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Integrated Clinical Trials is a virtual database currently indexing clinical trials from: EU Clinical Trials Register and ClinicalTrials.gov.
(last updated: Nov 28, 2022)
Clinical Trials Information| Database | Title | Recruitment | Conditions | Intervention | Sponsored By | Gender | |||||
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Clinicaltrials.gov | Effect of Weight Loss on Prostate Cancer Pathology | Completed | Obesity, Prostate Cancer | Behavioral, Other - Weight Loss, No Weight Loss Group | VA Office of Research and Development, U.S. Fed | Male | N/A - N/A | N/A | Interventional | The purpose of this study is to determine if weight loss prior to radical prostatectomy effects chemical substances in the blood stream and prostate tissue that may affect prostate cancer development and progression. | |
Clinicaltrials.gov | North Carolina WISEWOMAN: Weight-Wise Pilot Study | Completed | Overweight, Obesity | Behavioral - Weight loss intervention | University of North Carolina, Chapel Hill, Centers for Disease Control and Prevention, North Carolina Department of Health and Human Services, Other, U.S. Fed, Other | Female | 40 Years - 64 Years | N/A | Interventional | The purpose of this study is to test the effectiveness of a weight loss and weight loss maintenance intervention among low income women, conducted in a community health center setting. | |
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Clinicaltrials.gov | Sports to Prevent Obesity: Feasibility and Pilot RCT | Completed | Obesity | Behavioral, Behavioral - After school sports program, After school health education | Stanford University, Association of American Medical Colleges, Centers for Disease Control and Prevention, Other, Other, U.S. Fed | N/A - N/A | Phase 1/Phase 2 | Interventional | The purpose of this study is to learn whether overweight children who participate in an after school sports program improve their health as much as overweight children in a more traditional health education program. | ||
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Clinicaltrials.gov | Walking Aids in the Management of Knee Osteoarthritis | Completed | Obesity, Osteoarthritis | Device - Single point cane | VA Office of Research and Development, U.S. Fed | 45 Years - 85 Years | N/A | Interventional | The purpose of this study is to assess whether the single point cane will relieve pain and disability in overweight or obese people with knee OA through altered joint biomechanics and what factors influence acceptance of cane use. | ||
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Clinicaltrials.gov | Pragmatic Obstructive Sleep Apnea Weight Loss Trial Assessing Effectiveness and Reach | Not yet recruiting | Obesity, Sleep Apnea, Obstructive | Behavioral - lifestyle intervention | VA Office of Research and Development, U.S. Fed | 18 Years - N/A | N/A | Interventional | Prevalent obesity related conditions like obstructive sleep apnea (OSA) represent an important opportunity to improve population health. OSA reduces quality of life and is associated with greater risk for cardiovascular disease. Although obesity is the single greatest reversible risk factor for OSA, patients with OSA and obesity rarely receive weight loss care to reverse OSA and other serious comorbidities. Efficacy trials reinforce that time and resource intensive lifestyle-based weight loss programs improve weight and physiologic measures of OSA severity (apnea hypopnea index, AHI). However, there are barriers to translating these findings into meaningful gains for population health. To meet these challenges, the investigators propose a pragmatic trial of proactively offering a remote video-based and self-directed lifestyle-based weight loss intervention with remote coaching to patients with OSA. The investigators primary aim is to test the effectiveness of a proactively delivered and pragmatic lifestyle intervention to improve co-primary endpoints of sleep-related quality of life and weight among patients with OSA and obesity. Secondarily, the investigators will compare additional outcomes between groups: cardiovascular risk scores, sleep symptoms, and AHI. Finally, the investigators will also conduct an implementation process evaluation informed by the RE-AIM framework to identify barriers and facilitators to widespread implementation. The investigators will identify patients with OSA and obesity nationwide (n=696) in VA using data from the VA's Corporate Data Warehouse (CDW), and the investigators will contact potentially eligible patients. After confirming eligibility and consent, the investigators will randomly assign subjects to receive the study's lifestyle intervention or usual care alone. The study uses CDW to assess weight change, supplemented by self-report when necessary. Subjects will complete questionnaires at baseline at 3, 12 and 24 months after randomization. The lifestyle intervention in POWER focuses on gradual lifestyle behavior change aimed at improving eating habits and increasing physical activity. It encourages participants to gradually achieve and maintain a 5-10% loss of baseline body weight and at least 150 minutes of moderate-intensity physical activity, such as brisk walking, each week. The lifestyle intervention program consists of watching one video, completing corresponding written self-guided learning materials, and tracking food intake and physical activity each week for the first 12 weeks, then working through 10 additional written handouts and continued food and activity tracking for the next nine months. Intervention participants will have access to a lifestyle coach as desired for the full 12-month intervention period. | ||
