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

Deborah J Toobert, Ph.D1, Lisa A Strycker, M.A1, Diane K King, Ph.D2, Manuel Barrera Jr.,Ph.D3, Diego Osuna, M.D., M.P.H4, and Russell E Glasgow, Ph.D5

1 Oregon Research Institute, 1715 Franklin Blvd, Eugene, OR 97403- 1983, USA2 Institute for Health Research Address Kaiser Permanente Colorado, P.O. Box 378066, Denver,CO 80237-8066, USA3 Psychology Department, Arizona State University, Box 871104, Tempe, AZ 85287-1104, USA4 University of Colorado Health Sciences Center, Institute for Health Research, KaiserPermanente Colorado, P.O. Box 378066, Denver, CO 80237-8066, USA5 Dissemination and Implementation Science, Division of Cancer Control and PopulationSciences, National Cancer Institute, 6130 Executive Blvd., Room 6144, Rockville, MD 20852,USA

AbstractLatinas with type 2 diabetes are in need of culturally sensitive interventions to make recommendedlongterm 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 includedgroup meetings to promote a culturally adapted Mediterranean diet, physical activity, supportiveresources, problem solving, stress-management practices, and smoking cessation. ¡Viva Bien!participants achieved and maintained some lifestyle improvements from baseline through 24months, including significant improvements for psychosocial outcomes, fat intake, social–environmental support, body mass index, and hemoglobin A1c. Effects tended to diminish overtime. The ¡Viva Bien! multiple-behavior program was effective in improving and maintainingsome psychosocial, behavioral, and biological outcomes related to heart health across 24 monthsfor Latinas with type 2 diabetes, a high-risk, underserved population (ClinicalTrials.gov number,NCT00233259).

KeywordsLatina; Diabetes; Multiple behavior change Self-management; Randomized controlled trial

INTRODUCTIONLatinas with type 2 diabetes are an underserved population at high risk for coronary heartdisease. Hispanic Americans, the fastest-growing ethnic population in the USA—andparticularly Hispanic women (Latinas)—have a greater prevalence of type 2 diabetes andmore diabetes complications than Anglos [1]. By 2050, the Hispanic population will triple,and this population is among the least affluent of US ethnic groups. Disparities in the

Correspondence to: D J Toobert deborah@ori.org.The authors have no potential conflicts of interest relevant to this article.

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Published in final edited form as:Transl Behav Med. 2011 September ; 1(3): 416–426. doi:10.1007/s13142-010-0011-1.

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distribution of health and health care in North America are largely attributable to race/ethnicity and socioeconomic status [2, 3], and their effects on the social determinants ofhealth and health-related behaviors places low-income Latinas at greater risk for chronicdiseases such as diabetes [4, 5]. Mexican-American adults are twice as likely as non-Hispanic whites to be diagnosed with diabetes [6]. Studies controlling for social economicstatus find reduced disparities for some health outcomes, but not for diabetes in Latinos [7,8]. Emerging public health models advocate an appropriate response to diabetes disparitiesin health care, such as delivering culturally sensitive diabetes interventions [9].

The ¡Viva Bien! study was a multiple-behavior, coronary-heart-disease-risk-factorintervention designed for Latinas with type 2 diabetes. Prior research has identified the hearthealth benefits of “Mediterranean Diet”-style eating practices [10], being physically active[11–16], managing stress [17–19], and utilizing social–environmental support to initiate andsustain health-supporting behaviors [20–24]. Most US adults, including Latinas, engage inmultiple risk behaviors [25], but multiple-risk-factor intervention studies are rare [26–28].Studies investigating maintenance of multiple health behaviors are expensive, complicated,and infrequently reported. Yet, for individuals with type 2 diabetes, sustaining multiplehealthful behaviors over a lifetime is critical for improving risk factors [29] and avoidingadverse consequences of illness progression, such as coronary heart disease [30].

