Clinical Research Directory

Connecting Socioemotional Aspects of Exercise to Improvements in Physical Health Among Older Adults

Exercise is routinely recommended because of its benefits for physical, cognitive, and mental health. It is especially beneficial for older adults due to its potential buffering effects against Alzheimer's disease and related dementias (Luck et al., 2014). However, little is known about how to best encourage older adults to exercise. Based on behavior change theory, different intrapersonal and interpersonal motivational factors are likely to be relevant during the contemplation, action, and maintenance stages of behavior change. Generally, as a result of motivational shifts toward prioritizing positivity and socially meaningful goals with advancing age (Carstensen, 2006), socioemotional aspects of decision making may become more salient and influential for older adults (Mikels et al., 2015; Peter et al., 2011). Our previous work has demonstrated that positive affect (Mikels et al., 2020) and social goals (Steltenpohl et al., 2019) play a critical role in older adults' motivation to exercise, but these two lines of research have not been integrated to date. Recent work indicates that positive affect is particularly beneficial for health when shared in social connections (Fredrickson, 2016; Major et al., 2018), and the proposed work will, for the first time, examine how shared interpersonal positivity may impact exercise decision making and behavior, especially during the contemplation and action/maintenance stages of behavior change. But who are the older adults that benefit the most from exercise in terms of physical, cognitive, and mental health (and should be hence be targeted with messages)? Not all older adults reap the benefits of exercise (Sparks, 2014) and, conversely, sedentary older adults have the most to gain. Overall, the current proposed research program is innovative in its (a) translational application of insights from affective, cognitive, and aging theory and research to understand the antecedents and outcomes of exercise decision making in younger and older adults, (b) conceptualization of both the social and emotional aspects of decision making, (c) development of novel methods for health messaging that incorporate social influences, and (d) novel assessments of the exercise-health link.

Dime La VerDAD: Verify, Debunk, and Disseminate

Dime la Verdad (Tell me the truth) will evaluate the use of storytelling by community health workers as a communication strategy to disseminate reliable health information on social media and encourage informed decision-making in favor of recommended immunizations in communities with high morbidity and mortality due to respiratory virus infections. Dime La Verdad is an innovative social media capacity-building program based on theoretical frameworks related to health communication that empowers community health workers to disseminate reliable information about respiratory virus protection strategies through the use of personal narratives on social media. The proposed work will use a rigorous stepped wedge design to 1) deliver a scalable program of science communicators using an adapted curriculum grounded in principles of health communication, 2) evaluate how diffusion of health messaging is perceived on social media, and 3) discern how use of personal narratives to enhance science communication can encourage informed decision-making to promote evidence-based immunization practices and improve health outcomes.

Heart2Heart for Teens With CHD

The goal of this clinical trial is to learn if teens living with congenital heart disease like and will use Heart2Heart and if it affects how they think and feel about e-cigarettes. Heart2Heart is a website that provides health information for teens with congenital heart disease. The main questions this trial aims to answer are: * Will teens enroll in the trial and complete the trial activities? * Do teens use and like Heart2Heart? * Does using Heart2Heart affect how teens think and feel about e-cigarettes? Researchers will compare the Heart2Heart group to a group that does not use Heart2Heart to see if it affects teens' thoughts and feelings about e-cigarettes. Participants will: * Complete online surveys * If assigned, explore the Heart2Heart website * If invited, share their opinions about Heart2Heart in an online discussion

WhatsApp Messages to Improve Mothers' Oral Health Knowledge and Children's Toothbrushing

