Treatment Trials

127 Clinical Trials for Various Conditions

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ACTIVE_NOT_RECRUITING
Effectiveness and Cost-Effectiveness of Fully-Automated Digital vs. Human Coach-Based Diabetes Prevention Programs
Description

The purpose of this research study is to compare the effectiveness of a fully automated digital diabetes prevention program to standard of care human coach-based diabetes prevention programs for promoting clinically meaningful lifestyle changes to reduce the risk of type 2 diabetes in adults with prediabetes.

COMPLETED
WALK Study: Women's Active Living for Koreans Study
Description

The prevalence of metabolic syndrome (MetS) is a health concern among Asians. Growing evidence indicates that Korean Americans had higher MetS prevalence compared to non-Hispanic Whites, but a culturally and linguistically appropriate lifestyle intervention has not been developed for Korean American middle-aged and older women. Thus, the investigators propose to develop a 4-week lifestyle intervention (Women's Active Living for Koreans (WALK) Study) to increase physical activity (PA) and reduce sedentary behavior for Korean American women.

COMPLETED
Exercise Values of Life and Vitality Everyday
Description

The purpose of this study is to develop and test a brief program to help overweight people become more physically active. We plan to design a program that teaches people how to become more active by identifying how fitness enables them to live their lives better. Participants will be asked to complete questionnaires and wear a device that tracks their exercise for 1 week. If accepted into the study, they will receive a 1 day program designed to help them exercise more. Then they will receive phone calls and emails for support after the program. Finally, participants will come in 3 and 6 months after the program to complete the same questionnaires and wear the exercise tracker again. The study is primarily interested in increasing exercise levels, and so we hope to see participants exercising more after the program than they were before. We will also ask them questions (via the questionnaires) that tell us the degree to which they are exercising based on their one desires and values, as opposed to doing it because they were told to.

UNKNOWN
Community Activation for Prevention (CAPs): A Study of Community Gardening
Description

The investigators previous studies show that community gardening is associated with reduction of key health behaviors for cancer prevention in diverse populations. Community gardeners eat more fruits and vegetables per day, are more physically active, and are more likely to avoid age-associated increase in body mass index (BMI). The effect is partially explained by the finding that gardeners are more socially involved, and feel more social support than non-gardeners. The investigators propose a randomized controlled trial to determine whether community gardening improves cancer-preventive behaviors among a multi-ethnic, low-income adult population and elucidate the pathways that shape cancer-preventive behaviors. A randomized controlled trial is needed to demonstrate that the observed behavioral differences are due to the effect of gardening as an intervention rather than self-selection by gardeners.

COMPLETED
Denver Garden Environment and Microbiome Study Disease
Description

An interdisciplinary team with extensive garden study experience conducted a pilot randomized controlled clinical trial to see whether gardening reduced risk factors for diseases like cancer and heart disease. The pilot trial will provide preliminary data on associations between human microbiome, diet, physical activity, and social interactions and the outcomes of weight status and key inflammatory biomarkers.

ACTIVE_NOT_RECRUITING
Developing a Physiological Understanding of High Duration Activity
Description

When muscles are not contracting, the local energy demand by muscle and use of specific fuels used to produce energy by oxidative metabolism are minimal. The time people spend sitting inactive (sedentary time) typically comprises more than half of the day. This sedentary behavior is associated with elevated risk of diabetes, cardiovascular diseases, some cancers, and multiple conditions leading to poor aging. From a progressive series of experiments, the driving goal is to develop a physiological method for sustaining contractile activity via oxidative metabolism over more time than is possible by traditional exercise (hours, not minutes per day). Developing a physiological method suitable of prolonged muscular activity for ordinary people (who are often unfit) requires gaining fundamental insights about muscle biology and biomechanics. This also entails a careful appreciation of the ability to isolate specific muscles in the leg during controlled movements, such as the soleus muscle during isolated plantarflexion. This includes quantifying specific biological processes that are directly responsive to elevated skeletal muscle recruitment. The investigators will focus on movement that is safe and practical for ordinary people to do given their high amount of daily sitting time. This includes developing methods to optimally raise muscle contractile activity, in a way that is not limited by fatigue, and is feasible throughout as many minutes of the day as possible safely. This also requires development of methodologies to quantify specific muscular activity, rather than generalized body movement. There is a need to learn how much people can increase muscle metabolism by physical activity that is perceived to them as being light effort. It is important to learn if this impacts systemic metabolic processes under experimental conditions over a short term time span in order to avoid confounding influences of changes in body weight or other factors.

COMPLETED
Exergame Study for Family Caregivers
Description

The goal of this study is to examine Go\&Grow as a social exergame intervention to increase physical activity and social support, to promote well-being in family caregivers, and to test social support and physical activity as mechanisms for the effects of the intervention.

