Clinical trials

The goal of this study is to evaluate the impact of a multi-level intervention on cancer prevention and social determinants of health outcomes. This partnership between academic and community-based researchers aims to link community health centers and communities in ways that maximize both civic engagement and participation in cancer control care. The system-level intervention consists of two components: (1) provision of community health center systems-level tools for cancer screening (breast, cervical, colorectal) and tobacco cessation treatment gaps; and (2) digital access screening and navigation. These interventions will be delivered via usual care.

The overall goal is to identify trends and longitudinal associations in psychosocial, food-related, and cardiometabolic risk factors that can guide public health priorities and future research needs aimed at reducing cardiovascular-related disparities in Puerto Rico. To this end, investigators will establish 'PROSPECT: Puerto Rico Observational Study of Psychosocial, Environmental, and Chronic disease Trends', an island-wide, longitudinal population cohort of 2,500 adults (30-75 years) in PR recruited with a community-wide sampling strategy, and assessed in a network of several partner clinics across the island. The study will collect comprehensive data on multiple psychosocial, dietary, and food-related factors, CVD biological markers, and medical record data, with follow-up at 2-years, and will assess variations by urban-rural area and by timing before-after Maria.

This study is a three-arm, individually randomized controlled trial evaluating the impact of digitally delivered nutrition education, layered onto multiple micronutrient supplementation (MMS), on anemia and related health behaviors among adolescents in Dar es Salaam, Tanzania. A total of 1,200 adolescents aged 15-19 years with access to a phone (own or shared) will be enrolled from the Dar es Salaam Health and Demographic Surveillance System and followed for 9 months, with assessments at baseline, 4 months, and 9 months. All participants will receive a brief in-person nutrition education session, printed brochures on adolescent nutrition and anemia, and a 2-month supply of daily MMS tablets with instructions and access to refills (Control arm). In Intervention Arm I, participants will receive the same package plus weekly one-way SMS/WhatsApp messages reinforcing key nutrition content and adherence to MMS and refills. In Intervention Arm II, participants will receive all components of Arm I plus fortnightly, in-person group digital nutrition education sessions that include interactive content and opportunities to co-create and share digital nutrition messages with peers. All participants will receive information on replenishing the tablets. Participants in Intervention Arm I and Intervention Arm II will receive additional nutrition, diet, and physical activity-related messages along with reminders and motivational encouragement to replenish their supplement stocks. The primary outcome is anemia prevalence, assessed using hemoglobin concentration and WHO age- and sex-specific cutoffs. Secondary outcomes include moderate/severe anemia, hemoglobin levels, adherence to MMS pick-up and consumption, nutrition literacy, dietary diversity, fruit and vegetable intake, physical activity, underweight/overweight/obesity, and digital literacy. The trial also includes a mixed-methods process evaluation of feasibility, acceptability, reach, engagement with the digital components, and a cost estimation of the digital strategies.

This study will determine the effects of consuming whole fruit on blood sugar control, liver fat, and cardiovascular health in adults with type 2 diabetes who are not treated with insulin.

The goal of this stepped wedge trial is to assess the practical effects of air conditioners on hot weather impacts among older adults. The main questions it aims to answer are: How does the presence of an air conditioning unit affect heat stress, heat strain, mental health, and healthcare utilization among older adults who did not previously have access to air conditioning? How, and in what conditioners, do older adults use air conditioning once it is installed in their home? Researchers will compare participants in arms with (A) and without (B) air conditioning units in the first summer season; this will allow them to assess the effect of air conditioners. In the second summer season, both arms will have air conditioning units, but those in the year two distribution arm (B) will receive an electricity subsidy, while those in the year one AC distribution arm (A) will not, allowing researchers to assess the effect of an electricity subsidy. Participants will be randomized to receive an air conditioner and financial support for electricity costs in either the first summer season or the second summer season of the study. * Heat stress, heat strain, mental health, and healthcare utilization will be assessed via participant survey. * Air conditioner utilization will be assessed via continuous load monitoring devices. * Indoor air temperature will be assessed via continuous data loggers.

The goal of the LIFT-UP randomized controlled trial is to evaluate the efficacy of feeding routinely and fortified human milk using a standardized clinical protocol to very low birthweight (VLBW) or very preterm (VPT) infants in the NICU compared to not feeding routinely fortified human milk using the standardized clinical protocol. The primary research question is: Will VLBW or VPT infants in the NICU who are fed fortified human milk using a standardized feeding protocol have better growth outcomes by facility discharge and at 3 months of age, less illness by discharge, and decreased mortality by discharge and at one month compared to those who are not routinely fed fortified human milk using the same feeding protocol?

Bacterial infections among young infants, including sepsis, meningitis, and pneumonia, continue to cause a substantial number of deaths globally. Zinc supplementation in combination with standard antibiotic therapy may represent a new intervention to reduce mortality and improve treatment outcomes for young infants with clinical severe infection. The Investigators will conduct a randomized, double-blind, placebo-controlled trial of zinc supplementation among young infants 0-59 days with severe clinical infection. The trial will enroll 3,250 Tanzanian infants hospitalized with clinical severe infection as defined by WHO Integrated Management of Childhood Illness (IMCI) guidelines. Enrolled infants will receive standard clinical management including antibiotics and will be randomized to receive either a 14-day course of twice-daily 5 mg elemental zinc (10 mg per day) or a matching placebo regimen.

This project will determine whether a diet culturally adapted to adults in Puerto Rico can effectively decrease cardiometabolic risk factors. This will help define a culturally-appropriate, feasible, and sustainable diet intervention aimed at reducing cardiovascular, type 2 diabetes, and obesity outcomes.