Tooth decay is one of the most common health problems in young children in Saudi Arabia. Brushing twice a day with fluoride toothpaste is one of the most effective ways to prevent it, but preschool children cannot do this properly on their own and depend on their mothers to brush for them and to supervise them. Mothers usually receive oral health advice only once, during a dental visit, and a single session may not be enough to change daily habits at home. This study will test whether short oral health messages sent to mothers on WhatsApp, in addition to the usual face-to-face advice, help mothers know more about toothbrushing and help their children brush better. Mothers of children aged 3 to 6 years attending the Pediatric Dentistry Clinics at King Abdulaziz University Hospital in Jeddah will be invited to take part. All mothers will first answer a short questionnaire about what they know about toothbrushing and how their child currently brushes. All mothers will then receive the same 10 to 15 minute face-to-face oral health education session. After the session, each mother will be placed into one of two groups by chance, like flipping a coin. Mothers in the first group will also receive two WhatsApp messages a week for eight weeks, sixteen messages in total, covering how often to brush, how much fluoride toothpaste to use, correct brushing technique, and how to help and supervise their child. Mothers in the second group will not receive these messages. After eight weeks, all mothers will answer the same questionnaire again, and the answers of the two groups will be compared. Taking part involves no dental treatment or procedures beyond the child's normal care, and mothers may withdraw at any time.

The Barts Charity Children's Environmental Health Clinic

The study will be based from a newly formed NHS service, the children's environmental health service. Participants will be children with a known chronic respiratory condition. Participants will undergo personal environmental exposure monitoring as well as home environmental assessments, before personalised exposure reports will be provided including a summary of their exposure and advising mitigation strategies based on exposure patterns and behaviours. The monitoring will be repeated after introduction of mitigation strategies. This will allow a comparison of the effectiveness of each method of mitigation.

RADx-UP Phase 3D (Oregon Saludable: Juntos Podemos)

The ongoing Oregon Saludable: Juntos Podemos (OSJP, Healthy Oregon: Together We Can) project was developed to directly address the COVID-19 related health disparities among Latinx communities through community engagement funded by Phase I and II of the RADx-UP initiative. This project is organized by the University of Oregon's Oregon Saludable: Juntos Podemos (OSJP) project. In this Phase III study, study investigators build on the successful Phase I and Phase II partnerships with Latinx-serving community-based organizations and the project's established Community Scientific Advisory Board (CSAB) to employ a data-informed approach for implementing preventive interventions designed to advance health equity and ameliorate health disparities among vulnerable populations. Based on identity-stress and stereotype threat models for racial and ethnic minorities, study investigators will further tailor the Promotores de Salud COVID-19 evidence-based health promotion intervention to experimentally evaluate a brief behavioral self-affirming implementation intention (SAII) intervention; an approach that is evidence-based for increasing acceptance of health messaging, increasing intentions to change, increasing health promoting behaviors, and decreasing psychological distress. In collaboration with the Mexican Consulate (MC), research team members will attend the MC mobile events, invite MC attendees to participate in the research study and complete a survey, offer the Promotores de Salud, and SAII intervention to all attendees (if event is assigned to the intervention condition), and distribute rapid tests to participants.

The eHealth Integrated Maternal Physical Activity Programme in Prenatal Care Trial (E-IMPACT)

This will be a proof-of-concept randomised control trial (RCT) study, where 100 pregnant women will be recruited in the first trimester of pregnancy and followed-up until delivery. It aims to test these following hypotheses: 1. pregnancy is a window of opportunity to implement good lifestyle habits of physical activity and exercise as pregnant women are in regular contact with health professionals and are likely motivated and be more confident to carry out these activities according to the guidelines 2. this integrated programme will effective in a healthcare setting, and will bring Singapore's "Guidelines on Physical Activity and Exercise in Pregnancy" guidelines to implementation 3. with enhanced self-efficacy and motivation, the proportion of women engaging in adequate physical activity during pregnancy will increase to meet recommended guidelines.

