Long-Term Follow-Up of a Lifestyle Intervention for Late-Midlife, Rural-Dwelling Latinos in Primary Care.

IMPORTANCE: Rural-dwelling Latinos are an underresourced population in need of accessible and effective wellness programs. OBJECTIVE: To evaluate patients' long-term health-related outcomes after lifestyle intervention. DESIGN: An uncontrolled pilot trial assessing change in health from pretreatment to long-term follow-up (12 mo after intervention completion, no contact) and from posttreatment to long-term follow-up. SETTING: Rural, community-based primary care. PARTICIPANTS: Latino and Hispanic safety-net primary care patients, ages 50 to 64 yr. INTERVENTION: A culturally tailored, 4-mo lifestyle intervention co-led by occupational therapy practitioners and Latino community health workers that features telehealth and in-home sessions covering topics such as healthy eating and navigating health care. OUTCOMES AND MEASURES: Self-reported and physiological outcomes: symptom-well-being (primary), stress, sleep disturbance, social satisfaction, physical activity, patient activation, blood pressure, and weight. Exit interviews addressed health experiences and intervention impact on participants' lives. RESULTS: Participants (N = 27) demonstrated clinically significant pretreatment to long-term follow-up benefits in all symptom-well-being dimensions (Cohen's d ≥ 0.8, p ≤ .004), with additional gains from posttreatment to long-term follow-up (d ≥ 0.4, p ≤ .05). Significant improvements from pre- to posttreatment in systolic blood pressure, stress, and social role and activity satisfaction were maintained at long-term follow-up. No changes were observed in weight, physical activity, or diastolic blood pressure. Participants described the intervention's sustained positive effect on their wellness. CONCLUSIONS AND RELEVANCE: A lifestyle intervention led by occupational therapy practitioners and community health workers in a primary care context has potential to achieve long-term health benefits in rural-dwelling, late-midlife Latinos. WHAT THIS ARTICLE ADDS: This study reveals that rural, late-midlife Latinos showed long-lasting improvements in psychological and physical health after finishing a program that helped them make healthy lifestyle choices. This finding supports the unique contribution of occupational therapy in primary care settings.

Effectiveness of social media (Facebook), targeted mailing, and in-person solicitation for the recruitment of young adult in a diabetes self-management clinical trial.

BACKGROUND/AIMS: Research is needed to identify promising recruitment strategies to reach and engage diverse young adults in diabetes clinical research. The aim of this study was to examine the relative strengths and weaknesses of three recruitment strategies used in a diabetes self-management clinical trial: social media advertising (Facebook), targeted mailing, and in-person solicitation of clinic patients. METHODS: Strategies were compared in terms of (1) cost-effectiveness (i.e. cost of recruitment/number of enrolled participants), (2) ability to yield participants who would not otherwise be reached by alternative strategies, and (3) likelihood of participants recruited through each strategy to adhere to study procedures. We further explored the appeal (overall and among age and gender subgroups) of social media advertisement features. RESULTS: In-person recruitment of clinic patients was overall the most cost-effective strategy. However, differences in demographic, clinical, and psychosocial characteristics of participants recruited via different strategies suggest that the combination of these approaches yielded a more diverse sample than would any one strategy alone. Once successfully enrolled, there was no difference in study completion and intervention adherence between individuals recruited by the three recruitment strategies. CONCLUSIONS: Ultimately, the utility of a recruitment strategy is defined by its ability to effectively attract people representative of the target population who are willing to enroll in and complete the study. Leveraging a variety of recruitment strategies appears to produce a more representative sample of young adults, including those who are less engaged in diabetes care.

A Pilot Study of the ¡Vivir Mi Vida! Lifestyle Intervention for Rural-Dwelling, Late-Midlife Latinos: Study Design and Protocol.

