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Background: The Diabetes Prevention Program (DPP) and metformin can prevent or delay the onset of type 2 diabetes mellitus (T2DM) among patients with prediabetes. Yet, even when these evidence-based strategies are accessible and affordable, uptake is low. Thus, there is a critical need for effective, scalable, and sustainable approaches to increase uptake and engagement in these interventions., Methods: In this randomized controlled trial, we will test whether financial incentives and automated messaging to promote autonomous motivation for preventing T2DM can increase DPP participation, metformin use, or both among adults with prediabetes. Participants (n = 380) will be randomized to one of four study arms. Control Arm participants will receive usual care and educational text messages about preventing T2DM. Incentives Arm participants will receive the Control Arm intervention plus financial incentives for DPP participation or metformin use. Tailored Messages Arm participants will receive the Control Arm intervention plus tailored messages promoting autonomous motivation for preventing T2DM. Combined Arm participants will receive the Incentives Arm and Tailored Messages Arm interventions plus messages to increase the personal salience of financial incentives. The primary outcome is change in hemoglobin A1c from baseline to 12 months. Secondary outcomes are change in body weight, DPP participation, and metformin use., Discussion: If effective, these scalable and sustainable approaches to increase patient motivation to prevent T2DM can be deployed by health systems, health plans, and employers to help individuals with prediabetes lower their risk for developing T2DM., Competing Interests: Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Dr. Kevin Volpp is the co-owner of the consulting firm VALHealth. Dr. Jeff Kullgren has received consulting fees from SeeChange Health, HealthMine, and the Kaiser Permanente Washington Health Research Institute; and honoraria from the Robert Wood Johnson Foundation, AbilTo, Inc., the Kansas City Area Life Sciences Institute, the American Diabetes Association, the Donaghue Foundation, and the Luxembourg National Research Fund. All other authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Background: Motor vehicle collisions remain a leading cause of unintentional injury deaths among children in the United States despite the proven effectiveness of child restraint systems (CRS). Laws and public education campaigns have fallen short of ensuring child passenger safety guideline adherence (i.e., correct use of a size-appropriate CRS in the back seat on every trip) across the population., Methods: This randomized controlled trial will test the efficacy of Tiny Cargo, Big Deal!/Abróchame Bien, Cuídame Bien (TCBD/ABCB), a precision prevention intervention, grounded in Self-Determination Theory, that integrates motivational interviewing and tailored eHealth components to promote child passenger safety guideline adherence over the course of one year. Using in-person and remote recruitment, we seek to enroll 900 English or Spanish-speaking adult caregivers of children 6 months to 10 years of age who sought emergency or urgent care and screened non-adherent to child passenger safety guidelines. Eligible caregivers provide informed consent and complete a baseline assessment before randomization. At 6 months, only intervention group participants who remain non-adherent are re-randomized to standard or enhanced intervention. We assess caregiver-submitted photographs throughout the year using the Child Passenger Safety Score and provide personalized feedback. The primary outcome of guideline adherence is assessed at 12-months. The trial has been registered with clinicaltrials.gov: NCT04238247., Implications: We hypothesize TCBD/ABCB will be more efficacious than enhanced usual care for promoting guideline adherence at 12-month follow-up. The intervention is expected to benefit children in families who have not responded to legal requirements and population-based strategies for child passenger safety., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Despite the burdens costs can place on adults with diabetes, few evidence-based, scalable interventions have been identified that address prevalent health-related financial burdens and unmet social risk factors that serve as major obstacles to effective diabetes management. In this study, we will test the effectiveness of CareAvenue - an automated e-health tool that screens for unmet social risk factors and informs and activates individuals to take steps to connect to resources and engage in self-care. We will determine the effectiveness of CareAvenue relative to standard care with respect to improving glycemic control and patient-centered outcomes such as cost-related non-adherence (CRN) behaviors and perceived financial burden. We will also examine the role of patient risk factors (moderators) and behavioral factors (mediators) on the effectiveness of CareAvenue in improving outcomes. We will recruit 720 patients in a large health system with uncontrolled Type 1 diabetes mellitus (T1DM) or Type 2 diabetes mellitus (T2DM) who engage in CRN or perceive financial burden. Participants will be randomized to one of two arms: 1) receipt of a 15-20 min web-based program with routine follow-up (CareAvenue); or 2) receipt of contact information for existing health system assistance services. Outcomes will be assessed at baseline and 6- and 12-month follow-up. Clinical Trial Registration: ClinicalTrials.gov ID NCT03950973, May 2019., Competing Interests: Declaration of Competing Interest The authors have no conflicts of interest to disclose., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Background: Tobacco use prevalence is high among pregnant Alaska Native (AN) women but few interventions have been evaluated for this group. The Healthy Pregnancies Project aims to evaluate a multicomponent intervention for reducing tobacco use during pregnancy and the postpartum period among AN women. This report describes the study protocol and participant baseline characteristics., Design: Cluster-randomized controlled trial with village as the unit of assignment. Sixteen villages in rural