Ignite Pilot: Goal Setting in a Digital Weight Loss Intervention

The goal of this pilot trial is to learn about the optimal intensity level of goals in a digital weight loss intervention among adults with overweight or obesity. The main questions of the study are to assess the feasibility and acceptability of different goal intensities across four domains (calorie goal, step goal, eating window goal, red zone food goal). The investigators will recruit 32 total participants to the trial. Recruitment will occur through remote channels. Interested individuals will be directed to an online screening questionnaire; those who are eligible will then be invited to attend an initial remote session with study personnel to ensure interest and eligibility in the study. The weight loss intervention will last 10 weeks, and all participants will receive a "core" treatment consisting of self-monitoring weight, food intake, and steps (all via digital tools provided by the study team), along with behavioral lessons, action plans, and tailored feedback. Depending on which group participants are assigned to in the study, individuals will receive either a more or less challenging goal across the four domains. All study tasks will occur remotely, thus, participants will never come in-person for any tasks. Assessment of body weight and other measures will occur at the beginning of the trial ("baseline"), and at 4 weeks and 10 weeks. The investigators will use the Multiphase Optimization Strategy (MOST) framework to identify which of the goal intensity levels result in meaningful engagement and weight loss. The current study is the first step towards answering this question; it is designed as a pilot factorial trial, which focuses on feasibility and acceptability. In total, there will be 16 treatment conditions.

Reset: Enhancing Weight Loss in a Digital Intervention

The goal of the Reset trial is to learn about the optimal combination of dietary behavior strategies in a fully digital weight loss intervention. The intervention is designed for adults with overweight or obesity. The investigators will examine the impact on weight loss of four dietary strategies: 1) limiting Red Zone Foods (i.e., foods that are high in calories and low in nutrition), 2) limiting eating windows, 3) increasing protein intake, and 4) increasing fiber intake. Each of these strategies will include goal setting, daily self-monitoring, and tailored feedback. The investigators will recruit 208 participants. Broadly, adults with overweight or obesity who live in the U.S. will be eligible. The weight loss intervention will last 12 weeks. All participants will be asked to track their body weight daily and complete weekly behavioral lessons and action plans to promote healthy eating and physical activity. All study tasks will occur remotely. Assessment of body weight and survey measures will occur at the beginning of the trial ("baseline"), and at 1 month and 3 months. The Multiphase Optimization Strategy (MOST) framework will be used to identify which combination of the dietary behavior strategies results in the greatest weight loss. In total, there will be 16 treatment conditions.

The Effect of Motivational Interviewing in Women's Health

The behaviour of healthcare demand procrastination constitutes an obstacle for individuals to lead a healthy life, and an example of this is the low participation rate of women in pap-smear screening programs compared to the target population. It is known that motivational interviews are frequently used and effective in studies planned to change health behavior. According to the results of the power analysis, at least 104 women, 52 experimental and 52 control, should be included in the study. Data will be collected with the "Personal Information Form", "Healthcare Demand Procrastination Scale", "Health Belief Model Scale for Cervical Cancer and Pap Smear Test" and "Evaluation Form for Cervical Cancer Screening Participation". Motivational interviews will be given to the women in the experimental group.

The IGNITE for Kids Study on Concentrated Investment in Black Neighborhoods and Child Health and Well-Being

Black children and adults in the United States fare worse across nearly every health indicator compared to White individuals. In Philadelphia, the location of this study, these health disparities result in a stark longevity gap, with average life expectancies in poor, predominantly Black neighborhoods being 20 years lower than in nearby affluent, predominantly White neighborhoods. The investigators will conduct a cluster randomized controlled trial (RCT) of a suite of place- based and financial-wellbeing interventions at the community, organization, and individual/household levels that address the social determinants of racial health disparities. At the community level, the investigators address underinvestment in Black neighborhoods by implementing vacant lot greening, abandoned house remediation, tree planting, and trash cleanup. At the organization level, the investigators partner with community-based financial empowerment providers to develop cross-organizational infrastructure to increase reach and maximize efficiency. At the individual/household levels, the investigators increase access to public benefits, financial counseling and tax preparation services, and emergency cash assistance. The investigators will test this "big push" intervention in 60 Black neighborhood micro-clusters, with a total of 480 children. The investigators hypothesize that this "big push" intervention will have significant impact on children's health and wellbeing.

