36 Clinical Trials for Various Conditions
The purpose of this study is to study how people make decisions regarding delivery room management for infants born extremely premature when survival and long term outcomes are uncertain. The hypothesis is that the way in which information is presented will impact decisions. There have been many advances in neonatal care in recent decades. However, the investigators do not know if these children will grow up to be healthy or if they will have problems with mental retardation, behavior or physical handicaps. In these circumstances, where the medical profession cannot predict what sort of life a child will have, parents have a choice of having intensive care started or of allowing the baby to die naturally. The age most often cited by physicians at which this care is optional and under parental discretion is 23 weeks gestation. The purpose of this study was to ask people, recruited through the world wide web, what they would want for the doctor to do in the case of a hypothetical 23 week premature delivery in order to evaluate the decision process and the presence of autonomous choice. This study had two parts. The first part, presented outcome information in 2 different ways -either as survival and lack of severe disability or as mortality and presence of severe disability. The results of the first part have been published (Message Framing and Perinatal Decisions, Pediatrics, 2008). The second part, investigated whether the way in which the way in which delivery room management options were presented- either as agreeing with a course of action or opting out- impacted resuscitation decisions. This part was administered as a separate survey to a different sample of participants at a later date. The remainder of the questionnaires asked demographic and opinion questions as a means to assess variables that may influence how people respond to the information they receive.
This clinical trial evaluates the effect of message framing on smoking behaviors among lesbian, gay, bisexual, transgender, queer (LGBTQ+) young adults who use nicotine and/or tobacco. Tobacco regulation has contributed to a steady decline in tobacco products designed to be smoked (combustible), but there has been an increase in the use of new tobacco products, such as electronic nicotine delivery systems (ENDS). The use of more than one tobacco product (polytobacco) is high in LGBTQ+ populations. Both LGBTQ+ people and people who engage in polytobacco use are less likely to view tobacco as harmful, which may reinforce tobacco use. Message framing includes culturally targeted messages to communicate the absolute risks (AR) and relative risks (RR) of polytobacco use. Using message framing may increase quit rates or change smoking behaviors in LGBTQ+ young adults who use nicotine and/or tobacco products.
Assessment of dietary intake in large, free-living populations is inherently challenging due to the complex nature of human diet. Advancements in traditional methods of dietary assessment (i.e., web-based dietary recalls or records) have aimed at improving data accuracy while reducing participant burden. Further utilizing food recognition technologies to capture real-time food intake may aid in overcoming limitations of existing methods. Keenoa, an artificial intelligence-enhanced, image-assisted tool, is a newly designed mobile application that may facilitate collection of dietary data. Primarily, the investigators will assess acceptability and usability of Keenoa compared with the traditional, web-based Automatic Self-Administered 24-Hour (ASA24) Dietary Assessment Tool in the Framingham Heart Study Third Generation-based cohorts at examination 4. The investigators will also determine the proportion of participants who complete all three days of dietary assessment, either through Keenoa or ASA24. Further, the investigators will relate dietary determinants of glycemic variability (e.g., percent carbohydrate, fiber intake, etc.), obtained from each dietary assessment tool, to the continuous glucose monitor (CGM)-derived outcomes. With a randomized block design, this study will take place as part of the Framingham Heart Study (FHS) glucose study (R01 DK129305). Currently participants from the Third Generation-based cohorts are asked at their fourth examination to wear Dexcom G6 Pro continuous glucose monitor on either their arm or abdomen for a duration of at least 4 days. During this time, participants are asked to complete 3 consecutive days of dietary record through ASA24. For this trial, the investigators will randomize the dietary assessment tool weekly between ASA24 and Keenoa, therefore, depending on the week of administration, participants will be randomized to either a 3 days dietary record via ASA24 or a 3-day dietary record through Keenoa. This trial will last a total of 6 weeks.
This study aims to assess whether different message framing about front-of-package labeling policies elicits more policy support than the control (no framing) among Latino and limited English proficiency populations. The study also seeks to identify which message framing elicits the most policy support.
The goal of this study is to examine the effects of framed mobile messages on young adults' beliefs about their daily Inhaled Corticosteroids (ICS), intentions to take their ICS, adherence, and asthma control. College students (18-29 years) who owned a mobile phone and had a diagnosis of asthma with a prescription for an ICS will be recruited. Participants will be randomized to receive either gain- or loss-framed mobile messages three times per week for eight weeks. Outcomes including beliefs, intentions, adherence, and asthma control will be assessed.
