Clinical Research Directory

Testing the Feasibility and Impact of a Whole-Food Plant-Based Diet Intervention on College Students

The goal of this pilot randomized controlled trial (RCT) was to assess the feasibility, acceptability, and impacts of a whole-food plant-based (WFPB) vegan diet intervention for undergraduate university students randomly assigned, stratifying by sex and race/ethnicity, to one of two intervention groups (each with a distinct teaching-learning design, i.e., interactive (IA) versus lecture-based (LB)) and a control group. The main questions the researchers aimed to answer were: * Were the study procedures feasible and acceptable for the overall sample and were the intervention sessions, following a WFPB vegan diet, and the prospect of continuing this diet feasible and acceptable for the intervention participants? * Were there greater improvements in diet quality, WFPB vegan diet adherence, physical and mental health, and intrapersonal factor outcomes for the intervention group engaging in interactive learning compared to the intervention group learning through traditional lecture? And were there greater improvements in these outcomes for both intervention groups compared with the control group? The researchers compared the group outcome means for the two intervention groups against one another and those for the two intervention groups against those of the control group. Study participants completed two sets of measurements over the course of 6 weeks. * All participants completed online baseline and post-intervention surveys and in-person baseline and post-intervention biometric measurements. * Only the intervention group participants attended three 75-minute consecutive weekly intervention sessions to learn about different aspects of the WFPB vegan diet between the two sets of survey and biometric measurements.

Effectiveness and Implementation Evaluation of NeoMayor for Improving Cardiovascular Health in Chilean Older Adults

This study aims to evaluate the effectiveness and implementation of NeoMayor, a mobile health (mHealth) intervention designed to improve cardiovascular health among older adults at elevated cardiovascular risk in Chile. NeoMayor is a smartphone-based application that provides personalized guidance on physical activity, diet, sleep, and mental well-being through a multidomain lifestyle approach. This multicenter randomized controlled trial will enroll community-dwelling older adults aged 55 to 75 years recruited from primary healthcare centers in urban and rural settings. Participants will be randomized in a 2:1 ratio to either the NeoMayor intervention or a control group receiving standard health information and usual care. The intervention duration will be four months. The primary objective is to determine whether NeoMayor improves cardiovascularhealth, measured with the Life's Essential 8 Cardiovascular Health Index (CVHI).Secondary objectives include changes in cognitive performance, depressivesymptoms, anxiety symptoms, quality of life, physical performance, and urinaryalbumin-to-creatinine ratio (UACR). This is a Hybrid Type 1 effectiveness-implementation trial. As an exploratory aim, participants in the NeoMayor arm are further randomized (2x2 factorial) to receivethe app with or without human health coach support, and with or without a wearable device, both used as implementation support strategies. The study will describe engagement, adherence, retention, and maintenance of app use over four months.This aim is hypothesis-generating; the trial is not powered to compare implementation strategies.

Premature Ventricular Complex and Diet Inflamatuar Index

The aim of this study is to evaluate differences in energy, macro- and micronutrient intakes, dietary characteristics, quality of life, and biochemical parameters between individuals with and without premature ventricular complexes. The study will include a total of 100 adults who present to the Cardiology Outpatient Clinic of Buca Seyfi Demirsoy Training and Research Hospital, comprising 50 individuals with premature ventricular complexes and 50 healthy individuals. Participants will be instructed to discontinue caffeine-containing beverages, stimulants, and medications that may affect cardiac rhythm for 72 hours prior to Holter monitoring. The diagnosis of premature ventricular complexes will be established by a specialist cardiologist. Dietary intake will be assessed using three non-consecutive 24-hour dietary recalls, including two weekdays and one weekend day. Dietary intake data will be collected by the researcher through face-to-face interviews and recorded on the study questionnaire. The Dietary Inflammatory Index (DII) and Healthy Eating Index will be calculated based on the participants' three-day dietary intake data. No additional blood samples or biochemical tests will be requested specifically for the purposes of this study. Instead, the participants' most recent biochemical parameters obtained as part of routine clinical care will be retrieved from their medical records. These parameters will include fasting blood glucose (mg/dL), glycated hemoglobin (HbA1c, %), total cholesterol (mg/dL), high-density lipoprotein cholesterol (HDL-C, mg/dL), low-density lipoprotein cholesterol (LDL-C, mg/dL), triglycerides (mg/dL), vitamin D, and other routinely assessed biochemical parameters. The results will be interpreted according to the reference ranges used by Buca Seyfi Demirsoy Training and Research Hospital. Participants' quality of life will be assessed using the 36-Item Short Form Health Survey (SF-36).

