐COVID‐19 onset with Centers for Disease Control and Prevention precautions. Of those who expressed interest in the study pre‐ and post‐COVID‐19 onset (n = 485 & n = 269 respectively), 40% (n = 194) met all eligibility criteria pre‐COVID‐19 onset, and 45.7% (n = 123) post‐COVID‐19 onset. Although there were differences in the proportions of participants who completed or were eligible for some of the screening stages, the final eligibility rates did not differ significantly pre‐COVID‐19 versus post‐COVID‐19 onset. Examination of differences in participant demographics between pre‐ and post‐COVID‐19 onset revealed a significant decrease in the percentage of Black women recruited into the study from pre‐ to post‐COVID‐19 onset. Studies recruiting participants into physical activity studies should explore the impact of historical factors on recruitment.