53 Clinical Trials for Various Conditions
This study will determine how common lifestyle practices affect the behavior of neutrophils (a type of immune cell) at shorter time scales than previously possible.
This randomized clinical trial studies an integrative oncology (making changes in lifestyle and behavior) program in improving cancer-related outcomes in patients with stage II or III breast cancer undergoing radiation therapy. An integrative oncology program consisting of dietary recommendations, physical activity, stress management, social support, and control of environmental contaminants may modify cancer-related biological processes, influence long-term treatment results, and improve the quality of life of patients.
The goals of this research proposal are to further our understanding of the reproductive aging process in women and to improve our ability to clinically assess and model reproductive aging. Reproductive aging is a continuous process that begins many years prior to menopause. Women in their late 30s and early 40s usually maintain normal menstrual function and ovulatory status, yet fertility in these women is considerably compromised compared to younger women. The primary mechanism of reproductive aging is through the process of ovarian primordial follicle (egg) depletion, a process that exhibits considerable variation between women. As a result, the age at which an individual begins to experience infertility and menstrual cycle changes secondary to follicle depletion also varies significantly and is difficult to predict. Multiple studies have investigated the impact of lifestyle choices (tobacco use, oral contraceptives, BMI, alcohol use, and parity) on reproductive lifespan by correlating the impact of these exposures with the age of spontaneous menopause. Although occasionally in agreement, many of these studies report contradictory findings. Alcohol use either delays or has no effect upon the age of spontaneous menopause. Similarly, oral contraceptive pill use has been suggested to both accelerate and delay the onset of menopause. The most consistent findings regarding the impact of these factors is an acceleration in the age of menopause by 1-2 years in smokers. Given the lack of consistent findings in these investigations, the exact impact of lifestyle factors on reproductive age is currently unknown. Nevertheless, the magnitude of such exposures in the U.S. population is considerable, with 19% of adult women using oral contraceptives and 19.2% current smokers according to recent statistics. This proposal seeks to develop better models of normal female reproductive aging through anatomical studies investigating the impact of lifestyle choices on ovarian primordial follicle number. A secondary aim is to determine the relationship between newly described markers developed to assess biological aging in other organ systems (white blood cell telomere length and the measurement of advanced glycation end products (AGEs) through skin autofluorescence) and reproductive age.
RATIONALE: Lifestyle factors, such as physical activity, diet, and obesity, and hormone function may affect breast density. Screening tests, such as mammography, may help doctors find tumor cells early and plan better treatment for breast cancer. PURPOSE: This clinical trial is studying the effect of lifestyle factors and hormone function on breast density in healthy Hispanic women who are undergoing mammography for breast cancer screening.
The aim of this pilot study is to determine the effects of a 12-week indoor rock climbing training program on heart health, mental health, and behavioral health in generally healthy adults aged 18-35 years old who do not exercise. Participants will learn to rock climb using ropes on an indoor rock climbing wall and participate in the training program 2-3 days per week for 60 minutes each session over 12 weeks. Health outcomes will be measured at 4 time points over the course of the study (pre-intervention, 6-weeks/mid-intervention, 12-weeks/post-intervention, and 24-weeks post-intervention).
The overall goal is to determine how a sleep extension intervention (increasing time in bed) in individuals who maintain less than 6.5 hours sleep per night affects their plasma ceramides and insulin sensitivity. Participants will undergo a randomized controlled trial, with sleep extension (intervention) and healthy lifestyle (control) groups. The sleep extension is designed to increase participant's time in bed by 2 hours per night. Alternatively, the control group will receive basic health information (e.g., physical activity, goal setting, and nutrition when eating out).
This Study aims to build a diverse and inclusive group of participants to help researchers advance our understanding of how signals and information collected from apps and devices relate to health and may be used to predict, detect, monitor, and manage changes in health. Participants will be asked to complete tasks and surveys, using their iPhone and Apple Research app which include: * Selecting the types of data they would like to share with the study such as health and sensor data * Complete tasks and surveys including areas such as personal demographic information, personal medical history, family history, and social determinants of health
This study collects health and genetic information to implement cancer prevention and treatment strategies.
