Clinical Research Directory

Quality of Home Packed School Lunch Among Children Attending Kindergarten School in Jimma Zone, South West Ethiopia, 2026

A balanced diet is critical for preschool aged children; meals must be sufficiently diverse to provide the essential nutrients required for rapid physical and cognitive development. Because dietary habits established in early childhood often persist into adulthood, prioritizing this age group is a cost-effective investment in long-term national health and productivity. However, the National Food Consumption Survey in Ethiopia indicates a significant gap in dietary quality, with only 20% of households across all age groups consuming five or more food groups. Implementing multi-component nutrition interventions is essential, as these strategies significantly influence both the eating habits and dietary preferences of preschool children.

Breath Hydrogen and Methane as Biomarkers of Fiber Intake

This study is designed to examine if mobile phone-based breath hydrogen and methane monitors can be used as a biomarker of dietary fiber intake.

Optimizing Online Purchasing of Fruits, Vegetables, and Legumes for Low-Income Families

Food insecurity, that is, the lack of consistent access to nutritious and affordable food, is associated with poor diet, increased cardiovascular disease (CVD) risk, and has a negative long-term impact on the economy through increased health care costs. CVDs and food insecurity disproportionately affect Black and Hispanic families, and most of these racial health disparities can be attributed to social determinants of health, including poor access to healthy foods. A recent policy in the U.S. authorized the Supplemental Nutrition Assistance Program (SNAP) benefits to be used online to increase grocery access and promote healthy eating. Although online grocery shopping has been growing among populations of low-income, the selection of fruits, vegetables, and legumes (FVL), which are protective against CVD, is lower than in-store. Distrust of online hired shoppers' choices, fear of losing money on unsatisfactory purchases, and impulse of unhealthy food purchases have been the major barriers to online healthy food selection. Thus, there is a need for intervention packages that are effective, economical, and easily scalable into policies that address CVD-related outcomes and improve health equity. The proposed work will use a highly efficient methodological approach, the Multiphase Optimization Strategy (MOST), to test three experimental components aimed at barriers to online healthy food selection, called OPT-FRESH. This approach addresses weaknesses in prior studies, which cannot determine which elements of multicomponent interventions meaningfully improve outcomes. 360 families with children living in low-income urban communities of NYC will be randomized to receive some combination of the three experimental components for 12 weeks: 1) weekly text messages to improve the trust in online grocery services (off/on); 2) weekly match-up to $10 as a financial incentive for purchasing FVL online targeting loss aversion (off/on); 3) weekly instant shoppable grocery lists of culturally tailored meal suggestions using SNAP recipes targeted at impulse purchases (off/on). Delivery fee waiver and a tutorial video addressing digital literacy will be constant components to promote equity in participant enrollment. Aim 1 will determine the combination(s) of the three experimental components that improve overall household FVL purchase and food insecurity (primary outcomes) and FVL intake of children (secondary outcome). Aim 2 will identify the optimized intervention that balances component(s) that are affordable and scalable (high adoption, implementation, maintenance) that still produce meaningful effects on the outcomes, using decision analysis for intervention value efficiency. Aim 3 will determine the mechanistic effects of the three intervention components on the outcomes using factorial mediation analysis. Working with community-based organizations and nutrition and hunger relief programs in NYC, a grocery delivery service, and a team with unparalleled expertise in experimental trials, policy, and MOST, we will implement optimized, affordable, and scalable intervention strategies to improve neighborhood food access and ultimately CVD outcomes in socially vulnerable families.

A Comparative Intervention Study on Strategies for Fruit Distribution and Awareness Campaigns in Schools

This implementation study evaluates two strategies to increase fruit consumption among Swedish students. (1) installing fruit stands in schools and (2) combining fruit stands with a health-awareness campaign. The intervention is implemented in a set of participating schools, each following one of the predefined strategies. Students are asked to use a research app to photograph their meals and snacks during three data-collection periods before, during, and after the intervention. The study collects information on fruit intake, eating patterns, and the number of fruits taken from the stands to assess effectiveness and reduce food waste. The aim is to identify which strategy better supports healthy eating habits in school environments.

Eating Fruits and Vegetables With Pleasure!