Practical strategies and theoretical mechanisms for sustaining health behaviors over longerperiods are not well established or understood. Just as medication for chronic illnessesgenerally is prescribed for long periods and may require periodic changes and doseadjustments to retain efficacy, health-behavior interventions may require long activetreatment and similar dose adjustments to retain effects [31, 32]. Of the maintenance studiesavailable, there is clear evidence that few improvements are sustained long-term [33–37],and this research area is characterized by conflicting findings [15, 38, 39].

The purpose of this paper is to advance scientific knowledge and improve clinical practiceregarding the long-term effects of multiple-behavior-change programs in an underserved andhigh-risk Latina population. The study documents the extent to which the ¡Viva Bien!intervention helped Latinas with type 2 diabetes make simultaneous changes in psychosocialfactors and multiple lifestyle behaviors that were hypothesized to result in improvedbiologic and quality of life outcomes from baseline to 24 months.

METHODSStudy Design

The ¡Viva Bien! program was a cultural adaptation and evaluation of an established,evidence-based lifestyle change program for an underserved population at high risk for heartdisease: Latinas with type 2 diabetes [40]. Specific cultural adaptations are described in theappendix. The efficacy of this program was demonstrated previously in mostly non-Hispanicwhite women [41, 42]. The adaptation of ¡Viva Bien! addressed sociocultural, economic, andenvironmental contexts important for Latinas [40].

Patients were recruited from nine Kaiser Permanente clinics in the Denver, Colorado,metropolitan area, and one large community health center, the Salud Family Health Center,in Commerce City near Denver. Kaiser Permanente is a managed-care organization thatserves about 450,000 patients in the Denver metropolitan area, about 17% of whom areLatino. Salud is a community health center that provides comprehensive primary healthservices to low-income patients. About 65% of Salud’s patients are Latinos whose primarylanguage is Spanish.

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Inclusion criteria were self-identified Latina ethnicity, 30–75 years of age, diagnosis of type2 diabetes for at least 6 months identified by electronic medical record codes and using theWelborn criteria [43], living independently, having a telephone, and the ability to read ineither English or Spanish. Exclusion criteria included being on an insulin pump, beingdevelopmentally disabled, or having end-stage renal disease. Participants were recruited [44;Fig. 1) in four waves, with roughly one fourth of the sample participating in each wave.

Letters in English and Spanish, signed by the project’s Latino physician, were mailed topotential participants, along with self-addressed stamped postcards that could be returned todecline further contact or request information. Women who did not return postcards weretelephoned by bilingual project recruiters, who described the program, confirmed eligibility,and invited qualified candidates to participate. Those who agreed were scheduled forbaseline assessments. Those in the usual care condition received $25 gift cards forassessment completion; those in ¡Viva Bien! received the intervention at no cost to them andwere not paid for assessment completion or for their time in the study.

Research procedures followed were approved by the Kaiser Permanente Denver, Colorado,and Oregon Research Institute institutional review boards, and were in accordance with theHelsinki Declaration of 1975, as revised in 2000. All participants gave written informedconsent. Data were collected from 2006 through 2009 and analyzed for this report in 2010.

Treatment ProtocolParticipants who completed baseline assessments (N=280) were randomized to enhancedusual diabetes care or to the ¡Viva Bien! intervention. The ¡Viva Bien! program included a2½-day retreat followed by meetings that were weekly for the first 6 months, semi-monthlyfor months 6–12, monthly for months 12–18, and bi-monthly for months 18–24. Theprogram encouraged participants to (a) follow the Mediterranean diet adapted for Latinonationality subgroups, (b) practice stress-management techniques daily, (c) engage in 30 minof daily physical activity, (d) stop smoking, and (e) participate in problem- solving-basedsupport groups. The purpose of the retreat was to introduce the program and practice newskills. The intervention continued with 4-h facilitatorled meetings, providing 1 h each ofinstruction and practice of the above components except for smoking, which was addressedindividually due to the small number of smokers. The usual medical care condition at KaiserPermanente Denver, Colorado, consisted of management of complications associated withdiabetes, monitoring of other health factors, and specified frequencies of laboratory assaysand specialty exams in compliance with the American Diabetes Association standards ofcare. The enhancement included a choice of one free Kaiser-Permanente Denver, Coloradoclass covering the areas targeted in ¡Viva Bien!.

