Treatment Trials

67 Clinical Trials for Various Conditions

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NOT_YET_RECRUITING
An Evaluation of the Tobacco Prevention Toolkit Healthy Futures: Alternative-to-Suspension Vaping Intervention
Description

The Healthy Futures: Alternative-to-Suspension Curriculum is a free, online curriculum developed to educate students and provide them with resources to quit tobacco/nicotine use. The investigation aims to estimate the extent to which Healthy Futures: Alternative-to-Suspension changes high school student's knowledge of, attitudes towards, intentions to use, and actual use of tobacco/nicotine.

ENROLLING_BY_INVITATION
Evaluation of the Be Vape Free Curriculum of the Tobacco Prevention Toolkit
Description

The Stanford Tobacco Prevention Toolkit is a free online curriculum developed for use by educators and health professionals in providing tobacco-specific prevention education to middle and high school students. A set of lessons focused on e-cigarette/vaping prevention education specifically is called the Be Vape Free curriculum. The aims of this study are to determine: (1) whether the Be Vape Free curriculum is effective in increasing middle and high school students' resistance to using tobacco and in decreasing positive attitudes towards and intentions to use e-cigarettes; (2) whether the Curriculum is effective in changing middle and high school students' actual use of tobacco; and (3) Examine heterogenous treatment effects identifying groups that benefit the most and those who do not benefit at all from the intervention.

Conditions
COMPLETED
Media Literacy for High School Tobacco Prevention
Description

This research project will explore the feasibility and acceptability of a web-based media literacy tobacco prevention program. The project will be conducted with 9th or 10th graders in two high schools in Pittsburgh, Pennsylvania.

COMPLETED
Pittsburgh and Rural Area High School Tobacco Prevention
Description

This research project will explore the feasibility and acceptability of a web-based media literacy tobacco prevention program. The project will be conducted with 9th graders in two schools in the Pittsburgh area.

WITHDRAWN
Evaluation of The Stanford Tobacco Prevention Toolkit
Description

The Stanford Tobacco Prevention Toolkit is a free online curriculum developed for use by educators and health professionals in providing tobacco-specific prevention education to middle and high school students. The aims of this study are to determine: (1) whether the Curriculum is effective in changing middle and high school students' resistance to using tobacco as well as knowledge of, attitudes towards, and intentions to use different tobacco products; and (2) whether the Curriculum is effective in changing middle and high school students' actual use of tobacco in the short-term.

COMPLETED
Expanding the Click City Tobacco Prevention Program to Include E-cigarettes and Other Novel Tobacco Products
Description

The goal of this study is to modify a smoking prevention program for 5th and 6th grade students to also target vaping e-cigarettes. Aims were to modify the program along with associated materials and to conduct a trial with 5th grade students in the school setting to see how well the updated program worked. Students either participated in the four-week computer based program or continued with their usual tobacco prevention curriculum. This study showed that students who received the computer program reduced their intentions and willingness to use e-cigarettes or smoke in the future more than did students who used their usual tobacco curriculum.

Conditions
COMPLETED
Teens Against Tobacco Use: A Tobacco Prevention Curriculum and Advocacy Initiative
Description

This study evaluates the efficacy of Teens Against Tobacco Use anti-tobacco presentations on tobacco use susceptibility in 6th through 8th grade. Students will be randomly assigned to either receive 3 anti-tobacco presentations or 3 presentations on a different topic, unrelated to tobacco.

COMPLETED
Teens Against Tobacco Use: A Model for Universal Tobacco Prevention and Youth Advocacy
Description

This study evaluates the efficacy of Teens Against Tobacco Use anti-tobacco presentations on tobacco use susceptibility in 4th-8th grade. Classrooms are randomly assigned to either receive a series of two presentations or wait listed to receive them later in the school year.

COMPLETED
Intranet-based Tobacco Prevention Program for Children
Description

The purpose of this research is to create an effective, disseminable, and exciting computer-based tobacco prevention program for 5th and 6th grade students. The goal of this school-based program is to decrease children's behavioral intentions and willingness to use tobacco, and to prevent or delay their initiation of tobacco use. We will augment the 5th grade program with a booster program in 6th grade, and evaluate the long-term efficacy of the entire tobacco prevention program by conducting a randomized controlled trial in elementary and middle schools.

