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Continuous glucose monitors (CGMs) improve glycemic outcomes and quality of life for many people with diabetes. Research and clinical practice efforts have focused on CGM initiation and uptake. There is limited understanding of how to sustain CGM use to realize these benefits and limited consideration for different reasons/goals for CGM use. Therefore, we apply the Information-Motivation-Behavioral Skills (IMB) model as an organizing framework to advance understanding of CGM use as a complex, ongoing self-management behavior. We present a person-centered, dynamic perspective with the central thesis that IMB predictors of optimal CGM use vary based on the CGM use goal of the person with diabetes. This reframe emphasizes the importance of identifying and articulating each person's goal for CGM use to inform education and support.

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AIMS: Family/friend Activation to Motivate Self-care (FAMS) is a self-care support intervention delivered via mobile phones. We evaluated FAMS' effects on hemoglobin A1c (HbA1c) and intervention targets among adults with type 2 diabetes in a 15-month RCT. METHODS: Persons with diabetes (PWDs) were randomized to FAMS or control with their support person (family/friend, optional). FAMS included monthly phone coaching and text messages for PWDs, and text messages for support persons over a 9-month intervention period. RESULTS: PWDs (N = 329) were 52 % male, 39 % reported minoritized race or ethnicity, with mean HbA1c 8.6 ± 1.7 %. FAMS improved HbA1c among PWDs with a non-cohabitating support person (-0.64 %; 95 % CI [-1.22 %, -0.05 %]), but overall mean effects were not significant. FAMS improved intervention targets including self-efficacy, dietary behavior, and family/friend involvement during the intervention period; these improvements mediated post-intervention HbA1c improvements (total indirect effect -0.27 %; 95 % CI [-0.49 %, -0.09 %]) and sustained HbA1c improvements at 12 months (total indirect effect -0.19 %; 95 % CI [-0.40 %, -0.01 %]). CONCLUSIONS: Despite improvements in most intervention targets, HbA1c improved only among PWDs engaging non-cohabitating support persons suggesting future family interventions should emphasize inclusion of these relationships. Future work should also seek to identify intervention targets that mediate improvements in HbA1c.

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AIMS: Type 2 diabetes self-management occurs within social contexts. We sought to test the effects of Family/friend Activation to Motivate Self-care (FAMS), a self-care support intervention delivered via mobile phones, on psychosocial outcomes for persons with diabetes (PWDs) and their support persons. METHODS: PWDs had the option to enroll with a friend/family member as a support person in a 15-month RCT to evaluate FAMS versus enhanced usual care. FAMS included 9 months of monthly phone coaching and text message support for PWDs, and text message support for enrolled support persons. RESULTS: PWDs (N = 329) were 52% male and 39% reported minoritized race or ethnicity ; 50% enrolled with elevated diabetes distress. Support persons (N = 294) were 26% male and 33% reported minoritized race or ethnicity. FAMS improved PWDs' diabetes distress (d = -0.19) and global well-being (d = 0.21) during the intervention, with patterns of larger effects among minoritized groups. Post-intervention (9-month) and sustained (15-month) improvements were driven by changes in PWDs' self-efficacy, self-care behaviors, and autonomy support. Among support persons, FAMS improved helpful involvement without increasing burden or harmful involvement. CONCLUSIONS: FAMS improved PWDs' psychosocial well-being, with post-intervention and sustained improvements driven by improved self-efficacy, self-care, and autonomy support. Support persons increased helpful involvement without adverse effects.

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Aims: Type 2 diabetes self-management occurs within social contexts. We sought to test the effects of Family/friends Activation to Motivate Self-care (FAMS), a self-care support intervention delivered via mobile phones, on psychosocial outcomes for persons with diabetes (PWDs) and their support persons. Methods: PWDs had the option to enroll with a friend/family member as a support person in a 15-month RCT to evaluate FAMS versus enhanced usual care. FAMS included 9-months of monthly phone coaching and text message support for PWDs, and text message support for enrolled support persons. Results: PWDs (N=329) were 52% male and 39% from minoritized racial or ethnic groups; 50% enrolled with elevated diabetes distress. Support persons (N=294) were 26% male and 33% minoritized racial or ethnic groups. FAMS improved PWDs' diabetes distress ( d =-0.19) and global well-being ( d =0.21) during the intervention, with patterns of larger effects among minoritized groups. Post-intervention and sustained (15-month) improvements were driven by changes in PWDs' self-efficacy, self-care behaviors, and autonomy support. Among support persons, FAMS improved helpful involvement without increasing burden or harmful involvement. Conclusions: FAMS improved PWDs' psychosocial well-being, with post-intervention and sustained improvements driven by improved self-efficacy, self-care, and autonomy support. Support persons increased helpful involvement without adverse effects.

