Outcomes from a multiple risk factor diabetes self-management trial for Latinas: ¡Viva Bien!

BACKGROUND: Culturally appropriate interventions are needed to assist Latinas in making multiple healthful lifestyle changes. PURPOSE: The purpose of this study was to test a cultural adaptation of a successful multiple health behavior change program, ¡Viva Bien! METHODS: Random assignment of 280 Latinas with type 2 diabetes to usual care only or to usual care + ¡Viva Bien!, which included group meetings for building skills to promote the Mediterranean diet, physical activity, stress management, supportive resources, and smoking cessation. RESULTS: ¡Viva Bien! participants compared to usual care significantly improved psychosocial and behavioral outcomes (fat intake, stress management practice, physical activity, and social-environmental support) at 6 months, and some improvements were maintained at 12 months. Biological improvements included hemoglobin A1c and heart disease risk factors. CONCLUSIONS: The ¡Viva Bien! multiple lifestyle behavior program was effective in improving psychosocial, behavioral, and biological/quality of life outcomes related to heart health for Latinas with type 2 diabetes.

Methods for the cultural adaptation of a diabetes lifestyle intervention for Latinas: an illustrative project.

Because Latinas experience a high prevalence of type 2 diabetes and its complications, there is an urgent need to reach them with interventions that promote healthful lifestyles. This article illustrates a sequential approach that took an effective multiple-risk-factor behavior-change program and adapted it for Latinas with type 2 diabetes. Adaptation stages include (a) information gathering from literature and focus groups, (b) preliminary adaptation design, and (c) preliminary adaptation test. In this third stage, a pilot study finds that participants were highly satisfied with the intervention and showed improvement across diverse outcomes. Key implications for applications include the importance of a model for guiding cultural adaptations, and the value of procedures for obtaining continuous feedback from staff and participants during the preliminary adaptation test.

Outcomes of minimal and moderate support versions of an internet-based diabetes self-management support program.

OBJECTIVE: Internet and other interactive technology-based programs offer great potential for practical, effective, and cost-efficient diabetes self-management (DSM) programs capable of reaching large numbers of patients. This study evaluated minimal and moderate support versions of an Internet-based diabetes self-management program, compared to an enhanced usual care condition. RESEARCH DESIGN AND METHODS: A three-arm practical randomized trial was conducted to evaluate minimal contact and moderate contact versions of an Internet-based diabetes self-management program, offered in English and Spanish, compared to enhanced usual care. A heterogeneous sample of 463 type 2 patients was randomized and 82.5% completed a 4-month follow-up. Primary outcomes were behavior changes in healthy eating, physical activity, and medication taking. Secondary outcomes included hemoglobin A1c, body mass index, lipids, and blood pressure. RESULTS: The Internet-based intervention produced significantly greater improvements than the enhanced usual care condition on three of four behavioral outcomes (effect sizes [d] for healthy eating = 0.32; fat intake = 0.28; physical activity= 0.19) in both intent-to-treat and complete-cases analyses. These changes did not translate into differential improvements in biological outcomes during the 4-month study period. Added contact did not further enhance outcomes beyond the minimal contact intervention. CONCLUSIONS: The Internet intervention meets several of the RE-AIM criteria for potential public health impact, including reaching a large number of persons, and being practical, feasible, and engaging for participants, but with mixed effectiveness in improving outcomes, and consistent results across different subgroups. Additional research is needed to evaluate longer-term outcomes, enhance effectiveness and cost-effectiveness, and understand the linkages between intervention processes and outcomes.

Recruitment for an internet-based diabetes self-management program: scientific and ethical implications.

BACKGROUND: Little is known about the reach of Internet self-management interventions. PURPOSE: The aim of this study was to evaluate different definitions of participation rate and compare characteristics among subcategories of participants and nonparticipants on demographic and clinical factors using de-identified electronic medical record data. METHODS: Data are presented on recruitment results and characteristics of 2,603 health maintenance organization members having type 2 diabetes invited to participate in an Internet self-management program. RESULTS: There was a 37% participation rate among all members attempted to contact and presumed eligible. There were several significant differences between participants and nonparticipants and among subgroups of participants (e.g., proactive volunteers vs. telephone respondents) on factors including age, income, ethnicity, smoking rate, education, blood pressure, and hemoglobin A1c. CONCLUSION: These results have important implications for the impact of different recruitment methods on health disparities and generalization of results. We provide recommendations for reporting of eligibility rate, participation rate, and representativeness analyses.