This trial refines and evaluates how cultural targeting influences the effectiveness of anti-tobacco messages among lesbian, gay, bisexual, and transgender (LGBT) young adults at risk for the use of more than one tobacco product (polytobacco use). Polytobacco use is associated with nicotine dependence and tobacco use into adulthood, and is disproportionately high among LGBT young adults. This trial seeks to determine how cultural targeting can be applied to communicate polytobacco use risk to at-risk LGBT young adults.
This study investigates different ways to elevate intentions to get the COVID-19 booster via text-based reminders, including providing information about the booster and leveraging the consistency principle. The proposed randomized controlled trial will examine the impact of these reminders on booster uptake.
This study seeks to assess the efficacy of educational messages to correct misperceptions. People hold a number of misperceptions that are relevant to public health, including misperceptions regarding COVID vaccines. Some people incorrectly think the COVID vaccines authorized by FDA are not safe or effective. These misperceptions can reduce adherence to public health recommendations and result in continued spread of COVID. This study will test if humor and different types of framing increase the efficacy of messages to correct misperceptions about FDA's authorized coronavirus vaccine safety and effectiveness. The frames tested will include: framing the vaccine as a way to boost economic recovery and framing the vaccine as a way to increase freedom to choose how to behave. The addition of humor will also be tested. Message efficacy will be measured via improved accuracy of beliefs after being exposed to the message. In other words, participants will be asked how safe and effective FDA authorized COVID vaccines are before seeing a message, then they will see a message about why the COVID vaccines are safe and effective, and then they will again be asked how safe and effective they think the vaccines are. This study will also assess the accuracy of inferential beliefs. This will be accomplished by asking participants questions about other vaccines that either are or are not authorized by FDA. If participants have understood the messages and updated their mental models of how FDA evaluates vaccines, they should be able to infer if other vaccines are safe and effective based on their FDA authorization status. Hypotheses H1: Participants who are exposed to A.) a message with humor, B.) a message with an economic recovery fame, or C.) a message with a freedom frame will be more likely to increase their agreement with the statement that the FDA will only authorize coronavirus vaccines that are safe and effective after message exposure than participants exposed to the control condition. H2: Participants who are exposed to A.) a message with humor, B.) a message with an economic recovery fame, or C.) a message with a freedom frame will agree more strongly with the statement that the FDA approved flu vaccine is safe and effective after message exposure than participants exposed to the control condition. H3. Participants who are exposed to A.) a message with humor, B.) a message with an economic recovery fame, or C.) a message with a freedom frame will agree more strongly with the statement that the ResVax vaccine, which was not approved by the FDA for the treatment of RSV, is a safe and effective after message exposure than participants exposed to the control condition. H4. Participants who are exposed to A.) a message with humor, B.) a message with an economic recovery fame, or C.) a message with a freedom frame will be more likely to increase behavioral intentions to get an FDA authorized COVID vaccine after message exposure than participants exposed to the control condition.
This is a prospective, randomized controlled trial that will evaluate the effectiveness of two different targeted outreach interventions aimed at increasing Covid-19 vaccine uptake. Veterans who are eligible for COVID-19 vaccine receipt by priority status (based on institutional guidelines) will be identified. Veterans must be enrolled into Veterans Health Administration (VHA) care and meet age or illness institutional priority guidelines to be eligible. Veterans eligible for enrollment into the trial will be randomized in a 1:1:1 allocation at an individual level, using permuted block randomization (with random block sizes of 3 and 6) to the following interventions: 1. Control arm - receives a text message with standard messaging 2. Arm 2 - receives a text message with a message framed for scarcity 3. Arm 3 - receives a text message with a message framed for improving the social good
It is uncertain whether opt-out framing will increase participation in a clinical trial intended to promote physical activity in patients with peripheral artery disease (PAD). This study will test whether opt-in or opt-out framing of study participation upon initial contact affects the proportion of patients who ultimately enroll in the study and the demographic characteristics of enrolled patients.
Rationale: Shared decision-making models between clinicians and patients are critical to improving healthcare delivery and adherence to medication. One type of model, decision framing, is rarely studied in medicine. Decision framing is the way that a choice is worded. In a clinical context, patient choices can be worded positively, or "gain-framed", to explain the benefits of a therapy or negatively, or "loss-framed", to explain the risks of not taking a therapy. Previous literature suggests that decision-framing can significantly influence patients' decision-making regarding their healthcare. However, a critical gap exists in understanding how decision framing affects psoriasis patients' preferences for therapies. Objective: Determine whether loss-framed messages lead to greater therapy acceptance as compared to gain-framed messages among adults with psoriasis. Study population: 90 adults with psoriasis will be enrolled from USC ambulatory clinics and the general public. Intervention: Subjects will be exposed to gain-framed or loss-framed messages regarding psoriasis therapies. Specifically, gain-framed messages will explain the expected benefits of taking the psoriasis therapy and loss-framed messages will explain the potential risks of not taking the psoriasis therapy. Study Methodology: Cross-sectional single-intervention survey.