The Effects of an Evening Snack of Walnuts on Diet and Sleep Quality in Adolescents

The goal of this study is to examine whether an evening snack of 1 oz of walnuts consumed in place of usual evening snacks for 4 weeks has a beneficial effect on diet quality and sleep quality in adolescents age 13-17 years.

Improving Diet Quality of Community-Dwelling Seniors Using a Community-Based Participatory Approach

This study implements a community co-designed educational intervention program to improve diet quality of community-dwelling seniors.

Evaluating Care Integration Between Pediatric Primary Care Providers and WIC Nutritionists

This study looks at whether using secure digital systems to share information between pediatric health care providers (during regular well-child visits) and social care providers (during regular visits with WIC nutritionists) can help mothers receive consistent guidance on responsive parenting to support healthy child growth and development. Responsive parenting means learning how to respond to a baby's needs in ways that support healthy eating, sleep, activity, and emotion regulation habits. The main questions this study aims to answer are: 1. Does using secure digital systems to share information between pediatric health care providers and social care providers help mothers receive consistent guidance on responsive parenting to support healthy growth from birth to 24 months? 2. Does using secure digital systems to share information between pediatric health care providers and social care providers help mothers receive consistent guidance on responsive parenting, improve responsive parenting practices and child diet quality? The investigators will compare the group that receives secure digital systems for sharing information on responsive parenting to a group that receives standard care (does not receive this) to see if secure digital systems for sharing information on responsive parenting work to support healthy child growth and development. The goal is to see if this approach can improve early health behaviors and reduce health disparities for families in rural, low-income communities.

An Online Intuitive Eating Program for Pregnant Women With Obesity to Support Well-Being

The goal of this feasibility randomized controlled trial is to assess the feasibility, acceptability, and demand, as well as preliminary effects of an evidence-based Intuitive Eating (IE) intervention among pregnant women who have obesity. The main research questions are: RQ1: What is the feasibility (acceptability and demand) of implementing an Intuitive Eating Intervention among pregnant and postpartum women? RQ2: How does participation in the Pregnancy Intuitive Eating Intervention (PIE-I) impact key maternal health outcomes (i.e., gestational weight gain, intuitive eating behaviors, dietary quality, body image, and mental health) compared to a wait-list control? Researchers will compare the Pregnancy Intuitive Eating Intervention (PIE-I) intervention group with the wait-list control to see what impact the PIE-I has on maternal well-being. Participants randomized to the intervention group will complete the 8 week asynchronous IE intervention and have an opportunity to interview at the end of the study.

Healthy Children, Healthy Communities: Effectiveness of a Multilevel Rural Community Engagement Model for Improving Children's Dietary Intake in Family Child Care Homes

