Christchurch, Australia

Addressing Weight Bias Internalization to Improve Adolescent Weight Management Outcomes: Randomized Pilot Trial

The overall goal of this project is to examine the impact of intervening on weight bias internalization (WBI) in conjunction with evidence-based adolescent behavioral weight management (BWM) and to assess reduction in key mechanisms of stress resulting from weight stigma (i.e., biological markers of stress and inflammation, dysregulated eating behaviors) and subsequent impact on weight loss interference resulting from WBI. An open trial was previously conducted to test initial acceptability and feasibility of a newly developed 20-week WBI+BWM intervention (ClinicalTrials.gov ID: NCT06389656). The intervention consisted of 4 weeks of WBI followed by a 16-week BWM intervention with integrated WBI and weight stigma content. Quantitative and qualitative feedback concerning acceptability and feasibility were solicited to refine the intervention. The current study is a randomized trial that will compare the 20-week WBI+BWM intervention developed in the open trial to a Health Information Control (HIC) + BWM condition. The HIC+BWM intervention consists of a 4-week health information control (consisting of non-weight-related health promotion topics such as smoking and skin cancer) followed by the same 16-week BMI, but without WBI and weight stigma content. Primary and secondary outcomes will be assessed at the 4- and 20-week (post-treatment) timepoints. This study will evaluate the impact of the interventions on WBI, biological markers of stress and inflammation (cortisol, CRP, IL-6), and dysregulated eating behaviors. Changes in weight status will also be examined. Feasibility and acceptability will be measured during the pilot RCT to ensure ongoing fit of the intervention to the adolescent population. Data will provide effect size estimates of the impact on adolescent BMI for a large-scale randomized controlled trial (RCT).

Rhode Island - Statewide Postpartum Hypertension Remote Surveillance

Uncontrolled hypertensive disorders of pregnancy (HDP) are a major source of maternal mortality. National guidelines recommend blood pressure (BP) measurement 3-10 days after discharge and ≥1 preventive care visit within one year of delivery. Yet, barriers such as childcare or transportation issues reduce adherence to in-person BP checks, particularly among racial or ethnic minority patients. Programs in which patients self-measure BP (SMBP) at home show promising results regardless of patient race. However, a recent meta-analysis concluded current SMBP programs do not reduce maternal mortality or racial disparities in clinical outcomes, potentially due to their specific limitations: they end within six weeks of birth (though HDP can persist for months) and have decreased engagement with non-White people or those living in disadvantaged areas, though these populations are at the highest risk of persistent HTN and its adverse long-term effects. Thus, there is an urgent need to optimize SMBP programs to target short- and long-term HDP-related morbidity and to broadly implement these programs to eliminate disparities in HDP-related outcomes. One such program is Rhode Island (RI)-Statewide Postpartum HypErtension REmote Surveillance (RI-SPHERES), a technology-based SMBP program that aims to reduce short- and long-term HDP-associated morbidity in RI using the collaborative care model, a health services intervention that improves health outcomes and reduces racial disparities on a population level for people with chronic conditions. The proposed research aims to determine the effectiveness of RI-SPHERES in reducing short- and long-term morbidity associated with HDP throughout RI. This builds upon our pilot RCT (NCT05595629), in which a standard SMBP program was compared to a SMBP program that used a Bluetooth-enabled BP cuff that syncs to a smartphone application (app) to send automated reminders and provide adaptive messaging tailored to distinct BP values and symptoms. RI-SPHERES will expand this SMBP program to provide app-based patient-informed educational content on HDP-specific preventive care and bidirectional communication with RI-SPHERES staff for one year postpartum. Incorporating adaptive and automatic messaging increases RI-SPHERES' scalability by reducing clinical staff burden. However, formal analysis of factors that may hinder widespread implementation of RI-SPHERES is needed. Thus, we will conduct a Hybrid Type I Non-Inferiority Implementation-Effectiveness Trial among 1536 patients with HDP that compares a standard SMBP program to RI-SPHERES in terms of persistent HTN at six weeks postpartum and receipt of preventive care within one year of delivery (Specific Aim 1). We will examine the effect of both programs on increasing equity in terms of race, ethnicity, language, and geography for postpartum patients with HDP in Rhode Island (Specific Aim 2). We will also develop an implementation toolkit to facilitate the dissemination of RI-SPHERES (Specific Aim 3). The proposed project is expected to deliver a mechanism that will fill multiple research gaps for HDP identified by the US Preventive Services Task Force: 1) addressing health inequities through multilevel interventions, 2) evaluating SMBP programs; and 3) mitigating HDP's short- and long-term health consequences of HDP.