The goal of this study is to determine the effects of message framing (gain vs. loss) on African American parents' acceptance of the HPV vaccine and how such effects are moderated by parents' salient beliefs prior to message exposure. Participants are randomized into gain and loss conditions in which they view either gain-framed or loss-framed HPV vaccination messages. Key outcome variables include parents' attitudes and intentions toward vaccinating their children against HPV.
This study will evaluate the effects of dietary carbohydrate and sugar consumption, independent of energy content, on body fatness and metabolism in a rigorous feeding study.
Background: The Framingham Heart Study (FHS) was initiated by the U.S Public Health Service in 1948 and turned over to the newly established National Heart Institute in 1951. The FHS is now jointly led by the National Heart, Lung, and Blood Institute and Boston University. The FHS currently studies risk factors, and the genetics of heart and blood vessel disease, and other health conditions in three generations of study participants. Scientists want to use the data collected from this study to do more research. They want to use a technique that determines the sequence of ribonucleic acid (RNA) molecules. Objective: To study genes related to certain diseases and health conditions. These include heart and blood vessel diseases, lung and blood diseases, stroke, memory loss, and cancer. Eligibility: People in the FHS Third Generation cohort who already attended exam 2. Design: Researchers will study samples that have already been collected in the FHS. There will be no active examination or burden to participants. During FHS visits, participants gave blood samples. They gave permission for the blood to be used for genetic research. RNA will be generated from the samples. They will be given a new ID separate from any personal data. They will be stored in a secure FHS lab. The samples will be analyzed. Only certified researchers can access them. No study participants will be contacted in relation to this project. ...
The main purpose of this study is to promote colorectal cancer (CRC) screening among individuals who have never been screened, with these individuals being members of a panel who participant in online studies. The primary study goals are to test effects of the matching between level of comparative risk feedback for colorectal cancer (CDC), that is, how one's risk compares to others, and message framing (Gain vs. loss frame) on CRC screening intentions and screening as well as mediators of effects in the context of people who obtain CRC risk feedback and framing messages online (i.e., Internet).
This study will evaluate the effects of dietary composition on energy expenditure and chronic disease risk factors, while also exploring physiological mechanisms underlying these effects.
Employers are increasingly looking for opportunities to motivate sedentary employees to become more physically active. Workplace walking programs have had mixed success and typically show most improvement among participants that are already fairly active at a baseline. The goal of this study is to determine whether a financial incentive program can motivate sedentary employees to increase the number of steps they walk per day to meet a minimum threshold. The primary outcome measure is the proportion of days a minimum activity of 7000 steps or more is achieved. Outcomes will be assessed each week for 3 months using incentives followed by 3 months of follow-up without incentives. Secondary outcomes will include the average steps walked per day.
Employers are increasingly looking for opportunities to motivate sedentary employees to become more physically active. Workplace walking programs have had mixed success and typically show most improvement among participants that are already fairly active at a baseline. The goal of this study is to determine whether a financial incentive program can motivate sedentary employees to increase the number of steps they walk per day to meet a minimum threshold. The primary outcome measure is the proportion of days a minimum activity of 7000 steps or more is achieved. Outcomes will be assessed each week for 3 months using incentives followed by 3 months of follow-up without incentives. Secondary outcomes will include the average steps walked per day.
Employers are increasingly looking for opportunities to motivate sedentary employees to become more physically active. Workplace walking programs have had mixed success and typically show most improvement among participants that are already fairly active at a baseline. The goal of this study is to determine whether a financial incentive program can motivate sedentary employees to increase the number of steps they walk per day to meet a minimum threshold. The primary outcome measure is the proportion of days a minimum activity of 7000 steps or more is achieved. Outcomes will be assessed each week for 3 months using incentives followed by 3 months of follow-up without incentives. Secondary outcomes will include the average steps walked per day.
This trial is being conducted in order to compare angiographic outcomes in patients receiving 0.014-0.0155" platinum framing and filling coils (larger diameter coils) versus those treated solely with coils less than 0.014" (with a standard diameter). Hypothesis: Angiographic occlusion at follow-up imaging will be more frequent in patients receiving 0.014-0.0155" platinum coils during embolization compared to those receiving smaller-diameter coils.