COMPLETED
Incentive-based Intervention for Smoking Cessation and Prevention in High Schools
Description

The purpose of this study is to design an incentive-based intervention to motivate a tobacco-free lifestyle among high school students and to pilot the intervention in the first academic year in two schools (CT and NY) and examine feasibility and acceptability. Preliminary efficacy of the intervention will be assessed by implementing it in two new schools (CT and NY) in the second academic year and determine an effect size estimate for a larger trial. The study is intended to assess the number of students joining the program and pledging to be smoke-free and to examine changes in tobacco use rates and attitudes following intervention exposure. We hypothesize that the schools will have lower rates of tobacco use and improvement in attitudes, norms and behavioral control over tobacco use after participating in the program.

COMPLETED
The Impact of a Tobacco Control Intervention in African-American Families
Description

The purpose of this randomized control trial is to evaluate the effects of a multi-component intervention aimed at: 1. preventing tobacco initiation in youth 2. promoting anti-tobacco socialization in the home 3. decreasing environmental tobacco smoke exposure in children 4. promoting successful cessation in parent/guardian smokers. Control arm participants receive general health education. This family-based approach is implemented with school systems as the primary point of entry.

COMPLETED
Middle and High School Students' Reactions to a Health Interactive Website: ASPIRE Reactions
Description

The goal of this research study is to learn how middle and high school students react to an interactive website called ASPIRE ( A Smoking Prevention Interactive Experience) and health information online and what their preferences are when using ASPIRE. Researchers hope to use the results of this study to design more effective online health programs to provide middle and high school students with up-to-date information about tobacco use, meditation, and general health and well-being.

COMPLETED
Evaluation of a Brief Tobacco Intervention in the US Military
Description

While the military has taken steps to reduce tobacco use over the past two decades, over a quarter of new military recruits report regular tobacco use prior to enlistment. This rate is higher than the national prevalence of 21.3% of US adults. Brief health prevention programs may be particularly effective for Airmen in Technical Training, given that all Airmen have been tobacco free for 11 ½ weeks and nearly 2/3rds are confident that they won't return to tobacco. We have developed and validated a Brief Tobacco Intervention (BTI) that is currently being implemented as part of Technical Training. We found that a motivational interviewing based, 40 minute BTI was efficacious in increasing perceived harm and decreasing intentions to use tobacco in a sample of 1055 Air Force trainees. Although we obtained significant positive changes in latent cognitive constructs for tobacco behavior that are highly predictive of future tobacco use in youth and young adults, the Little et al study did not obtain measures of actual tobacco resumption following the ban on tobacco in Air Force training. Given that 69.8% of all tobacco resumption/initiation occurs in Technical Training, a study that evaluates the short-term impact of our BTI on actual tobacco use is necessary prior to conducting the full scale R01 that would evaluate the long term efficacy of the BTI intervention. Thus, we propose the following Specific Aims: (1) To recruit approximately 2,000 Air Force trainees at the beginning of Technical Training at Joint Base San Antonio-Lackland Air Force in San Antonio, Texas during the 11 ½ week involuntary cessation ban; (2) To randomize participants to either (a) receive our cigarette smoking military tailored pamphlet (HL095758), The Airmen's Guide to Remaining Tobacco Free (Airmen's Guide; which has been disseminated and is now the standard of care in the Air Force) or (b) the Airmen's Guide + Brief Tobacco Intervention (BTI); (3) To determine the short-term (3 month, end of Technical Training) efficacy of the intervention on tobacco abstinence. Our primary outcome is tobacco abstinence at the end of Technical Training to determine an estimated effect size as well as establish the requisite preliminary work for a subsequent R01. Given that over 220,000 new recruits enter the military annually in one of the service branches, the public health implications of an effective brief tobacco intervention targeting the most commonly used tobacco for military personnel in Technical Training is considerable. If the BTI is proven efficacious it can be easily disseminated to other service branches that have similar tobacco bans during Technical Training.

COMPLETED
Smoking Prevention Through Social Connections Among Adolescents - ASPIRE
Description

The central hypothesis of this study is that the addition of social influence strategies to a web-based program called ASPIRE will boost its success in lowering intention to use tobacco among adolescents and experiencing stronger positive social influence. The study will involve a nested group randomized controlled trial with adolescents from after-school programs and schools (e.g., the PK Yonge school) in Florida.

COMPLETED
Clinician Promotion of Healthy Diet and Activity to Reduce Obesity Among Adolescents: HEALTHY SMILES
Description

This study will test an 18-month intervention designed to increase physical activity, reduce sedentary practices and promote healthy diets or reduce tobacco use and exposure among preteens who obtain orthodontic care. Relevance: If successful, this study may inform policies that would promote all specialists (orthodontists, physicians, general dentists) to deliver brief counseling for diet, physical activity, and tobacco prevention.