The purpose of this study is to find out whether a program called "Healthy Children, Healthy Communities" can help young children in rural areas eat healthier and improve their health. The study focuses on children ages 3 to 5 who attend family childcare homes in rural communities. The main goal is to see if the program can: Help children eat healthier foods, like more fruits and vegetables. Support childcare providers in using positive mealtime practices that encourage healthy eating. The study will involve about 120 licensed family childcare providers in rural areas who participate in the Child and Adult Care Food Program (CACFP), along with about 240 children they care for. Childcare providers will be randomly placed into one of two groups: EAT Family Style Group (Intervention Group): Complete 7 online training modules over 16 weeks about healthy mealtime practices. Join 7 individual coaching sessions on Zoom. Record short videos of their mealtimes to get personalized feedback from a coach. Work with a coach to set goals and make plans to improve mealtimes. Receive printed materials and conversation cards to use during meals. Some providers may join Zoom interviews to share their experiences. Better Kid Care Group (Comparison Group): Complete 10 online modules about general childcare topics like child development, oral health, play, and managing a childcare home. For both groups, the research team will: Ask providers to fill out online surveys about how mealtimes work in their childcare homes. Visit the childcare homes to observe and record children's mealtimes on two days at each data collection point. Measure the height and weight of participating children. Use a painless skin scanner (Veggie Meter) to check how many fruits and vegetables children have been eating. Ask providers to complete surveys about the children's eating habits. The study focuses on rural, low-income communities, where children are at higher risk of having poor diets and obesity compared to children in urban areas. Information will be collected at the start of the study, after 16 weeks, and again after 24 weeks to see if there are lasting changes.

Nutricity: An mHealth Nutrition Intervention to Improve Diet Quality Among Latino Children

The overall objective of this application is to pilot test an mHealth nutrition intervention within pediatric clinics serving Latino families and evaluate its potential for implementation. The investigators hypothesize the intervention will improve child diet quality and will be feasible for use within the clinic setting. To test this hypothesis, the investigators will pursue 3 specific aims and 1 exploratory aim: 1. Aim 1: Pilot Nutricity with 40 Latino families (English or Spanish speaking) vs. 40 waitlist control in primary care clinics and estimate differences in child diet quality at 3 month's post Nutricity exposure. Preliminary data will inform power calculations for a future larger Nutricity intervention. 2. Aim 2: Evaluate other individual (dyad) level factors including reach, engagement, and changes in secondary effectiveness outcomes (e.g. nutrition literacy, BMI, skin carotenoid, psychosocial constructs) at 3 months post exposure. 3. Aim 3: Evaluate organizational-level factors (adoption, implementation, and organizational-level maintenance) in Latino-serving pediatric clinics that may support or inhibit future uptake of Nutricity. The investigators will seek to understand the context of interventions and scalability to other clinics using mixed methods. 4. Exploratory Aim 1: Explore the relationship among nutrition literacy, psychosocial constructs and diet quality outcomes; and explore how engagement and satisfaction influence outcomes.

Young Adult Food Messaging Experiment

The primary objective of this study is to identify the food counter-marketing messages (i.e., messages that describe deceptive marketing tactics used by food companies) that are perceived as most effective among young adults.

Evaluating Food Messaging Campaigns for Young Adults

This study aims to determine whether online social media campaigns improve diet quality among young adults. Young adults will be exposed to one of three social media campaigns.

Advancing Precision Medicine for Cardiovascular Disease and Diabetes in Asian Populations: Digital Intervention Cohort

The overarching aim is to improve cardiometabolic health and promote healthy ageing by supporting adults to adopt favourable lifestyle patterns identified through our observational research. The trial will recruit n=600 to be involved in Phase I (referred to as the "Optimisation Phase") of a two-phase project (Phase II trial registration will be submitted separately). All participants will complete a baseline study visit where, after consent taking, will complete a baseline questionnaire, receive a smartwatch each and additional wearables if applicable, and download the study app for the receiving and testing of interventions and completion of short form surveys. Participants will be involved in the continual evaluation and optimisation of ecological momentary interventions (EMIs) in adaptive, factorial, micro-randomised trials over 12 months. Consenting participants may also be contacted to participate in interviews to be involved in the co-design of interventions, or to provide insights to the feasibility and process evaluation of the trial.

