A systematic review of diabetes prevention programs adapted to include family members.

Objectives: Family-based programs may be a strategy to prevent health conditions with hereditary risk such as diabetes. This review examined the state of the science regarding interventions that adapted the Diabetes Prevention Program (DPP) lifestyle change curriculum to include family members. Methods: CINAHL, Cochrane Central, PsycINFO, PubMed, and Scopus were searched for reports that were peer reviewed, written in English, evaluated interventions that adapted the DPP lifestyle change curriculum to be family-based, reported diabetes risk related outcomes, and published between 2002 and August 2023. Records were reviewed, data extracted, and quality assessed by two researchers working independently. A narrative synthesis was completed. Meta-analysis was not completed due to the small number of studies and the heterogeneity of the study characteristics. Results: 2177 records were identified with four meeting inclusion criteria. Primary participants for three studies were adults and one study focused on youth. Family participants were adult family members, children of the primary participant, or caregivers of the enrolled youth. For primary participants, two studies found significant intervention effects on weight-related outcomes. Of the studies with no intervention effects, one was a pilot feasibility study that was not powered to detect changes in weight outcomes. Three studies assessed outcomes in family participants with one finding significant intervention effects on weight. Conclusions: While DPP interventions adapted to include family showed promising or similar results as individual-based DPP interventions, additional studies are needed to better understand the mechanisms of action and the most effective methods to engage family members in the programs.

An exploratory study of mothers engaging in physical activity in rural communities.

Gender gaps in physical activity (PA) exist with women being less active than men. Multiple cultural and psychosocial factors influence women's ability to successfully negotiate barriers to PA and other health promoting behaviors. The goal of this exploratory descriptive study was to better understand the daily experiences of mothers in making health promoting decisions for themselves and their families. Semi-structured interviews (N = 17) were conducted with rural dwelling mothers who were the primary caregivers of children in the home. Participants were asked to share their experiences with PA and other health behaviors, focusing on their motivators, barriers, and facilitators. Interviews were audio-recorded, transcribed verbatim, and analyzed using thematic content analysis. Emerging themes focused on 1) feeling internal and external pressures to prioritize family's needs over one's health, 2) family exerting both positive and negative influences on health choices, and 3) living in a rural community often resulting in a lack of opportunities to engage in physical activity and feelings of being isolated from social networks. To close the gender gap in PA, interventions should support mothers in navigating their multiple roles and competing demands while engaging in health promoting behaviors such as physical activity.

Sport Specialization and Sport Motivation in Middle School-Aged Athletes.

CONTEXT: Sport specialization has been assumed to have psychosocial ramifications for athletes, especially autonomous motivation, which has been associated with continued sport participation. Sport dropout is common in youth athletes, yet it is unknown how sport specialization may affect this population psychosocially. OBJECTIVE: To determine the association of sport specialization with autonomous and controlled motivation and amotivation in middle school-aged athletes. DESIGN: Cross-sectional study. SETTING: An anonymous online questionnaire was distributed to athletes via schools, club sports, and social media. PATIENTS OR OTHER PARTICIPANTS: A total of 178 athletes (male = 59%; private school = 51%; grade: sixth = 20%, seventh = 32%, eighth = 48%) completed the questionnaire. MAIN OUTCOME MEASURE(S): The questionnaire assessed demographics, sport participation, and motivation using the Youth Behavioral Regulation in Sport Questionnaire. Sport specialization was defined using a modified 3-point scale (low, moderate, or high) and multisport versus single-sport athletes. Nonparametric tests were used to analyze the differences among the types of motivation and specialization levels and between multisport and single-sport athletes. RESULTS: Sport specialization categories were not significantly associated with autonomous motivation, controlled motivation, or amotivation. No significant associations were present between multisport or single-sport athletes and any type of motivation. However, multisport athletes had higher scores for intrinsic motivation, a subscale of autonomous motivation, compared with single-sport athletes (single sport: median = 5.00, 25th-75th quartile = 4.50-5.00; multisport: median = 5.00, 25th-75th quartile = 5.00-5.00; P = .04). CONCLUSIONS: Sport motivation did not differ between sport specialization groups in middle school athletes. Dropout from sport is common in this age group but is multifactorial in nature. A lack of sport motivation could be a factor for some athletes, but all specialization groups appeared to have similar outcomes. Our exploratory analysis suggests that clinicians may consider having an open dialogue with single-sport athletes, their parents or guardians, and coaches to ensure that athletes are enjoying their sport.

