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Background: Among 96 million U.S. adults with prediabetes, adoption of evidence-based treatment to prevent diabetes remains low. Primary care represents an essential venue for preventing diabetes, yet providers in this setting have limited time to address prevention. This highlights the need for low-touch interventions that promote diabetes prevention and are not delivered by primary care providers. Text messaging and decision aids displaying disease risk and treatment information have improved outcomes in prior research. However, these approaches have not been definitively studied for managing prediabetes., Methods: The Behavioral Nudges for Diabetes Prevention (BEGIN) trial is a pragmatic, cluster randomized trial testing the effectiveness of text messaging about diabetes prevention and a prediabetes decision aid. These interventions are being studied in 8 primary care clinics using a 2 × 2 factorial design, in which pairs of clinics are randomized in a 1:1:1:1 ratio to receive usual care, text messaging alone, prediabetes decision aid alone, or both interventions. A total of 656 patients are recruited to participate, receive the study interventions, and contribute data at baseline and 12 months. The primary outcome is 12-month weight change, and the secondary outcome is adoption of evidence-based treatment to prevent diabetes. Change in hemoglobin A1c is an exploratory outcome that will be assessed among participants with available values., Conclusion: Findings from the BEGIN trial will provide evidence about the effectiveness of two novel, low-touch interventions focused on diabetes prevention in primary care, where patients are diagnosed with prediabetes and there is little prior research., Trial Registry: NCT04869917., Competing Interests: Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Dr. Ackerman has received consultant fees from UnitedHealth Group unrelated to this study. The other authors have no potential competing financial interests., (Copyright © 2023 Elsevier Inc. All rights reserved.)

This pilot trial studied a novel intervention that integrated diabetes technologies into team-based primary care for type 2 diabetes. We found clinically significant reductions in blood pressure, weight, and glucose. The latter two were statistically significant., (Copyright © 2021. Published by Elsevier Ltd.)