Conditions
COMPLETED
Adolescent Smoking Cessation in Pediatric Primary Care
Description

This is a study of the effectiveness of adolescent smoking cessation interventions in pediatric primary care settings. Our specific aims are to: 1. Demonstrate providers' fidelity to guidelines for tobacco counseling and delivery of cessation interventions using practice system changes over time, (including systematic screening using charting tools and linkages to adjunct materials, including self-help handouts and Internet resources); and 2. Assess the impact of primary care provider counseling interventions on adolescent smoking cessation. We hypothesize that adolescents who receive guidelines-based clinician-delivered smoking cessation counseling at primary care visits will be more likely to make quit attempts and more likely to remain abstinent (with better long term cessation rates) at 6 and 12 months after intervention, compared to those who do not receive interventions. In addition, we hypothesize that successful referral to stage-based self-help adjuncts, and more adjunct use will be associated with more quit attempts and better long-term cessation rates. We will evaluate provider interventions in up to 120 pediatric practices, recruited from the American Academy of Pediatric's Pediatric Research in Office Settings (PROS) practice-based research network. Adolescents presenting for care will complete a short baseline survey prior to their doctor-visit, and a percentage of participants will be surveyed by phone 4-6 weeks after their visits to assess quit attempts and short-term cessation, and again at 6 and 12 months to evaluate long-term cessation outcomes. We will describe the patterns of smoking among youth, and explore how much receiving interventions affects motivation, quitting, abstinence/relapse attitudes, attitudes and use of adjunct strategies, and other smoking behaviors for adolescent smokers.

COMPLETED
Tobacco Zero: Interactive Tobacco Education for Teens
Description

There have been a number of tobacco prevention programs developed and tested in the past few years, and some of the comprehensive programs have been promoted by the Office on Smoking and Health at the Centers for Disease Control (CDC). However, the use of these programs and integration into school-based curriculum has been lacking due to a number of factors. We are proposing to develop an interactive computer-based program for tobacco prevention aimed at middle school students. The CD-ROM is designed to be an adjunct to the existing health education curriculum provided for 6th through 8th grade students.

COMPLETED
Development of a Videogame Prototype Targeting Cigarette and Marijuana Smoking, and Tobacco Product Prevention Among Young Adolescents (smokeScreen)
Description

The goal of this sub-study is to learn more about how an educational videogame can feasibly be implemented and disseminated in youth programs.

Conditions
COMPLETED
Development of a Videogame Prototype Targeting Cigarette and Marijuana Smoking, and Tobacco Product Prevention Among Young Adolescents
Description

To study feasibility and implementation of a education videogame and the effects on adolescents knowledge and beliefs around tobacco products.

Conditions
COMPLETED
Hutchinson Smoking Prevention Project
Description

The Hutchinson Smoking Prevention Project is a 16-year, group-randomized trial to determine the extent to which a school-based (grades 3-10), theory-based, social-influences tobacco use prevention intervention can deter youth tobacco use throughout and beyond high school.

COMPLETED
Implementation and Dissemination of an Evidence-Based Tobacco Product Use Prevention Videogame Intervention With Adolescents
Description

To examine the effects on participants who play the smokeSCREEN game in that the game will have positive changes in their attitudes, beliefs, knowledge, intentions, behaviors and other outcomes related to smoking and tobacco products.

WITHDRAWN
Peer-to-peer Tobacco and ENDS Prevention
Description

In Phase I, the REAL media Plus prototype will be developed and a usability test conducted among students and teachers. In Phase II a group randomized trial will be conducted among 27 high schools to evaluate the effects of REAL media Plus on smoking and vaping.

Conditions
COMPLETED
Tobacco-Related Disease Prevention Among Korean Americans
Description

The study evaluates the effectiveness of an internet-based smoking cessation program for Korean Americans.

COMPLETED
Prevention of Environmental Tobacco Smoke Exposure in Children 0-12 Months Old
Description

