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Design and methods for a randomized clinical trial of a diabetes self-management intervention for low-income Latinos: Latinos en Control.

ABSTRACT: 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.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%.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.

SUBMITTER: Rosal MC

PROVIDER: S-EPMC2800841 | biostudies-literature | 2009 Dec

REPOSITORIES: biostudies-literature

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Design and methods for a randomized clinical trial of a diabetes self-management intervention for low-income Latinos: Latinos en Control.

Rosal Milagros C MC White Mary Jo MJ Restrepo Angela A Olendzki Barbara B Scavron Jeffrey J Sinagra Elise E Ockene Ira S IS Thompson Michael M Lemon Stephenie C SC Candib Lucy M LM Reed George G

BMC medical research methodology 20091209

<h4>Background</h4>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.<h4>Methods and design</h4>This randomized clinical trial tested the efficacy of a culturally- and literacy-tailored diabetes self-management intervention (Latinos en Control) on ...[more]

PMID: 20003208

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Project description:BACKGROUND:Diabetes is a major contributor to global death and disability. Text-messaging interventions hold promise for improving diabetes outcomes through better knowledge and self-management. OBJECTIVE:The aim of this study was to examine the implementation and impact of a diabetes text-messaging program targeted primarily for low-income Latino patients receiving care at 2 federally qualified health centers (FQHCs). METHODS:A mixed-methods, quasi-experimental research design was employed for this pilot study. A total of 50 Spanish or English-speaking adult patients with diabetes attending 2 FQHC sites in Los Angeles from September 2015 to February 2016 were enrolled in a 12-week, bidirectional text-messaging program. A comparison group (n=160) was constructed from unexposed, eligible patients. Demographic data and pre/post clinical indicators were compared for both the groups. Propensity score weighting was used to reduce selection bias, and over-time differences in clinical outcomes between groups were estimated using individual fixed-effects regression models. Population-averaged linear models were estimated to assess differential effects of patient engagement on each clinical indicator among the intervention participants. A sample of intervention patients (n=11) and all implementing staff (n=8) were interviewed about their experiences with the program. Qualitative data were transcribed, translated, and analyzed to identify common themes. RESULTS:The intervention group had a mean glycated hemoglobin (HbA1c) reduction of 0.4 points at follow-up, relative to the comparison group (P=.06). Patients who were more highly engaged with the program (response rate ≥median of 64.5%) experienced a 2.2 point reduction in HbA1c, relative to patients who were less engaged, controlling for demographic characteristics (P<.001). Qualitative analyses revealed that many participants felt supported, as though "someone was worrying about [their] health." Participants also cited learning new information, setting new goals, and receiving helpful reminders. Staff and patients highlighted strategies to improve the program, including incorporating patient responses into in-person clinical care and tailoring the messages to patient knowledge. CONCLUSIONS:A diabetes text-messaging program provided instrumental and emotional support for participants and may have contributed to clinically meaningful improvements in HbA1c. Patients who were more engaged demonstrated greater improvement. Program improvements, such as linkages to clinical care, hold potential for improving patient engagement and ultimately, improving clinical outcomes.

Project description:Diabetes risk is extremely high for Latinos from low-income households. Health guidelines recommend that individuals learn strategies to self-manage their diabetes, but getting people to adopt required lifestyle changes is challenging and many people are not able to prevent their pre-diabetes from escalating or effectively control their diabetes. Systematic reviews show that culturally competent self-management programs can significantly improve diabetes outcomes and different models for culturally competent programming have been developed.This patient-engaged study will compare the effectiveness of two distinct evidence-based models for culturally competent diabetes health promotion at two sites that serve a large Latino patient population from low-income households: 1) The Diabetes Self-Management Support Empowerment Model, an educational session approach, and 2) The Chronic Care Model, a holistic community-based program. Data collection will involve interviews, focus groups, surveys and assessments of each program; and testing of patient participants for A1c, depression, Body Mass Index (BMI), and chronic stress with hair cortisol levels. We will recruit a total of 240 patient-social support pairs: Patients will be adults (men and women over the age of 18) who: 1.) Enter one of the two diabetes programs during the study; 2.) Self-identify as "Latino;" 3.) Are able to identify a social support person or key member of their social network who also agrees to participate with them; 4.) Are not pregnant (participants who become pregnant during the study will be excluded); and 5.) Have household income 250% of the Federal Poverty Level (FPL) or below. Social supports will be adults who are identified by the patient participants.Improved capacity for diabetes self-management measured through improvements in diabetes knowledge and diabetes-related patient activation.Successful diabetes self-management as measured by improvements in A1c, depression scale scores, BMI, and circulating levels of cortisol to determine chronic stress.Our hypothesis is that the program model that interfaces most synergistically with patients' culture and everyday life circumstances will have the best diabetes health outcomes.This study was registered with ClinicalTrials.gov on December 16, 2016 (Registration # NCT03004664 ).