Church-based breast cancer screening education: impact of two approaches on Latinas enrolled in public and private health insurance plans.

INTRODUCTION: The Tepeyac Project is a church-based health promotion project that was conducted from 1999 through 2005 to increase breast cancer screening rates among Latinas in Colorado. Previous reports evaluated the project among Medicare and Medicaid enrollees in the state. In this report, we evaluate the program among enrollees in the state's five major insurance plans. METHODS: We compared the Tepeyac Project's two interventions: the Printed Intervention and the Promotora Intervention. In the first, we mailed culturally tailored education packages to 209 Colorado Catholic churches for their use. In the second, promotoras (peer counselors) in four Catholic churches delivered breast-health education messages personally. We compared biennial mammogram claims from the five insurance plans in the analysis at baseline (1998-1999) and during follow-up (2000-2001) for Latinas who had received the interventions. We used generalized estimating equations (GEE) analysis to adjust rates for confounders. RESULTS: The mammogram rate for Latinas in the Printed Intervention remained the same from baseline to follow-up (58% [2979/5130] vs 58% [3338/5708]). In the Promotora Intervention, the rate was 59% (316/536) at baseline and 61% (359/590) at follow-up. Rates increased modestly over time and varied widely by insurance type. After adjusting for age, income, urban versus rural location, disability, and insurance type, we found that women exposed to the Promotora Intervention had a significantly higher increase in biennial mammograms than did women exposed to the Printed Intervention (GEE parameter estimate = .24 [+/-.11], P = .03). CONCLUSION: For insured Latinas, personally delivering church-based education through peer counselors appears to be a better breast-health promotion method than mailing printed educational materials to churches.

Effects of acculturation on a culturally adapted diabetes intervention for Latinas.

OBJECTIVE: To inform the refinement of a culturally adapted diabetes intervention, we evaluated acculturation's association with variables at several sequential steps: baseline measures of diet and physical activity, intervention engagement, putative mediators (problem solving and social resources), and outcomes (fat consumption and physical activity). METHOD: Latina women (N = 280) recruited from health organizations were randomly assigned to a culturally adapted lifestyle intervention (¡Viva Bien!) or usual care. A brief version of the Acculturation Rating Scale for Mexican Americans-II (ARSMA-II) acculturation scales (Anglo and Latina orientations) was administered at baseline. Assessments at baseline, 6 months, and 12 months included social supportive resources for diet and exercise, problem solving, saturated fat consumption, and physical activity. RESULTS: Latina orientation was negatively related to saturated fat intake and physical activity at baseline. Latina orientation also was positively related to session attendance during Months 6-12 of the intervention. Independent of 6-month intervention effects, Anglo orientation was significantly positively related to improvements in problem solving and dietary supportive resources. Anglo orientation related negatively to improved physical activity at 6 and 12 months. There were no Acculturation × Intervention interactions on putative mediators or outcomes. CONCLUSION: The cultural adaptation process was successful in creating an engaging and effective intervention for Latinas at all levels of acculturation. However, independent of intervention effects, acculturation was related to putative mediating variables (problem solving and social resources) and an outcome variable (physical activity), an indication of acculturation's general influence on lifestyle and coping factors.

Linking internet-based diabetes self-management to primary care: lessons learned and implications for research translation and practice implementation.

There has been little discussion of or research on the key translational issue of how to integrate patient self-management programs across multiple primary care clinics within an HMO. The purpose of this study was to summarize our experiences and lessons learned in trying to integrate information from a web-based diabetes self-management program into primary care and the electronic health record (EHR). We describe plans, implementation, adaptations made, and data on patient and physician reactions to the My Path diabetes self-management program provided to 331 adult primary care patients. Mixed methods results revealed that, despite the availability of a state-of-the-art EHR, the intervention was not well integrated into primary care. Information from health-promotion and disease management programs, even within the same organization and with advanced EHR systems, is challenging to integrate into busy primary care.

Twelve-month outcomes of an Internet-based diabetes self-management support program.