Diet, Metabolic Health, and Exercise Responses

Regular physical activity, healthy dietary habits, and good metabolic health are associated with numerous physical and cognitive health benefits. However, individuals vary substantially in their affective, motivational, and cognitive responses to exercise, and the factors contributing to this variability are not fully understood. This prospective observational study will examine whether habitual dietary fat quality and metabolic health are associated with exercise responses, cognitive function, and academic-related outcomes in healthy young adults. Participants will complete assessments of dietary intake, body composition, metabolic health, aerobic fitness, cognitive function, and academic engagement. They will also complete a standardized moderate-intensity cycling session during which affective responses, exercise enjoyment, subjective energy, and motivation for future physical activity will be assessed. The findings will improve understanding of how habitual dietary habits and metabolic health may influence responses to exercise and cognitive functioning and may help inform future lifestyle recommendations aimed at promoting physical activity participation, cognitive performance, and overall health.

Advancing North Shore Community Health Through Ocean-raised and faRm-grown Foods (ANCHOR Study)

This study is testing a new way to support healthy eating by providing free meal kits through a food pantry. Adults who use The Open Door food pantry will receive meal kits that include fresh produce, seafood, and other ingredients, along with simple recipes and optional cooking demonstrations, over a 3-month period. The goal is to learn whether these meal kits are helpful, easy to use, and a good fit for the community. Researchers will also look at whether they help improve access to healthy foods, diet quality, and confidence with cooking. Participants will be asked to complete short surveys at the beginning and end of the study, and some may be invited to join a group discussion to share their experiences. Overall, the study aims to improve programs that connect people to healthy, locally sourced food and to inform future efforts to support nutrition and food access in the community.

Randomized Evaluation of Voucher Interventions for Value and Effectiveness (REVIVE) in Philippines

This study aims to evaluate whether revised food voucher programs, combined with nutrition education sessions, can improve food security, dietary quality, nutrition knowledge, and nutritional outcomes among low-income households in the Philippines. Researchers will compare different monthly voucher amounts-Philippine Peso (PhP) 3,000, PhP 5,000, and PhP 8,000-with a no-voucher control group to determine which approach is most effective. The main questions the study aims to answer are: * Do food vouchers improve household food security, reduce hunger, and improve dietary quality and nutrient intake? * Do larger voucher amounts lead to greater improvements in nutrition and health outcomes? * Does enhanced nutrition education improve nutrition knowledge and healthy eating practices? Participants will: * Receive either a monthly food voucher or no voucher, depending on study group assignment * Attend nutrition education and Social and Behavior Change Communication (SBCC) sessions if assigned to a voucher group * Complete household interviews on food consumption, household expenditures, food security, and nutrition knowledge * Participate in dietary assessments and anthropometric measurements for women and children under 5 years of age

Assessing the Effects of Cool Roofs on Indoor Environments and Health in Tavua, Fiji

Ambient air temperatures in Fiji are increasing due to climate change. Solutions are needed to build heat resilience in communities and adapt. Sunlight-reflecting cool roof coatings may passively reduce indoor temperatures and energy use to protect home occupants from extreme heat. Occupants living in poor housing conditions in Fiji are susceptible to increased heat exposure. Heat exposure can instigate and worsen numerous physical, mental and social health conditions. The worst adverse health effects are experienced in communities that are least able to adapt to heat exposure. By reducing indoor temperatures, cool roof use can promote physical, mental and social wellbeing in household occupants. The long-term research goal of the investigators is to identify viable passive housing adaptation technologies with proven health benefits to reduce the burden of heat stress in communities affected by heat in Fiji. To meet this goal, the investigators will conduct a cluster-randomized controlled trial to establish the effects of cool roof use on health, indoor environment and economic outcomes in Tavua, Fiji.