The goal of our pragmatic clinical trial is to compare how well three different strategies might do to reduce risk factors for cardiovascular disease in patients experiencing health disparities. The three different strategies are: 1) text messages, 2) interactive chatbot messages, and 3) chatbot messages with proactive pharmacist support. To measure cardiovascular risk factors, the investigators are using the American Heart Association's Life's Essential 8 (LE8) factors-blood glucose, cholesterol, blood pressure, physical activity, body mass index, diet, and smoking. This study focuses on improving cardiovascular risk factors for individuals facing health disparities, such as ethnic minorities, limited English proficiency, and low-income groups. These groups are more likely to be seriously affected by cardiovascular diseases. Self-management, or an individual's roles in managing their own chronic disease, includes lifestyle changes, medication adherence. Improving patients' self-management has been shown to improve health behaviors, better disease control and improved patient outcomes. The main question this study aims to answer is if one of the strategies (texting, chatbot, or chatbot with pharmacist support) may improve patient self-management and patient outcomes. The investigators will enroll up to 2,100 patients from three health systems that serve large populations experiencing health disparities: Denver Health, Salud Family Health Centers, and STRIDE Community Health Center. The results might help researchers and health care systems find the best ways to involve patients with health disparities to managing their chronic cardiovascular disease.
This research project seeks to learn more about how lifestyle interventions can help liver and kidney transplant recipients achieve weight loss goals. The investigators want to evaluate if an intervention using weight and activity wrist monitors, as well as nutritional coaching group sessions is acceptable and useful for post-transplant patients aiming for weight loss. All participants will be given a wrist activity monitor, and a scale. Half of participants will be invited to participate in the nutritional coaching group sessions. The research team will look at weight loss, devices' usage, and satisfaction, and see if there are any difference among the two groups.
The overall goal is to examine the efficacy of a circadian intervention in people with overweight and obesity and habitual short sleep duration (HSSD). Participants will undergo a randomized controlled trial, with circadian intervention and control (healthy lifestyle) groups. The circadian intervention is designed to reduce nighttime light exposure and after-dinner snack food intake. Alternatively, the control group will receive basic health information (e.g., physical activity, goal setting, and nutrition when eating out).
This study has two phases: Phase 1 is to examine blood pressure, microvascular function, and sympathetic nerve activity in mid-life adult binge drinkers vs. alcohol abstainers/moderate drinkers. Phase 2 is to examine the effect of 8-week aerobic exercise training on blood pressure, microvascular function, and sympathetic nerve activity in mid-life adult binge drinkers
This proposal will involve a pilot study to evaluate the feasibility, acceptability, and outcomes of a lifestyle behavior protocol in managing chronic migraine. Additionally, the proposal will investigate biomolecules that are uniquely involved in chronic migraine patients who respond to the protocol. Successful completion of this proposal will inform the design of a future full-scale behavioral clinical trial to control chronic migraine.
The purpose of this project is to apply a community-based participatory research (CBPR) approach to rigorously refine and test the feasibility and preliminary efficacy of an existing cardiovascular (CV) health and wellness digital application (app) prototype to improve CV health according to the American Heart Association Life's Simple 7 (LS7) framework among African-American (AA) adults within faith communities. The investigators hypothesize that the app-based intervention will be feasible and improve LS7 among AAs from baseline to 6-months post-intervention.
This research study is designed to better understand how a virtual reality (VR) exercise application may influence overall physical activity and well-being. VR games can make exercise more enjoyable and interactive, which has been shown to increase engagement in physical activity. Adult participants will do a progressive exercise program and report on overall physical activity, health, and psychological wellbeing. The intervention is expected to have a positive impact on these lifestyle factors.
The purpose of this pilot study is to evaluate the feasibility of a cognitive and affective intervention for foreign born Arab American dyads consisting of the person with Mild Cognitive Impairment (MCI) and participants caregiver. This study will evaluate the feasibility of a cognitive and affective intervention combining Cognitive Behavioral Therapy (CBT), Cognitive Rehabilitation Therapy (CRT), and modifiable lifestyle factors to address the cognitive and affective dysfunctions associated with Mild Cognitive Impairment (MCI) or those with cognitive complaints. The study team hypothesizes that combining evidence-based cognitive and affective therapies (CRT+CBT) with lifestyle modifications is feasible and will improve the cognitive performance and Quality of Life (QoL) in patients with MCI and participants caregivers compared to usual care.
The purpose of this study is to examine the feasibility of comprehensive multimodal individually tailored Cognitive Behavioral Therapy (CBT), Cognitive Rehabilitation Therapy (CRT), and modifiable lifestyle sessions. The study team hypothesizes that combining evidence-based cognitive and affective therapies with lifestyle modifications is feasible and will improve the community integration (CI) and Quality of life (QoL) in patients with a neurocognitive disorder compared to usual care.