Youth Sport Participation Experiences From the Perspective of Hispanic/Latinx Parents and Their Children.

Hispanic/Latinx communities remain an underserved population in terms of health and physical activity opportunities. The rise of sport specialization can jeopardize these opportunities. Understanding the appeal and welcomeness that minoritized populations feel toward sport and sport specialization culture can play an important role in health promotion and breaking down barriers that widen the gap on physical activity levels in Hispanic/Latinx communities. To date, these studies have not qualitatively investigated Hispanic/Latinx youth sport dyads (parent and child) and how sport specialization perceptions have affected their sport participation experiences. We used a qualitative interpretative phenomenological analysis to explore experiences of Hispanic/Latinx high school athletes. We engaged in semistructured interviews with 12 parent-child dyads. The following 3 interrelated themes emerged: (a) expectations of youth sport participation, (b) meeting expectations of youth sport participation, (c) and (mis)alignment of cultures. Dyads describe a negative youth sport experience when both cultures do not align because of the rise in sport specialization and pay-to-play culture. Findings indicate that dyads understand what is necessary to participate in organized sport and do this by methods that are rooted in their Hispanic/Latinx culture.

To care for them, we need to take care of ourselves: A qualitative study on the health of home health aides.

OBJECTIVE: To understand the perspectives of home health aides (HHAs) toward their own health and health behaviors, and how their job impacts both. DATA SOURCES AND STUDY SETTING: Interviews were conducted with 28 HHAs from 16 unique home care agencies from August 2021 to January 2022. The study was conducted in partnership with the 1199SEIU Training and Employment Fund, a labor-management fund of the largest health care union in the US. STUDY DESIGN: A qualitative study with English and Spanish-speaking HHAs. Interviews were conducted using a semi-structured topic guide, informed by Pender's Health Promotion Model and the National Institute for Occupational Safety and Health's Total Worker Health Model. To be eligible, HHAs had to be currently employed by a home care agency in New York, NY. DATA COLLECTION/EXTRACTION METHODS: Interviews were recorded, professionally transcribed, and analyzed thematically. PRINCIPAL FINDINGS: The 28 HHAs had a mean age of 47.6 years (SD 11.1), 39% were non-Hispanic Black, 43% were Hispanic, and they had a mean of 14.1 years (SD 7.8) of job experience. Five themes emerged; HHAs were: (1) Healthy enough to work, but were managing their own chronic conditions while working; (2) Motivated to be healthy, in part driven by their desire to care for others; (3) Worked closely with sick patients, which influenced their perceptions of health; (4) Experienced occupational and patient-level barriers to practicing healthy behaviors; (5) Sought support and resources to improve their health and wellbeing. CONCLUSIONS: HHAs have numerous health challenges, many of which are influenced by their job. Culturally and occupationally tailored interventions may mitigate the barriers that HHAs experience to achieve optimal health.

Secondary School Athletic Trainers' Strategies and Barriers to Overuse Injury Treatment in Adolescent Athletes.

