OBJECTIVE: To test whether a theory-based, literacy, and culturally tailored self-management intervention, Latinos en Control, improves glycemic control among low-income Latinos with type 2 diabetes. RESEARCH DESIGN AND METHODS: A total of 252 patients recruited from community health centers were randomized to the Latinos en Control intervention or to usual care. The primarily group-based intervention consisted of 12 weekly and 8 monthly sessions and targeted knowledge, attitudes, and self-management behaviors. The primary outcome was HbA(1c). Secondary outcomes included diet, physical activity, blood glucose self-monitoring, diabetes knowledge and self-efficacy, and other physiological factors (e.g., lipids, blood pressure, and weight). Measures were collected at baseline and at 4- and 12-month follow-up. Change in outcomes over time between the groups and the association between HbA(1c) and possible mediators were estimated using mixed-effects models and an intention-to-treat approach. RESULTS: A significant difference in HbA(1c) change between the groups was observed at 4 months (intervention -0.88 [-1.15 to -0.60] versus control -0.35 [-0.62 to 0.07], P < 0.01), although this difference decreased and lost statistical significance at 12 months (intervention -0.46 [-0.77 to -0.13] versus control -0.20 [-0.53 to 0.13], P = 0.293). The intervention resulted in significant change differences in diabetes knowledge at 12 months (P = 0.001), self-efficacy (P = 0.001), blood glucose self-monitoring (P = 0.02), and diet, including dietary quality (P = 0.01), kilocalories consumed (P < 0.001), percentage of fat (P = 0.003), and percentage of saturated fat (P = 0.04). These changes were in turn significantly associated with HbA(1c) change at 12 months. CONCLUSIONS: Literacy-sensitive, culturally tailored interventions can improve diabetes control among low-income Latinos; however, strategies to sustain improvements are needed.

PURPOSE: To describe methods used to recruit and retain low-income Latinos in a randomized clinical trial (RCT) of a diabetes self-management intervention at 5 community health centers (CHCs) in Massachusetts. METHODS: Consent from primary care providers (PCPs) was obtained to screen their patients. Trained site research coordinators (SRCs) screened, recruited, and enrolled participants following a multistep process (medical record reviews, PCP approval, a patient eligibility interview) and provided support for retention efforts. Assessment staff were trained in motivational strategies to facilitate retention and received ongoing support from a retention coordinator. Electronic tracking systems facilitated recruitment and retention activities. RESULTS: Of an initial pool of 1176 patients, 1034 were active at the time of screening, 592 (57%) were eligible by medical record review, and 487 received PCP approval (92% of reviewed patients). Of these, 293 patients completed the patient screening interview (60% of patients with PCP approval, and 76% of those reached), and 276 were eligible. Sixteen percent of all active patients refused participation, and 8% of contacted patients were unreachable. Two hundred fifty-two patients were randomized after completion of baseline assessments. Clinical, behavioral, and psychosocial assessment completion rates were 92%, 77%, and 86% at 12-month follow-up, respectively, and 93% of patients completed at least one study assessment at 12 months. CONCLUSIONS: CHCs are a prime setting for translation research aimed to eliminate diabetes health disparities. Successful recruitment and retention efforts must address institutional/organizational, research team, and patient-related challenges.

BACKGROUND: US Latinos have greater prevalence of type 2 diabetes (diabetes), uncontrolled diabetes and diabetes co-morbidities compared to non-Latino Whites. They also have lower literacy levels and are more likely to live in poverty. Interventions are needed to improve diabetes control among low-income Latinos. METHODS AND DESIGN: This randomized clinical trial tested the efficacy of a culturally- and literacy-tailored diabetes self-management intervention (Latinos en Control) on glycemic control among low-income Latinos with diabetes, compared to usual care (control). Participants were recruited from five community health centers (CHCs) in Massachusetts. The theory-based intervention included an intensive phase of 12 weekly sessions and a follow-up maintenance phase of 8 monthly sessions. Assessments occurred at baseline, and at 4 and 12 months. The primary outcome was glycosylated hemoglobin (HbA1c). Secondary outcomes were self-management behaviors, weight, lipids and blood pressure. Additional outcomes included diabetes knowledge, self-efficacy, depression and quality of life. The study was designed for recruitment of 250 participants (estimated 20% dropout rate) to provide 90% power for detecting a 7% or greater change in HbA1c between the intervention and control groups. This is a difference in change of HbA1c of 0.5 to 0.6%. DISCUSSION: Low-income Latinos bear a great burden of uncontrolled diabetes and are an understudied population. Theory-based interventions that are tailored to the needs of this high-risk population have potential for improving diabetes self-management and reduce health disparities. This article describes the design and methods of a theory driven intervention aimed at addressing this need.