Project description:PurposeWe undertook a study to ascertain patient characteristics associated with enrollment and engagement in a type 2 diabetes peer health coaching program at an urban health care facility serving predominantly Black veteran men, to improve the targeting of such programs.MethodsA total of 149 patients declined enrollment in a randomized controlled trial but provided sociodemographic, clinical, and psychosocial information. A total of 290 patients enrolled and were randomized to 2 peer coaching programs; they provided sociodemographic, clinical, and survey data, and were analyzed according to their level of program engagement (167 engaged, 123 did not engage) irrespective of randomization group. Qualitative interviews were conducted with 14 engaged participants.ResultsPatients who enrolled were more likely to be Black men, have higher levels of education, have higher baseline hemoglobin A1c levels, describe their diabetes self-management as "fair" or "poor," and agree they "find it easy to get close to others" (P <.05 for each). At the program's end, patients who had engaged were more likely than those who had not to describe their peer coaches as being supportive of their autonomy (mean score, 85.4 vs 70.7; P <.001). The importance of coaches being encouraging, supportive, and having common ground/shared experiences with participants also emerged as key themes in interviews with engaged participants.ConclusionIndividuals with greatest perceived need were more likely to enroll in our trial of peer coaching, but the only factor associated with engagement was finding one's coach to support autonomy. Our findings reinforce the importance of training and ensuring fidelity of peer coaches to autonomy-supportive communication styles for participant engagement. In tailoring peer support programs for Black men, future research should elucidate which shared characteristics between participant and peer coach are most important for engagement and improved outcomes.Visual abstract.

Project description:BackgroundLower socioeconomic status is associated with excess disease burden from diabetes. Diabetes self-management support interventions are needed that are effective in engaging lower income patients, addressing competing life priorities and barriers to self-care, and facilitating behavior change.ObjectiveTo pilot test feasibility, acceptability, and effect on disease control of a problem-based diabetes self-management training adapted for low literacy and accessibility.DesignTwo-arm randomized controlled trial powered to detect a 0.50% change in A1C at follow-up with a 2-sided alpha of 0.05 in a pooled analysis.ParticipantsFifty-six urban African-American patients with type 2 diabetes and suboptimal blood sugar, blood pressure, or cholesterol control recruited from a diabetes registry within a university-affiliated managed care organization.InterventionsA group, problem-based diabetes self-management training designed for delivery in an intensive and a condensed program format. Three intensive and three condensed program groups were conducted during the trial.Main measuresClinical (A1C, systolic blood pressure [SBP], diastolic blood pressure [DBP], LDL and HDL cholesterol) and behavioral (knowledge, problem solving, self-management behavior) data were measured at baseline, post-intervention, and 3 months post-intervention (corresponding with 6-9 months following baseline).ResultsAdoption of both programs was high (>85% attendance rates, 95% retention). At 3 months post-intervention, the between-group difference in A1C change was -0.72% (p?=?0.02), in favor of the intensive program. A1C reduction was partially mediated by problem-solving skill at follow-up (ß = -0.13, p?=?0.04). Intensive program patients demonstrated within-group improvements in knowledge (p?<?0.001), problem-solving (p?=?0.01), and self-management behaviors (p?=?0.04). Among the subsets of patients with suboptimal blood pressure or lipids at baseline, the intensive program yielded clinically significant individual improvements in SBP, DBP, and LDL cholesterol. Patient satisfaction and usability ratings were high for both programs.ConclusionsA literacy-adapted, intensive, problem-solving-based diabetes self-management training was effective for key clinical and behavioral outcomes in a lower income patient sample.