CONTEXT: Studies have illustrated that overuse injuries occur in adolescent athletes more often than previously reported. The general purpose of this study was to provide a thorough report of secondary school athletic trainers encounters, practices, and perceptions of overuse injury in adolescent athletes. DESIGN: Cross-sectional. METHODS: An anonymous online questionnaire was distributed via email to athletic trainers in the secondary school setting. The questionnaire was sent to participants during the summer of 2021 and 430 participants (highest educational degree earned: master's degree = 66%) completed the survey. Various survey methods were used to evaluate athletic trainers (1) demographics, (2) estimations about what percentage of injuries evaluated and treated were classified as overuse, (3) methods for treating overuse injuries, (4) confidence in treating overuse injuries and the complete implementation of their treatment plan, (5) perceptions of various barriers to treating overuse injuries, and (6) perception as to why patients did not want to reduce activity to treat their overuse injuries. RESULTS: Participants reported that about half of all evaluations and treatments in a year were overuse injuries and they were "fairly" or "completely" confident (90%) in their ability to treat these injuries. The most common treatments cited were stretching (91%) and reducing activity (90%). Only 61% of participants were "fairly" or "completely" confident in the complete implementation of their treatment plan. Participants believed that patients' reluctance to reduce sport activities (82% "moderate" or "extreme" barrier) was the most significant barrier to treatment. Participants cited athletes' avoidance of missing games as the most common reason athletes were reluctant to reduce sporting activity. CONCLUSIONS: Participants felt confident in treating overuse injuries yet faced significant barriers in treating these injuries. Clinicians should be prepared to have conversations about the importance of reducing sporting activity to allow proper healing for overuse injuries in adolescent athletes.

Secondary School Athletic Trainers' Navigation of Patient Socioeconomic Status Challenges in Care: A Qualitative Study.

Secondary school ATs (SSATs) are uniquely positioned healthcare providers at an optimal public health intersection where they can provide equitable healthcare to low socioeconomic status (SES) adolescents. SSATs face similar challenges to physicians in treating low SES patients, but their strategies may be different compared to other medical professions. However, the consequences of low SES population healthcare delivery by SSATs have not been explored. SSATs were asked to share what challenges, if any, they encounter with providing care for their low SES patients and what strategies they find most effective to overcome these challenges. Data were collected via semi-structured interviews and reflective field notes and analyzed using a four-step, interpretative phenomenological analysis (IPA) guided theme development. Data saturation was met, and the sample size aligned with other IPA studies. Trustworthiness was established with research triangulation and Yardley's four principles. Three interrelated themes emerged: (a) mechanisms for identifying SES, (b) the impact of SES on care, and (c) navigating SES challenges. SSATs described many strategies that were gained through their clinical experiences to overcome healthcare barriers. SSATs have the potential to decrease health disparities through their role as a liaison and advocates for their low SES patients.

Peer-delivered Cognitive Behavioral Therapy-based Intervention Reduced Depression and Stress in Community Dwelling Adults With Diabetes and Chronic Pain: A Cluster Randomized Trial.

BACKGROUND: Finding effective, accessible treatment options such as professional-delivered cognitive behavioral therapy (CBT) for medically complex individuals is challenging in rural communities. PURPOSE: We examined whether a CBT-based program intended to increase physical activity despite chronic pain in patients with diabetes delivered by community members trained as peer coaches also improved depressive symptoms and perceived stress. METHODS: Participants in a cluster-randomized controlled trial received a 3-month telephonic lifestyle modification program with integrated CBT elements. Peer coaches assisted participants in developing skills related to adaptive coping, diabetes self-management goal-setting, stress reduction, and cognitive restructuring. Attention controls received general health advice with an equal number of contacts but no CBT elements. Depressive symptoms and stress were assessed using the Centers for Epidemiologic Studies Depression and Perceived Stress scales. Assessments occurred at baseline, 3 months, and 1 year. RESULTS: Of 177 participants with follow-up data, 96% were African Americans, 79% women, and 74% reported annual income <$20,000. There was a significant reduction in perceived stress in intervention compared to control participants at 3-months (ß = -2.79, p = .002 [95% CI -4.52, -1.07]) and 1 year (ß = -2.59, p < .0001 [95% CI -3.30, -1.87]). Similarly, intervention participants reported significant decreases in depressive symptoms at 3-months (ß = -2.48, p < .0001 [95% CI -2.48, -2.02]) and at 1 year (ß = -1.62, p < .0001 [95% CI -2.37, -0.86]). CONCLUSIONS: This peer-delivered CBT-based program improved depressive symptoms and stress in individuals with diabetes and chronic pain. Training community members may be a feasible strategy for offering CBT-based interventions in rural and under-resourced communities. CLINICAL TRIAL REGISTRATION: NCT02538055.