A New Clinical Model for the Engagement of Latinx Youth with Suicidal Behavior

The objective of this proposal is to test a New Clinical Model to engage Latinx/Hispanic (L/H) youth and their caregivers in a culturally centered, evidence-based treatment for suicidal behaviors (SB). The Socio-Cognitive Behavioral Therapy for Suicidal Behavior (SCBT-SB) is an affirmative and culturally relevant treatment with empirical evidence supporting its use for L/H youth with suicidality. The New Clinical Model consists of the addition of community health workers (CHWs) to the SCBT-SB. CHWs are trusted members of their communities who provide education and connection to resources to L/H families in their native language. A community based participatory research approach is proposed and the Socio-Cultural Framework for Health Service Disparities will be the theoretical model used.

The Dream Team: Testing Implementation of a Sleep Intervention for Perinatal Women Delivered by Direct Care Workers

Disrupted, insufficient sleep occurs in the majority of pregnant women and increases the risk of negative health consequences for mothers and their infants, including pregnancy and childbirth complications as well as chronic illnesses, such as major depression and weight retention/obesity. Conventionally, perinatal sleep disturbances have been viewed as expected and intractable, but recent studies demonstrate that behavioral interventions are effective for improving sleep in pregnant and postpartum women. Nevertheless, efficient, scalable sleep interventions that are tailored to expectant and new mothers are scarce. This Administrative Supplement for Research on Women's Health seeks to develop a high-fidelity, evidence-based sleep intervention in collaboration with direct care workers who engage with perinatal women and to collect preliminary data regarding delivery of the resulting intervention to expectant and new parents. This pilot project is grounded in the RE-AIM framework, and will assess the Reach, Effectiveness, Adoption, Implementation, and Maintenance dimensions of this model to prepare for a large-scale future R01 hybrid effectiveness-implementation trial. In Phase 1, the investigators will develop short, evidence-based, educational videos in English (with Spanish subtitles) that focus on improving perinatal sleep and that map onto modules in the free, publicly-available mobile app, CBTi Coach. Videos will be produced and refined in cooperation with direct care workers and a video production company with community engagement experience. Direct care workers who work with perinatal women will be trained to deliver the intervention (target n=35). In Phase 2, direct care workers will be invited to use the intervention with clients who report sleep problems and the investigators will study implementation in workers and clients (target n=20).

Prolonged Manual Ventilation Simulation

Remote Approaches for Optimizing Weight Loss (Elevate Weight Loss Trial)