Project description:BackgroundOverweight and obesity are prevalent among young women and are greater among minority and low-income women. The postpartum period is critical in women's weight trajectories as many women do not lose their pregnancy weight, and others lose some and then plateau or experience weight gain. Excess weight puts women at greater risk of chronic disease and thus weight loss in the postpartum period may be key to the long-term health of young women. This paper describes the design and methods of a randomized clinical trial of Fresh Start, an innovative narrative-based group intervention aimed at promoting postpartum weight loss among low-income, diverse women.Methods/designStudy participants were recruited from the five sites of the Women, Infants and Children (WIC) program in central Massachusetts. Participants were English-speaking, age ≥ 18 years, 6 weeks to 6 months postpartum, with a body mass index (BMI) ≥ 27 kg/m(2). The Fresh Start postpartum weight loss intervention, adapted from the Diabetes Prevention Program (DPP) in collaboration with WIC staff and clients, consisted of an 8-week group-based curriculum followed by nine monthly telephone calls. It included a narrative component (i.e., storytelling), group discussions, print materials and access to exercise facilities. The study is a two-arm randomized controlled trial. The control condition included print materials and access to exercise facilities. In-person assessments were conducted at baseline and at 6 and 12 months following the eight-week intervention phase.DiscussionThe Fresh Start intervention translated key elements of an evidence-based weight loss protocol into a format that is hypothesized to be relevant, acceptable and effective for the target audience of low-SES postpartum women. This novel intervention was developed in collaboration with WIC to be sustainable within the context of its clinics, which reach approximately 9 million individuals per year across the U.S. via 10,000 clinics.Trial registrationclinicaltrials.gov NCT02176915 . Registered 25 June 2014.

Project description:Background and objectivesThe Diabetes Self-Management Program (DSMP) and Programa de Manejo Personal de la Diabetes (PMPD) have been shown to reduce complications from poorly controlled diabetes. Only a few research studies have examined Latino individuals' participation in them. This study examines workshop completion among DSMP and PMPD participants and the effects of race/ethnicity, workshop language, workshop type, and workshop site on program completion rates by participants.Research design and methodsWe used data from the National Council on Aging's data repository of individuals who participated in DSMP or PMPD between January 2010 and March 2019. Using a pooled cross-sectional study design, we examined workshop completion among 8,321 Latino and 23,537 non-Latino white (NLW) participants. We utilized linear probability models to estimate the effects of race/ethnicity and workshop language/type among the full sample; a stratified model estimated the separate effects of workshop language, type, and delivery site among Latinos. Participant characteristics included age, sex, education, number of chronic health conditions, living arrangement, health insurance status, and geographic location of workshop.ResultsCompared to NLW participants in DSMP English workshops, Latinos enrolled in any workshop had a higher probability of completing at least four workshop sessions, and Latinos enrolled in PMPD Spanish workshops had a higher probability of completing six of six sessions. Among the Latino subsample, participation in PMPD Spanish or English workshops was associated with completing at least four sessions or all six sessions compared with participation in DSMP Spanish or English workshops. Among Latino participants, the effects of workshop site on completion rates were mixed.Discussion and implicationsDiabetes self-management education programs tailored for Latino participants had higher completion rates. Further research is warranted to better understand the effect of workshop site and participant characteristics on completion of DSMP and PMPD programs.

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Design and methods for a randomized clinical trial of a diabetes self-management intervention for low-income Latinos: Latinos en Control.

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Design and methods for a randomized clinical trial of a diabetes self-management intervention for low-income Latinos: Latinos en Control.

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