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Aims: Family/friends Activation to Motivate Self-care (FAMS) is a self-care support intervention delivered via mobile phones. We evaluated FAMS effects on hemoglobin A1c (HbA1c) and intervention targets among adults with type 2 diabetes in a 15-month RCT. Methods: Persons with diabetes (PWDs) and their support persons (family/friend, optional) were randomized to FAMS or control. FAMS included monthly phone coaching and text messages for PWDs, and text messages for support persons over a 9-month intervention period. Results: PWDs (N=329) were 52% male, 39% from minoritized racial or ethnic groups, with mean HbA1c 8.6±1.7%. FAMS improved HbA1c among PWDs with a non-cohabitating support person (-0.64%; 95% CI [-1.22%, -0.05%]), but overall effects were not significant. FAMS improved intervention targets including self-efficacy, dietary behavior, and family/friend involvement during the intervention period; these improvements mediated post-intervention HbA1c improvements (total indirect effect -0.27%; 95% CI [-0.49%, -0.09%]) and sustained HbA1c improvements at 12 months (total indirect effect -0.19%; 95% CI [-0.40%, -0.01%]). Conclusions: Despite improvements in most intervention targets, HbA1c improved only among PWDs engaging non-cohabitating support persons suggesting future family interventions should emphasize inclusion of these relationships. Future work should also seek to identify intervention targets that mediate improvements in HbA1c.

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Background: Text message-delivered interventions for chronic disease self-management have potential to reduce health disparities, yet limited research has explored implementing these interventions into clinical care. We partnered with safety net clinics to evaluate a texting intervention for type 2 diabetes called REACH (Rapid Encouragement/Education And Communications for Health) in a randomized controlled trial. Following evaluation, we explored potential implementation determinants and recommended implementation strategies. Methods: We interviewed clinic staff (n = 14) and a subset of intervention participants (n = 36) to ask about REACH's implementation potential. Using the Consolidated Framework for Implementation Research (CFIR) as an organizing framework, we coded transcripts and used thematic analysis to derive implementation barriers and facilitators. We integrated the CFIR-ERIC (Expert Recommendations for Implementing Change) Matching Tool, interview feedback, and the literature to recommend implementation strategies. Results: Implementation facilitators included low complexity, strong evidence and quality, available clinic resources, the need for a program to support diabetes self-management, and strong fit between REACH and both the clinics' existing workflows and patients' needs and resources. The barriers included REACH only being available in English, a lack of interoperability with electronic health record systems, patients' concerns about diabetes stigma, limited funding, and high staff turnover. Categories of recommended implementation strategies included training and education, offering flexibility and adaptation, evaluating key processes, and securing funding. Conclusion: Text message-delivered interventions have strong potential for integration in low-resource settings as a supplement to care. Pursuing implementation can ensure patients benefit from these innovations and help close the research to practice gap.

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In this paper, we describe our approach to individualizing messages to promote the health of middle-aged and older heterosexual, cisgender African American men. After arguing the importance of being population specific, we describe the process we use to increase the salience of health messages for this population by operationalizing the identity concepts of centrality and contextualization. We also present a measure of African American manhood and discuss how manhood is congruent with qualitative research that describes how African American men view their values, identities, goals, and aspirations in ways that can be utilized to create more meaningful and impactful messages to promote and maintain health behaviors. Our tailoring strategy uses an intersectional approach that considers how the centrality of racial identity and manhood and the salience of religiosity, spirituality, and role strains may help to increase the impact of health messages. We highlight the need to consider how the context of health behavior and the meaning ascribed to certain behaviors are gendered, not only from a man's perspective, but also how his social networks, behavioral context, and the dynamic sociopolitical climate may consider gendered ideals in ways that shape behavior. We close by discussing the need to apply this approach to other populations of men, women, and those who are non-gender binary because this strategy builds from the population of interest and incorporates factors that they deem central and salient to their identities and behaviors. These factors are important to consider in interventions using health messages to pursue health equity.