MeasuresAssessments were conducted at baseline and at 6, 12, and 24 months for all participants. Theabbreviated form of the ARSMA-II [45] was used to measure bidirectional acculturation. Inaddition, questions about participant nativity and nativity of parents were asked to determinegenerational status. Problem-solving ability was assessed using the Diabetes Problem-Solving Interview [46]. Self-efficacy was measured with the Confidence in OvercomingChallenges to Self-Care instrument [47]. Social support was assessed using the UCLASocial Support Inventory [48]. The semi-quantitative food frequency questionnaire [49] wasused to document percent of calories from saturated fat. Stress-management practice wasassessed using a self-monitoring log to track daily minutes of yoga stretches, breathingexercises, progressive relaxation, and meditation and visualization. The stress-managementpractice score was the summed minutes across 7 days of these activities (square-roottransformed for analyses) [41]. The Modified International Physical Activity Questionnaire

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was used to calculate the number of days per week participants engaged in exercise [50].This measure has been previously validated [50] and in the present study correlated 0.34(p=0.007) at baseline in a subset of participants (n=60) wearing ActiGraph (MTI HealthServices) accelerometers for 7 days. The Brief Chronic Illness Resources Survey [51]provided frequencies of an individual’s perceived social–environmental support for diseasemanagement. Measures of height and weight were taken on a sensitive digital scale (DetectoElectronics). Hemoglobin A1c assays were performed at the Kaiser Permanente Denver,Colorado Regional Reference Laboratory in Aurora, CO, and measured on a Bio-RadVariant II Turbo liquid by high-pressure liquid chromatography. Ten-year coronary heartdisease risk was assessed using the United Kingdom Prospective Diabetes Study logisticequation [52]. Hemoglobin A1c values and the coronary heart disease 10-year risk scorewere square-root transformed for analyses.

AnalysesDescriptive analyses were used to determine whether transformations were needed. Chi-square or t tests were used to evaluate differences in participant characteristics between thetwo treatment conditions and between dropouts and those who completed the study at 24months.

Long-term effects—Generalized estimating equations models [53] were used to comparelong-term treatment effects on outcome measures from baseline to 24 months. Models werespecified using a first-order autoregressive correlation structure, and separate models wereconducted to examine treatment group interactions with both linear and quadratic trends.Linear-trend results are presented here, as model results were similar for linear and quadratictrends. Wave was covaried in all analyses, as was age, which was found in univariatecorrelational analyses to be significantly associated with outcomes at baseline. Effect sizes(d) were calculated on the difference between the two treatment conditions at all followuptime points.

Missing data—Mean percent (averaged across ten measures) of total observations missingat each assessment point were as follows: 10% usual care vs. 9% ¡Viva Bien! at baseline;25% usual care vs. 27% ¡Viva Bien! at 6 months; 32% usual care vs. 39% ¡Viva Bien! at 12months; and 39% usual care vs. 43% ¡Viva Bien! at 24 months. Generalized estimatingequations analyses were performed two ways. First, a complete-case approach was used, inwhich participants with missing follow-up data on the outcome variable of interest wereexcluded from the analysis. Identical analyses were conducted after missing data wereimputed using multiple imputation procedures via the expectation-maximization algorithmwith NORM software [54]. The results were similar; therefore, only intent-to-treat (imputed)results are presented in the tables (with superscripts indicating differences from complete-case results).

Statistical analyses were performed using SPSS 12.0 (SPSS Inc., Chicago, IL).

RESULTSParticipants

Recruitment results have been reported previously [44]. The study recruited a diverse,relatively highrisk sample of Latina women (N=280). About 51% of those confirmedeligible agreed to participate.