Background: The NIH and the American Association of Retired Persons (AARP) conducted a Diet and Health Study. It studied the links between diet, cancer, and cause of death in a group of middle-aged people in the U.S. Researchers want to learn more about how diet and lifestyle can affect cancer and mortality. Objective: To clarify links between diet, lifestyle, cancer, death, and chronic diseases. Eligibility: AARP members ages 50 to 71 who took part in study #OH95CN025 and lived in California, Florida, Pennsylvania, New Jersey, North Carolina, Louisiana, Atlanta, or Detroit in 1995 1996. Design: This study will use existing data and samples. Participants will not be contacted. Participants personal data, like name, date of birth, and address, will be used. This data will be kept private. Their data and samples will get a unique ID. Data from other follow-up studies will be used. Cancer outcome data will be obtained from the 8 sample areas. Many participants have moved to Arizona, Nevada, and Texas. Data will be obtained from those states as well. Cause of death and date of death will be obtained from the National Death Index. Cheek swab samples were gathered from 2004 to 2005. They will be used to study the oral microbiome. The University of Washington (UW) will be added as a study site. UW will study air pollution. The process of linking with the Virtual Pooled Registry Cancer Linkage System will be explored. It uses one system. Right now, 11 state systems are used to get and link data. Paper records will be stored in locked file rooms. Electronic data will be stored on secure servers.
Little is known about the epidemiologic risk factors associated with the development of acute myelogenous leukemia (AML), and less is known about the role that genetic susceptibility plays in the development of AML. We propose to conduct a population-based study to investigate genetic susceptibility in adult AML patients, both de novo and treatment-related in a well-defined geographical area. Using a case-control design, we will prospectively enroll 400 patients from Texas and 800 healthy controls. Controls will be recruited using random digit dialing, and will be matched to the cases by age, gender, and ethnicity. Epidemiological and demographic information will be obtained through personal interviews, and will be integrated with clinical information, cytogenetic data, and genotypic markers. Blood specimens will be collected on all participants, who will be genotyped for markers associated with activation and detoxification of chemical carcinogens, including chemotherapy drugs. Polymorphisms in genes such as cytochrome p450 (CYP2E1), glutathione S-transferases (GSTT1, GSTM1, GSTP1), epoxide hydrolase (HYL1), NADPH-quinone oxidoreductase (NQO1), and myeloperoxidase (MPO) will be analyzed. This study will provide insight into the role that these susceptibility markers, along with clinical epidemiological, and cytogenetic factors, play in the identification of people at risk of developing AML. Understanding how genetic predisposition and exogenous exposures interact to determine AML susceptibility will allow the development of prevention strategies in the future.
This is a prospective cohort study of diet and cancer in relation to several major cancers, especially breast, prostate, and colorectal malignancies. The cohort comprises 50-69 year-old male and female members of the American Association of Retired Persons (AARP). In 1995-6 we mailed baseline questionnaires to 3.5 million AARP members. Over 615,000 AARP members responded, with over 540,000 providing adequate dietary data. Preliminary analysis indicates that the cohort, both men and women, has the desired wide distributions of percent calories from fat, dietary fiber, fruits and vegetables, and red meat. Approximately 330,000 of the initial respondents (with satisfactory data) returned a second questionnaire containing questions on exposures not assessed in the first instrument. In terms of field activities, the study has been relatively quiescent over the past year. At the end of the five-year period of observation, we will mail to cohort members a brief follow-up questionnaire primarily targeted to endpoint assessment. (Because of cancer registry lag-time, we do not expect to mail this questionnaire until early 2002.) Follow-up will be largely passive, through established state registries. The initial questionnaire mailing will be to AARP members in those states selected on the basis of having registries with adequate coverage and quality. We will use active follow-up, with record retrieval, for the small percentage of cohort members who have moved out of the cancer registry areas. The buccal cell collection pilot study has been completed; over 50% of those pilot study partricipants who had completed the baseline and risk factor questionnaires returned buccal cell speciments. Preliminary data from a pilot study of the end point ascertainment procedure indicate that cohort incidence rates for major cancers, determined from registry data, are consistent with SEER rates.
RADICAL PC1 is a prospective cohort study of men with a new diagnosis of prostate cancer. RADICAL PC2 is a randomized, controlled trial of a systematic approach to modifying cardiovascular and lifestyle risk factors in men with a new diagnosis of prostate cancer.
RATIONALE: Collecting and storing samples of tissue, blood, and other body fluids to test in the laboratory and gathering information about health and lifestyle from participants may help doctors learn more about cancer risk factors. PURPOSE: This clinical trial is looking at biological, genetic, and lifestyle risk factors for developing colorectal adenomas or polyps in participants undergoing colonoscopy.
This study investigates the extent to which lifestyle factors including mental health, social support, diet, and exercise are associated with quality of life and melanoma patient outcomes. Knowledge gained from this study may be used to guide the design of prospective clinical trials of lifestyle interventions to improve the outcomes of melanoma patients and assist doctors in counseling their patients.