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OBJECTIVE: To assess the feasibility and acceptability of an educational sleep-promoting intervention (Sleep Coach Jr.) for school-aged children (ages 5-9) with type 1 diabetes (T1D) and their parents. METHODS: Parents and children (N = 39 dyads, mean child age = 8 years, 64% girls,) were randomized to either the Sleep Coach Jr. intervention, consisting of educational materials and three individual phone calls (N = 20), or the Standard Care condition (N = 19). Data were collected at enrollment and 3 months later. Children and parents wore actigraphy devices to obtain an objective measure of sleep characteristics, and parents completed questionnaire measures of sleep quality and psychosocial outcomes. Clinical data (i.e., hemoglobin A1c, glucose data) were obtained from children's medical records. RESULTS: Feasibility and acceptability of the study were demonstrated to be high; all three sessions were completed by 80% of parents randomized to the Sleep Coach Jr. intervention, and 90% of parents completed follow-up data at 3 months. Parents reported high levels of satisfaction with the study and identified barriers to participation. No changes were observed in children's sleep or diabetes outcomes, but parental sleep quality and well-being improved. CONCLUSIONS: A brief, behavioral sleep-promoting intervention is feasible and acceptable for school-aged children with T1D and their parents. A larger trial is needed to evaluate efficacy of the intervention.

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BACKGROUND: Family and friends have both helpful and harmful effects on adults' diabetes self-management. Family-focused Add-on to Motivate Self-care (FAMS) is a mobile phone-delivered intervention designed to improve family/friend involvement, self-efficacy, and self-care via monthly phone coaching, texts tailored to goals, and the option to invite a support person to receive texts. PURPOSE: We sought to evaluate how FAMS was received by a diverse group of adults with Type 2 diabetes and if FAMS improved diabetes-specific family/friend involvement (increased helpful and reduced harmful), diabetes self-efficacy, and self-care (diet and physical activity). We also assessed if improvements in family/friend involvement mediated improvements in self-efficacy and self-care. METHODS: Participants were prospectively assigned to enhanced treatment as usual (control), an individualized text messaging intervention alone, or the individualized text messaging intervention plus FAMS for 6 months. Participants completed surveys at baseline, 3 and 6 months, and postintervention interviews. Between-group and multiple mediator analyses followed intention-to-treat principles. RESULTS: Retention, engagement, and fidelity were high. FAMS was well received and helped participants realize the value of involving family/friends in their care. Relative to control, FAMS participants had improved family/friend involvement, self-efficacy, and diet (but not physical activity) at 3 and 6 months (all ps < .05). Improvements in family/friend involvement mediated effects on self-efficacy and diet for FAMS participants but not for the individualized intervention group. CONCLUSIONS: The promise of effectively engaging patients' family and friends lies in sustained long-term behavior change. This work represents a first step toward this goal by demonstrating how content targeting helpful and harmful family/friend involvement can drive short-term effects. TRIAL REGISTRATION NUMBER: NCT02481596.

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OBJECTIVE: Text messaging interventions have high potential for scalability and for reductions in health disparities. However, more rigorous, long-term trials are needed. We examined the long-term efficacy and mechanisms of a tailored text messaging intervention. RESEARCH DESIGN AND METHODS: Adults with type 2 diabetes participated in a parallel-groups, 15-month randomized controlled trial and were assigned to receive Rapid Education/Encouragement and Communications for Health (REACH) for 12 months or control. REACH included interactive texts and tailored texts addressing medication adherence and nontailored texts supporting other self-care behaviors. Outcomes included hemoglobin A1c (HbA1c), diabetes medication adherence, self-care, and self-efficacy. RESULTS: Participants (N = 506) were approximately half racial/ethnic minorities, and half were underinsured, had annual household incomes <$35,000, and had a high school education or less; 11% were homeless. Average baseline HbA1c was 8.6% ± 1.8%; 70.0 ± 19.7 mmol/mol) with n = 219 having HbA1c ≥8.5% (69 mmol/mol). Half were prescribed insulin. Retention was over 90%. Median response rate to interactive texts was 91% (interquartile range 75%, 97%). The treatment effect on HbA1c at 6 months (-0.31%; 95% CI -0.61%, -0.02%) was greater among those with baseline HbA1c ≥8.5% (-0.74%; 95% CI -1.26%, -0.23%), and there was no evidence of effect modification by race/ethnicity or socioeconomic disadvantage. REACH improved medication adherence and diet through 12 months and self-efficacy through 6 months. Treatment effects were not significant for any outcome at 15 months. REACH reduced barriers to adherence, but barrier reduction did not mediate outcome improvements. CONCLUSIONS: REACH engaged at-risk patients in diabetes self-management and improved short-term HbA1c. More than texts alone may be needed to sustain the effects.