Participant characteristics are presented in Table 1. On average, participants were about 57years of age, had been diagnosed with diabetes for almost 10 years, were obese, and had a

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baseline hemoglobin A1c level greater than 8. Approximately two thirds reported an annualfamily income of less than $50,000. The recruited sample varied by acculturation, with40.8% mostly Anglo-oriented, 24.3% somewhat Anglo-oriented, 17.6% mixed Latino-and-Anglo-oriented, 4.8% somewhat Latino-oriented, and 12.5% mostly Latino-oriented [40].Sixteen percent preferred Spanish to English, and health literacy scores were considerablylower than in our prior primary care-based diabetes projects. Most participants were born inthe USA (79.6%) or Mexico (15.8%), with one to two women each reporting their birthcountry as El Salvador, France, Morocco, Brazil, Peru, Panama, Cuba, Puerto Rico,Guatemala, or Honduras. The participants’ parents were also born primarily in the USA(mother= 72.1%; father=69.8%) and Mexico (mother=21.6%; father=23.7%), with smallpercentages in many other European, Asian, and Latin American countries. Acculturationlevel was not significantly associated with outcomes at baseline. Despite randomization,there were significant baseline differences between conditions on age, body mass index, andyears diagnosed with diabetes (which significantly correlated with age). Usual careparticipants were older, had diabetes longer, and had lower bodymass index than ¡Viva Bien!participants.

Attendance at ¡Viva Bien! sessions varied. Weekly meeting attendance during the first 6months averaged 65%, declined to 48% for meetings between 6 and 12 months, andaveraged 46% for meetings between 12 and 24 months.

Attrition rates were 22.5% at 6 months, 30.0% at 12 months, and 38.6% at 24 months, withno significant differences between treatment conditions in attrition at any time point.

Relative to dropouts, study completers were older (mean years at baseline=59.0 years[SD=8.9] vs. 54.1 [SD=11.1]; t(189)=3.76, p<.001), had higher health literacy (mean scoreat baseline=4.4 [SD=0.8] vs. 4.1 [SD=0.9]; t(196)=2.65, p=.009), had higher numeracyscores (mean score at baseline=3.7 [SD=1.2] vs. 3.4 [SD=1.2]; t(217)=2.21, p=.028), had alower prevalence of smoking (7.1% vs. 17.0%; χ2(1)=6.6, p=.01), and had a lowerproportion of taking insulin (24.0% vs. 41.0%; χ2 (1)=9.2, p=.01). Dropouts and completersdid not differ significantly on body mass index, years diagnosed with diabetes, income,education, language preference, or acculturation.

Psychosocial OutcomesThere were large and consistent differences between conditions on improvement in thepsychosocial variables hypothesized to be influenced by the intervention (Table 2). The¡Viva Bien! condition improved considerably more than the usual care condition by the 6-month follow-up on measures of problem solving, self-efficacy, and perceived supportiveresources. Gains were essentially maintained at 12- and 24-month follow-ups, with 24-month follow-up effect sizes ranging from no effect for self-efficacy to 0.75 for problemsolving and perceived support.

Behavior ChangeBetween-condition effects were found across 24 months on two of the targeted behavioraloutcomes (Table 3): percent calories from saturated fat and engagement in social–environmental support activities. Effect sizes ranged from 0.04 (for physical activity) to 0.33(for percent calories from saturated fat) at the 24-month follow-up. The ¡Viva Bien!participants did not maintain their initial 6-month significant improvements relative to theusual care condition on practice of stress management. For physical activity, initial 6-monthsignificant improvements relative to usual care also were not maintained, in part because theusual care condition improved on this outcome.

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Biological OutcomesBiological outcomes across 24 months were inconsistent (Table 4). The ¡Viva Bien!condition improved significantly more than the usual care condition on body mass index, butearly improvement in hemoglobin A1c was not maintained. Coronary heart disease risk asmeasured by the United Kingdom Prospective Diabetes Study logistic equation was notsignificantly improved. Biologic improvements generally decreased across the 2-yearperiod.

DISCUSSIONThere is a paucity of information on the long-term effects of multiple-risk-factor trials,especially in high-risk populations [15, 38]. The primary goal of this paper was to evaluatewhether the effects of a multiple-behavior-change program, ¡Viva Bien!, adapted for anunderserved and high-risk Latina population, sustained improvements on targeted diabetesself-management, psychosocial variables, and biologic outcomes after the interventionfaded.