Fit2Thrive is a theory-guided physical activity promotion trial using the Multiphase Optimization Strategy (MOST) to test efficacy for improving physical activity of five technology-supported physical activity promotion intervention components among breast cancer survivors. This trial will recruit 256 inactive breast cancer survivors nationwide. All participants will receive the core intervention which includes a Fitbit and standard self-monitoring Fit2Thrive smartphone application which will be downloaded to their personal phone. Women will be randomized to one of 32 conditions in a factorial design involving five factors with two levels: support calls (No vs. Yes), app type (standard vs. deluxe), text messaging (No vs. Yes), online gym (No vs. Yes) and Fitbit Buddy (No vs. Yes). The proposed trial examines the effects of the components on physical activity at 12 and 24weeks. Results will support the selection of a final package of intervention components that has been optimized to maximize physical activity and is subject to an upper limit of cost. The optimized intervention will be tested in a future trial. Fit2Thrive is the first trial to use the MOST framework to develop and test a physical activity promotion intervention in breast cancer survivors and will lead to an improved understanding of how to effectively change survivors' physical activity. These findings could result in more scalable, effective physical activity interventions for breast cancer survivors, and, ultimately, improve health and disease outcomes., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Intervening in Diabetes with Healthy Eating, Activity and Linkages To Healthcare (I-D-HEALTH) is a community-based randomized trial evaluating the effectiveness of a group-based adaption of the Look AHEAD intensive lifestyle intervention. Most potentially eligible patients were identified through electronic medical record queries or referral to a diabetes resource hub. Trial enrollees had a usual source of primary care, elevated body mass index (BMI) and type 2 diabetes. I-D-HEALTH participants were randomized to either standard care alone or standard care plus free-of-charge access to a group-based lifestyle intervention (GLI) offered by the YMCA. GLI participation was encouraged, but not required, for the latter group. The primary outcome is percent weight change over 6, 12 and 24months. Secondary outcomes include direct intervention costs and direct medical and non-medical expenditures, as well as changes in systolic blood pressure, hemoglobin A1c and cholesterol. Among 331 I-D-HEALTH participants, 167 were randomized to standard care and 164 to GLI. The mean age (±standard deviation) in each group was 57.1years (±12.2) and 57.6years (±10.5), respectively. Mean BMI was 34.9kg/m(2) (±7.3) among standard care participants and 36.2kg/m(2) (±7.8) among GLI participants. In both groups, approximately one third of participants were non-Hispanic Whites. We detected no significant differences between groups in mean systolic blood pressure, hemoglobin A1c or total cholesterol (P >0.05 for all characteristics above). The I-D-HEALTH study enrolled a diverse sample of adults with diabetes and offers a unique opportunity to evaluate the effectiveness of offering a community-based intensive lifestyle intervention., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Promotora Effectiveness Versus Metformin Trial (PREVENT-DM) is a randomized comparative effectiveness trial of a lifestyle intervention based on the Diabetes Prevention Program delivered by community health workers (or promotoras), metformin, and standard care. Eligibility criteria are Hispanic ethnicity, female sex, age ≥ 20 years, fluent Spanish-speaking status, BMI ≥ 23 kg/m(2), and prediabetes. We enrolled 92 participants and randomized them to one of the following three groups: standard care, DPP-based lifestyle intervention, or metformin. The primary outcome of the trial is the 12-month difference in weight between groups. Secondary outcomes include the following cardiometabolic markers: BMI, waist circumference, blood pressure, and fasting plasma glucose, hemoglobin A1C (HbA1c), total cholesterol, triglycerides, LDL cholesterol, HDL cholesterol, and insulin. PREVENT-DM participants are socioeconomically disadvantaged Latinas with a mean annual household income of $15,527 ± 9922 and educational attainment of 9.7 ± 3.6 years. Eighty-six percent of participants are foreign born, 20% have a prior history of gestational diabetes, and 71% have a first-degree relative with diagnosed diabetes. At baseline, PREVENT-DM participants had a mean age of 45.1 ± 12.5 years, weight of 178.8 ± 39.3 lbs, BMI of 33.3 ± 6.5 kg/m(2), HbA1c of 5.9 ± 0.2%, and waist circumference of 97.4 ± 11.1cm. Mean baseline levels of other cardiometabolic markers were normal. The PREVENT-DM study successfully recruited and randomized an understudied population of Latinas with prediabetes. This trial will be the first U.S. study to test the comparative effectiveness of metformin and lifestyle intervention versus standard care among prediabetic adults in a "real-world" setting., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Reaching Out and Preventing Increases in Diabetes (RAPID) is a community-based randomized trial evaluating the comparative costs and effectiveness of a group-based adaption of the DPP lifestyle intervention developed and implemented in partnership with the YMCA. RAPID enrolled adult primary care patients, with BMI 24 kg/m(2) or higher and abnormal glucose metabolism (HbA1c 5.7-6.9% or fasting plasma glucose 100-125 mg/dL). 509 participants were enrolled and randomized to one of two groups: standard clinical advice plus free-of-charge access to a group-based adaption of the DPP offered by the Y, versus standard clinical advice alone. Key outcomes for future analysis will include differences in body weight and other cardiovascular risk factors over a 24-month intervention period. At baseline, RAPID participants had a mean (SD) age of 51 ± 12.1 years, weight of 225.1 ± 56.2 lbs, and BMI of 36.9 ± 8.6 kg/m(2). 70.7% were women, 57.2% were African American, 35.4% were non-Hispanic White, and 3.2% were Hispanic. Mean HbA1c was 6.05 ± 0.34%. Additionally, 55.4% of participants had a baseline systolic blood pressure of ≥130 mmHg, 33.1% had a total blood cholesterol exceeding 200mg/dL, and 74% reported a household income of <$25,000. The RAPID Study successfully randomized a large cohort of participants with a wide distribution of age, body weight, and race who are at high risk for developing type 2 diabetes., (© 2013.)

Objective: To evaluate Positive Choices (PC), a program that employed lay health workers to motivate antiretroviral adherence among persons living with HIV with coverage from Indiana's high-risk insurance pool., Methods: Four hundred and forty nine participants living in the greater Indianapolis area were randomly allocated to treatment (n = 91) or control (n = 358) groups and followed for one year., Results: Compared to control subjects, PC subjects were more likely to adhere to HIV medications (medication possession ratio adherence ≥ 0.95, OR = 1.83, p = 0.046), and to achieve undetectable viral load (<50 copies/mL, OR = 2.01, p = 0.011) in the 12 months following introduction of PC. There were no significant differences observed between groups in any of self-reported health status indicators., Conclusion: Estimates suggest that PC clients were 16% more likely to have undetectable viral loads than clients in standard care. The incremental program cost was approximately $10,000 for each additional person who achieved an undetectable viral load., Practice Implications: As persons living with HIV experience greater longevity and healthcare reform expands coverage to these high-risk populations, greater demands will be placed on the HIV-care workforce. Results suggest lay health workers may serve as effective adjuncts to professional care providers., (Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.)