Older, rural-dwelling Latinos face multiple health disparities. We describe the protocol of a pilot study of a community health worker-occupational therapist-led lifestyle program, ¡Vivir Mi Vida! ( ¡VMV!), designed for delivery in primary care and adapted for late-midlife, Latino rural-living patients. Using mixed methods, we collected feasibility, acceptability, and preliminary efficacy data on ¡VMV!. Forty 50- to 64-year-old Latinos participated in a 16-week lifestyle intervention led by a community health worker-occupational therapist team. We conducted pre- and post-intervention assessments to evaluate the efficacy of ¡VMV! in improving psychosocial and clinical health outcomes. Focus groups and interviews were held post-intervention with participants and key stakeholders to assess feasibility and acceptability. This is the first trial designed to evaluate a lifestyle intervention that includes collaboration between occupational therapists and community health workers within primary care. The detailed description of methodology promotes research transparency and reproducibility of a community health worker-occupational therapist-led lifestyle intervention.

Contextualizing the Positive Effects of the Well Elderly 2 Trial: A Response to Schelly and Ohl (2019).

IMPORTANCE: A recent reanalysis of data from the Well Elderly (WE) 2 study purportedly indicated that the intervention did not achieve clinically meaningful or statistically significant effects; this article addresses these criticisms. OBJECTIVE: To contextualize the WE 2 study as targeting a nonclinical population and demonstrate that the intervention produced substantively important, statistically significant effects. DESIGN: Secondary analysis of WE 2 intervention-based pre-post change scores. SETTING: The original trial occurred primarily in senior centers and senior housing facilities in greater Los Angeles. PARTICIPANTS: Independent-living older adults (N = 324) who were assessed before and after intervention. INTERVENTION: The WE intervention, a version of the Lifestyle Redesign® (LR) approach, was administered by occupational therapists over 6 mo by means of group and individual sessions. OUTCOMES AND MEASURES: The 36-item Short Form Health Survey, the Life Satisfaction Index-Z, and the Center for Epidemiologic Studies Depression Scale. RESULTS: The WE intervention was associated with statistically significant improvement on 10 of 12 outcome variables that were examined. CONCLUSIONS AND RELEVANCE: Because the WE intervention was hypothesized to reduce age-related decline and followed a population-oriented approach, the expectation that average results would be clinically meaningful was inappropriate. The intervention produced positive effects across a wide array of outcome domains. In settings in which clinical meaningfulness is an appropriate index of intervention outcomes, evidence suggests that LR produces effects that are clinically meaningful. As an evidence-based intervention, LR should be considered useful both in population-oriented contexts and in addressing discrete health conditions. WHAT THIS ARTICLE ADDS: Valid analyses demonstrate that the positive experimental effects of the WE 2 study are, in fact, genuine and cost-effective, and LR in clinically oriented contexts has produced statistically significant, clinically meaningful results. Clearly and accurately representing the evidence base of occupational therapy in prevention and chronic care is of critical importance to advance the field as a whole.

Psychosocial and Behavioral Correlates of A1C and Quality of Life Among Young Adults With Diabetes.

PURPOSE: The purpose of this study was to evaluate relationships between behavioral and psychosocial constructs, A1C, and diabetes-dependent quality of life (DQoL) among low-socioeconomic status, ethnically diverse young adults with diabetes. METHODS: Using baseline data of 81 participants in the Resilient, Empowered, Active Living (REAL) randomized controlled trial, behavioral, cognitive, affective, and experiential variables were correlated with A1C and DQoL while adjusting for demographic characteristics, and these relationships were examined for potential effect modification. RESULTS: The data indicate that depressive symptoms and satisfaction with daily activities are associated with both A1C and DQoL, while diabetes knowledge and participation in daily activities are associated with neither A1C nor DQoL. Two constructs, diabetes distress and life satisfaction, were associated with DQoL and were unrelated to A1C, while 2 constructs, self-monitoring of blood glucose and medication adherence, were associated with A1C but unrelated to DQoL. These relationships were largely unchanged by adjusting for demographic characteristics, while numerous effect modifications were found. CONCLUSION: The data suggest that when tailoring interventions, depressive symptoms and satisfaction with daily activities may be particularly fruitful intervention targets, as they represent modifiable risk factors that are associated with both A1C and DQoL.

Evaluation of ¡Vivir Mi Vida! to improve health and wellness of rural-dwelling, late middle-aged Latino adults: results of a feasibility and pilot study of a lifestyle intervention.