The ¡Viva Bien! intervention was initially intense, with a 2½-day retreat followed by 6months of weekly 4-h meetings, but the study was also designed to maximize participantreach and generalizability of the outcomes. Few exclusion criteria were employed, andpatients were recruited from two different health systems. The intervention componentswere delivered by a mix of bilingual clinical staff and community professionals and wereevaluated systematically for their appropriateness and appeal to Latina participants in focusgroups, a review by Latino/a professionals, and pilot testing prior to the intervention trial[40]. Cultural appropriateness was assured by systematically giving participantsopportunities to inform and influence intervention components to ensure cultural fit whilemaintaining fidelity to the original intervention. The finding that attrition rates were notassociated with language preference or acculturation suggests that the program wasculturally relevant to most Latinas in the sample.

While the 38.6% 24-month dropout rate was disappointing, attrition did not differsignificantly by treatment condition or key participant characteristics, and attrition analysesindicated that those unavailable for the 24-month follow-up were generally similar to thosewho continued participation. Compared with our previous lifestyle-change study withmostly Anglo women [55], the Mediterranean Lifestyle Program (MLP), from which ¡VivaBien! was adapted, program attendance was higher (65% for 0–6 months and 47% for 6–24months in ¡Viva Bien! vs. 54% for 0–6 months and 31% for 6– 24 months). The ¡Viva Bien!attendance rates are in line with those reported in similar studies with this population, suchas those reported in a review of multifactorial lifestyle interventions to prevent chronicillness (diabetes and coronary heart disease) by Angermayr et al. [56]. All studies in thereview contained a stress-management component. In eight of the studies that explicitlyreported attendance rates, most reported that participants attended more than 60% of thescheduled sessions.

The 24-month retention rate in ¡Viva Bien! was lower than in the MLP (61.4% in ¡VivaBien! vs. 85.3% in the MLP). There are few studies with which to compare the ¡Viva Bien!retention rates directly (i.e., multiple-risk-factor programs with Latinas having type 2diabetes, at 24-month followup). Somewhat comparable studies report retention ratesranging from 56% to 100%, although mostly for much shorter follow-up times (with anotable exception [57]). Silberman et al. [58] reported that 78.1% of the participantsremained enrolled in the program at the end of 1 year. In the Angermayr et al. review [56],the proportion of participants terminating study interventions prematurely varied from 0% to44%, depending on length of follow-up. At 24 months in the Diabetes Prevention Program

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Outcome Study [57], 81% of participants were still enrolled. In a program by Eakin et al.[59] targeting urban Latinos with multiple chronic conditions, the retention rate at 6 monthswas 81%. However, this intervention was much lower in intensity than either the MLP or¡Viva Bien!. A dietary intervention targeting Latinas [60] found that at 12 months 79% ofthe original 357 study participants were available for follow-up analyses. Brown, Garcia,Kouzekanani, and Hanis [61] reported a 12-month retention rate of 90% in their studyinvolving a culturally competent lifestyle intervention targeting Mexican- Americans withtype 2 diabetes. Poston et al. [62] reported a 12-month retention rate of 66% in a study of108 Mexican-American women testing a culturally tailored lifestyle modificationintervention.

¡Viva Bien! employed a number of methods to maximize attendance and retention. Theseincluded family member involvement, expert presentations, practical, and relevant skill-based intervention components, friendly competitions, and active involvement. Socialconnection with staff and peers was strongly encouraged. Staff and peers made phone callsand sent cards to participants who missed sessions. Health benefits experienced in theprogram also exerted a strong influence to remain in the study. Transportation barriers wereminimized by the provision of taxi service and by locating meetings in convenientcommunity settings. Of those giving a reason for non-attendance, the most frequent wasillness (9.9%), followed by work-related conflicts (4.5%), being on vacation (4.2%), orhaving a social conflict (3.7%). Anecdotal evidence from exit interviews suggested that asthe in-person intervention sessions faded, intervention condition participants felt adiminished responsibility to themselves and to the program. Future studies in this populationmight improve adherence/retention by introducing maintenance strategies from thebeginning of the program, maintaining the level of intensity throughout the interventionperiod and offering greater incentives for follow-up assessment participation.

