Mansfield

Researchers are evaluating a new digital health tool called Prioritize Personalize Prescribe EXercise P3-EX designed to help physicians prescribe personalized exercise plans to adults with cardiovascular disease CVD risk factors such as obesity, hypertension, dyslipidemia, and diabetes. This pilot randomized controlled trial aims to test the usability and satisfaction of P3-EX compared to a standard exercise prescription method ACSM Physical Activity Vital Sign among physicians and their patients. The study addresses barriers physicians face in prescribing exercise, including lack of time, training, and tools. Physicians recruited for the study will each recruit two patients with CVD risk factors. One patient receives a personalized exercise prescription using P3-EX, and the other receives a generic exercise program based on ACSM guidelines, delivered in a random crossover design. Patients will follow their assigned exercise plans unsupervised for 12 weeks with virtual weekly support from graduate research assistants. The P3-EX tool assesses cardiovascular risk factors, prioritizes the greatest risk, and creates a tailored Frequency, Intensity, Time, and Type FITT exercise prescription. Patients will record their exercise activities in a diary and receive weekly progress reports and guidance. Participants will attend several in-person visits for assessments including cardiovascular risk factors, physical activity levels measured by accelerometry, and blood tests. Physicians and patients will rate the feasibility and acceptability of each prescription method shortly after delivery. Patient exercise adherence and changes in cardiovascular health and physical activity will be monitored over 12 weeks. The study includes virtual visits for guidance and ends with follow-up assessments to evaluate patient satisfaction and health outcomes. The total participation time for patients covers baseline and post-intervention visits plus the 12-week exercise period.

This research aims to evaluate the feasibility and usefulness of two types of play-based training programs delivered by researchers and caregivers at home or in community settings. These programs focus on improving arm function in children aged 3 to 8 years with hemiplegia, a condition causing weakness on one side of the body. The study compares a joystick-operated powered ride-on toy program called SPEED training with a creative upper extremity training program called CRAFT training, assessing their acceptance, implementation, and impact on arm use and motor skills. Participants will be randomly assigned to either the SPEED or CRAFT training group. The SPEED group uses ride-on toys modified for joystick control on the affected side, involving navigation games and object tasks to encourage arm use. The CRAFT group engages in seated creative motor games, stretching, strengthening, building, and art activities using the affected arm. Training sessions last 30-45 minutes twice weekly for 6 weeks, with caregivers providing two additional 15-20 minute sessions weekly. The ride-on toy is kept at home during the intervention, and families log all training and other therapies received. Before starting, children undergo standardized assessments and wear sensors and activity monitors to track arm use over a week. These evaluations and caregiver questionnaires are repeated after the 6-week intervention and at a 1-month follow-up. Researchers video record sessions for scoring and monitor treatment adherence, retention, satisfaction, and changes in arm function, strength, movement control, and habitual activity. Participation lasts about 12 weeks, including pretests, intervention, posttests, and follow-up assessments.

Researchers are studying individuals who have undergone anterior cruciate ligament reconstruction ACLR surgery to evaluate how specific asymmetric walking patterns can help restore balanced limb loading. The study aims to compare two different walking speed differences applied between the legs to see which better improves gait symmetry and reduces harmful knee stress. Computational modeling and machine learning will also be used to model knee loading in clinical settings to identify the best asymmetric walking approach for these patients. Participants will take part in two separate asymmetric walking sessions on different days, with at least three weeks between sessions. One session involves walking where one leg moves at 1.0 ms and the other at 1.25 ms a 0.25 ms speed difference, and the other session involves a 0.50 ms difference where one leg moves at 1.0 ms and the other at 1.5 ms. Each session includes three 15-minute asymmetric walking intervals followed by 5-minute periods of walking symmetrically at 1.0 ms. The order of sessions is randomized for each participant. During the study, researchers will gather data on walking patterns and knee joint loading before and immediately after the sessions. They will measure changes in loading rate, ground reaction forces, stride time, and knee loading using patient-specific simulations. The study will assess how these asymmetric walking protocols influence gait and joint stress in post-ACLR individuals. The total participation spans across the two walking sessions with a minimum three-week gap between them.