Participants will be randomized at baseline to one of four weight loss intervention conditions: 1) automated program + coaching, 2) automated program + no coaching, 3) group videoconference program + coaching, and 4) group videoconference program + no coaching. All participants will be provided with weekly goals, instructed to self-monitor diet, exercise, and weight daily, and provided with feedback based upon these data. Those receiving the online program will also be instructed to view video lessons (24 in total, 10-15 min each) which focus on behavioral strategies for changing diet and exercise. Individuals randomized to the videoconference program will participate in 24 group sessions (1 hour each) designed to mimic in-person treatment and allow for participant interaction via large and small group discussions. The content across conditions will be similar and the lessons will be provided weekly during months 1-3, twice per month during months 4-6, and monthly during months 7-12. Those receiving coaching will have individual, monthly meetings with a coach via videoconference (~15 min each). Coaching sessions will focus on individual barriers, problem solving, goal setting, and fostering support and accountability. The primary aim of this study is to examine the effects of delivery format (automated online vs. videoconference) and coaching (individualized vs. none) on weight loss at 12 months. Secondary aims will examine the effects of delivery format and coaching on intervention engagement (e.g., frequency of self-monitoring), psychosocial outcomes (e.g., perceived support, self-efficacy, and motivation), 18-month weight loss, and the cost per kilogram of weight loss (to examine whether the addition of human support is cost-effective). Two algorithms will also be developed to predict which treatment type should be recommended to whom, using only baseline characteristics: 1) a 'widely-applicable' algorithm which will use metrics common to electronic medical records (sex, BMI, age, race, ethnicity), and 2) a 'more comprehensive' algorithm which will further include additional baseline characteristics (e.g., education, household income, health literacy, group preference, etc).

Pilot Neurobehavioral Therapy for Functional Neurological Disorder

The study aims to enroll 40 participants at Rhode Island Hospital. 20 participants with Motor Functional Neurological Disorder (mFND) will be randomized to Neurobehavioral Therapy (Group 1) and 20 participants with mFND to Standard Medical Care (Group 2). Those randomized to neurobehavioral therapy will be asked to complete treatment sessions over the course of 12 to 18 weeks. Those in the standard medical care arm will continue to receive their routine care with their clinicians. All participants regardless of group assignment, will complete a total of five in-person clinic visits at the following time points: Baseline, 6 weeks, 12 weeks, 8 Months and 12 Months. These visits will include the completion of interview questions and self-report surveys that will assess functional status, quality of life and mFND symptoms. Please see the "Arms and Interventions" section to see a more detailed description of each group/arm. The goal of this Clinical Trial is to investigate the feasibility and efficacy of Neuro-Behavioral Therapy in Individuals aged 18 to 70 diagnosed with Motor Functional Neurologic Disorder. The main questions this study aims to answer are: Aim 1: Examine the feasibility, acceptability, and practicality of manualized Neuro-Behavioral Therapy (NBT) in Functional Neurological Disorder (FND). Hypothesis 1: Manualized NBT will demonstrate feasibility through acceptability and practicality, defined as ≥80% of participants enrolling in the study will participate in the study measures (acceptability) and complete the entire study protocol (practicality), respectively. Aim 2: Examine the preliminary effectiveness of manualized NBT in improving health-related quality of life and reducing the severity and disability of mFNDs, as measured by the SF-36 and PMDRS/S-FMDRS (primary outcome), respectively. Hypothesis 2: NBT will show improvements in SF-36 scores and reductions in PMDRS scores. We will evaluate this by conducting a preliminary examination of the manualized NBT intervention, with a focus on interpreting effect sizes. We will also gather key statistics needed to inform a fully powered clinical trial, such as the standard deviation and pre-post correlation of the SF-36 and PMDRS.

Brain and Behavior Influences on Obesity Development From Infancy Through Childhood