Despite missing data arising from attrition, results of generalized estimating equationanalyses using complete-case and imputed data were similar. ¡Viva Bien! participantscompared with usual care significantly improved by the 6-month follow-up on thepsychosocial measures of problem solving, selfefficacy, and perceived support, and thesegains were maintained at 12- and 24-month follow-ups. Between-condition effects werefound across 24 months on dietary patterns (percent calories from saturated fat) and use ofsocial–environmental resources to support chronic disease self-management. Improvementsin stress management and days per week exercised were sustained by ¡Viva Bien!participants; however, there were improvements in these factors by usual care participantsby the end of 24 months as well, thus diminishing the longitudinal intervention effect.Effects of ¡Viva Bien! on biological outcomes were initially promising. These effects werenot maintained, however, as participants in both conditions approached baseline levels by 24months.

Although the treatment condition improved across the 24-month intervention, the challengein sustaining physical activity is well documented [63, 64], and sustaining stressmanagement over long periods is virtually undocumented. For behaviors that are notcurrently part of daily living, such as physical activity or stress management (as opposed toeating) to become habitual, it may be that the intervention must address not only individualbehaviors, but also the home, neighborhood, job, and social environments, which mayincrease stress and promote sedentary lifestyles. While these environments may alsoencourage unhealthful eating, it is possible that changing eating habits (e.g., modifying foodpreparation techniques to reduce saturated fat) requires less effort to sustain, once mastered,than a daily walk or stress-management practices [65]. Recent evidence suggests that peoplewith diabetes experience greater perceived exertion than those without diabetes,necessitating greater motivational and supportive resources than the general population to

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maintain physical activity [66]. And, in general, participation in regular physical activityamong Hispanics tends to be lower than in non- Hispanic whites [67]. Thus, an ecologicalapproach that includes personal, intrapersonal, organizational, and environment/policychanges to support healthful lifestyles, particularly among populations with increased riskand disproportionate burden for chronic conditions such as diabetes, may be required forsustained change in multiple health behaviors.

This practical trial has both methodological strengths and weaknesses, as well asimplications for practice, policy, and research [68, 69]. Strengths include an interventionthat addressed a multiple-risk-factor problem with a previously tested multiple-behavior-change intervention, cultural adaptation for a Latina population, a reasonably large anddiverse Latina sample, use of multiple measures, multiple imputation procedures forhandling missing data, and generalized estimating equation analyses across 24 months.

A possible limitation of our study was the use of primarily self-report measures forbehavioral outcomes. Most of these measures have been validated against more objectivestandards in previous studies, but it is not known whether possible self-reportinginaccuracies influenced the observed results. The correlation (r=0.34) in this study betweenthe Modified International Physical Activity Questionnaire and accelerometer data, thoughmoderate, is similar to findings of other studies correlating self-reports of activity and moreobjective indicators (e.g., our study [70] correlating 7-day pedometer step counts 0.31 with a7-day diary physical activity in a sample of older women). Such results suggest that the twomodes of physical activity measurement (self-report and pedometer/accelerometers) provideboth common and unique information. Another limitation was that the comprehensivelifestyle intervention cannot be easily disentangled to understand the contribution of discreteelements. The efficacy of the core components of the lifestyle intervention (diet, physicalactivity, stress management, and social support) have been well established in the literature;less understood is how they work in concert.

Future DirectionsThe short-term effectiveness of multibehavioral interventions, such as ¡Viva Bien!, isencouraging, but the inability of behavioral interventions to sustain behavior change orimprovements in biologic or quality-of-life outcomes over time continues to be a challenge[71]. More research is needed to develop and test novel and cost-effective interventions thatcan sustain the motivation and support needed to accomplish successful, lifelong diabetesself-management. Research that investigates characteristics of social and physicalenvironments associated with sustaining multiple-health-behavior change is sorely needed[72].