southwest Alaska were stratified on village size and randomized to a multicomponent intervention (n = 8 villages) or usual care (n = 8 villages)., Methods: Pregnant AN women from the study villages were enrolled. All participants receive the usual care provided to pregnant women in this region. Participants from intervention villages additionally receive individual phone counseling on healthy pregnancies plus a social marketing campaign targeting the entire community delivered by local AN "Native Sisters." Baseline measurements for all enrolled pregnant women have been completed. Follow-up assessments are ongoing at delivery, and at 2 and 6 months postpartum. The primary outcome is biochemically verified tobacco use status at 6 months postpartum., Results: Recruitment was feasible with 73% of eligible women screened enrolled. The program reached more than half (56%) of AN pregnant women from the study villages during the recruitment period. Participants are N = 352 pregnant AN women, 188 enrolled from intervention villages and 164 from control villages. At baseline, participants' mean (SD) age was 25.8 (5.0) years, they were at 26.8 (9.8) weeks gestation, and 66.5% were current tobacco users., Discussion: Processes and products from this project may have relevance to other Native American populations aiming to focus on healthy pregnancies in their communities., (Copyright © 2019 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: The Families Improving Together (FIT) randomized controlled trial tests the efficacy of integrating cultural tailoring, positive parenting, and motivational strategies into a comprehensive curriculum for weight loss in African American adolescents. The overall goal of the FIT trial is to test the effects of an integrated intervention curriculum and the added effects of a tailored web-based intervention on reducing z-BMI in overweight African American adolescents., Design and Setting: The FIT trial is a randomized group cohort design the will involve 520 African American families with an overweight adolescent between the ages of 11-16 years. The trial tests the efficacy of an 8-week face-to-face group randomized program comparing M + FWL (Motivational Plus Family Weight Loss) to a comprehensive health education program (CHE) and re-randomizes participants to either an 8-week on-line tailored intervention or control on-line program resulting in a 2 (M + FWL vs. CHE group) × 2 (on-line intervention vs. control on-line program) factorial design to test the effects of the intervention on reducing z-BMI at post-treatment and at 6-month follow-up., Intervention: The interventions for this trial are based on a theoretical framework that is novel and integrates elements from cultural tailoring, Family Systems Theory, Self-Determination Theory and Social Cognitive Theory. The intervention targets positive parenting skills (parenting style, monitoring, communication); cultural values; teaching parents to increase youth motivation by encouraging youth to have input and choice (autonomy-support); and provides a framework for building skills and self-efficacy through developing weight loss action plans that target goal setting, monitoring, and positive feedback., (Copyright © 2015. Published by Elsevier Inc.)

Background: Stroke is a disease with tremendous individual, family, and societal impact across all race/ethnic groups. Mexican Americans, the largest subgroup of Hispanic Americans, are at even higher risk of stroke than European Americans., Aim: To test the effectiveness of a culturally sensitive, church-based, multi-component, motivational enhancement intervention for Mexican Americans and European Americans in reducing stroke risk factors., Methods: Participants enroll in family or friendship pairs, from the same Catholic church in the Corpus Christi Texas area, and are encouraged to change diet and physical activity behaviors and provide support for behavior change to their partners. Churches are randomized to either the intervention or control group. Goal enrollment for each of the 10 participating churches is 40 participant pairs. The intervention consists of self-help materials (including a motivational short film, cookbook/healthy eating guide, physical activity guide with pedometer, and photonovella), five motivational interviewing calls, two tailored newsletters, parish health promotion activities and environmental changes, and a peer support workshop where participants learn to provide autonomy supportive counseling to their partner. SHARE's three primary outcomes are self-reported sodium intake, fruit and vegetable intake, and level of physical activity. Participants complete questionnaires and have measurements at baseline, six months, and twelve months. Persistence testing is performed at 18 months in the intervention group. The trial is registered with clinicaltrials.gov (NCT01378780)., (Copyright © 2012 Elsevier Inc. All rights reserved.)

Background: Higher rates of attrition in health research have been reported for African Americans (AAs). However, little is known about which AAs are more prone to drop out and why. One potential predictor that has not been explored is Ethnic Identity (EI). This study examined the association between EI and loss-to-follow-up among AAs enrolled in a health promotion intervention to increase fruit and vegetable intake., Methods: Five hundred and sixty AA adults from two integrated health care delivery systems in Atlanta and Detroit were enrolled into a randomized intervention trial. At baseline, all participants were classified into six EI core groups: Afrocentric, Black American, Bicultural, Multicultural, Assimilated, and High Cultural Mistrust. We examined loss-to-follow-up rates by these EI type., Results: Overall, 92 participants (16%) were lost to follow up. Loss-to-follow-up rates were higher among those classified as Afrocentric (24%) than those without an Afrocentric identity (13%). After adjustment for covariates, Afrocentric participants were 1.9 times (CI: 1.1-3.6) more likely to be lost to follow up than participants without this identity type., Conclusions: Assessing EI of AAs in research studies may help identify groups at risk for dropout and/or non-response., (Copyright 2010 Elsevier Inc. All rights reserved.)