AimThe aim of this study was to determine the feasibility and efficacy of a culturally tailored lifestyle intervention, ¡Vivir Mi Vida! (Live My Life!). This intervention was designed to improve the health and well-being of high risk late middle-aged Latino adults and to be implemented in a rural primary care system. BACKGROUND: Rural-dwelling Latino adults experience higher rates of chronic disease compared with their urban counterparts, a disparity exacerbated by limited access to healthcare services. Very few lifestyle interventions exist that are both culturally sensitive and compatible for delivery within a non-metropolitan primary care context. METHODS: Participants were 37 Latino, Spanish-speaking adults aged 50-64-years-old, recruited from a rural health clinic in the Antelope Valley of California. ¡Vivir Mi Vida! was delivered by a community health worker-occupational therapy team over a 16-week period. Subjective health, lifestyle factors, and cardiometabolic measures were collected pre- and post-intervention. Follow-up interviews and focus groups were held to collect information related to the subjective experiences of key stakeholders and participants.FindingsParticipants demonstrated improvements in systolic blood pressure, sodium and saturated fat intake, and numerous patient-centered outcomes ranging from increased well-being to reduced stress. Although participants were extremely satisfied with the program, stakeholders identified a number of implementation challenges. The findings suggest that a tailored lifestyle intervention led by community health workers and occupational therapists is feasible to implement in a primary care setting and can improve health outcomes in rural-dwelling, late middle-aged Latinos.

Implementing trials of complex interventions in community settings: the USC-Rancho Los Amigos pressure ulcer prevention study (PUPS).

BACKGROUND: Randomized trials of complex, non-pharmacologic interventions implemented in home and community settings, such as the University of Southern California (USC)-Rancho Los Amigos National Rehabilitation Center (RLANRC) Pressure Ulcer Prevention Study (PUPS), present unique challenges with respect to (1) participant recruitment and retention, (2) intervention delivery and fidelity, (3) randomization and assessment, and (4) potential inadvertent treatment effects. PURPOSE: We describe the methods employed to address the challenges confronted in implementing PUPS. In this randomized controlled trial, we are assessing the efficacy of a complex, preventive intervention in reducing the incidence of, and costs associated with, the development of medically serious pressure ulcers in people with spinal cord injury. METHODS: Individuals with spinal cord injury recruited from RLANRC were assigned to either a 12-month preventive intervention group or a standard care control group. The primary outcome is the incidence of serious pressure ulcers with secondary endpoints including ulcer-related surgeries, medical treatment costs, and quality of life. These outcomes are assessed at 12 and 24 months after randomization. Additionally, we are studying the mediating mechanisms that account for intervention outcomes. RESULTS: PUPS has been successfully implemented, including recruitment of the target sample size of 170 participants, assurance of the integrity of intervention protocol delivery with an average 90% treatment adherence rate, and enactment of the assessment plan. However, implementation has been replete with challenges. To meet recruitment goals, we instituted a five-pronged approach customized for an underserved, ethnically diverse population. In intervention delivery, we increased staff time to overcome economic and cultural barriers to retention and adherence. To ensure treatment fidelity and replicability, we monitored intervention protocol delivery in accordance with a rigorous plan. Finally, we have overcome unanticipated assessment and design concerns related to (1) determining pressure ulcer incidence/severity, (2) randomization imbalance, and (3) inadvertent potential control group contamination. LIMITATIONS: We have addressed the most daunting challenges encountered in the recruitment, assessment, and intervention phases of PUPS. Some challenges and solutions may not apply to trials conducted in other settings. CONCLUSIONS: Overcoming challenges has required a multifaceted approach incorporating individualization, flexibility, and persistence, as well as the ability to implement needed mid-course corrections.

Predictors of retention among African American and Hispanic older adult research participants in the Well Elderly 2 randomized controlled trial.

The purpose of this study was to document predictors of long-term retention among minority participants in the Well Elderly 2 Study, a randomized controlled trial of a lifestyle intervention for community-dwelling older adults. The primary sample included 149 African American and 92 Hispanic men and women aged 60 to 95 years, recruited at senior activity centers and senior residences. Chi-square and logistic regression procedures were undertaken to examine study-based, psychosocial and health-related predictors of retention at 18 months following study entry. For both African Americans and Hispanics, intervention adherence was the strongest predictor. Retention was also related to high active coping and average (vs. high or low) levels of activity participation among African Americans and high social network strength among Hispanics. The results suggest that improved knowledge of the predictors of retention among minority elders can spawn new retention strategies that can be applied at individual, subgroup, and sample-wide levels.