Researchers are studying the effects of Cannabidiol CBD on fear learning and anxiety in college students who have high levels of social anxiety. This early phase 1 trial recruits undergraduates at the University of Connecticut who show elevated social anxiety on standard tests. The study aims to see if CBD can help reduce fear responses during a controlled fear conditioning experiment. Participants will undergo a fear conditioning test where they learn to associate one face with a mild wrist shock and another face with no shock. After learning, half of the participants will receive a single 600 mg dose of CBD isolate gel capsules, while the other half will receive placebo capsules. Following this, participants will be exposed to the faces again without shocks to measure how quickly and effectively their fear responses diminish. Throughout the study, researchers will monitor participants electrodermal responses and subjective fear ratings using a visual scale to assess fear extinction. The primary outcome is the electrodermal activity measured over 20 minutes. The trial is randomized and double-blind, with all participants completing the study within a single session. Safety and response data will be collected during this time to evaluate how CBD affects anxiety and learning.

Researchers are investigating whether a specially designed amino acid supplement can help adults with Parkinsons disease improve their nutrition, metabolism, body composition, and physical and mental health. The study aims to see if this tailored supplement increases key essential amino acids and antioxidants, reduces harmful amino acids linked to oxidative stress, and improves overall health compared to a placebo. The trial focuses on people aged 60 to 80 years who have Parkinsons disease and are on stable dopamine replacement therapy. Participants will be randomly assigned to take either the targeted amino acid supplement or an inactive placebo containing alanine daily for six months. The supplement includes a blend of essential, conditionally essential, and non-essential amino acids chosen to meet the unique nutritional needs of people with Parkinsons disease. The study is designed as a quadruple-blind trial, meaning neither participants nor researchers know who receives the supplement or placebo during the study. During the trial, participants will visit the lab at the start, after three months, and after six months for fasting blood tests to measure amino acid levels and oxidative stress. Their body composition will be assessed using bioelectrical impedance and ultrasound techniques. Physical function tests such as balance, walking speed, strength, and grip will be conducted, along with questionnaires on quality of life, fatigue, sleep, mood, anxiety, motivation, and depression. Physical activity will be monitored before and after the study, and insulin sensitivity will also be evaluated. Participants will keep diaries of their food and supplement intake throughout the six months.

This research aims to evaluate the Diabetes LIVE JustICE application, designed to support diabetes self-management among formerly incarcerated individuals transitioning to supervised community housing. This group experiences a higher rate of diabetes and faces challenges such as limited diabetes knowledge, cognitive impairment, and restricted access to healthcare skills. The study uses a randomized clinical trial design with repeated assessments at 0, 6, and 12 weeks to examine feasibility, acceptability, and preliminary effects on behavior and clinical outcomes including glycemic control. Participants will be assigned to either the Diabetes LIVE JustICE intervention or a control group receiving enhanced pre-release diabetes education. The intervention group accesses a multi-user virtual environment via IOSAndroid mobile devices, offering real-time communication, instructor-led education, support sessions, and interactive resources over six weekly 1-hour sessions plus a support hour. The control group receives nurse-delivered diabetes education and literacy-tailored materials. The six-week series will be run multiple times over 18 months. During the study, participants will be monitored for recruitment, engagement, participation rates, and user experience. Assessments include diabetes knowledge, emotional distress, self-care behaviors, social support, perceived competence, and metabolic indicators like A1C. Focus groups will gather feedback on acceptability. Researchers will track changes from baseline through week 12, aiming to understand the interventions impact on diabetes management and support for this vulnerable population.

