Mansfield

Researchers are evaluating the feasibility and preliminary effectiveness of a new digital health tool called Prioritize Personalize Prescribe EXercise (P3-EX) for physicians to use when prescribing exercise to patients with cardiovascular disease (CVD) risk factors such as obesity, hypertension, dyslipidemia, and diabetes. This pilot randomized controlled trial will involve 24 physicians and 48 patients, aiming to compare P3-EX with the American College of Sports Medicine Physical Activity Vital Sign (ACSM-PAVS) method. The study addresses the challenge that many patients with CVD risk factors do not receive exercise advice due to barriers faced by physicians, including lack of time, training, and tools. Physicians will each prescribe exercise to two patients, one receiving the P3-EX exercise prescription and the other receiving the ACSM-PAVS prescription, in a randomized crossover design. Patients will follow a 12-week unsupervised exercise program with virtual weekly support from University of Connecticut Graduate Research Assistants. Participants will receive a detailed exercise information packet, record their daily exercise in a diary, and attend two virtual guidance visits during the intervention. Weekly progressive exercise goals and summary reports will be emailed to patients to support adherence. Participants will attend multiple in-person visits for assessments before and after the exercise program, including cardiovascular risk factor measurements, physical activity monitoring using accelerometers, blood tests, and questionnaires on exercise adherence and satisfaction. Physicians and patients will also complete usability and satisfaction surveys within 48 hours after receiving the exercise prescriptions. The study will monitor exercise adherence through diaries and virtual oversight over the 12 weeks, aiming to inform the feasibility and user satisfaction of P3-EX and explore its potential to improve cardiovascular health and physical activity levels.

Researchers are evaluating two play-based training programs designed to improve arm function in children aged 3 to 8 years with hemiplegia, a condition causing weakness on one side of the body. The study aims to assess how feasible and satisfying these community-based programs are when co-delivered by researchers and caregivers. The programs being compared are a joystick-operated powered ride-on toy training (SPEED) and a creative upper extremity training program (CRAFT). The goal is to see how these approaches affect the children's arm motor skills and spontaneous use of their affected arm in daily activities. After confirming eligibility, children undergo baseline assessments including arm function tests and wearing activity monitors on both wrists for a week. They are then randomly assigned to either the SPEED group, which involves navigation and object tasks using modified ride-on toys controlled by the affected arm, or the CRAFT group, which involves seated creative motor games and exercises using the affected arm. Training occurs twice weekly at home or in the community for six weeks, with caregivers encouraged to provide two additional weekly sessions. The ride-on toy is provided for use during the intervention in the SPEED group, and both groups track their sessions using logs. Participants are evaluated at baseline, after the 6-week intervention, and at a 1-month follow-up through standardized assessments, questionnaires, and activity monitoring. Researchers measure treatment adherence, satisfaction, arm use in daily activities, and hand grip strength. Families also log other therapies the child receives during the study. All sessions are video recorded for detailed performance scoring. The study monitors progress over 24 months from randomization to final data collection to assess retention of treatment effects.

Researchers are evaluating how different asymmetric walking protocols help restore healthy, balanced limb loading in people who have had anterior cruciate ligament reconstruction (ACLR) surgery. The study also uses computer modeling and machine learning to predict knee loading and find the best walking pattern to improve gait symmetry after ACLR. This research focuses on individuals aged 18 to 30 who have between-limb gait differences after surgery. Participants will complete two walking sessions on separate days, walking with different speed differences between their legs. One session will have a 0.25 meters per second speed difference between limbs, and the other a 0.50 meters per second difference. The order of these sessions will be randomized, with at least three weeks between the two visits. During the sessions, participants will walk for three 15-minute intervals at set speeds: either 1.0 m/s and 1.25 m/s or 1.0 m/s and 1.50 m/s depending on the session. Throughout the study, researchers will measure changes in limb loading, stride times, and knee forces before and immediately after the walking sessions. Computer simulations will be created for each participant to assess knee joint loading, and machine learning will help analyze the effectiveness of the walking protocols in reducing harmful knee loading and improving gait. The study team will monitor these outcomes to determine which walking speed difference better restores healthy walking patterns.