Peer coach delivered storytelling program improved diabetes medication adherence: A cluster randomized trial.

BACKGROUND: Because medication adherence is linked to better diabetes outcomes, numerous interventions have aimed to improve adherence. However, suboptimal adherence persists and necessitate continued research into intervention strategies. This study evaluated the effectiveness of an intervention that combined storytelling and peer support to improve medication adherence and health outcomes in adults with diabetes. METHODS: Living Well with Diabetes was a cluster randomized controlled trial. Intervention participants received a six-month, 11-session peer-delivered behavioral diabetes self-care program over the phone. Control participants received a self-paced general health program. Outcomes were changes in medication adherence and physiologic measures (hemoglobin A1c, systolic blood pressure, low-density lipoprotein cholesterol, body mass index). RESULTS: Of the 403 participants with follow-up data, mean age was 57 (±SD 11), 78% were female, 91% were African American, 56.4% had high school education or less, and 70% had an annual income of < $20,000. At follow-up, compared to controls, intervention participants had greater improvement in medication adherence (ß = -0.25 [95% CI -0.35, -0.15]). Physiologic measures did not change significantly in either group. Intervention participants had significant improvements in beliefs about the necessity of medications (ß = 0.87 [95% CI 0.27, 1.47]) concerns about the negative effects of medication (ß = -0.91 [95% CI -1.35, -0.47]), and beliefs that medications are harmful (ß = -0.50 [95% CI -0.89, -0.10]). In addition, medication use self-efficacy significantly improved in intervention participants (ß = 1.0 [95% CI 0.23, 1.76]). 473 individuals were enrolled in the study and randomized. DISCUSSION: Living Well intervention resulted in improved medication adherence, medication beliefs, and medication use self-efficacy but not improved risk factor levels.

Peer Support Intervention Improves Pain-Related Outcomes Among Rural Adults With Diabetes and Chronic Pain at 12-Month Follow-Up.

PURPOSE: Adults with diabetes mellitus (DM) suffer often from chronic pain, yet evidence-based interventions for comorbid pain and DM are scarce. We tested the effect of a peer-led cognitive behavioral training (CBT) intervention on pain self-efficacy (PSE), pain intensity, and pain-related functional limitations (PRFL) in adults with DM, 1 year after trial initiation. METHODS: The yearlong "Living Healthy" cluster-randomized trial included 230 residents of rural Alabama with DM, who reported pain in the past month; communities were treated as clusters. Intervention participants received a peer-delivered 8-session structured CBT intervention in the context of diabetes self-management; attention control arm participants received a peer-delivered 8-session general health education program. Outcomes included PSE (Arthritis Self-Efficacy Scale, range 10-100); pain intensity (McGill Pain Questionnaire, range 0-45); and PRFL (Western Ontario and McMaster Universities Osteoarthritis Index scale, range 0-100). We examined control-intervention differences in changes in outcome scores from baseline to 3-month and 12-month follow-up, adjusted for clustering. FINDINGS: The 195 participants with follow-up data were aged 59 ± 10.4 years, 96% were African American, 79% were women, and 80% reported pain on the day of baseline data collection. At 3-month follow-up, PSE increased more for intervention (21-point increase) than control (5-point increase) participants (P for control-intervention (C-I) difference in change < .001); pain intensity decreased for both groups; and PRFL decreased only for intervention participants (-11 score; P for C-I difference in change < .001). Results were sustained at 12 months, and pain intensity significantly improved in only the intervention arm (P for C-I difference in change = .01). CONCLUSIONS: This peer-delivered CBT intervention improved pain self-efficacy, pain-related functional limitations, and pain intensity over 12 months among rural participants with DM and chronic pain.

Systematic Review of Exercise for Caregiver-Care Recipient Dyads: What Is Best for Spousal Caregivers-Exercising Together or Not at All?

