Response: Re: A Lifestyle Intervention Study in Patients with Diabetes or Impaired Glucose Tolerance: Translation of a Research Intervention Into Practice

To the Editor: We appreciate the interest and comments from Ms. Williams¹ regarding our research article.² She expressed some concern about our adaptation of the Diabetes Prevention Program (DPP)³ for a study group that included patients with prediabetes and diabetes. Unlike the Diabetes Prevention Program study, we enrolled patients with diabetes. However, for those patients, enrollment was limited to individuals who were in the early stages of diabetes (diagnosis within the past 5 years) and who had never used insulin. Although including both types of patients somewhat increased the heterogeneity of the study group, we felt that doing so would not unduly compromise the objectives of the study.

It is correctly noted that differences in pharmacotherapy regimens for patients with diabetes can influence patient weight. Five participants started or discontinued a diabetes medication during the study. We believe these changes probably had a minor effect on our overall observed anthropometric differences. These and other medication changes that occurred during the evaluation period were summarized.

Although our study was conducted on a university campus, it could have been implemented in any community setting with office space available for meeting with participants. We did not use any special equipment or resources that are unique to the academic setting. Our educational sessions consisted of one-on-one discussion with our participants and periodic assessment of outcomes, including anthropometric measurements and questionnaires. Perhaps the only advantage of having our participants come to campus was that they had access to a fitness area in our building, which we used to conduct cardiovascular fitness assessments and carry out personal physical activity sections to help our participants get started with an exercise program. The majority of our participants chose walking (on a treadmill or track) as their exercise mode and thus did not use any special exercise equipment. We should, however, point out that our campus may be somewhat different from traditional academic settings. Most notably, our university does not contain an academic medical center. It is small (13,000 students) and easily accessible to the public. Thus, we consider our campus a “real-world” setting, although we realize that this may not be the case for larger universities.

Translational research studies are a relatively new area of investigation, and the optimal design for these types of studies still requires clarification. Translation of original research into the community setting using exactly the same format may not always be possible or practical. For example, studies that evaluate therapies on disease incidence or progression are usually longitudinal and use a large sample size. This design is not feasible for many practitioners and small communities. Does this mean that findings from large-scale studies should not be translated unless the conditions of the original study are reproduced? We agree with the reader that “researchers must be mindful of the intent of the original research.” However, we also believe that there should be some flexibility in how findings are translated depending on individual community needs and resources.