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BACKGROUND: Potential research participants, particularly those from racial and ethnic groups underrepresented in medical research, often decide to participate based on how they judge people, places, and study protocols as trustworthy. And yet, few studies have explored notions of trustworthiness or determinants of trustworthiness from the perspective of potential medical research participants. OBJECTIVE: This paper describes how racially and ethnically diverse potential medical research participants conceptualize what makes researchers, research settings, and research protocols seem trustworthy. DESIGN: Using a criterion sampling strategy, we recruited African American, Latinx, and White adults for participation in focus groups conducted at a community center servings the Latinx community and at a health clinic that primarily serves the African American community. PARTICIPANTS: A total of 57 African American, Latinx, and White adults APPROACH: We conducted seven focus groups that explored perceptions and determinants of research, trust, privacy, confidentiality, and research participation. We used a phenomenological thematic analytic approach to explore the determinants of trustworthiness to conduct medical research. RESULTS: In our effort to identify the factors that affect potential research participants' perspectives on the trustworthiness of medical research, we found three themes: Who is trustworthy to conduct medical research? What influences perceptions of trustworthiness in medical research? And what institutions or settings are trustworthy to conduct medical research? CONCLUSIONS: These findings highlight that one's willingness to participate in research is driven in part by their perception of the trustworthiness of researchers, research institutions, and the information they are given about potential research opportunities. There are important and modifiable determinants of trustworthiness that may facilitate minority participation in research. We found that research, researchers, and research institutions each have things that can be done to increase trustworthiness and minority participation in research.

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Objective: To better understand African American and Hispanic perspectives on the potential benefits of precision medicine, along with the potential barriers that may prevent precision medicine from being equally beneficial to all. We also sought to identify if there were differences between African American and Hispanic perspectives. Design: Six semi-structured focus groups were conducted between May 2017 and February 2018 to identify benefits and barriers to precision medicine. Three groups occurred in Nashville, TN with African American participants and three groups occurred in Miami, FL with Hispanic participants. Setting: At community-based and university sites convenient to community partners and participants. Participants: A total of 55 individuals participated (27 in Nashville, 28 in Miami). The majority of participants were women (76.5%) and the mean age of participants was 56.2 years old. Results: Both African Americans and Hispanics believed precision medicine has the potential to improve medicine and health outcomes by individualizing care and decreasing medical uncertainty. However, both groups were concerned that inadequacies in health care institutions and socioeconomic barriers would prevent their communities from receiving the full benefits of precision medicine. African Americans were also concerned that the genetic and non-genetic personal information revealed through precision medicine would make African Americans further vulnerable to provider racism and discrimination in and outside of health care. Conclusions: While these groups believed precision medicine might yield benefits for health outcomes, they are also skeptical about whether African Americans and Hispanics would actually benefit from precision medicine given current structural limitations and disparities in health care access and quality.

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BACKGROUND: Teens with type 1 diabetes (T1D) experience increased sleep disturbances, which have been linked to problems with adherence and glycemic control. As such, sleep represents a novel target to improve outcomes in teens. OBJECTIVE: To evaluate the feasibility, acceptability, and preliminary efficacy of a sleep-promoting intervention in teens with T1D. RESEARCH DESIGN AND METHODS: Teens aged 13 to 17 with T1D (n = 39) completed measures of sleep quality and diabetes management and wore actigraphs to obtain an objective measure of sleep. Hemoglobin A1C (HbA1c) was collected from medical records. Teens were randomized to Usual Care (n = 19) or the Sleep Coach intervention (n = 20). Teens in the Sleep Coach group received educational materials on healthy sleep habits and completed three individual telephone sessions. Follow-up data were collected at 3 months, including exit interviews with teens and parents. RESULTS: Feasibility of the study was excellent; 80% of teens in the Sleep Coach group completed all three sessions, and retention was high (90%). Based on actigraphy data, a significant improvement in sleep efficiency and sleep duration was observed (48-minute increase) among teens randomized to the Sleep Coach intervention, and teens in the control group were 7.5 times more likely to report poor sleep quality after 3 months than intervention participants. No change in HbA1c was observed. CONCLUSIONS: The Sleep Coach intervention for teens with T1D is a feasible and acceptable program that increased sleep duration and improved sleep quality for this high-risk population.