Researchers are studying how Cannabidiol (CBD) might help college students with high social anxiety reduce fear responses. The study focuses on fear conditioning, where participants learn to fear a face that is sometimes followed by a mild wrist shock, while another face is never paired with a shock. The goal is to see if CBD helps these participants unlearn, or extinguish, this fear more effectively compared to a placebo. This is an early phase 1 trial involving adults aged 18 to 50. Participants will be randomly assigned to receive either a single dose of 600 mg CBD isolate in six 100 mg gel capsules or a placebo of six capsules. After the dose, participants will be exposed to the faces without any shocks to assess how quickly and thoroughly their fear responses diminish. The study compares the effects of CBD versus placebo on these fear extinction processes. Throughout the 20-minute testing session, researchers will monitor participants' electrodermal activity, which measures sweating related to fear or anxiety responses. Participants will also rate their fear using a visual scale. These measures will help determine if CBD affects the speed and extent of fear extinction. The total participation time involves this single session for learning, dosing, and testing fear responses.

Researchers are evaluating whether a specially designed amino acid supplement can help adults aged 60 to 80 living with Parkinson's disease improve their nutrition, metabolism, body composition, and physical and mental health. The study aims to find out if this supplement increases essential amino acids, boosts antioxidants, reduces amino acids linked to oxidative stress, and enhances overall health compared to a placebo. This trial focuses on addressing the unique nutritional needs of people with Parkinson's disease who have been taking dopamine replacement medication for at least two years. Participants will take either the tailored amino acid supplement, which includes essential, conditionally essential, and non-essential amino acids designed for Parkinson's disease, or a placebo containing an inert amino acid daily for six months. The study compares these two groups to see if the targeted supplement offers benefits over the placebo. The intervention is delivered as a dietary supplement taken every day over the six-month period. During the trial, participants will visit the lab at the start, after three months, and at six months for fasting blood draws, body composition assessments, and tests of physical and mental health. They will also keep diaries tracking their food and supplement intake. Researchers will measure amino acid bioavailability, oxidative stress, and other health-related markers to evaluate the supplement's effects and monitor participant safety throughout the study.

This research aims to evaluate the Diabetes LIVE JustICE application, a mobile virtual environment designed to support diabetes self-management for formerly incarcerated individuals transitioning to supervised community housing. The study addresses the higher diabetes rates and challenges faced by this population, including limited health skills, knowledge deficits, and increased hospitalizations post-release. The trial uses a randomized clinical design with a non-equivalent control group, measuring outcomes at 0, 6, and 12 weeks to assess feasibility, acceptability, and preliminary effects on diabetes knowledge, distress, self-care, social support, and metabolic control. Participants will either use the Diabetes LIVE JustICE platform or receive usual pre-release diabetes care supplemented with low-literacy diabetes education materials. The Diabetes LIVE JustICE is an interactive multi-user virtual environment accessible via IOS/Android devices, allowing real-time communication, instructor-led sessions, and access to educational resources and support. The intervention includes community areas like a community center, tranquility center, and message board, with gaming activities added during the study to enhance engagement. During the study, researchers will track recruitment, participation, engagement, user experience, and behavioral and clinical outcomes including A1C levels. Repeated assessments will be conducted at baseline, 6 weeks, and 12 weeks to monitor diabetes knowledge, emotional distress, self-management behaviors, social support, and perceived competence. Focus groups will also be conducted to evaluate acceptability among intervention participants, providing comprehensive data on the intervention's impact and user satisfaction.