Obesity risk shows individual variation such that some children are more likely than others to gain excess weight. One potential reason is that, due to genetic and environmental factors, individuals vary in appetitive behaviors that drive food intake and weight. However, the neurodevelopmental mechanisms underpinning variation in appetite and weight, and effects of risk and protective factors on those outcomes, are not understood. Preliminary data from RESONANCE, the investigators large MRI cohort, suggests obesity risk factors such as maternal pre-pregnancy obesity and obesity-associated genetic variants are associated with not just heightened parent-reported child appetite and adiposity, but with altered patterns of brain structure development from infancy through early childhood. However the relevance of these findings to appetitive behaviors and development of obesity in middle childhood is unknown. This is important because obesity rates and metabolic complications increase through development, adiposity and eating habits measured in later childhood track into adulthood, and obesity is harder to treat later in development, making middle childhood a key stage for capturing outcomes with relevance for lifetime metabolic health. Further, although functional magnetic resonance imaging (MRI) studies have identified altered patterns of activation in brain appetite circuits in association with pediatric obesity and early risk factors for obesity, the predictors of altered functioning of brain appetite circuits in middle childhood are unknown. Identifying the patterns of brain development that predict obesity-promoting behaviors and brain functioning in middle childhood is essential to understand the neural mechanisms by which early obesity risk factors drive excess intake and obesity, and may help pinpoint neurobehavioral targets for early obesity prevention. Finally, although preclinical research and MRI studies of children under 9 years of age support that hypothalamic gliosis, a cellular inflammatory response, plays a role in obesity pathogenesis, it is unclear whether it occurs or impacts appetite in earlier life. For the proposed study, RESONATE, the investigators will address the above research gaps by extending the RESONANCE study to administer meal tests, behavioral and functional magnetic resonance imaging (fMRI) tasks assessing food and non-food reward and cognitive control, and weight/ adiposity measures in middle childhood, and examining hypothalamic gliosis, in a sub-sample of RESONANCE children. By combining this data with extant MRI data and extant or newly-collected data on obesity risk and protective factors, the investigators will test a multi-faceted hypothesis that prenatal, genetic and postnatal factors lead to differential early development of brain appetite circuits, which in turn gives rise to variation in appetitive behaviors and behaviors involving reward processing and cognitive control as well as altered function of brain appetite circuits, that act to influence the development of obesity into middle childhood. The investigator's long-term goal is to lay foundations for developmentally-appropriate, neurobehaviorally-informed interventions to address child obesity.

Teen Health Choices & Wellness

Improving Social Connectedness Through Digital Health to Enhance Recovery from OUD Among the Justice Involved Population

Individuals with criminal justice involvement experience elevated rates of Opioid Use Disorder (OUD) and are at significantly higher risk of death from opioid overdose in the first year following release from jail/prison. Medications for OUD (MOUD) are an evidence-based approach to treating OUD and offer extensive benefits including lowering rates of mortality, illicit opioid use, HIV transmission, violent crime, and arrest. While many correctional settings have started to implement MOUD, there are significant challenges to continuing medication/treatment while transitioning back to the community. Intersectional stigma related to addiction and history of incarceration is associated with greater difficulties with reintegration, increased isolation, and heightened feelings of loneliness. Lack of social connectedness further serves as a risk factor for decreased retention in treatment, discontinuation of MOUD, and a return to substance use. Peer support is a key component of many evidence-based OUD recovery programs. When used in conjunction with MOUD, it has the potential to improve perceived social support, self-efficacy, and treatment engagement. However, access to live peer support has been challenged by COVID restrictions, highlighting a critical need for digital health platforms to deliver peer support. The Marigold Mobile Peer Support ("MPS") App is a dedicated, secure, mobile application that employs structured, live peer moderation to guide text-based conversations with groups of participants and behind-the-scenes natural language processing (NLP) to automatically identify "red flag" content within peer chats. While initial work demonstrates the utility of deploying the MPS App in outpatient treatment settings for OUD, it has yet to be tested in correctional settings or among justice-involved populations. The goal of the proposed application is to advance evidence-based and scalable treatments for OUD, by decreasing loneliness and enhancing perceived social support via novel application of an established mobile app among individuals with a history of engaging in MOUD while in jail/prison. The study will be accomplished through two primary aims: (1) develop an implementation manual to guide delivery of the MPS App for those with a recent (past year) history of engaging in MOUD while in jail/prison by conducting in-depth interviews with prospective app users and other key stakeholders; and (2) conduct a randomized controlled trial to assess feasibility, acceptability, and preliminary efficacy of the MPS App relative to enhanced treatment-as-usual among individuals with a recent (past year) history of engaging in MOUD while in jail/prison. Findings from this study will be used to develop a R01 application to conduct a fully-powered Hybrid Type 1 Effectiveness-Implementation study.