The BFBW program was successful at reaching and helping patients with low income, high risk, and from predominantly African-American obese community health center to stay engaged with a program to improve health-promoting behaviors, make modest reductions in blood pressure and less so in weight, and to maintain these gains for at least 24 months. However, lower income and Spanish-speaking patients were less engaged in the intervention and that the program was not sustained at any of the participating clinics. As described in more detail in the main outcome study, this is one of the few weight loss programs designed specifically for low-income African-Americans and Latinos facing such challenging socioeconomic conditions to produce encouraging, albeit modest, long-term results [10
The purpose of this article was to describe the use of the RE-AIM model to help design and evaluate this intervention. There are likely multiple reasons for the recruitment, adoption, implementation, and success of BFBW (and the mixed maintenance success—good at the patient level, poor at the setting level), but we conclude that factors related to RE-AIM issues such as designing a program with the input of key stakeholders and placing minimal burden on the primary care providers (both addressing adoption); that was attractive and accessible to patients and did not require much travel or extra visits (reach); and that had user-friendly interfaces, patient choice of tracking modalities, and community health workers to provide ongoing support and prompts (implementation and maintenance) were at least partially responsible. To address setting-level maintenance challenges, from a RE-AIM perspective, we might recommend actions including ensuring that the program is aligned with clinic mission, exploring the fit with new health policy changes such as the enhanced community health workforce to have ongoing responsibility, and advocacy to make the reimbursement policies worth the time of clinics to invest in obesity prevention and treatment.
We further speculate that other keys to success were likely “designing for dissemination” [4
] at the outset and the focus on keeping both time and resource demands on an already overworked and underfunded community health center staff low [22
]. Compatible with pragmatic and adaptive trials [7
], we also made adjustments during the study to enhance recruitment, keep the website and IVR components novel, respond to participants’ concerns, and maintain a high level of intervention engagement.
RE-AIM analyses of the percent and representativeness of results at multiple levels and across different outcomes, including reach, adoption, effectiveness, implementation and maintenance generally revealed robust results, with modest differences across patient characteristics. These results are encouraging and tentatively suggest that BFBW may have broad appeal to a relatively wide range of community health centers and patients, and are of at least modest benefit even to high-risk patients. A separate publication documented that the BFBW study was significantly more pragmatic than other POWER weight loss studies funded under the same grant mechanism [18
The BFBW program was not uniformly successful and could likely be improved and further adapted to fit different settings and populations to make it more effective and generalizable. For example, the group meetings were poorly attended, eventually discontinued, and likely did not add much to the intervention effectiveness. Magnitude of weight loss that was not clinically significant might be increased by increasing program intensity or contacts. Despite use of local community health workers, there were implementation differences by income and preferred language. Lower-income and Spanish-speaking participants were less engaged than others despite considerable efforts to make the intervention culturally and contextually appropriate. One possible reason for the discrepancies in call completion among the lowest-income participants could be that they had less consistent access to telephones and could not afford the costs of the calls. At 24-month follow-up, questions of economic hardship were assessed, including phone disconnections. Approximately 20 % of the participants at follow-up indicated that their phone line had been disconnected at least once within the 2-year study period. It is possible that either use of text messaging or expanding the intervention to more directly address fundamental determinants of health (e.g., housing, food insecurity, racism) would help to reduce these implementation subgroup differences.
Similarly, lessons learned during recruitment could be applied, and alternative strategies, such as recruiting from a weight loss registry or directly from primary care visits, would likely reduce recruitment costs substantially. The site differences in results in multi-site studies are not unusual; however, many studies do not report on-site differences. This is a feature that we would recommend and think would enhance the transparency of reporting. For this study, we speculate that differences across sites were attributable to multiple factors. Administrative issues may have impacted the variance as recruitment at site 2 began 1–2 months before sites 1 and 3. Therefore, more individuals were assessed for eligibility at site 2, so while there were a larger number of refusals, there was not necessarily a higher rate of refusal. Additionally, language barriers may have resulted in some of the discrepancies. Site 3 had the highest percentage of Spanish speakers, and the materials were not translated into Spanish until about 4–5 months after recruitment started at site 2, therefore limiting the number of Spanish-speaking participants from that site. Additionally, site 1 had a number of ineligible participants due to language as that center has a large Cape Verdean clientele.
This study must be interpreted in context. Over the past 30 years, economic inequality has grown, and the divide between the rich and poor has deepened [24
]. Growing economic inequality leads to worse health outcomes [25
]. These problems are exacerbated by a poor health environment and an overstretched primary care system that is unable to recover from decades of underinvestment in fundamental health care and prevention. The Affordable Care Act [26
], as its provisions take effect, promises to increase access to health care for many, but it faces a host of challenges in the coming years.
Within this challenging context, BFBW [10
] attempted to engage the poor and underserved in healthy eating, physical activity, and blood pressure control mediated through support of healthy behaviors and enhanced interactions with their primary care clinic. We used RE-AIM as well as experience working in low-income settings to design and evaluate the BFBW intervention for community health centers. This focus on those most in need stands in contrast to many studies that (often unintentionally) exclude the most vulnerable because they cannot be reached at the outset, devote considerable time and resources, and/or face substantial barriers to access of needed resources. The studies closest in scope to ours focused on community health center or low-income-setting-based studies that explicitly recruited low income, largely African-American or Latino samples for weight loss interventions that we could locate, were by Clark et al. [27
], Samuel-Hodge et al. [28
], and Ockene et al. [29
]. All three studies used in person rather than electronic interventions. The study of Clark et al. reported challenges with reach and implementation with 16 % of those eligible having intervention contact but only 2 % having ten or more contacts, which they found necessary for significant weight loss. The study of Samuel-Hodge et al. [28
] reported larger weight losses but did not report on reach. Samuel-Hodge et al. [23
] have, however, recently reported initial recruitment results from a follow-up study conducted in county health departments that demonstrated high reach and adoption by health department, but weight loss data have not yet been reported. Finally, Ockene et al. [29
] recently reported results from a low-cost version of the Diabetes Prevention Program tailored for low-income Latino populations that was moderately successful at producing weight loss (2.5 lbs over 12 months) but also reported challenges with group meeting attendance.
This study has both limitations and strengths. Limitations include the fact that BFBW results are undoubtedly due to many factors, and we did not experimentally evaluate the use of RE-AIM vs. other implementation models to guide intervention and evaluation. Other limitations are that our conclusions must be limited to the types of community health centers and patient populations studied, the relatively small number of health centers, the moderate patient sample size, the limited magnitude of weight loss, and that the intervention was not continued after the study. Finally, the most important outcomes, namely factors such as long-term cost-effectiveness and levels of adoption and successful implementation by other settings, will not be available for several years, although initial cost-effectiveness results are shared elsewhere [22
]. Strengths include the high-risk, diverse, and largely African-American sample studied, the multiple, low-resource urban community health center settings, the pragmatic intervention and study design, the 24-month evaluation period, the general robustness of results across multiple RE-AIM dimensions, and the systematic use of an implementation science framework such as RE-AIM for intervention planning and evaluation.
In conclusion, RE-AIM can be applied as a framework to help plan and analyze interventions to address health inequities. Further research using and comparing different implementation science models, with greater use of cost and economic analyses, and pragmatic research on interventions for low-income African-American and other underserved populations in low-resource service settings is clearly needed to address pressing health equity issues.