Researchers are evaluating the effects of consuming grape powder on immune system markers in healthy middle-aged and older adults aged 50 to 75. The study focuses on how grapes may influence immune function, inflammation, and metabolism changes that typically occur with aging. Grapes contain nutrients and antioxidants like resveratrol, quercetin, vitamin K, and fiber, which are thought to support heart and immune health, but their impact on immune profiles during aging is not well known. Participants will consume a freeze-dried grape powder beverage and a control grape-free powder beverage that tastes the same but lacks grape compounds. Each beverage will be taken daily for 4 weeks in separate periods. During the entire 13-week study, participants will avoid eating grapes and other similar antioxidant-rich foods and beverages. The study includes 7 visits over approximately 6.25 hours total. Throughout the study, participants will complete surveys about their diet, physical activity, and medical history. Blood samples and body weight measurements will be taken to monitor changes. The main outcome measured is the concentration of interleukin-1 beta, a marker of immune response, secreted from immune cells after stimulation. Safety and adherence will be closely observed during the study period.

Researchers are studying whether daily intake of milk polar lipids (MPLs) affects heart and metabolic health risks in adults with dyslipidemia and abdominal obesity. This early phase 1 trial focuses on adults aged 18 to 70 with specific cholesterol and waist circumference criteria. The study aims to assess MPL impact on blood lipids, inflammation, lipoprotein metabolism, and gut health markers. Participants will be randomly assigned to consume either a control dairy beverage or an MPL-rich dairy beverage daily for 8 weeks. The MPL group receives dairy powder containing 6.5 grams of milk polar lipids, while the control group receives a standard dairy powder. The intervention is double-blind and parallel in design. During the 8-week period, researchers will measure changes in blood LDL cholesterol and other cardiometabolic factors. They will also evaluate systemic inflammation markers, lipoprotein particle characteristics, gut microbiota composition, gut permeability, and fecal lipids. The study includes detailed assessments and monitoring to understand the effects of MPL consumption on these health indicators.

Researchers are conducting the first dose-determination trial to find the optimal number of behavioral counseling sessions needed to improve and maintain adherence to HIV treatment. This study aims to understand how much intervention is necessary for different patient groups to achieve lasting viral suppression, helping guide health policy and the implementation of behavioral programs. It focuses on people living with HIV who have low adherence to antiretroviral therapy (ART). Participants will receive telephone-delivered behavioral self-regulation counseling focused on cognitive-behavioral skills to support HIV treatment adherence. They will be randomly assigned to one of two groups: a dose-determination group receiving weekly counseling sessions until HIV viral suppression is achieved, or a fixed-dose group receiving five scheduled counseling sessions. Counseling in the dose-determination group stops once optimal adherence or viral suppression occurs, while the fixed group completes all five sessions regardless. Participants who initially respond but later lose viral suppression may receive additional counseling. Throughout the 12-month follow-up period, researchers will assess changes in ART adherence and HIV viral load from baseline. They will monitor participants' response to counseling and track any rebound in viral load. The study will analyze how counseling dose affects different patient subgroups and the related costs, to inform decisions on resource allocation and intervention implementation. Overall, the research aims to support sustained HIV suppression through tailored behavioral interventions.

Researchers are conducting a pilot study to explore the effects of a probiotic supplement called Lactobacillus acidophilus (strain TW01), which is isolated from fermented coffee grounds, on gut health, body composition, and inflammation. This probiotic is commonly found in fermented foods like yogurt and cheese and is generally safe for healthy people. The study focuses on how this probiotic impacts substances in stool and blood, gut bacteria makeup, body composition, and their connection with inflammation markers to understand its potential health benefits. Participants will take either capsules containing the probiotic L. acidophilus (TW01) at a dose of 1.2×10¹¹ CFU per day along with a commercial fiber source or capsules with an inactive placebo (maltodextrin and magnesium stearate). The probiotic is given as three capsules daily. This study involves a crossover design where each participant receives both the probiotic and placebo during separate 6-week intervention phases. During the study, participants will be monitored for changes in fecal butyrate and other stool and blood substances, gut bacterial composition, and body composition. Researchers will track how these factors relate to inflammation markers. Participants must consume experimental capsules daily and meal kits provided. The total participation includes multiple 6-week intervention phases, with assessments at baseline and after each phase to evaluate the probiotic's effects.