BACKGROUND AND OBJECTIVES: Though exercise for care recipients receives considerable emphasis, few dyadic studies focus on caregivers. This systematic review identified dyadic exercise interventions, which measured outcomes for older adult caregivers. Studies that met inclusion criteria were examined to better understand whether caregivers derived greater benefit from exercising with care recipients, or not exercising at all. RESEARCH DESIGN AND METHODS: PRISMA guidelines were followed to identify quantitative studies of dyadic exercise interventions in which caregivers enrolled with care recipients, and either coparticipated in exercise; or while their care recipients exercised independently, caregivers received a separate, nonexercise intervention or usual care (UC). To be included, studies had to measure physical or psychosocial outcomes for caregivers. Study quality was assessed via the Downs and Black checklist. RESULTS: Eleven studies met inclusion criteria. In six, the dyad exercised; in five, care recipients exercised while caregivers received a separate program, or UC. Results suggest that caregivers may improve both psychosocial and physical health when exercising together with care recipients. Caregivers who did not exercise but received a separate, nonexercise intervention, such as support, education, or respite, showed psychosocial benefits. Those who received UC were less likely to derive physical or psychosocial benefits. Included studies were fair to good quality with moderate to high risk of bias. DISCUSSION AND IMPLICATIONS: Often examined secondarily, caregivers are overlooked for participation in interventions with care recipients. This analysis suggests that caregivers may benefit from dyadic interventions in which they either exercise together with their care recipients or receive a separate nonexercise intervention or respite.

Peer coach delivered storytelling program for diabetes medication adherence: Intervention development and process outcomes.

INTRODUCTION: Diabetes medications can substantially lower blood sugar, thereby improving health outcomes. Despite substantial efforts targeting this issue, diabetes medication adherence remains suboptimal. We present the development and implementation of an intervention emphasizing peer modeling and support as strategies to improve medication adherence. METHODS: Program adaptation, pretesting, and peer coach training were combined in an iterative process with community stakeholders. Peer coaches were community residents who had diabetes or took care of family members with diabetes. Study participants were community-dwelling adults taking diabetes oral medications who reported medication non-adherence or wanted help taking their medications. RESULTS: The resulting intervention consisted of a six-month, 11-session telephone-delivered program. Nineteen peer coaches were trained and certified to deliver the intervention. The 473 study participants were mostly African-Americans (91%), women (79%), and low-income (70% reporting annual income <$20,000). Of the 203 intervention participants, 85% completed the program, with 82% completing all program sessions. Ninety-five percent reported high program satisfaction, and 91% found the program materials helpful, 96% found the videos helpful, 93% felt their peer was easy to talk with, and 95% reported that support from their peer was great or good. Moreover, 93% reported peers knew the program well, and 93% would recommend a peer to a relative with a similar health condition. DISCUSSION: This intervention was developed and implemented in underserved communities with high retention and fidelity. Participants expressed high satisfaction with the program. Our approach may be helpful for others seeking to develop a medication adherence program in their communities.

Peer-Delivered Cognitive Behavioral Training to Improve Functioning in Patients With Diabetes: A Cluster-Randomized Trial.

PURPOSE: Cognitive behavioral therapy (CBT)-based programs delivered by trained community members could improve functioning and pain in individuals who lack access to such programs. We tested the effectiveness of a peer-delivered diabetes self-management program integrating CBT principles in improving physical activity, functional status, pain, quality of life (QOL), and health outcomes in individuals with diabetes and chronic pain. METHODS: In this community-based, cluster-randomized controlled trial, intervention participants received a 3-month, peer-delivered, telephone-administered program. Attention control participants received a peer-delivered general health advice program. Outcomes were changes in functional status and pain (Western Ontario and McMaster Universities Osteoarthritis Index), QOL (Short Form 12), and physiologic measures (hemoglobin A1c, systolic blood pressure, body mass index); physical activity was the explanatory outcome. RESULTS: Of 195 participants with follow-up data, 80% were women, 96% African Americans, 74% had annual income <$20,000, and 64% had high school education or less. At follow-up, compared with controls, intervention participants had greater improvement in functional status (-10 ± 13 vs -5 ± 18, P = .002), pain (-10.5 ± 19 vs -4.8 ± 21, P = .01), and QOL (4.8 ± 8.8 vs 3.8 ± 8.8, P = .001). Physiologic measures did not change significantly in either group. At 3 months, a greater proportion of intervention than control participants reported no pain or did other forms of exercise when pain prevented them from walking for exercise. CONCLUSION: This peer-delivered CBT-based intervention improved functioning, pain, QOL, and self-reported physical activity despite pain in individuals with diabetes and chronic pain. Trained community members can deliver effective CBT-based interventions in rural and under-resourced communities.