This study will: 1) test the effectiveness of a program to prevent the exposure of infants to environmental tobacco smoke; and 2) evaluate the health effects associated with prenatal and postpartum exposure to tobacco smoke products and environmental tobacco smoke among infants. African-American and Hispanic women who are 18 years of age or older, and who are between 28 and 35 weeks pregnant may be eligible for this study. Participants complete an interview and home visit assessment and are then randomly assigned to participate in Program A or Program B of the study, as follows: Program A: Involves discussions with an Infant Health Advisor about parenting skills to promote child safety and infant growth and development, such as ways to prevent childhood injuries caused by falls, poisons, and other hazards. Program B: Involves discussions with an Infant Health Advisor about ways to prevent infant tobacco smoke exposure, such as how to adopt smoke-free household rules in the home and how to work with friends and family members to prevent the baby from being exposed to tobacco smoke. In addition, participants who smoked cigarettes before becoming pregnant or while pregnant are given advice on how to quit smoking and how to remain a non-smoker once the baby is born. Participants come to the clinic four times- once during a regularly scheduled prenatal visit and again when the baby is 6 weeks, 4 months, and 6 months old - to see the Infant Health Advisor for the activities described above in Program A or Program B. Between visits, the Advisor calls the participant to check on her progress regarding the program objectives. In addition, the study involves the following for all participants: * Telephone interview during the week after joining the study to obtain information on participant's background, pregnancy and family history, tobacco use and exposure to other people's cigarette smoke during pregnancy, strategies to reduce tobacco use and exposure, stressful life events, drug and alcohol use during pregnancy, and sources of social support. Similar interviews are repeated when the baby is 6 weeks old, and again when the baby is 4 months, 6 months, and 12 months old. * Home visit about 1 week after entering the study to check the home for possible safety hazards to the baby and to place one or more nicotine air monitors (small plastic objects that measure the amount of tobacco smoke in the air of each room). The home visitor returns a week late...

COMPLETED
Impact of E-Cigarette Prevention Messages on Adolescents
Description

The purpose of this trial is to determine whether a vaping prevention text message program reduces susceptibility to vaping among adolescents and young adults. This study addresses this issue by exposing participants to a vaping prevention text message program over a 28-day period in a randomized controlled trial with a matched attention control condition. A follow-up assessment is also made 4 weeks after the text messaging ends.

Conditions
ENROLLING_BY_INVITATION
Precision Prevention Strategy to Increase Uptake and Engagement in Lung Cancer Screening and Smoking Cessation Treatment
Description

This trial tests the effects of two versions of RiskProfile, a clinically-informed and a genetically-informed version of a patient-specific risk feedback tool, in comparison to usual care, on lung cancer screening and tobacco treatment. The trial assesses the multilevel effects of these precision risk feedback tools on the likelihood of clinicians to order lung cancer screening and tobacco treatment and of their patients to utilize these cancer prevention interventions.

WITHDRAWN
Equitable Smoking Relapse Prevention
Description

The goal of this clinical trial is to test a GPS (Global Positioning System)-enabled smartphone app (QuitBuddy) in current smokers. The main questions it aims to answer are: * Is Quitbuddy a good treatment for quitting smoking and "staying quit"? * Will a second treatment that connects people to help for their social and financial needs improve Quitbuddy? Participants will: * get nicotine lozenges in the mail * check in with the study team to report on their quitting progress after 1 day, 1 week, 1 month, 2 months, 3 months, and 6 months Researchers will compare Quitbuddy to an app made by the National Cancer Institute to see if Quitbuddy is better for helping people stay quit.

RECRUITING
Developing a Positive Approach to Substance Use Prevention in North American Indian Adolescents
Description

The overall objective of this project is to develop and obtain preliminary data on acceptability, feasibility, and initial efficacy of Native PATHS. This work is guided by the stage model guidelines for treatment development and adaptation 25. Stage 1a will occur in two sequential steps. First, the investigators will recruit youth who are in 5th - 8th grade and their family members (N=24, 12 youth, 12 adults 18+) to participate in three talking circle sessions to obtain feedback on the cultural adaptation and implementation of the treatment. Next, the investigators will conduct an open label pilot (N=9). Youth and their family members, (up to 3 per youth) will provide qualitative and quantitative feedback after each session. In Stage 1b, 60 youth will participate in a pilot randomized controlled trial, testing the efficacy of the newly created program (n=30) against a wait list control (WLC) condition (n=30). Ultimately, this program of research is expected to result in a well-specified, efficacious prevention program that could be readily disseminated and generalizable to other Indigenous populations with minimal adaptation.

ENROLLING_BY_INVITATION
Antibiotic Prophylaxis in High-Risk Arthroplasty Patients
Description

To determine the effectiveness of a 7-day course of an oral, prophylactic antibiotic on the incidence of periprosthetic joint infection and wound complications following primary total hip and knee arthroplasty in a high-risk patient population.

COMPLETED
Black Raspberry Nectar for the Prevention of Lung Cancer, BE WELL Study
Description

This trial studies how well black raspberry nectar works in changing the gut microbiome and in reducing inflammatory processes that may lead to lung cancer. Studying the effects of black raspberry beverage on inflammation may help doctors find strategies to reduce the risk of developing lung cancer.