Conducting intervention research among underserved populations: lessons learned and recommendations for researchers.

Randomized controlled trials (RCTs) are considered the criterion standard in research design for establishing treatment efficacy. However, the rigorous and highly controlled conditions of RCTs can be difficult to attain when conducting research among individuals living with a confluence of disability, low socioeconomic status, and being a member of a racial/ethnic minority group, who may be more likely to have unstable life circumstances. Research on effective interventions for these groups is urgently needed, because evidence regarding approaches to reduce health disparities and improve health outcomes is lacking. In this methodologic article, we discuss the challenges and lessons learned in implementing the Lifestyle Redesign for Pressure Ulcer Prevention in Spinal Cord Injury study among a highly disadvantaged population. These issues are discussed in terms of strategies to enhance recruitment, retention, and intervention relevance to the target population. Recommendations for researchers seeking to conduct RCTs among socioeconomically disadvantaged, ethnically diverse populations are provided.

Effectiveness of a lifestyle intervention in promoting the well-being of independently living older people: results of the Well Elderly 2 Randomised Controlled Trial.

BACKGROUND: Older people are at risk for health decline and loss of independence. Lifestyle interventions offer potential for reducing such negative outcomes. The aim of this study was to determine the effectiveness and cost-effectiveness of a preventive lifestyle-based occupational therapy intervention, administered in a variety of community-based sites, in improving mental and physical well-being and cognitive functioning in ethnically diverse older people. METHODS: A randomised controlled trial was conducted comparing an occupational therapy intervention and a no-treatment control condition over a 6-month experimental phase. Participants included 460 men and women aged 60-95 years (mean age 74.9 ± 7.7 years; 53% <$12000 annual income) recruited from 21 sites in the greater Los Angeles metropolitan area. RESULTS: Intervention participants, relative to untreated controls, showed more favourable change scores on indices of bodily pain, vitality, social functioning, mental health, composite mental functioning, life satisfaction and depressive symptomatology (ps<0.05). The intervention group had a significantly greater increment in quality-adjusted life years (p<0.02), which was achieved cost-effectively (US $41218/UK £24868 per unit). No intervention effect was found for cognitive functioning outcome measures. CONCLUSIONS: A lifestyle-oriented occupational therapy intervention has beneficial effects for ethnically diverse older people recruited from a wide array of community settings. Because the intervention is cost-effective and is applicable on a wide-scale basis, it has the potential to help reduce health decline and promote well-being in older people. Trial Registration clinicaltrials.gov identifier: NCT0078634.

Confronting challenges in intervention research with ethnically diverse older adults: the USC Well Elderly II Trial.

BACKGROUND: Community-dwelling older adults are at risk for declines in physical health, cognition, and psychosocial well-being. However, their enactment of active and health-promoting lifestyles can reduce such declines. PURPOSE: The purpose of this article is to describe the USC Well Elderly II study, a randomized clinical trial designed to test the effectiveness of a healthy lifestyle program for elders, and document how various methodological challenges were addressed during the course of the trial. METHODS: In the study, 460 ethnically diverse elders recruited from a variety of sites in the urban Los Angeles area were enrolled in a randomized experiment involving a crossover design component. Within either the first or second 6-month phase of their study involvement, each elder received a lifestyle intervention designed to improve a variety of aging outcomes. At 4-5 time points over an 18-24 month interval, the research participants were assessed on measures of healthy activity, coping, social support, perceived control, stress-related biomarkers, perceived physical health, psychosocial well-being, and cognitive functioning to test the effectiveness of the intervention and document the process mechanisms responsible for its effects. RESULTS: The study protocol was successfully implemented, including the enrollment of study sites, the recruitment of 460 older adults, administration of the intervention, adherence to the plan for assessment, and establishment of a large computerized data base. LIMITATIONS: Methodological challenges were encountered in the areas of site recruitment, participant recruitment, testing, and intervention delivery. CONCLUSIONS: The completion of clinical trials involving elders from numerous local sites requires careful oversight and anticipation of threats to the study design that stem from: (a) social situations that are particular to specific study sites; and (b) physical, functional, and social challenges pertaining to the elder population.