Impact of Peer Support on Acute Care Visits and Hospitalizations for Individuals With Diabetes and Depressive Symptoms: A Cluster-Randomized Controlled Trial.

OBJECTIVE: Comorbid depression is associated with increased health care utilization and cost. We examined the effects of peer support on acute care (AC) and hospital utilization in individuals with diabetes with or without depressive symptoms. RESEARCH DESIGN AND METHODS: This was a cluster-randomized controlled trial conducted in 2010-2012, with the clusters being practices and their surrounding communities. Adults with type 2 diabetes who wanted help with self-management were eligible to participate. Those without a doctor, with limited life expectancy, with plans to move within the next year, and with an unwillingness to work with a peer advisor were excluded. Intervention participants received 1 year of peer support. Control participants received usual care. The Patient Health Questionnaire (PHQ-8) (range 0-24; 5 indicates mild and 10 indicates moderate depressive symptoms) assessed depressive symptoms. AC and hospital utilization were measured by self-report. Data were collected at baseline, 6 months, and 12 months. Quasi-Poisson regression using generalized estimating equations examined differences in utilization per year attributable to the intervention for those with and without mild depressive symptoms (and separately, moderate depressive symptoms), controlling for imbalance across treatment arms. RESULTS: At baseline, half of the sample reported mild depressive symptoms (52% intervention and 48% control, P = 0.37), a quarter reported moderate depressive symptoms (25% intervention and 26% control, P = 1.0), and there were no significant differences in utilization. A total of 168 intervention (six clusters) and 187 control (five clusters) participants had follow-up data. In individuals with mild depressive symptoms, the incident rate ratio (IRR) for hospitalization among intervention compared with control was 0.26 (95% CI 0.08-0.84) per 10 patient-years. The IRR for AC was 0.55 (95% CI 0.28-1.07) per 10 person-years. Findings were similar for individuals with moderate depressive symptoms. CONCLUSIONS: Peer support lowered AC visits and hospitalizations for individuals with depressive symptoms but not for those without depressive symptoms; these findings can guide resource allocation for population health management.

Development of a Community Health Worker-Delivered Cognitive Behavioral Training Intervention for Individuals With Diabetes and Chronic Pain.

Cognitive behavioral therapy (CBT) programs have the potential to improve quality of life in individuals with chronic pain and diabetes. Rural communities often lack the infrastructure necessary to implement such programs. CBT traditionally requires trained therapists, who are rarely available in these areas. An alternative may be programs delivered by community health workers (CHWs). We present an iterative developmental approach that combined program adaptation, pretesting, and CHW training processes for a CBT-based diabetes self-care program for individuals living with diabetes and chronic pain. Collaborative intervention refinement, combined with CHW training, is a promising methodology for community-engaged research in remote, underresourced communities.

Blood Pressure Measurement Biases in Clinical Settings, Alabama, 2010-2011.