The purpose of this study is to compare gain-framed counseling + gain-framed materials" to standard care Quitline counseling + standard print materials. The investigators hypothesize that gain-framed counseling + gain-framed materials group will produce higher abstinence rates than standard care counseling and standard care information. The data in this study will be used to determine effect size estimates for a large scale study.
Since 1948, the Framingham Study has examined a group of men and women every two years for the primary purpose of studying the incidence and prevalence of cardiovascular disease and its risk factors. In 1971 the Framingham Study began a study of the offspring of the original group, including data collection on blood pressure, cigarette smoking, weight, and other factors that are of interest to studies of eye disease. Researchers gave eye exams to some of the original group and to the offspring group. Data from these eye exams have been used to examine risk factors for cataracts, diabetic retinopathy, myopia, and glaucoma. The purpose of this study is to use the previously collected data for continued research on eye-related disorders. No new eye examinations will be conducted. ...
Studies have shown that there is a significant association between serum bilirubin concentrations and risk of coronary artery disease (CAD). So far, no linkage analysis in humans between serum bilirubin and DNA markers has been reported. The purpose of this protocol is to identify chromosome regions that contain quantitative trait loci (QTL) involved in serum bilirubin metabolism and bilirubin concentration. In the Framingham Study, a 10cM genome scan (about 400 markers) has been conducted in more than three hundred families. Serum bilirubin was measured in the first and second exams of the Framingham Offspring. These data provide us the opportunity to undertake linkage analyses to map QTL of serum bilirubin.
This is a randomized study of message framing in individuals beginning a smoking cessation program utilizing bupropion SR and brief counseling, videos, and pamphlets.
Since 1948, residents of Framingham, Massachusetts, have participated in a program that collects blood samples and clinical data to provide a rare and valuable database for scientific research. The purpose of this study is to support this national resource by aiding in its research capacity. Specifically, researchers in this study will (1) investigate heart, lung, and blood diseases; stroke; memory loss; joint disease; bone loss; deafness; cancer; blood vessel diseases and other health conditions, and (2) examine DNA and its relationship to risk of developing these disease and health conditions. Approximately 330 families have participated in the Framingham Study. Participants will be required to undergo a four-hour exam and to take that exam every two years thereafter. During the exam, the Framingham investigators will (1) interview participants about medical status, health issues, and lifestyles; (2) perform a regular physical exam; (3) obtain blood and urine samples and administer a glucose-tolerance test; (4) supervise a brisk six-minute treadmill walk; (5) administer an ultrasound procedure; and (6) review and obtain copies of medical and hospital records. Participants will also be asked to complete a questionnaire at home regarding dietary and health habits.
Selective redesign of order sets using different ways to frame the order and physician decision-making in a computerized provider order entry system could increase adherence to evidence-based care and reduce population-specific variance.
US residents who have obesity and sign the informed consent form and are screened and enrolled for this study. Participants who are enrolled complete a survey upon enrollment and are randomized into one of three arms. This study is direct to participant and will not utilize clinical sites.
In the electronic Framingham Heart Study (eFHS), the investigators developed and deployed a mobile app to collect cardiovascular risk factors and event data and test them against cardiovascular data collected in the Framingham research clinic for the FHS. Participants enrolled in eFHS receive a series of digital surveys modules to complete on a regularly occurring schedule. The objective of the planned randomized trial is to test the effect of administering half of survey modules every 2 weeks versus all survey modules every 4 weeks on improving participants' response rates. There will be 4 survey periods. Period 1 encompasses all survey modules administered from baseline up to week 8 (19 surveys/tasks per participant); period 2 from week 8 up to week 16 (18 surveys/tasks per participant); period 3 from week 16 up to week 24; period 4 from week 24 (16 surveys/tasks per participant).
In this evaluation, 4 different versions of letters are being sent with mailers promoting colorectal cancer screening with an at-home test. The researchers hypothesize that the use of behavioral nudges in the message should lead to increased colorectal cancer screening (either with the at-home test or a colonoscopy).
The researchers' mission is to promote healthier eating behavior and to reduce costs associated with healthcare. The purpose of this study is to evaluate the effects of mailing randomly selected participants a letter promoting a plant-based diet. Depending on the experimental condition, participants may additionally receive a free documentary, Forks Over Knives, and they may also get letters which use commitment- or prevention-focused messages to encourage watching the documentary and changing their eating behavior. The researchers hypothesize that receiving the documentary will be associated with lower insurance claims and improved health outcomes one and two years later. The researchers also hypothesize that using either commitment- or prevention-focused messages will also contribute to lower insurance claims and improved health outcomes compared to experimental conditions where materials did not include these messages. This study will help the researchers design evidence-supported programs that can improve people's health.