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Methods: A community prevention model was employed in planning and implementing this study. A longitudinal randomized controlled trial was conducted to evaluate the effects of a culturally tailored LSBI with a comparable length control condition (Disaster Preparedness and Home Safety). Both conditions were delivered in Spanish by separate teams of specially trained CHWs, commonly known in other parts of the world as lay health advisors or village workers and called “promotoras” in Latino communities in the U.S. These promotoras were culturally and linguistically similar to the participants in the study, had a high school diploma or equivalent, 4 or more years of employment as a CHW, and either lived in or had extensive work experience in the community where the study was implemented. The bilingual (Spanish-English) promotoras (n=6) assigned to the LSBI received extensive training to foster understanding of the intervention and to promote program fidelity (e.g., correct use of curriculum manual and protocol-defined content). The sample, recruited from community settings in Southern California, was composed of 223 low-income, immigrant Latino women between 35-64 years of age (mean=45 years) who faced risk for cardiovascular disease, diabetes, and other chronic diseases due to being overweight/obese. Participants were mainly of Mexican descent (85%) and had low education and acculturation levels; 111 women were randomly assigned to the LSBI. The LSBI was comprised of eight weekly 2-hour group education classes based upon an adaptation of Su Corazón Su Vida (Your Heart, Your Life) (National Heart, Lung, and Blood Institute, 2008), a curriculum designed for use by promotoras working with Latinas. Following completion of the classes, Individual Teaching and Coaching (ITC) was provided over the course of 4 months, including four home visits and four telephone calls. The ITC was designed to reinforce content presented in classes and to address women’s individual needs in adopting and maintaining healthy lifestyle behaviors. Key messages of the LSBI were healthy food choices, portion control, handling emotional eating, and increasing physical activity. Within these areas topics such as preparation of food, cooking, healthy shopping, and reading food labels were addressed. Women were instructed on use of self-monitoring tools that were provided to them (i.e. measuring cups, food diaries, pedometers for displaying steps walked, physical activity logs, an exercise DVD, and a hunger scale to help distinguish hunger from emotional eating. A case management approach was used with women assigned to the care of specific promotoras. Documentation forms were given to promotoras for recording of implementation of ITC activities (study protocols) with participants; e.g., delivery of key messages and discussions related to self-monitoring tools. Outcome variables were evaluated at 6 and 9 months and compared with baseline data to determine effects of the LSBI on lifestyle behaviors (dietary habits and selected clinical measures [weight, lipids, blood pressure, glucose level]). Previously reported findings showed that women in the LSBI improved significantly in dietary habits (F[2,262]=4.99, p=.007), waist circumference (3 cm decrease, p=.041), and physical activity (t[201]=1.99, p=.048) in comparison to those in the control group (Author, et al., 2015). To further understand these outcomes a process evaluation was conducted examining program implementation of the LSBI by the promotoras. i.e., class attendance, quantity of the ITC delivered, and activities conducted during the home visits and telephone calls. The evaluation questionnaire completed by women included a question about satisfaction with the teaching and coaching component of the LSBI. Data were obtained from a computer-based system that recorded entries from class attendance records and specific dates that ITC components were delivered (home visits and telephone calls) for all women in the LSBI (n=111). The detailed analyses of the ITC activities conducted during home visits and telephone calls were based upon chart reviews for a subsample of women (n=66) A specially trained research assistant performed content analysis of the data for each participant. Three documents were provided to promotoras for record keeping: 1) a checklist of activities, 2) an assessment guide; and 3) narrative note forms. Fifty-six charts (84.8%) contained all three documents, whereas the first two forms only were included in 3 (4.5%) charts. One promotora used narrative notes only to document activities during home visits with her assigned women (n=7, 10.6%) and did not maintain notes on her telephone calls. Process evaluation data were analyzed with descriptive statistics (means, standard deviations [SD], frequencies, and percents) and Pearson correlation.
Results: Women (n=66) in the subsample for the chart reviews were very similar to those in the previously described larger sample of the study. They had a mean age of 44.2 years (SD=7.8), were predominantly born in Mexico (81.8%) and were married or living with a partner (71.2%); the majority had 8th grade or less education (51.6%). Analysis of the computer-generated data showed that of the 111 women receiving the LSBI, 42 (37.8%) attended all eight classes and 91 (82%) attended at least half of the classes. All home visits and telephone calls were received by 86 (77.4%) and 93 (83.8%) women, respectively, per protocols. Review of the 66 charts similarly showed that the large majority of women (n=59, 89.4%) received the 4 home visits. Although most home visits (76%) were implemented in the home as planned, 21.1% were conducted at “other” sites, most often McDonald’s Restaurant and, in some cases, the local church or family members’ homes. Other community settings and parks were also used as meeting places (2.9%). Further review of documentation by promotoras showed that for 53 women (80.3%), key messages related to all six areas of teaching/coaching were covered during home visits, and an additional 10 women (15.2%) received key messages related to five intervention topics. At least four of the six teaching/coaching areas were implemented with all women during the home visits. Similarly at least four of the six self-monitoring tools were discussed during home visits. All six self-monitoring tools were addressed with 53 women (80.3%). The most frequently talked about tools during the course of home visits were the food diaries, pedometers, hunger scales, physical activity logs, and exercise DVDs (100% to 95.4%, respectively). The implementation of planned key messages (study protocols) was more varied for the telephone component of the ITC, ranging from all 5 planned messages (n=50 women, 75.8%) to no message areas (n=10, 15.1%). Shopping for healthy foods, weight loss, and physical activity were most frequently discussed during telephone calls. Positive correlations were found between the number of home visit interventions (key messages) delivered and discussion of self-monitoring tools (r=.26, p=.035) and telephone call interventions (r=.59, p<.001). Six-month evaluation data collected on 58 women in the subsample showed that 14 (24.1%) were satisfied and 41 (70.7%) were very satisfied with the ITC part of the study.
Conclusion: The high rate of attendance for classes and participation in the ITC support the effectiveness of the promotora model of care as evidenced by acceptance among the Latino women. Review of the documentation indicates that the large majority of intervention topics/key messages were addressed and use of self-monitoring tools were discussed at some time during the home visits and/or telephone calls, with evidence suggesting that home visits may be more effective than telephone calls for delivery of intended protocols. Correlational findings also indicate that implementation of key messages is more highly related to home visits than telephone calls. The findings on specific activities implemented during the ITC are limited to documentation provided in the charts maintained by promotoras for a subsample of women. The data were not validated by direct observation of activities, and there was variation among promotoras in the scope of details recorded. Further, we are unable to make conclusions about activities that may have been conducted but not described in the records. Our findings lead to recommendations for more extensive training in documentation and regular review of records at staff meetings with promotoras. These strategies may enhance the richness of details in records of specific activities.
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