There are close to 700,000 survivors of adolescent and young adult (AYA) cancer (aged 15 to 39 at diagnosis) in the US. Survivorship for AYAs is often complicated by long-term and late-effects. Cardiovascular disease (CVD), in particular, is a leading cause of death for cancer survivors and is a growing public health concern for survivors diagnosed as AYAs. Risk of CVD may be associated with treatment exposures and may be potentiated by weight gain and poor health behaviors. Healthy eating and physical activity are key behaviors for weight loss and maintenance and may be protective against CVD risk, yet few AYA cancer survivors adhere to guidelines for healthy eating or activity. AYA survivors' abilities to engage in health behaviors (i.e., healthy eating, physical activity) necessary to manage weight may also be challenged by persistent cancer-related symptoms (i.e., pain, fatigue, psychological distress). Thus, weight gain is common. Using input from AYA cancer survivors, the investigators have adapted a behavioral weight and symptom management protocol for AYA cancer survivors with obesity to create an intervention that is responsive to AYAs' unique needs. A pilot randomized controlled trial will be conducted to examine intervention feasibility and acceptability and to examine patterns of change in outcomes including weight, body mass index, symptoms (e.g., pain, fatigue, distress) as well as other CVD risk factors, including blood pressure, cholesterol (total, HDL, LDL), HbA1c, and atherosclerotic cardiovascular disease (ASCVD) risk score.
The overarching goal of this study is to evaluate plasma ceramides (Cers) as early nutrition-sensitive biomarkers of metabolic health. The investigators will implement a diet and lifestyle intervention to improve cardiometabolic risk factors and test the corresponding change in Cer levels. The intervention will incorporate: a) family-level engagement, enrolling both adolescents and one parent/adult caretaker (PAC); and b) a behavior change mobile health (m-health) app, which will offer real-time support, education and monitoring of diet and activity.
The objective of this study is to evaluate the efficacy of a NeuroQ supplement designed by Dr. Bredesen to complement his Lifestyle modification protocol. Eligible participants will be expected to consume the NeuroQ supplement and are recommended to make lifestyle changes based on Dr. Bredesen's protocol. Forty participants are expected to enroll into the study, completing study assessments at check in visits days 30 and 60, and at the end of study visit on day 90. A brief follow up phone call will be conducted approximately 30 days after study completion to ask participants if they have continued using the lifestyle changes and if they have purchased and continued to consume the NeuroQ supplement.
It has been suggested that the best medicine should include four principles (4P) - Medicine should be personalized, predictive, preventative and participatory. Technology has provided the tools to collect data in ways not previously possible. Individuals can now collect information on their genome (including their genetic predisposition to tolerate medications and to respond to healthy lifestyle programs) that will modify their lifestyle and therapeutic choices. Beyond spot checks of vital signs and weight, individuals can now collect information on body composition, continuous monitoring of heart rate, blood pressure, and even blood sugar. Data on food consumption at a caloric, macronutrient and even micronutrient level can be collected. Standard medical histories and detailed physical examination findings and laboratory biomarkers can be correlated with this data. Collections of individual patient data will need to be managed through computer programs and smart phone applications that provide direct feedback about the influence of lifestyle on health, wellness and biomarkers. To this end, Metagenics is designing and is launching a smart phone application, Personal Lifestyle Engine (PLX), for individual use by patients and their healthcare providers. The statistical analysis of these data is the primary objective of this study.
The LIFE-HOUSE research project is designed to evaluate the impact of a personalized lifestyle intervention program on functional capacity as an approach to quantitating health, and its relationship to well understood disease risk determinants. LIFE-HOUSE will utilize an innovative Tent-Umbrella-Bucket design. Participants will gather under the Tent of an all-inclusive 'N of 1' Case Series providing a shelter of Functional Medicine interventions against the storm of chronic disease. Under this Tent are a collection of Umbrellas where participants with similar clinical challenges are evaluated as clinically defined groups with loose guidelines for the planned interventions. Finally, participants standing under these Umbrellas may step into specific Buckets that gather individuals with nearly identical clinical presentations into more formally described prescriptive randomized arms for intervention. Individuals will be offered the opportunity to participate in all Umbrellas and Buckets for which they qualify. They may accept or reject participation in any Umbrella or Bucket and yet remain eligible for participation in the overall Tent.
This is a pilot study to determine whether a lifestyle medicine intervention following stroke may increase levels of Brain-Derived Neurotrophic Factor (BDNF).
The RECOVER Study will examine clinical, environmental and socioeconomic factors in recovery from opioid use disorder (OUD) over a 24-month period following exit from a Phase III clinical program for a buprenorphine extended-release injection (RBP-6000). The study population will consist of participants from studies NCT02357901 (RB-US-13-0001) and NCT02510014 (RB-US-13-0003). The RECOVER study will characterize OUD subjects' recovery process as they transition from the controlled clinical trial environment to the real world setting.