INTRODUCTION: Blood pressure measurement in clinical care settings seldom follows the protocol recommended by national guidelines, potentially leading to overestimates or underestimates of blood pressure control. We evaluated blood pressure measurement methods as a source of bias in determining blood pressure control among community-dwelling adults with diabetes. METHODS: In a community-based trial of patients with diabetes, we measured both "clinical blood pressure" (clinical BP) (taken by a community nurse or medical assistant instructed to "take the participant's blood pressure like you do in your own clinic") and "research blood pressure" (research BP) (research staff followed a guideline-concordant protocol). Each participant had both types of blood pressure assessment on the same day over the course of 2 hours. RESULTS: The 227 participants had a mean age of 59 years; 86% were black and 74% were women. The mean clinical BP was 5 mm Hg higher than the mean research BP for systolic blood pressure (P < .001) and 2 mm Hg higher for diastolic blood pressure (P < .001). The proportion of participants whose clinical BP was 130/80 mm Hg or higher was 8 percentage points higher than the proportion whose research BP was 130/80 mm Hg or higher (P < .001), and the proportion whose clinical BP was 140/90 mm Hg or higher was 10 percentage points higher than the proportion whose research BP was 140/90 mm Hg or higher (P < .001). Among those aged 65 years or older, the proportion whose clinical BP was 130/80 mm Hg or higher was 10 percentage points higher than proportion whose research BP was 130/80 mm Hg or higher, and the proportion whose clinical BP was 140/90 mm Hg or higher was 14 percentage points higher than the proportion whose research BP was 140/90 mm Hg or higher. Whites and smokers had the greatest risk for having a clinical BP 5 mm Hg or more higher than their research BP. CONCLUSION: Measurement biases in clinical settings may be a component of observed poor blood pressure control rates in real-world settings.

Volunteer peer support, diabetes, and depressive symptoms: Results from the ENCOURAGE trial.

AIMS: Depression in diabetes mellitus (DM) is common and is associated with poor health outcomes. Peer support DM interventions include encouraging interactions that could improve depressive symptoms. We examined intervention effects for those with and without depressive symptoms in a peer support trial. METHODS: The 1-year ENCOURAGE trial included 424 persons with DM living in rural Alabama. Intervention participants worked with community volunteers who encouraged participants to engage in daily self-management; control arm participants received usual care. Outcomes included HbA1c, body mass index (BMI) and quality of life (QoL) with EuroQuol-5D (range 0.0-1.0). Depressive symptoms were assessed with the Patient Health Questionnaire (PHQ-8, range 0-24). Generalized Additive Models (GAM) examined control-intervention differences in changes in HbA1c, BMI, and QoL for those with PHQ-8 ≥ 5 and PHQ-8 < 5. RESULTS: Of the 424 participants enrolled at baseline, 355 completed follow-up and had data were that could be included into the study; they were aged 60.2 ± 12.1 years, 87% African American, 75% female, and 39% insulin-treated. In an overall GAM adjusting for imbalance across trial arms and time-related covariates, depressive symptoms improved for all, but after 15 months of follow-up intervention, participants experienced greater reduction in PHQ-8 score than control participants (p = 0.01). In stratified analyses, those with PHQ-8 ≥ 5 had unchanged HbA1c, lost weight (p = 0.03) and improved QoL (p = 0.04). Those with PHQ-8 < 5 also had unchanged HbA1c and lost weight, but did not improve QoL (p = 0.06). CONCLUSIONS: Peer support improved depressive symptoms for all, but resulted in greater weight loss and gains in QoL for those with baseline depressive symptoms compared to those without.

Peer Coaches to Improve Diabetes Outcomes in Rural Alabama: A Cluster Randomized Trial.

PURPOSE: It is unclear whether peer coaching is effective in minority populations living with diabetes in hard-to-reach, under-resourced areas such as the rural South. We examined the effect of an innovative peer-coaching intervention plus brief education vs brief education alone on diabetes outcomes. METHODS: This was a community-engaged, cluster-randomized, controlled trial with primary care practices and their surrounding communities serving as clusters. The trial enrolled 424 participants, with 360 completing baseline and follow-up data collection (84.9% retention). The primary outcomes were change in glycated hemoglobin (HbA1c), systolic blood pressure (BP), low density lipoprotein cholesterol (LDL-C), body mass index (BMI), and quality of life, with diabetes distress and patient activation as secondary outcomes. Peer coaches were trained for 2 days in community settings; the training emphasized motivational interviewing skills, diabetes basics, and goal setting. All participants received a 1-hour diabetes education class and a personalized diabetes report card at baseline. Intervention arm participants were also paired with peer coaches; the protocol called for telephone interactions weekly for the first 8 weeks, then monthly for a total of 10 months. RESULTS: Due to real-world constraints, follow-up was protracted, and intervention effects varied over time. The analysis that included the 68% of participants followed up by 15 months showed only a significant increase in patient activation in the intervention group. The analysis that included all participants who eventually completed follow-up revealed that intervention arm participants had significant differences in changes in systolic BP (P = .047), BMI (P = .02), quality of life (P = .003), diabetes distress (P = .004), and patient activation (P = .03), but not in HbA1c (P = .14) or LDL-C (P = .97). CONCLUSION: Telephone-delivered peer coaching holds promise to improve health for individuals with diabetes living in under-resourced areas.