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OBJECTIVE: Explore acceptability of engaging family/friends in patients' type 2 diabetes (T2D) self-management using text messaging. MATERIALS AND METHODS: Participants (N = 123) recruited from primary care clinics for a larger trial evaluating mobile phone support for T2D completed self-report measures and a hemoglobin A1c test and then had the option to invite an adult support person to receive text messages. We examined characteristics and reasons of participants who did/did not invite a support person, responses to the invitation, and feedback from patients and support persons. RESULTS: Participants were 55.9 ± 10.1 years old, 55% female, 53% minority, and 54% disadvantaged (low income, less than high school degree/GED, uninsured, and/or homeless). Participants who invited a support person (48%) were slightly younger, more likely to be partnered, and reported more depressive symptoms and more emergency department visits in the year prior to study enrollment as compared to participants who did not (all p <.05). Participants' reasons for inviting a support person included needing help and seeing benefits of engaging others, while reasons for not inviting a support person included concerns about being a "burden" and support person's ability or desire to text. Support persons reported the texts increased awareness, created dialogue, and improved their own health behaviors. DISCUSSION: Patients inviting a support person had higher need and thus may stand to benefit most. Most support persons were open to engagement via text messages. CONCLUSION: Across race and socioeconomic status, text messaging may engage support persons to increase health-related support-particularly for patients with higher levels of need. TRIAL REGISTRATION: Clinicaltrials.gov NCT02409329.

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Problems with adherence are common among adolescents with type 1 diabetes (T1D), who must follow a complex treatment regimen. Positive psychology interventions increase adherence and improve health outcomes in adults with chronic conditions; however, they have not been translated to pediatric populations. We evaluated the acceptability and feasibility of Check It!, a positive psychology intervention to improve adherence in adolescents with T1D. Adolescents with T1D and their parents were randomized to a positive psychology intervention (via phone or text message) or an attention control (education) group. Exit interviews and satisfaction surveys were conducted with adolescents (n=63) and parents (n=55) to assess the acceptability and feasibility of Check it! from a representative sample of each group. Chi-square, t-tests, ANOVA and content analysis methods were used to analyze data. Parents and adolescents indicated interest in the intervention, and enrollment numbers support feasibility. In terms of intervention delivery, we identified challenges in implementing the positive psychology reminders to adolescents, particularly in the phone group. Parents in the positive psychology group appreciated the reminders to provide affirmations to their children, and adolescents enjoyed the affirmations and reported using the positive psychology exercises. Regarding acceptability, participants in both groups reported high satisfaction with the intervention overall. Participants reported favorable experiences with Check It!, and findings indicate that text messages are more feasible than phone calls for interventions with adolescents. Overall, a positive psychology intervention delivered with automated text messages is feasible and acceptable to adolescents with T1D and their parents.

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PURPOSE: The purpose of this study is to identify barriers, facilitators, and consequences of obtaining sufficient sleep in adolescents with type 1 diabetes. METHODS: Semistructured interviews were conducted with 25 adolescents (52% female, mean age = 15.6 years) and 25 caregivers. Interviews were transcribed and coded using Atlas.ti. A thematic analytic approach was used to identify and organize significant patterns of meaning (themes) and interpret themes across the data. RESULTS: Several barriers were identified, with the most common being the use of electronics before bed and sleep disturbances related to diabetes management. Caregivers described strategies for helping adolescents achieve sufficient sleep, such as enforcing bedtimes and limiting distractions, but many adolescents could not identify facilitators of sleep. Weekday/weekend discrepancies in sleep timing were commonly disclosed. CONCLUSIONS: This study is the first to examine the perceptions of barriers and facilitators to obtaining sufficient sleep in adolescents with T1D and their caregivers. Results have the potential to inform providers' recommendations regarding sleep, including possible interventions to promote sleep in this high-risk population.