The ¡Viva Bien! program succeeded in changing multiple key health behaviors. As contactfaded after 6 months, so did the intervention effects. For people with chronic conditions,maintenance interventions that provide ongoing social, motivational, and problem-solvingsupport may be as important as addressing long-term medication adherence. Suchinterventions may be best delivered through community organizations (e.g., faith-based,worksites, schools), neighborhoods (e.g., infrastructures that support activity; neighborhoodgroups that support norms for health), and technology (e.g., phone, social media, internet).

AcknowledgmentsWe acknowledge the invaluable contributions of the assessment and intervention staffs of the ¡Viva Bien! project,including Cristy Geno Rasmussen, Alyssa Doty, Fabio Almeida, Sara Hoerlein, Carmen Martin, Angela Casola,Eve Halterman, and Breanne A. Griffin. We are deeply indebted to the 280 dedicated and committed women whoparticipated in the study.

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Funding disclosure: This research was supported by grant number R01- HL077120 from the National Heart, Lung,and Blood Institute.

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Appendix

Cultural adaptations of ¡Viva Bien! intervention components1. Intervention Component: Initial 2½-Day Retreat

The kickoff retreat started the program and built camaraderie between participants and staff.The retreat consisted of introductions and practice of all ¡Viva Bien! program pieces:

Mediterranean diet meals (catered)

Physical activity (aerobic and strength training)

Stress management

Social support groups

Smoking cessation

Cultural Adaptations—The Mediterranean Diet was adapted to the tastes of the Latinoculture (see below). Bilingual staff gave presentations in English and Spanish. English andSpanish PowerPoint slide shows and program pamphlets were provided, illustrated withphotographs of Latina women.

2. Intervention Component: MeetingsWeekly 4-h meetings were held for the first 6 months. Meetings were bimonthly for months7–12 and further tapered from months 12–24. Meetings featured of 1 h each of:

Mediterranean diet (potluck)

Physical activity

Stress management

Social support groups

Cultural Adaptations—After 6 months, family nights were added to involve familymembers in participants’ activities and to celebrate their achievements. Family Nights wereintended to increase the families’ support for participants’ intervention engagement. At thesuggestion of participants who wanted to ask questions they were unable to ask theirpersonal health care providers, we added presentations and question–answer sessions withthe project’s Latino physician.

3. Intervention Component: Mediterranean DietParticipants were encouraged to follow the Mediterranean diet emphasizing vegetables,fruits, legumes, nuts, cereals, olive oil, limited animal fat, and portion control.

Cultural Adaptations—Latin American recipes were altered by the Latina projectdietitian to conform to the ¡Viva Bien! diet. The goal was to lower the fat and calories whilemaintaining flavor with traditional ingredients and spices. Latinas represent a diverse group,and there is no typical “Latino diet,” so recipes from specific Latin American countries weremodified using common staples. In this way, the program covered the wide range of ethnicLatin American foods. Potluck dinners were key to the diet component. The Latina dietitianconducted cooking demonstrations to show new methods for preparing typical foods.Participants were shown how to modify their favorite recipes by incorporating the principlesof the Mediterranean diet into their usual foods. Attention was paid to acceptance andsupport from family members who might benefit from dietary changes. To help participants

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follow the diet, colorful pamphlets were created in English and Spanish and includedphotographs of common Latino foods and Latina women.

4. Intervention Component: Physical ActivityThe program recommended 30 min of moderate aerobic activity most days per week and theperformance of ten strength-training exercises two times per week.

Cultural Adaptations—At physical activity sessions during the retreat and meetings,participants could choose to walk outside or follow a trained instructor in an aerobics classled in both English and Spanish, with Latin (for example, salsa) style steps and music. Thus,women could determine for themselves which physical activities were culturallyappropriate. Colorful pamphlets, available in English and Spanish, were created to supportthe physical activity component. The pamphlets included photographs of Latina women.Take-home exercise DVDs/CDs available in English and Spanish also were created for theprogram.

5. Intervention Component Stress ManagementParticipants were encouraged to practice stress-management techniques for at least 1 h perday, consisting of: 20 min of yoga stretches, 15 min of progressive deep relaxation, 15 minof meditation, and 5 min of directed or receptive imagery.