COMPLETED
Smartphone App to Improve Physical Activity in Older Adults With MCI/Mild Dementia
Description

The purpose of this study is to develop and test a physical activity-tracking smartphone app designed to facilitate physical activity in older adults with mild cognitive impairments or mild dementia. The app targets provides tips, messages, and strategies to overcome common barriers older adults face to being physically active. Participants will include older adults with memory or thinking problems or those diagnosed with mild cognitive impairment or mild forms of dementia who are smartphone users age 65 years or older and who are not meeting nationally recommended levels of physical activity. In the clinical trial phase of this study, 15 participant-study partner dyads will be oriented to the app and use it for a two-month period. Dyads will keep a diary to document their experiences and participants' activity patterns will also be tracked at the beginning and end of the study. After the two-month app trial is complete, dyads will return for a follow-up interview to discuss their experiences and provide suggestions for app improvements. Findings from this stage of the overall study will be combined with previous study phases to derive specifications for an optimized app for older people with mild cognitive impairments or mild dementia.

COMPLETED
Testing Self-Control as a Behavior Change Mechanism to Increase Physical Activity
Description

The goal of this study is to test self-control as a behavior change mechanism for physical activity and to investigate whether a smartphone-based self-control intervention can increase physical activity among sedentary middle-aged adults.

COMPLETED
The Effects, Perceptions, and Attitudes of Previously Sedentary Individuals Starting an Exercise Program
Description

To examine whether starting an exercise program with or without education can influence dietary choices in previously sedentary of 20-40 years.

COMPLETED
Blueberry Enhances Activity and Cognition Through Increased Vascular Efficiency
Description

Recent evidence suggests that increased berry intake results in a variety of health benefits, across multiple health domains. This 3-month randomized, double-blind, placebo-controlled trial assess the effects of combining daily blueberry intake with weekly exercise (BB-EX) on cardiovascular function, as well as physical activity and cognitive function, in sedentary older adults (\>60 years). We will compare these effects to the same outcomes with a control group consuming a blueberry placebo (P-EX) at 0, 4, 8 and 12 weeks.

TERMINATED
NEAT!2 Sedentary Behavior Reduction for Individuals With Past or Present Knee Symptoms, Injuries, or Surgeries
Description

This study will evaluate the effectiveness of an mHealth sedentary reduction program over a 6-month period of time in adults with past or present knee symptoms, injuries, or surgeries.

TERMINATED
Adaptation of an eHealth (Web-application) Platform for Delivery of a Sedentary Behavior Intervention Among Prostate Cancer Patients
Description

The overall objective of this study is to adapt and refine an existing eHealth (web-application/web-app/app) platform designed to promote spontaneous movement (reducing sedentary behavior) among older adults, to men with prostate cancer.

COMPLETED
Healthy Aging Resources to Thrive (HART)
Description

Healthy Aging Resources to Thrive (HART) uses a rigorous two-stage randomized control design, adapted and refined based on pilot studies, to test a novel intervention to reduce sitting time in older adults. Half the participants will be randomized to the intervention aimed at decreasing sitting time, and the other half will be randomized to a healthy living control that does not focus on reduced sitting time. After 6 months, the intervention group will be further randomized so that half continue with the intervention and the other half receive no further intervention. All participants will be followed for 12 months.

UNKNOWN
Active Workplace Study
Description

Exposure to sedentary work is an occupational hazard with significant health and safety consequences. Sedentary behavior is an independent predictor of heart disease, diabetes, early mortality, and accounts for the majority of the increase in obesity in the US. Prolonged sitting, common in modern sedentary work environments, contributes to increases in musculoskeletal pain, injuries, and detrimental changes in physiological functioning. Call center employees, who are among the most sedentary workers in the US, area priority population for Total Worker Health interventions. This project is designed to substantially improve health, safety, and well-being in call center employees, including physiological outcomes that contribute to chronic diseases.The study tests whether a Total Worker Health oriented intervention is more effective than usual practices for increasing the utilization of health and safety resources and improving worker health and safety. Study results will have implications for over 30 million sedentary workers in the US.

COMPLETED
Sit Less for Successful Aging
Description

The objective of this pilot study is to quantify patterns of activity and sedentary behavior in independent living residents and to collect preliminary data on the feasibility of reducing sedentary behavior using a 12-week, behavioral intervention in older adults. We will also measure the effects of reducing sedentary behavior on physical function, sleep, quality of life, energy/mood, pain and blood pressure. Participants will act as their own controls through the use of a double baseline period to examine stability of the physical activity and outcome measures.

