Introduction and Background
A 3-month pilot study with 12 participants was conducted as a preliminary test of cultural adaptation procedures. The pilot also provided an opportunity to collect (a) reactions from staff and participants on the engagement and intervention procedures, and (b) suggestions about elements to add or change to increase cultural fit. Secondarily, the study design allowed for crude tests of pre-post change on a variety of measures and for satisfaction ratings. The statistical significance of pre-post change on specific measures was not the primary interest. We were interested, however, in determining whether the data generally indicated that participants were implementing intervention procedures and showing expected changes on outcome and mediating variables. Feedback from staff and participants during the course of the pilot led to several valuable additions to the original intervention procedures.
Potential participants for the pilot program were identified using the procedures described for the focus groups. To recruit 12 participants for the pilot study, 201 recruitment letters were mailed, of which 44 (22%) declined via return postcard. A total of 157 recruitment telephone calls were attempted; 75 were successful. Of those assessed for eligibility, 43 were ineligible (primarily non-Latinas) and 8 were eligible but declined (mostly because of lack of time and transportation). Twenty-four women agreed to participate, 16 completed baseline assessment, 13 attended the retreat, and 12 completed the 3-month post-intervention assessment. The original recruitment target for the pilot was 20. Recruitment trends differed somewhat between the ¡Viva Bien! pilot and the MLP from which it was adapted. Although about the same proportion of calls was attempted from the original mailing list in the two studies (78% in ¡Viva Bien! vs. 84% in MLP), fewer of the calls in ¡Viva Bien! were successful (48% in ¡Viva Bien! vs. 87% in MLP) and, of those reached, fewer in ¡Viva Bien! were eligible (43% in ¡Viva Bien! vs. 64% in MLP), in most cases (58%) because women did not identify themselves as Latinas. Of women who were eligible, about 50% participated in the pilot (16/32), similar to the 51% participation rate in the MLP (279/544).
Both quantitative and qualitative data were gathered throughout the pilot to evaluate cultural adaptation of the program. Demographic (e.g., language preference, ethnicity, age, education, income, marital and smoking status, diabetes medications, self-reported height and weight), physiologic (e.g., blood pressure, HbA1c, coronary risk panel, staff-measured height and weight), behavioral (e.g., 7-day self monitoring of targeted behaviors, International Physical Activity Questionnaire), and psychosocial (e.g., supportive resources, depression) measures were collected at baseline and immediately following the abbreviated intervention at 3 months. More than 76 measures were examined in the pilot study, including fiber intake and saturated fat intake from the Food Frequency Questionnaire (Patterson et al., 1999
), body mass index, social support for diet and exercise from the Chronic Illness Resources Survey (Glasgow, Strycker, Toobert, & Eakin, 2000
), and problem-solving ability from the Diabetes Problem Solving Interview (Glasgow et al., 2004
). Measures of attendance and program satisfaction also were used.
For the most part, the ¡Viva Bien! intervention was delivered to participants in the pilot study as adapted from the MLP in stage 2. However, the program was expanded during the pilot to respond to participants’ requests for: (a) additional family involvement, (b) additional cooking demonstrations, and (c) additional physician demonstrations. Changes were as follows:
- Additional family involvement. During support group sessions, we learned that women wanted their family members to be better informed about the ¡Viva Bien! intervention to more fully support their lifestyle changes. Subsequently, we added a “Family Night” so that family members could join participants during the social support group portion of the meeting, hear an overview of ¡Viva Bien! activities, and exchange questions and answers. Families were also invited to a final celebratory meeting at the end of the 3-month program. The involvement of Latino families in the intervention is consistent with familismo or familism, one of the most fundamental cultural values for Latinos and one that is not specific to a particular Latino nationality (Almeida, Molnar, Kawachi, & Subramanian, 2009).
- Additional cooking demonstrations. During the adaptation planning, we did not anticipate how much participants would value cooking demonstrations by the project’s Latina dietitian. The adaptation of the Mediterranean diet utilized foods and preparation methods that were familiar to participants as well as some that were not (e.g., certain types of seafood, grilling vegetables). The dietitian paid close attention to allaying women’s fears about preparing new foods by showing simple and fast alternative methods for cooking lower-saturated-fat meals.
- Additional physician presentations. During support group meetings, the participants repeatedly expressed a desire to learn more about diabetes causes, treatments, and complications. Therefore, diabetes group education sessions were initiated and conducted regularly by the study physician.
Descriptive statistics were computed on baseline and 3-month survey and physiologic data, as well as implementation and process measures, to understand the nature of the data and describe the sample. The pilot study was not designed to evaluate outcomes with traditional statistical tests; however, as an exploratory tool, the conservative, nonparametric Wilcoxon rank-sum matched-pairs test was used to analyze differences in outcome measures from baseline to 3 months. Together with qualitative data, the quantitative data were useful in evaluating recruitment procedures, participant engagement, and effectiveness of the adapted program.
A consistent pattern of improvement was found across the complete set of outcomes with 70 of the 76 outcomes tested indicating improvement from baseline to 3 months. The binomial probability of returning 70/76 positive results is quite low, p < .00001. It was particularly encouraging to observe significant pre-post change on our primary outcomes and putative mediators: grams of total fiber (pre=15.90, post=21.90, p=.04) and grams of saturated fat (pre=18.70, post=9.45, p=.01), body mass index (pre=34.66 kg/m2, post=33.17 kg/m2, p=.004), social support for diet (pre=3.08, post=3.98, p=.002) and exercise (pre=3.27, post=3.98, p=.01), and rated quality of problem-solving strategies (pre=3.70, post=4.31, p=.01).
Two important process measures were attendance and satisfaction. Attendance at the retreat was 92% the first two days and 100% the third day. Weekly meeting attendance averaged 89% over the 3 months, ranging from 67% to 100% per meeting. Arriving late for the weekly meeting was fairly common, with an average 22% arriving more than 30 minutes late across the 3-month period, generally due to employment demands or family obligations. Regarding program satisfaction, all (100%) of the women said they liked each day of the retreat “a lot”; 91% said they liked the weekly meetings “a lot.”
We planned for the collection of staff and participant reactions during the course of the pilot, but did not anticipate how valuable that feedback would be. Although support group meetings were not intended to be primary vehicles for delivering information about adaptations, they proved to be particularly helpful in gauging what Latina participants liked, what they perceived as barriers, and what additional resources they needed. Additions to social support groups, and added contact with the dietitian and physician resulted directly from that feedback. Our fears that participants might object to meditation and yoga on cultural or religious grounds proved to be unfounded. In general, pre-post data showed that participants were making changes in the desired directions on most outcome measures, despite the fact that the 3-month pilot intervention was only a fraction of the duration of the intervention planned for the main study.