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Clinicaltrials.gov | Mindfulness-Based Intervention for Depression and Insulin Resistance in Adolescents | Not yet recruiting | Type 2 Diabetes, Depression, Insulin Resistance, Obesity, Adolescent Development | Behavioral, Behavioral, Behavioral - Mindfulness-Based Intervention, Cognitive-Behavioral Therapy, Health Education | Colorado State University, National Center for Complementary and Integrative Health (NCCIH), University of Colorado, Denver, Children's National Health System, Uniformed Services University of the Health Sciences, Other, NIH, Other, Other, U.S. Fed | 12 Years - 17 Years | N/A | Interventional | Rates of type 2 diabetes (T2D) in adolescents have escalated. Adolescent-onset is associated with greater health comorbidities and shorter life expectancy than adult-onset T2D. T2D is preventable by decreasing insulin resistance, a physiological precursor to T2D. T2D prevention standard-of-care is lifestyle intervention to decrease insulin resistance through weight loss; yet, this approach is insufficiently effective in adolescents. Adolescents at risk for T2D frequently experience depression, which predicts worsening insulin resistance and T2D onset, even after accounting for obesity. Mindfulness-based intervention (MBI) may offer a targeted, integrative health approach to decrease depression, and thereby, ameliorate insulin resistance in adolescents at risk for T2D. In a single-site, pilot randomized controlled trial (RCT), we established initial feasibility/acceptability of a 6-week group MBI program, Learning to BREATHE, in adolescents at risk for T2D. We demonstrated feasible single-site recruitment, randomization, retention, protocol adherence, and MBI acceptability/credibility in the target population. Our preliminary data also suggest MBI may lead to greater reductions in stress-related behavior, vs. CBT and a didactic/health education (HealthEd) control group. The current study is multisite, pilot RCT to test multisite fidelity, feasibility, and acceptability in preparation for a future multisite efficacy trial that will have strong external validity, timely recruitment, and long-term follow-up. Adolescents (N=120) at risk for T2D will be randomized to MBI vs. CBT vs. HealthEd and followed for 1-year. Specific aims are to: (1) test multisite fidelity of training and implementation of 6-week group MBI, CBT, and HealthEd, to teens at risk for T2D; (2) evaluate multisite feasibility/acceptability of recruitment, retention, and adherence for an RCT of 6-week group MBI, CBT, HealthEd with 6-week and 1-year follow-up; and (3) modify intervention training/implementation and protocol procedures in preparation for a future, fully-powered multisite efficacy RCT. | ||
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Clinicaltrials.gov | Modulation of the Intestinal Microbiome by a High Protein Diet | Recruiting | Obesity | Dietary Supplement, Dietary Supplement - Protein powder supplement, standard dosage based on 0.5 gram protein per pound of subject's lean body mass, Protein powder supplement, High Level Protein, based on 1 gram of protein per pound of lean body mass: 25% protein and 45% carbohydrate | VA Office of Research and Development, U.S. Fed | 20 Years - 60 Years | N/A | Interventional | The objective of this study is to test and determine whether a high protein diet induces weight loss by modulating the composition and function of the intestinal microbiome in obesity. This will be investigated in a randomized clinical study comparing the effect of isocaloric high and normal protein diets on the intestinal microbiome composition, gene content, and metabolome of obese subjects. | ||
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Clinicaltrials.gov | Metabolic and Bio-behavioral Effects of Following Recommendations in the Dietary Guidelines for Americans | Not yet recruiting | Obesity, Body Weight | Other, Other, Other - DGA Mediterranean diet pattern, energy balance, DGA Mediterranean diet pattern, negative energy balance, TAD diet pattern, negative energy balance | USDA, Western Human Nutrition Research Center, U.S. Fed | Female | 35 Years - 64 Years | N/A | Interventional | This study, at the Western Human Nutrition Research Center (WHNRC), will focus on whether or not achieving and maintaining a healthy body weight is the most important health promoting recommendation of the Dietary Guidelines for Americans (DGA).The investigators hypothesize that improvement in cardiometabolic risk factors resulting from eating a DGA style diet will be greater in people whose energy intake is restricted to result in weight loss compared to those who maintain their weight. The investigators further propose that during a state of energy restriction, a higher nutrient quality diet such as the DGA style diet pattern, will result in greater improvement in cardiometabolic risk factors compared to a typical American diet (TAD) pattern that tends to be lower nutrient quality (more energy-dense and less nutrient-rich.) | |