ACTIVE_NOT_RECRUITING
Sedentary Behavior Interrupted: A Trial of Acute Effects on Biomarkers of Healthy Aging
Description

This protocol "Sedentary Behavior Interrupted: A randomized crossover trial of acute effects on biomarkers of healthy aging in the laboratory (Project 1)" is part of a National Institutes of Aging Program Grant called "Sedentary Time \& Aging Mortality and Physical Function (STAR). The overall purpose of the STAR program to is to better understand how to interrupt sitting time and the consequences for healthy aging in postmenopausal women. This protocol (also referred to Project 1 of the STAR program) is a 3-condition randomized crossover clinical trial of up to 86 postmenopausal women to test whether different interruptions to prolonged sitting improve metabolism.

ACTIVE_NOT_RECRUITING
Sedentary Behavior Interrupted Randomized Controlled Trial (P2)
Description

Epidemiological findings indicate that older adults do not meet physical activity (PA) guidelines \& spend up to 11 hrs/day sitting. Given the high prevalence of sedentary behavior (SB), the higher chronic disease risk in this population, \& the age-associated challenges of meeting traditional PA guidelines, involving longer bouts of moderate PA, the investigators hypothesize that older adult health will benefit from new strategies to interrupt sitting. This protocol "Sedentary Behavior Interrupted: A randomized trial of 3-month effects on biomarkers of healthy aging and physical functioning in the real world (Project 2)" is part of a National Institutes of Aging Program Grant called "Sedentary Time \& Aging Mortality and Physical Function (STAR). The overall purpose of the STAR program to is to better understand how to interrupt sitting time and the consequences for healthy aging in postmenopausal women. This protocol (also referred to Project 2 of the STAR program) is a 3-arm randomized control trial designed to assess ways of interrupting sitting in 405 overweight, postmenopausal women.

COMPLETED
Fatigue Interventions in Cancer (Exercise Intervention)
Description

This randomized pilot phase II trial studies how well exercise intervention with or without internet-based cognitive behavior therapy works in reducing fatigue in participants with prostate cancer that has spread to other places in the body and usually cannot be cured or controlled with treatment. Exercise intervention and internet-based cognitive behavior therapy may help to improve feelings of tiredness in participants with prostate cancer. The study originally included both prostate cancer and breast cancer participants, but due to low accrual of breast cancer participants, the breast cancer cohort was closed and the study continued with prostate cancer participants only.

COMPLETED
A Smartphone App to Improve Physical Activity
Description

The purpose of this study is to develop, test, and optimize a physical activity (PA)-tracking smartphone app and specialty features, which are designed to facilitate older adults' PA by targeting common barriers in this population. For example, one feature sends messages throughout the day about the good things about growing older to combat negative views about aging which has been linked to decreased PA. Participants will include older adult smartphone users who are between the ages of 65 and 84 and are not very physically active. In phase one of the study, three groups of five older adults will be formed to test the PA-tracking app and one of three specialty features for a two-week period, followed by a focus group to learn about the older adults' experiences. In phase two, approximately 100 participants will be randomly assigned to one of eight groups that include various combinations of specialty features with the PA tracker, for the purpose of pilot testing the app for a four-month period. Testing will occur at the beginning and the end of the four-month intervention period, and will measure PA levels, sedentary activity time, self-reported PA, and functional mobility.

COMPLETED
A "Stand Up and Move More" Intervention for Older Adults
Description

The purpose of the expanded study is to examine the effectiveness of a "Stand Up and Move More" intervention to reduce sedentary behavior in older adults from underserved communities.

COMPLETED
Development and Validation of an Automated Measurement of Child Screen Media Use: FLASH
Description

Children's screen media use has been identified as a prominent cause for sedentary time that has been linked to obesity and metabolic syndrome, as well as other unwanted physiologic, psychosocial, and academic outcomes in children. However, no system that is automatic, accurate and unobtrusive has been developed to assess children's screen use on different platforms. Advances in technology, such as person detection, accurate facial recognition based on images, and imaging, computer vision and signal processing algorithms now offer novel and promising solutions to objectively and automatically measure people's screen viewing behaviors. Investigators will leverage these recent advances and integrate them to develop a first of its kind, in-home, unobtrusive, automatic, privacy preserving screen use monitoring system: Family Level Assessment of Screen use in the Home (FLASH) that uses an embedded computing platform connected to a video camera on larger, stationary screens (FLASH-TV); or functions as a background app using a front facing camera (FLASH-Mobile). The trans-disciplinary group, consisting of behavioral researchers at Baylor College of Medicine (BCM) and electrical engineers at Rice University, will develop and asses the validity of the FLASH to accurately identify whether and for how long a child is using screen media devices. In this multiple-PI study, the development of FLASH is led by engineers at Rice. Once a final system has been developed, alpha and beta tested, a validation study will take place in observation labs by the BCM behavioral researchers with 6-11 year old children for FLASH-TV and FLASH-Mobile (n=43). Comparisons of FLASH output will be made to staff observations of children participating in a set of structured predefined activities. Next FLASH will be assessed for feasibility and accuracy for identifying children's screen use across platforms in a naturalistic home setting (n=46), compared to direct observation and screen use diaries. FLASH has the potential of having a significant impact on public health and clinical research regarding screen media use by improving scientist's ability to assess the children's screen use. This can lead to better methodology to understand the impact of screen use on children's health outcomes or intervention effects of screen media reduction programs.