OBJECTIVE: Internet-based programs offer potential for practical, cost-effective chronic illness self-management programs. METHODS: We report 12-month results of an Internet-based diabetes self-management program, with and without additional support, compared to enhanced usual care in a 3-arm practical randomized trial. Patients (n=463) were randomized: 77.3% completed 12-month follow-up. Primary outcomes were changes in health behaviors of healthy eating, physical activity, and medication taking. Secondary outcomes were hemoglobin A1c, body mass index, lipids, blood pressure, and psychosocial factors. RESULTS: Internet conditions improved health behaviors significantly vs. usual care over the 12-month period (d for effect size=.09-.16). All conditions improved moderately on biological and psychosocial outcomes. Latinos, lower literacy, and higher cardiovascular disease risk patients improved as much as other participants. CONCLUSIONS: The Internet intervention meets the reach and feasibility criteria for a potentially broad public health impact. However, 12-month magnitude of effects was small, suggesting that different or more intensive approaches are necessary to support long-term outcomes. Research is needed to understand the linkages between intervention and maintenance processes and downstream outcomes. PRACTICE IMPLICATIONS: Automated self-management interventions should be tailored and integrated into primary care; maintenance of patient self-management can be enhanced through links to community resources.

Long-term outcomes from a multiple-risk-factor diabetes trial for Latinas: ¡Viva Bien!

Latinas with type 2 diabetes are in need of culturally sensitive interventions to make recommended longterm lifestyle changes and reduce heart disease risk. To test the longer-term (24-month) effects of a previously successful, culturally adapted, multiple-healthbehavior- change program, ¡Viva Bien!, 280 Latinas were randomly assigned to usual care or ¡Viva Bien!. Treatment included group meetings to promote a culturally adapted Mediterranean diet, physical activity, supportive resources, problem solving, stress-management practices, and smoking cessation. ¡Viva Bien! participants achieved and maintained some lifestyle improvements from baseline through 24 months, including significant improvements for psychosocial outcomes, fat intake, social-environmental support, body mass index, and hemoglobin A1c. Effects tended to diminish over time. The ¡Viva Bien! multiple-behavior program was effective in improving and maintaining some psychosocial, behavioral, and biological outcomes related to heart health across 24 months for Latinas with type 2 diabetes, a high-risk, underserved population (ClinicalTrials.gov number, NCT00233259).

Self-efficacy, problem solving, and social-environmental support are associated with diabetes self-management behaviors.

OBJECTIVE: To evaluate associations between psychosocial and social-environmental variables and diabetes self-management, and diabetes control. RESEARCH DESIGN AND METHODS: Baseline data from a type 2 diabetes self-management randomized trial with 463 adults having elevated BMI (M = 34.8 kg/m(2)) were used to investigate relations among demographic, psychosocial, and social-environmental variables; dietary, exercise, and medication-taking behaviors; and biologic outcomes. RESULTS: Self-efficacy, problem solving, and social-environmental support were independently associated with diet and exercise, increasing the variance accounted for by 23 and 19%, respectively. Only diet contributed to explained variance in BMI (beta = -0.17, P = 0.0003) and self-rated health status (beta = 0.25, P < 0.0001); and only medication-taking behaviors contributed to lipid ratio (total-to-HDL) (beta = -0.20, P = 0.0001) and A1C (beta = -0.21, P < 0.0001). CONCLUSIONS: Interventions should focus on enhancing self-efficacy, problem solving, and social-environmental support to improve self-management of diabetes.

Viva bien!: Overcoming recruitment challenges in a multiple-risk-factor diabetes trial.

OBJECTIVES: To describe recruitment of Latinas in a randomized clinical trial conducted within 2 health care organizations. METHODS: The study relied on project-initiated telephone calls as part of a multifaceted recruitment approach. Chi-square and t tests were conducted to compare participants and nonparticipants on a number of variables. RESULTS: From 4045 telephone contacts, 280 Latinas agreed to participate. Most were ineligible due to non-Latino ethnicity (89%). Of eligible candidates, 61% took part. Few significant differences were found on participant vs nonparticipant characteristics. CONCLUSIONS: Using appropriate recruitment procedures, a representative sample of Latinas can be obtained.

A qualitative case study examining intervention tailoring for minorities.

OBJECTIVES: To explore issues of intervention tailoring for ethnic minorities based on information and experiences shared by researchers affiliated with the Health Maintenance Consortium (HMC). METHODS: A qualitative case study methodology was used with the administration of a survey (n = 17 principal investigators) and follow-up telephone interviews. Descriptive and content analyses were conducted, and a synthesis of the findings was developed. RESULTS: A majority of the HMC projects used individual tailoring strategies regardless of the ethnic background of participants. Follow-up interview findings indicated that key considerations in the process of intervention tailoring for minorities included formative research; individually oriented adaptations; and intervention components that were congruent with participants' demographics, cultural norms, and social context. CONCLUSIONS: Future research should examine the extent to which culturally tailoring long-term maintenance interventions for ethnic minorities is efficacious and should be pursued as an effective methodology to reduce health disparities.