Assessing the Effects of Cool Roofs on Indoor Environments and Health in Colima, Mexico

Ambient air temperatures in Mexico have broken record highs in 2024. Solutions are needed to build heat resilience in communities and adapt to increasing heat from climate change. Sunlight-reflecting cool roof coatings may passively reduce indoor temperatures and energy use to protect home occupants from extreme heat. Occupants living in poor housing conditions in the northern zone of Mexico are susceptible to increased heat exposure. Heat exposure can instigate and worsen numerous physical, mental and social health conditions. The worst adverse health effects are experienced in communities that are least able to adapt to heat exposure. By reducing indoor temperatures, cool roof use can promote physical, mental and social wellbeing in household occupants. The long-term research goal of the investigators is to identify viable passive housing adaptation technologies with proven health benefits to reduce the burden of heat stress in communities affected by heat in Mexico. To meet this goal, the investigators will conduct a cluster-randomized controlled trial to establish the effects of cool roof use on health, indoor environment and economic outcomes in Colima, Mexico.

Assessing the Effects of Cool Roofs on Indoor Environments and Health

Ambient air temperatures in Asian, Latin American, African, and Pacific climate hotspots have broken record highs in 2024, driven by man-made climate change. Solutions are needed to reduce heat exposure in communities. Sunlight-reflecting cool roof coatings passively reduce indoor temperatures and energy use to protect home occupants from extreme heat. Occupants living in poor housing conditions globally - for example in informal settlements, slums, and low-socioeconomic households - are especially vulnerable to increased indoor heat exposure. Heat exposure can instigate and worsen numerous physical, mental and social health conditions. The worst adverse health effects are being experienced in communities least able to adapt to heat exposure. By reducing indoor temperatures, cool roof use can promote physical, mental and social wellbeing in occupants. The long-term research goal is to identify viable passive housing adaptation technologies with proven health and environmental benefits to reduce the burden of heat stress in communities affected by heat globally. To meet this goal, the investigators will conduct a cluster-randomized controlled trial to establish the effects of cool roof use on health, indoor environment and economic outcomes in five urban climate hotspots: Ouagadougou, Burkina Faso; Colima, Mexico; Ahmedabad, India; Niue; and Tavua, Fiji.

An Evaluation of "Growing Healthy Places: Mississauga"

The goal of this intervention study is to learn if community co-designed activities to improve diet and physical activity can impact the health of children ages 6-13 in Mississauga, Canada. The main questions it aims to answer are: 1. Do the community co-designed interventions improve health-related quality of life of children after one year and two years? 2. Do the community co-designed interventions improve the physical activity and eating behaviors of children after one year and two years? Ten intervention and 12 control schools will take part in this study. The schools were recruited from the Mississauga area using an application process. Selection and group assignment involved a multi-stage process with initial randomization followed by manual adjustment (to balance groups on key observable characteristics and respond to stakeholder concerns about spillovers and implementation feasibility). Researchers will compare students in schools that receive the interventions to students in schools that receive no interventions to see if the interventions improve health-related quality of life, increase physical activity and improve eating behaviors. Participants will: * attend participating elementary or middle schools (in either intervention neighborhoods or control neighborhoods) * complete an anonymous questionnaire about their wellbeing, physical activity, and eating behaviors at baseline, after one year, and after two years * potentially participate in school and community programs (if in an intervention school neighborhood)

Promoting Physical Activity and Healthy Eating in Latinas

The goal of this clinical trial is to learn if an Internet-based behavioral intervention can increase physical activity and improve diet quality among Latina adults. The main question aims to answer is whether participants in the Internet-based behavioral intervention group increase their physical activity levels, increase their consumption of fruits and vegetables, and decrease their consumption of sugar-sweetened beverages over 12 weeks. Researchers will compare the Internet-based physical activity and healthy eating intervention to a wait-list control group (participants who do not receive any intervention until after completing the study) to see if the Internet-based behavioral intervention works to improve physical activity and diet quality. Participants who receive the Internet-based behavioral intervention receive access to the online intervention for 12 weeks, and complete assessments at baseline and week-12. Participants in the wait-list control complete the same assessments at baseline and week 12, then receive access to the online intervention for 12 weeks.