Trust in Institutions, Environment, and Physical Activity

Trust is the willingness of people to cooperate. Although much research has been conducted on physical activity, little research has explored trust in institutions regarding environmental and physical activity recommendations. This study aims to assess the level of trust in sources of physical activity recommendations as well as to determine the factors that may influence trust in sources of physical activity recommendations, such as environmental, sociodemographic, or lifestyle factors.

Health Promotion Model, Fertility Awareness, Preconception Knowledge and Attitude

The effect of education given to preconceptional women in line with the health promotion model on fertility awareness, preconceptional knowledge and attitude levels

Mobile Video Directly Observed Therapy (DOT) for Immunosuppression Medication Adherence in Adolescent Heart Transplant Recipients

We will conduct a two-group randomized controlled trial to examine the eMocha DOT intervention with pediatric HT recipients.In this population, medication nonadherence remains a primary cause of late acute rejection (LAR) episodes, increased number of hospitalizations, graft failure, and patient mortality. Herein, we propose an innovative approach to promote medication adherence and improve patient and graft outcomes.

Social Cognitive Theory-Based Education for Improving Health Outcomes in Older Adults

This study aims to evaluate the effectiveness of a Social Cognitive Theory-based education program on self-efficacy, healthy lifestyle behaviors, and health literacy in older adults aged 65 years and over attending primary care centers. Participants will be assigned to either an intervention group receiving a structured education program or a control group receiving routine care. The intervention consists of three face-to-face educational sessions delivered weekly. Outcomes will be assessed at baseline and 4-6 weeks after the intervention using validated scales. The findings are expected to contribute to improving health behaviors and health literacy among older adults in primary care settings.

Alcohol Labeling Study

This study aims to examine the effects of new front-of-package alcohol warnings on alcohol consumption. Participants will be randomly assigned to either new front-of-package health warnings or control labels. Participants will bring in their own alcohol to weekly study visits and take home the alcohol to consume as usual. Participants will receive study labels on their alcohol containers per their assigned trial arm.

THRIVE-Belize: A School-Based Life-Skills Program to Support Teen Health in Toledo District, Belize (Feasibility)

THRIVE-Belize is a school-based program being developed to support the health and well-being of adolescents in the Toledo District of southern Belize. The program covers seven topics: communication and emotional regulation, healthy expressions of masculinity, sexual and reproductive health, healthy relationships, mental and physical health, substance use prevention, and environmental health. Before testing whether the program works, the research team needs to learn whether students, teachers, parents, school staff, and community members find it acceptable, appropriate, and practical to deliver at Toledo Community College. This study (Phase I) does not deliver the program to anyone. Instead, it gathers feedback through surveys, focus groups, and interviews with about 280 participants across these five groups. The information collected will be used to refine the program and decide whether to move forward to a future pilot study. No medical or educational intervention is given to participants in this phase.

Brief Psychological Intervention to Reduce Alcohol Consumption

Continuous levels of hazardous alcohol consumption (i.e., 14 or more units per week) is one of the leading risk factors of ill health and early mortality, contributing to around 9,809 deaths a year in the UK. The aim of the present research is to test the effect of helping people to reward themselves when they have successfully reduced/abstained from their previous levels of alcohol consumption. Each participant will be randomly allocated to one of two conditions. The trial requires 128 participants to perform a fully powered statistical analysis. The two conditions include: (1) a control condition (asked to form a plan to reduce/abstain from alcohol consumption), or (2) a weekly self-incentivising condition (asked to reward themselves at the end of each week that they have successfully reduced/abstained their previous levels of alcohol consumption). The main outcome measure will be units of alcohol consumed/not consumed, which will be self-reported at 1-week and 1-month follow-up time points.