The objective of this interventional study is to pilot test a newly evidence-based intervention integrating different dimensions of eating pleasure to promote the consumption of fruits et vegetables. The target population for this study is men and women, aged 18-65 years old, living with a higher weight.The main hypothesis is that this newly pleasure-oriented intervention is feasible and acceptable for the target population. Participants will be randomized in two groups, a first group receiving the newly, 12-week pleasure-oriented intervention (intervention group) and a second group receiving no intervention (control group). Participants will: * Complete a battery of online questionnaires at home before and after the 12-week nutritional intervention (both intervention and control groups); * For participants assigned to the intervention group only: take part in a 12-week nutritional intervention consisting of 10 group sessions held at Laval University (approximately 2 hours each) and an individual follow-up by phone (30 to 45 minutes). After each session, participants will complete a short questionnaire assessing their appreciation of the session (5 to 10 minutes), as well as a comprehensive appreciation questionnaire at the end of the 12-week intervention (25 to 30 minutes).

The Neighborhood & Health Study

The objective of The Neighborhood \& Health Study is to use a quasi-experimental mixed-methods approach to assess the impact of living in an agrihood-an agriculturally integrated community. This study follows a longitudinal cohort of residents of a newly developed neighborhood (the Indigo Neighborhood) and a geographically and socio-demographically matched neighborhood (the Elyson Neighborhood), both located in Fort Bend County, Texas, providing a unique opportunity for a natural experiment.

Diet, Food, Exercise and Nutrition During Social Distancing

Our long-term goal is to contribute to the development of evidence-based nutritional and physical activity recommendations for the prevention and management of overweight and obesity and related chronic diseases. The overall objective for this study is to determine if a 20-week educational program, project DFEND, related to behavior change and health will improve nutrition and physical activity outcomes as well as indicators of wellbeing. Our central hypothesis is that regular attendance of weekly lectures, weekly meetings with personalized coaches, and weekly health challenges via virtual platforms (e.g. Zoom, Facebook, YouTube) will improve health outcomes related to nutrition and physical activity. Our rationale for these studies is that the results of this research will enhance the potential to develop evidence-based nutritional and physical activity behavioral recommendations to treat and/or prevent development of overweight and obesity.

Childhood Obesity Treatment Designed for Low Income and Hispanic Families

This study is a type-1 hybrid effectiveness-implementation RCT comparing a novel family-inclusive childhood obesity treatment program, the "Healthy Living Program" (HeLP), to a protocol that enhances usual primary care to deliver Recommended Treatment of Obesity in Primary Care (RTOP). Children with obesity and their families will be referred to the study by primary care providers and randomized to HeLP or RTOP. The clinical setting is a practice-based research network serving majority Hispanic and Medicaid-insured populations. The intensive phase and booster sessions of HeLP will take place at recreation centers located near the clinics and will be led by health educators employed by the clinics. Visits with primary care providers (PCPs) for HeLP maintenance or RTOP will occur at the clinics.

Examining Engagement Predictors of Health and Fitness App Uptake and Subscription in the General Population

This will be a 24-week prospective study that will incorporate user base data of WayBetter Inc.'s app, "WayBetter," to examine user mHealth app engagement. The primary objective of this study is to examine predictors (i.e., socio-demographics, past health behaviours, psychological determinants, app engagement metrics) of (a) initial six-month subscription and b) subscription renewal rates at six months for the WayBetter app. The secondary objective is to characterize WayBetter app engagement over the first 24 weeks of app use. Participants will be asked to complete a survey that aims to collect the information regarding individual-level socio-demographics, previous health behaviours, and behavioural/personality traits. App engagement metrics will be collected from the WayBetter app.

Effectiveness of Interventions to Improve Resiliency & Burnout in Behavioral Health Residential Staff

The goal of this clinical trial is to compare Integrated Resiliency Training and Task Sharing (IRTTS) to Workplace Improvement Learning Collaborative (WILC) in group homes for adults with serious mental illness and/or intellectual and developmental disabilities. The main questions it aims to answer are: * Is IRTTS superior to WILC in improving residential care worker (RCW) resiliency; stress management and burnout; depression and anxiety; and positive health behaviors? * Is IRTTS superior to WILC in improving RCW turnover/retention; RCW sick days/absenteeism; and group home safety and resident incidents? * What are the barriers, facilitators, and resources required to successfully implement IRTTS and WILC? Participants may engage in training sessions, collaborate with residents and other RCWs in their group homes, attend meetings with RCWs from other group homes, complete surveys, participate in focus groups, and/or give qualitative interviews. Researchers will compare IRTTS to WILC to see which intervention should be implemented to achieve the greatest improvement in RCW resiliency and greatest reduction in burnout and turnover in group homes for adults with serious mental illness and/or developmental and intellectual disabilities.