COMPLETED
Assessing the Effects Of Treadmill On LPA, Sitting Time, and Cardiovascular Risk
Description

The purpose of this study is to: 1. Evaluate the relative efficacy of a treadmill desk intervention on light physical activity and sitting behaviors at work over four weeks; 2. Evaluate the relative efficacy of a treadmill desk intervention on the cardiovascular risk profiles (blood pressure, body weight, body fat percentage) over a four-week period.

COMPLETED
Sedentary Behavior and Health Outcomes Study
Description

This study is a randomized crossover trial to compare the effectiveness of interrupting SB on glucose homeostasis in the lab and free-living settings. All participants (N=56) will complete one screening visit to determine eligibility, complete at fitness test, and body composition analysis by bioelectrical impedance. After 7-21 days, all participants will complete two 3-hour in-lab oral glucose tolerance tests (spaced 7-21 days apart). Prior to the in-lab OGTT visits, participants will wear an activity monitor for 7 days on the right thigh. The experimental conditions for the OGTTs will be: 1) 3-hour OGTT of continuous sitting; and 2) 3-hour OGTT with sitting interrupted every 30 minutes with 3-minutes of moderate intensity walking on a treadmill. There will be a 7-21 day washout period between the OGTT visits. In addition, a subset of participants (N=12) who meet inclusion criteria and who successfully complete both OGTT visits will complete a second randomized crossover trial in the free-living environment. The experimental conditions for the free-living components will be: 1) 4 days of habitual sedentary behaviors; and 2) 4 days of prompted short exercise breaks during times in which sedentary behaviors have exceeded 30 minutes. Participants in the free-living trial will wear an activity monitor and a continuous glucose monitor.

COMPLETED
CalFitness Smartphone-Delivered Physical Activity Intervention With Messaging
Description

The overall goal of this study is to test personalized mobile phone-based physical activity interventions among students at the University of California, Berkeley. Most physical fitness applications for smartphones and activity trackers use a constant goal for the number of steps each day. However, if the step goals are dynamically adjusted according to past behavior, then the corresponding goals may encourage individuals to increase their physical activity level. This study consists of a randomized controlled trial in which we are assessing the efficacy of four different algorithms for calculating personalized goals for the number of steps each day and for determining which motivational messages to send each day.

COMPLETED
Development of An Exergame for Caregivers of Individuals With Alzheimer's Disease or Related Dementias
Description

The study goal is to evaluate user experience with our developed exergame, which was designed to increase physical activity, exercise self-efficacy, and social connections among caregivers of individuals with Alzheimer's disease (AD) or related dementias. Participants will use this garden-themed exergame for six weeks. Tailoring an exergame for caregivers of AD or related dementias has the potential to increase physical activity and to improve overall health and well-being in this vulnerable population, which in turn can benefit the patients for whom they provide care. All study sessions be held at a location convenient to participants.

COMPLETED
Increasing Physical Activity Among Sedentary Older Adults:What, Where, When, and With Whom
Description

The goal of this study is to develop a smart phone app to administer a behavior change program that helps adults to increase daily steps by planning where, when, and with whom to walk. The investigators tested the effectiveness of the walking program app for increasing the number of daily steps among sedentary older adults. The investigators examined the effects on self-efficacy and social integration/support.

COMPLETED
Exercise Effects on Brain Health and Learning From Minutes to Months
Description

Given the accelerating growth of older adults worldwide and the decline in cognitive function with aging, therapeutics that remediate age-related cognitive decline are needed more than ever. The proposed research seeks to better understand and enhance the detection of exercise effects on hippocampal network function and learning and memory, which decline with aging and Alzheimer's. Success would lead to new ways to detect benefits of exercise on cognitive aging and would lead to mechanistic insight on how such plasticity is possible while also informing prevention strategies.

COMPLETED
Exercise, Cognitive Function and Neuroplasticity in Healthy Adults
Description

The overall goal of the proposed study is to compare the effects of 4 weeks of moderate or high intensity aerobic exercise on neuroplasticity, cognitive performance and gait and postural control in sedentary healthy adults.

COMPLETED
Senior Change Makers Study: Improving Physical Activity Environments
Description

Senior Change Makers is an intergenerational intervention that compares two, 8-week programs: (1) an advocacy program wherein senior participants perform audits of their physical activity environments, identify an advocacy project, and advocate for improvements; and (2) a walking program designed to increase participant physical activity through education and guided walks. The investigators expect that the advocacy program will produce greater improvements in seniors' advocacy skills, confidence, and attitudes at 8 weeks.