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Clinicaltrials.gov | Shop For Success: Experimental Grocery Store Study | Completed | Overweight, Obesity | Other, Other - Own-Price Elasticity, Cross-Price Elasticity | USDA Grand Forks Human Nutrition Research Center, U.S. Fed | Female | 18 Years - N/A | N/A | Interventional | The purpose of this research is to study how the price of foods affects food buying choices at the grocery store. The researchers are interested in this topic because the price of foods can have a big impact on what people choose to buy and prices change over time. The researchers are doing this study to see how changes in food prices affect what foods mothers choose for their families. | |
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Clinicaltrials.gov | Dietary Carbohydrate and GERD in Veterans | Active, not recruiting | Gastroesophageal Reflux Disease, Obesity | Other - Dietary Carbohydrate | VA Office of Research and Development, U.S. Fed | 21 Years - N/A | N/A | Interventional | 4-Arm Diet Intervention Investigating Effects of Dietary Carbohydrate Type and Amount on gastroesophageal pH, gastroesophageal reflux disease (GERD) symptoms and medication use. | ||
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Clinicaltrials.gov | Auricular Acupuncture in the Treatment of Obesity | Completed | Obesity | Other, Other - Auricular Acupuncture, Sham Acupuncture | Mike O'Callaghan Military Hospital, U.S. Fed | 18 Years - N/A | Phase 4 | Interventional | Male and female DoD beneficiaries ages 18 years or older, who are referred for a standard of care weight loss intervention for treatment of obesity will be recruited. Subjects will be randomized into one of two groups receiving either a standard of care weight loss intervention plus auricular acupuncture at Shen Men, Point Zero, and Appetite Control Point/Hunger Point or receiving a standard of care weight loss intervention plus sham auricular acupuncture. Subjects will receive treatment in accordance with their randomization group for 12 weeks then have one additional follow up visit at week 24. The following measures will be obtained: height, weight, waist circumference, and Body Mass Index will be calculated. | ||
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Clinicaltrials.gov | Oral Glucose Tolerance Testing After Gestational Diabetes | Completed | Gestational Diabetes, Pregnancy, Obesity | MetroHealth Medical Center, Centers for Disease Control and Prevention, Loyola University, Other, U.S. Fed, Other | Female | 18 Years - N/A | Observational | This is an observation study of women with gestational diabetes. Subjects recruited undergo immediate postpartum diabetic screening prior to discharge. Post-partum screening for overt diabetes is repeated 6-12 weeks postpartum. The outcome of interest is the utility of an immediate post partum screen for overt diabetes compared to a traditional 6 week test. | |||
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Clinicaltrials.gov | Healthy Caregivers-Healthy Children | Recruiting | Obesity, Child, Only | Behavioral, Behavioral - Healthy Caregivers- Healthy children, Jump Start | University of Miami, HRSA/Maternal and Child Health Bureau, Other, U.S. Fed | 2 Years - N/A | N/A | Interventional | The purpose of the study is to further develop and examine the Health Caregivers Healthy Children (HC2) program, which encourages obesity prevention through promoting healthy eating and physical activity. | ||
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Clinicaltrials.gov | Cardiometabolic Effects of Sweet Cherry Juice | Recruiting | Obesity, Metabolic Syndrome | Other, Other - Cherry juice, Placebo beverage | USDA, Western Human Nutrition Research Center, Washington State Fruit Commission, U.S. Fed, Other | 20 Years - 65 Years | N/A | Interventional | This study aims to determine the effects of consuming sweet cherry juice on cardiovascular function, glucose regulation, and lipid status in overweight human subjects. The investigators hypothesize that sweet cherry juice consumption will improve metabolic and physiological status in overweight persons compared to a placebo. | ||
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Clinicaltrials.gov | Increasing Steps Per Day in Rural Veterans | Completed | Obesity, Overweight | Behavioral, Behavioral - VA MapTrek, Fitbit Only | University of Iowa, US Department of Veterans Affairs, Other, U.S. Fed | 18 Years - 100 Years | N/A | Interventional | VA MapTrek is a mobile-phone-based web application that allows participants to take a virtual walk in interesting locations around the world while tracking their progress against the progress of other veterans on an interactive map. Steps are counted using a commercially-available triaxial accelerometer (e.g., Fitbit), and users see their progress overlaid on Google Maps. The objective of this study is to report activity levels to veterans, thereby encouraging them to walk more. Once participants know how to text and use Google maps, no additional training is needed. VA MapTrek does not require a special app, so there are no logins or passwords to remember. Simply registering one's Fitbit and mobile phone at an initial enrollment meeting suffices. | ||