Challenges of Prolonged Follow-up and Temporal Imbalance in Pragmatic Trials: Analysis of the ENCOURAGE Trial.

PURPOSE: Peer support intervention trials are typically conducted in community-based settings and provide generalizable results. The logistic challenges of community-based trials often result in unplanned temporal imbalances in recruitment and follow-up. When imbalances are present, as in the ENCOURAGE trial, appropriate statistical methods must be used to account for these imbalances. We present the design, conduct, and analysis of the ENCOURAGE trial as a case study of a cluster-randomized, community-based, peer-coaching intervention. METHODS: Preliminary data analysis included examination of study data for imbalances in participant characteristics at baseline, the presence of both secular and seasonal trends in outcome measures, and imbalances in time from baseline to follow-up. Additional examination suggested the presence of nonlinear trends in the intervention effect. The final analyses adjusted for all identified imbalances with accounting for community clustering by supplementing linear mixed effect models with generalized additive mixed models (GAMM) to examine nonlinear trends. RESULTS: Largely due to the location of participants across a considerable geographic area, temporal imbalances were discovered in recruitment, baseline, and follow-up data collection, along with evidence for both secular and seasonal trends in study outcome measures. Using the standard analytical approach, ENCOURAGE appeared to be a null trial. After incorporating adjustment for these temporal imbalances, linear regression analyses still showed no intervention effect. Upon further analyses using GAMM to consider nonlinear intervention trends, we observed intervention effects that were both significant (P <.05) and nonlinear. DISCUSSION: In community-based trials, recruitment and follow-up may not occur as planned, and complex temporal imbalance may greatly influence the analysis. Real-world trials should use careful logistic planning and monitoring to avoid temporal imbalance. If imbalance is unavoidable, sophisticated statistical methods may nevertheless extract useful information, although the potential problem of residual confounding due to other unmeasured imbalances must be considered.

Perceptions of and barriers to use of generic medications in a rural African American population, Alabama, 2011.

INTRODUCTION: Using generic medications for chronic diseases provides efficacy similar to that of brand-name medication use, but at a lower price, potentially enhancing adherence. However, previous studies show that disadvantaged people, who may particularly benefit from cost savings, have low trust of generics and increased reluctance to switch to generics. The rural South includes areas of high poverty and minority communities whose members are at high risk for poor health outcomes; however, whether such beliefs exist in these communities has not been reported. We sought to obtain qualitative insight into beliefs about generic medication use among African Americans in the rural South. METHODS: Investigators conducted 4 focus groups with 30 community members from Alabama's Black Belt area. Transcribed discussions were analyzed and common themes identified. RESULTS: Participants were primarily unemployed middle-aged women, one-fourth of whom were uninsured and more than half of whom had a high school education or less. Barriers to generic medication use included perceptions that generics are less potent than brand-name medications, require higher doses, and, therefore, result in more side effects; generics are not "real" medicine; generics are for minor but not serious illnesses; the medical system cannot be trusted; and poor people are forced to "settle" for generics. CONCLUSION: Although education about generics could rectify misinformation, overcoming views such as mistrust of the medical system and the sense of having to settle for generics because of poverty may be more challenging. Policy makers and providers should consider these perspectives when working to increase generic drug use in these populations.