BACKGROUND: The prevalence of type 2 diabetes and diabetes-related morbidity and mortality is higher among low-income Hispanics when compared to that of Whites. However, little is known about how to effectively promote self-management in this population. PURPOSE: The objectives were first to determine the feasibility of conducting a randomized clinical trial of an innovative self-management intervention to improve metabolic control in low-income Spanish-speaking individuals with type 2 diabetes and second to obtain preliminary data of possible intervention effects. METHODS: Participants for this pilot study were recruited from a community health center, an elder program, and a community-wide database developed by the community health center, in collaboration with other agencies serving the community, by surveying households in the entire community. Participants were randomly assigned to an intervention (n = 15) or a control (n = 10) condition. Assessments were conducted at baseline and at 3 months and 6 months postrandomization. The intervention consisted of 10 group sessions that targeted diabetes knowledge, attitudes, and self-management skills through culturally specific and literacy-sensitive strategies. The intervention used a cognitive-behavioral theoretical framework. RESULTS: Recruitment rates at the community health center, elder program, and community registry were 48%, 69%, and 8%, respectively. Completion rates for baseline, 3-month, and 6-month assessments were 100%, 92%, and 92%, respectively. Each intervention participant attended an average of 7.8 out of 10 sessions, and as a group the participants showed high adherence to intervention activities (93% turned in daily logs, and 80% self-monitored glucose levels at least daily). There was an overall Group x Time interaction (p = .02) indicating group differences in glycosylated hemoglobin over time. The estimated glycosylated hemoglobin decrease at 3 months for the intervention group was -0.8% (95% confidence intervals = -1.1%, -0.5%) compared with the change in the control group (p = .02). At 6 months, the decrease in the intervention group remained significant, -0.85% (95% confidence intervals = -1.2, -0.5), and the decrease was still significantly different from that of the controls (p = .005). There was a trend toward increased physical activity in the intervention group as compared to that of the control group (p = .11) and some evidence (nonsignificant) of an increase in blood glucose self-monitoring in the intervention participants but not the control participants. Adjusting for baseline depressive scores, we observed a significant difference in depressive symptoms between intervention participants and control participants at the 3-month assessment (p = .02). CONCLUSIONS: Low-income Spanish-speaking Hispanics are receptive to participate in diabetes-related research. This study shows that the pilot-tested diabetes self-management program is promising and warrants the conduct of a randomized clinical trial.

PURPOSE: This study explored self-reported barriers to diabetes self-management in a population of urban, low-income Puerto Rican individuals. METHODS: A cross-sectional exploratory survey was conducted with 30 Puerto Rican adults with type 2 diabetes. Participants were randomly selected and recruited from a health center, an elder center, and a community outreach database. A survey was used to assess participants' diabetes-related knowledge, attitudes, and patterns of and barriers to self-management. RESULTS: Participants were older and had limited education and good access to health care. Although two thirds had participated in diabetes education, most demonstrated major deficits in diabetes knowledge. Negative attitudes about living with diabetes were common as was dietary knowledge and nonadherence. Most participants were overweight or obese, did regular self-monitoring of blood glucose but did not use the results to improve their diabetes control, and frequently missed doses of their diabetes medications. Self-reported barriers to self-management were financial and social obstacles and competing health and family concerns. CONCLUSIONS: The knowledge and self-management behaviors in this population of Puerto Rican individuals with type 2 diabetes need to be improved.