Cultural Adaptations—Take-home stress-management CDs were created for the programin English and Spanish. The research team considered adapting the stress-managementcomponent out of concern that yoga and meditation practices may be seen as religiousactivities incongruent with Latina participants’ cultural experiences. But, focus groupparticipants did not raise objections, and the yoga and meditation components were retained.

6. Intervention Component: Social SupportGroup support constituted 1 h at each meeting. Support group sessions included structuredmini units (for example, pleasant activities, goal setting, social support, problem solving,negative thoughts) and less-structured “check-in” sessions so that participants could discusssuccesses and barriers to making lifestyle changes.

Cultural Adaptations—Participants were offered groups conducted primarily in Englishor Spanish to accommodate language preferences. Because the support-group structure wasflexible, participants could choose topics that were culturally appropriate and personallyrelevant. Handout materials were available in English or Spanish.

7. Intervention Component: Smoking CessationParticipants who used tobacco were encouraged to set a quit date and stop.

Cultural Adaptations—To help participants stop smoking, colorful pamphlets werecreated for the program in English and Spanish and featuring Latina women. Smokingcessation sessions were led by a bilingual facilitator.

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Fig. 1.CONSORT diagram of ¡Viva Bien! study participation

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Tabl

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Toobert et al. Page 18

Tabl

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Tabl

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es a

t 6, 1

2, a

nd 2

4 m

onth

s (es

timat

ed m

eans

and

SEs

[n=2

80])

Bas

elin

e6

Mon

ths

12 M

onth

s24

Mon

ths

Con

d χ2

Tim

e χ2

C ×

T χ

2M

SEM

SEM

SEM

SE

Bod

y m

ass i

ndex

8.9*

7.2a

3.8a

Usu

al c

are

33.0

0.58

32.1

0.58

32.6

0.57

32.5

0.62

¡Viv

a Bi

en!

35.4

0.58

34.6

0.59

34.3

0.62

35.0

0.62

Effe

ct si

ze0.

430.

290.

40

Hem

oglo

bin

A1c

(%)c

0.03

4.2b

19.1

*

Usu

al c

are

8.4

0.02

8.4

0.03

7.8

0.02

7.8

0.03

¡Viv

a Bi

en!

8.4

0.03

7.8

0.03

8.4

0.03

8.4

0.03

Effe

ct si

ze0.

330.

400.

33

UK

PDS

CH

D 1

0-ye

ar ri

sk sc

orec

1.3

10.5

*4.

3

Usu

al c

are

9.6

0.01

9.0

0.01

9.0

0.01

9.0

0.01

¡Viv

a Bi

en!

9.0

0.01

7.8

0.01

9.0

0.01

7.8

0.01

Effe

ct si

ze0.

20N

o di

ff0.

20

Bas

ed o

n ge

nera

lized

est

imat

ing

equa

tions

ana

lysi

s res

ults

, cov

aryi

ng w

ave

and

age

at b

asel

ine.

DF(

cond

ition

)=1;

DF(

time)

and

DF(

cond

ition

×tim

e)=3

* Sign

ifica

nt a

t p<0

.05

or le

ss

a Sign

ifica

nt ti

me

mai

n ef

fect

and

con

ditio

n×tim

e in

tera

ctiv

e ef

fect

wer

e fo

und

for b

ody

mas

s ind

ex in

com

plet

e-ca

se a

naly

sis

b A si

gnifi

cant

tim

e m

ain

effe

ct w

as fo

und

for h

emog

lobi

n A

1c in

com

plet

e-ca

se a

naly

sis

c Hem

oglo

bin

A1c

and

the

Uni

ted

Kin

gdom

Pro

spec

tive

Dia

bete

s Stu

dy c

oron

ary

hear

t dis

ease

risk

scor

e w

ere

squa

re-r

oot t

rans

form

ed fo

r ana

lysi

s, bu

t rev

erse

-tran

sfor

med

her

e fo

r eas

e of

inte

rpre

tatio

n

Transl Behav Med. Author manuscript; available in PMC 2011 October 19.