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Clinicaltrials.gov | Daily Protein Intake Patterns on Energy Metabolism and the Motivation to Snack | Recruiting | Obesity | Other, Other - Even protein, Skewed protein | USDA Grand Forks Human Nutrition Research Center, U.S. Fed | 20 Years - 60 Years | N/A | Interventional | The purpose of this study is to determine if when one eats protein can change how the body uses food for energy. Researchers will also test if eating a high protein breakfast can change one's craving for snack foods. | ||
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Clinicaltrials.gov | Prevention of Obesity in Military Communities - Fit4Duty | Completed | Obesity, Overweight, Adiposity | Behavioral, Other - Fit4Duty, Nutrition Education | Henry M. Jackson Foundation for the Advancement of Military Medicine, Madigan Army Medical Center, Oregon Research Institute, Other, U.S. Fed, Other | 18 Years - N/A | N/A | Interventional | This randomized controlled trial assesses the efficacy of a 6-week, dissonance-based, weight-gain prevention program (Fit4Duty) designed to reduce unhealthy weight gain among military service members at-risk for obesity. The Fit4Duty program is an adaptation for the military of an existing civilian obesity prevention program, Project Health, which reduced obesity onset by 50% in healthy civilian young adults. Fit4Duty is compared to a nutrition education control condition and is hypothesized to reduce excess weight gain beyond the control comparison program during the 2 year period following study participation. | ||
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Clinicaltrials.gov | Improving Weight Management at the VA | Completed | Obesity | Behavioral, Behavioral - MOVE! Toward Your Goals, Enhanced Usual Care | VA Office of Research and Development, U.S. Fed | 18 Years - 69 Years | N/A | Interventional | Compared to the general public, a higher percentage of Veterans are obese or overweight with a weight-related medical condition. The VA currently offers an effective weight management program called MOVE!, but the majority of eligible patients do not attend. Veterans see their primary care providers (PCPs) very frequently, making it an important place to receive information on weight management. However, PCPs often fail to discuss weight management with patients, so interventions are needed to encourage weight management counseling within the team-based care model used in primary care at the VA. Investigators used focus groups, interviews, and other research methods to develop the MOVE! Toward Your Goals (MTG) intervention. This intervention combines online tools, counseling by a health coach, and the team-based care model to deliver weight management information to patients. Investigators will conduct a randomized controlled trial of 320 Veteran patients and their providers at two VA sites (Manhattan and Brooklyn campuses, New York Harbor Healthcare System) to study the impact of the 12-month MTG intervention when compared to Enhanced Usual Care. Veterans in the MTG intervention arm will take the MTG tool, receive personalized weight management materials, health coach counseling, and go to their scheduled primary care (PC) visit. After the initial visit, MTG-arm Veterans will receive follow up telephone coaching over 12 months. All Veterans will attend follow-up visits at 3, 6 and 12 months to assess body mass index, diet and physical activity, and goal attainment. The objectives of this study are to: (a) test the impact of the MTG intervention on weight and behavior changes; (b) identify predictors of weight loss in Veterans who use goal setting techniques; and (c) determine the impact of the MTG intervention on primary care team obesity-related counseling practices and attitudes. | ||
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Clinicaltrials.gov | Acute Effects of Fats on Satiety and Energy Needs | Completed | Obesity | Other, Other, Other, Other, Other - SFA, MUFA, PUFA-LA, ALA, LCn3 | USDA Grand Forks Human Nutrition Research Center, U.S. Fed | 18 Years - 50 Years | N/A | Interventional | The purpose of this study is to assess the acute effect of dietary fat on satiety and energy metabolism. | ||
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Clinicaltrials.gov | Coalition for a Healthier Community-Utah Women and Girls - Phase II (UWAG-II) | Completed | Obesity, Physical Activity, Diabetes | Behavioral, Behavioral - High Intensity Arm (Intervention), Low Intensity Arm (Comparison) | University of Utah, Department of Health and Human Services, Other, U.S. Fed | Female | 18 Years - N/A | N/A | Interventional | This 12-month randomized trial is designed to evaluate the impact of low intensity (quarterly) versus high intensity (monthly) wellness coaching programs on women's success achieving individual health goals related to active living and healthy eating and changes in these health behaviors over time. |
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