A Parental Support Intervention for Children's Nature-Based Physical Activity: A Randomized Controlled Trial

This three-arm randomized controlled trial evaluated the effectiveness of an 8-week, WeChat-based parental support intervention designed to increase parents' support for children's physical activity in outdoor natural spaces. Participants were randomly assigned to a Self-Determination Theory plus identity intervention group, a Self-Determination Theory intervention group, or an education control group. Across the intervention period, each group received two articles per week via a WeChat Official Account, which were disseminated through condition-specific WeChat groups. The primary outcome was parental support for children's physical activity in outdoor natural spaces. Secondary outcomes included children's physical activity in outdoor natural spaces and theory-based psychological variables related to parental support. Assessments were conducted at baseline, immediately post-intervention, and 8 weeks after the intervention had ended. Findings are intended to inform the development of feasible, theory-informed digital interventions to enhance parental support for children's nature-based physical activity.

Evaluation Of Cardiovascular Health Outcomes Among Survivors 2

Childhood cancer survivors who received certain treatments are at a higher risk of developing heart problems in the future. This study is looking at ways to educate childhood cancer survivors about that risk and encourage them to receive a recommended heart screening test.

Multimedia Hydration Education During Physical Education in Schoolchildren

Here's a plain-language Brief Summary ready to paste - it follows the PRS lay-language style (short sentences, explains the "why," avoids jargon) and fits well within 5,000 characters: Staying well hydrated helps children stay healthy and concentrate, and it matters most during physical activity. Yet many young children do not drink enough water during physical education (PE) lessons, and some begin the school day already short of fluid. This study tested whether a short, fun teaching programme could help young children learn about hydration and drink more during PE. The programme used slideshows with simple words, pictures, and short animations, delivered by the children's own teacher for 15 minutes at the start of each PE class, once a week for six weeks. The study took place in two public primary schools in Sfax, Tunisia, and involved 204 first-grade children aged 6 to 7 years. Twelve classes took part. Whole classes (not individual children) were placed by chance into one of two groups: six classes received the teaching programme, and six classes continued their usual PE with no hydration lessons. Comparing whole classes in this way is called a cluster-randomized trial. The researchers measured three things each week: how much the children knew about hydration (using a simple yes/no questionnaire), whether they drank water during the PE session, and the small change in each child's body weight across the session, which is an indirect sign of fluid loss. The aim was to see whether learning about hydration in an engaging way actually changes children's drinking behaviour during activity, not just what they know.

Consumer Perceptions of Alcoholic Beverages

This study aims to examine the effects of marketing claims on alcoholic beverage packaging on alcohol consumers' perceptions and intentions. Participants will be randomized to view three images of alcoholic beverages (beer, hard seltzer, flavored malt beverage) with one of three marketing claims (or a no claim control), and then queried about their perceptions of the product and intentions to consume the product.

Health Ahead Comparative Effectiveness Study

The Health Ahead Comparative Effectiveness Study is a pragmatic, parallel-arm interventional platform that systematically compares successive changes to preventive health screening - each isolated as a single variable against current practice - on the path toward a fully automated screening system deployable in any environment, including the most isolated and resource-limited communities. Each comparison is evaluated with a common set of engagement, behavior-change, experience, cost, and longitudinal outcome measures, allowing results to accumulate on a consistent yardstick across the life of the platform. The first comparison evaluates static versus interactive personalized health report delivery. Subsequent pre-planned comparisons, added by protocol amendment, evaluate mobile community versus fixed laboratory screening; and a hybrid medical-droid plus human-delivery model versus human-only screening. All participants are simultaneously enrolled in the 100-Year Human Aging Study and the Human Observatory Study, contributing individual longitudinal and population-level causal inference data through those protocols.

Mobile Health Program for Teens With Congenital Heart Disease

The goal of this clinical trial is to understand what teens with congenital heart disease like and want in a mobile health program that helps them learn about their health and make healthy choices. The main questions it aims to answer are: Are participants satisfied with the program? Is the program easy to use? Participants will: 1) complete two online surveys, 2) interact with the mobile health program, and 3) participate in an interview.