Researchers are investigating how consuming grape powder affects immune system markers, inflammation, and metabolism in healthy adults aged 50 to 75. This study focuses on understanding how grapes, which contain nutrients and antioxidants like resveratrol and quercetin, may influence immune function changes that occur with aging. The study is sponsored by the University of Connecticut and aims to explore the impact of grape consumption on immune health in middle- and older-aged individuals. Participants will consume a freeze-dried grape powder or a control powder that tastes the same but lacks grape compounds. Each powder is taken daily as a beverage for 4 weeks, with a total study duration of 13 weeks. During this time, participants must avoid eating grapes and certain other foods rich in antioxidants and polyphenols. The study includes a randomized, double-blind design comparing the effects of the grape powder to the control. Throughout the 13 weeks, participants will attend 7 visits lasting about 6.25 hours in total. They will provide blood samples, complete surveys about diet, physical activity, and medical history, and have their body weight measured. Researchers will measure immune markers such as the concentration of lipopolysaccharide-induced interleukin-1 beta secreted from immune cells. The study monitors health and immune responses to understand the effects of grape powder consumption in healthy aging adults.

Researchers are evaluating the effects of daily consumption of milk polar lipids MPLs on cardiometabolic risk factors in adults with dyslipidemia and abdominal obesity. This randomized, double-blind, controlled study aims to assess how MPLs influence serum lipid levels, inflammation markers, lipoprotein metabolism, and gut health in this population. Participants will be randomly assigned to one of two groups one consuming a dairy beverage rich in MPLs containing 6.5 g of MPL daily, and a control group consuming a dairy beverage with less than 0.1 g of MPL daily. Both groups will follow this regimen for 8 weeks. The study evaluates four key objectives including effects on serum lipids, inflammation, lipoprotein particle features, and gut microbiota and permeability. During the study, participants will have their serum LDL cholesterol measured at baseline and after 8 weeks to assess changes. Researchers will also monitor systemic biomarkers of inflammation, lipoprotein characteristics, and gut-related markers. The study includes careful monitoring of adherence and safety, with the entire participation lasting 8 weeks of intervention.

This research aims to find the best number of behavioral counseling sessions needed to help people with HIV improve and maintain their treatment adherence and viral suppression. It is the first dose-determination trial that studies how much counseling is needed for different patients facing various individual and social challenges. The results will help guide health policy and how behavioral interventions are used to support lasting HIV viral suppression among patients on antiretroviral therapy ART. Participants who are confirmed HIV positive and non-adherent to ART will be randomly assigned to one of two groups. One group receives up to 16 weekly phone counseling sessions that adjust based on their response to achieve viral suppression. The other group gets a fixed dose of five weekly counseling sessions over the phone focused on improving medication adherence. Counseling aims to support cognitive-behavioral skills for HIV treatment adherence, with follow-up assessments for 12 months. During the study, researchers will regularly measure changes in ART adherence and HIV viral load from baseline through 12 months. Participants who respond but later experience viral rebound can receive additional counseling sessions. The study will analyze how counseling dose relates to patient subgroups and costs to help make informed decisions about resource allocation for behavioral interventions. Overall, the trial involves phone counseling sessions, adherence and viral load monitoring, and 12 months of follow-up to assess outcomes and intervention dose effectiveness.

Researchers are evaluating the effects of a probiotic supplement, Lactobacillus acidophilus strain TW01, on gut health, body composition, and inflammation in overweight or obese but otherwise healthy adults aged 18 to 60 years. This early phase pilot study aims to understand how this probiotic, isolated from fermented coffee grounds, influences substances found in stool and blood, gut bacteria composition, and markers of inflammation to explore its impact on overall health. Participants are randomly assigned to one of two groups in a single-blind design. One group consumes capsules containing an inactive placebo, while the other group takes capsules with L. acidophilus TW01 at a dose of 1.2 x 1011 CFU per day plus a commercial fiber source, Fibersol-2. Each intervention phase lasts six weeks. Participants are expected to consume the capsules daily and prepare and eat provided meal kits throughout the study. During the study, researchers collect stool and blood samples to measure fecal butyrate levels, serum inflammation markers, and body fat composition at baseline and after each six-week intervention phase. The study includes safety monitoring and tracks participants adherence to the protocol. The total participation period covers the duration of the intervention phases and assessments, ending by December 2027.