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BACKGROUND: Nonadherence to self-care is common among patients with type 2 diabetes (T2D) and often leads to severe complications. Moreover, patients with T2D who have low socioeconomic status and are racial/ethnic minorities disproportionately experience barriers to adherence and poor outcomes. Basic phone technology (text messages and phone calls) provides a practical medium for delivering content to address patients' barriers to adherence; however, trials are needed to explore long-term and sustainable effects of mobile phone interventions among diverse patients. OBJECTIVE: The aim of this study is to evaluate the effects of mobile phone-based diabetes support interventions on self-care and hemoglobin A1c (HbA1c) among adults with T2D using a 3-arm, 15-month randomized controlled trial with a Type 1 hybrid effectiveness-implementation approach. The intervention arms are (1) Rapid Encouragement/Education And Communications for Health (REACH) and (2) REACH + Family-focused Add-on for Motivating Self-care (FAMS). METHODS: We recruited primary care patients with T2D (N=512) from Federally Qualified Health Centers and an academic medical center, prioritizing recruitment of publicly insured and minority patients from the latter. Eligible patients were prescribed daily diabetes medication and owned a cell phone with text messaging capability. We excluded patients whose most recent HbA1c result within 12 months was <6.8% to support detection of intervention effects on HbA1c. Participants were randomly assigned to REACH only, REACH + FAMS, or the control condition. REACH provides text messages tailored to address patient-specific barriers to medication adherence based on the Information-Motivation-Behavioral skills model, whereas FAMS provides monthly phone coaching with related text message content focused on family and friend barriers to diet and exercise adherence. We collect HbA1c and self-reported survey data at baseline and at 3, 6, and 12 months, and again at 15 months to assess sustained changes. We will use generalized estimating equation models to test the effects of REACH (either intervention arm) on HbA1c relative to the control group, the potential additive effects of FAMS, and effects of either intervention on adherence to self-care behaviors and diabetes self-efficacy. RESULTS: The trial is ongoing; recruitment closed December 2017. We plan to perform analyses on 6-month outcomes for FAMS in July 2018, and project to have 15-month data for REACH analyses in April 2019. CONCLUSIONS: Our study will be one of the first to evaluate a long-term, theory-based text messaging intervention to promote self-care adherence among racially/ethnically and socioeconomically diverse adults with T2D. Moreover, our study will assess the feasibility of a family-focused intervention delivered via mobile phones and compare the effects of text messaging alone versus text messaging plus phone coaching. Findings will advance our understanding of how interventions delivered by phone can benefit diverse patients with chronic conditions. TRIAL REGISTRATION: ClinicalTrials.gov NCT02409329; https://clinicaltrials.gov/ct2/show/NCT02409329 (Archived by WebCite at http://www.webcitation.org/6yHkg9SSl); NCT02481596; https://clinicaltrials.gov/ct2/show/NCT02481596 (Archived by WebCite at http://www.webcitation.org/6yHkj9XD4).

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Relatively little is known about what helps increase physical activity in African American men, and even less is known about promoting physical activity among Latino men. This systematic review aimed to address the key questions: (a) what is the state of the evidence on health-related behavior change interventions targeting physical activity among African American or Latino men? and (b) What factors facilitate physical activity for these men? For this review, nine electronic databases were searched to identify peer-reviewed articles published between 2011-2017 that reported interventions to promote physical activity among African American or Latino men. Following PRISMA guidelines, nine articles representing seven studies that met our criteria were identified: six published studies that provided data for African American men, and one published study provided data for Latino men. Consistent with previous reviews, more research is needed to better understand how gender can be incorporated in physical activity interventions for African American and Latino men. Future interventions should explore how being an adult male and a man of color shapes motivations, attitudes, and preferences to be physically active. Studies should consider how race and ethnicity intersect with notions of masculinity, manhood and Machismo to enhance the effectiveness of physical activity interventions for these populations. Despite the health benefits of physical activity, rates of these behaviors remain low among African American and Latino men. It is essential to determine how best to increase the motivation and salience for these men to overcome the obesogenic environments and contexts in which they often live.

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