Development of a 5As-based technology-assisted weight management intervention for veterans in primary care.

BACKGROUND: Obesity is a worldwide epidemic, and its prevalence is higher among Veterans in the United States. Based on our prior research, primary care teams at a Veterans Affairs (VA) hospital do not feel well-equipped to deliver effective weight management counseling and often lack sufficient time. Further, effective and intensive lifestyle-based weight management programs (e.g. VA MOVE! program) are underutilized despite implementation of systematic screening and referral at all VA sites. The 5As behavior change model (Assess, Advise, Agree, Assist, Arrange) is endorsed by the United States Preventive Service Task Force for use in counseling patients about weight management in primary care and reimbursed by Medicare. In this paper, we describe the iterative development of a technology-assisted intervention designed to provide primary care-based 5As counseling within Patient-Centered Medical Homes without overburdening providers/healthcare teams. METHODS: Thematic analyses of prior formative work (focus groups with patients [n = 54] and key informant interviews with staff [n = 25]) helped to create a technology-assisted, health coaching intervention called Goals for Eating and Moving (GEM). To further develop the intervention, we then conducted two rounds of testing with previous formative study participants (n = 5 for Round 1, n = 5 for Round 2). Each session included usability testing of prototypes of the online GEM tool, pilot testing of 5As counseling by a Health Coach, and a post-session open-ended interview. RESULTS: Three main themes emerged from usability data analyses: participants' emotional responses, tool language, and health literacy. Findings from both rounds of usability testing, pilot testing, as well as the open-ended interview data, were used to finalize protocols for the full intervention in the clinic setting to be conducted with Version 3 of the GEM tool. CONCLUSIONS: The use of qualitative research methods and user-centered design approaches enabled timely detection of salient issues to make iterative improvements to the intervention. Future studies will determine whether this intervention can increase enrollment in intensive weight management programs and promote clinically meaningful weight loss in both Veterans and in other patient populations and health systems.

Immunization of malignant melanoma patients with full-length NY-ESO-1 protein using TLR7 agonist imiquimod as vaccine adjuvant.

T cell-mediated immunity to microbes and to cancer can be enhanced by the activation of dendritic cells (DCs) via TLRs. In this study, we evaluated the safety and feasibility of topical imiquimod, a TLR7 agonist, in a series of vaccinations against the cancer/testis Ag NY-ESO-1 in patients with malignant melanoma. Recombinant, full-length NY-ESO-1 protein was administered intradermally into imiquimod preconditioned sites followed by additional topical applications of imiquimod. The regimen was very well tolerated with only mild and transient local reactions and constitutional symptoms. Secondarily, we examined the systemic immune response induced by the imiquimod/NY-ESO-1 combination, and show that it elicited both humoral and cellular responses in a significant fraction of patients. Skin biopsies were assessed for imiquimod's in situ immunomodulatory effects. Compared with untreated skin, topical imiquimod induced dermal mononuclear cell infiltrates in all patients composed primarily of T cells, monocytes, macrophages, myeloid DCs, NK cells, and, to a lesser extent, plasmacytoid DCs. DC activation was evident. This study demonstrates the feasibility and excellent safety profile of a topically applied TLR7 agonist used as a vaccine adjuvant in cancer patients. Imiquimod's adjuvant effects require further evaluation and likely need optimization of parameters such as formulation, dose, and timing relative to Ag exposure for maximal immunogenicity.