105 Clinical Trials for Various Conditions
The purpose of this study is to compare an onsite to virtual whole-body high intensity interval training (HIIT) program on anthropometric variables, aerobic fitness measures, and vascular markers of cardiac risk in a single study of overweight and obese women.
This study is a randomized clinical trial to test the effect of a type of non-invasive brain stimulation on the response to a behavioral intervention designed to enhance cognitive control over food cravings in obese and overweight women. The brain stimulation is called transcranial Direct Current Stimulation (tDCS). All eligible participants will engage in a behavioral intervention known to enhance control over food cravings and will be randomly assigned to receive either tDCS or sham stimulation to the prefrontal cortex of the brain.
A prospective study to determine the metabolic effects of the contraceptive vaginal ring among overweight and obese women with polycystic ovary syndrome (PCOS). We will recruit a total of 40 participants and study use of the vaginal ring over a 4-month period.
The aim of this trial is to investigate the effectiveness of a mobile health (mhealth) intervention to help overweight and obese women achieve appropriate gestational weight gain (GWG) for their pre-pregnancy body mass index (BMI). The goal of the intervention is to help women achieve GWG within the range recommended by the Institute of Medicine. The investigators propose an adaptive intervention that begins with an effective, yet low resource-intensive treatment and then provides incremental support and resources only to patients who need them. The intervention includes: 1) an mHealth tool allowing data to be automatically transmitted to a mobile website; 2) personalized text messages; and 3) personalized 1:1 telephone coaching sessions. The latter more intensive components are reserved for patients whose GWG is not within the IOM guidelines. The lifestyle intervention will be delivered through 1 telephone counseling session with a study dietician trained in motivational interviewing techniques, as well as through technology-based tools, automated text messages and weekly e-mails of core lifestyle intervention sessions. Personalized text messages and 1:1 telephone coaching sessions will be given to those who are not meeting the GWG guidelines. The lifestyle intervention will be compared to usual medical care. Maternal outcomes will be assessed shortly before delivery and at 6 weeks postpartum. Infant birthweight and weight at one year will also be assessed.
The purpose of the study is to examine the effect of chia seed consumption on body composition, blood pressure, blood glucose, satiety, mood, joint pain, and dietary displacement in overweight and obese females (18-45years). It is hypothesized that consuming chia seeds will bring about a positive change in body composition (lower % body fat), satiety, mood, joint pain, and blood pressure, lower blood glucose levels, increased fiber and improved nutrient intake, in overweight/ obese females.
The goal of this trial is to investigate the efficacy of a lifestyle intervention of healthy diet and physical activity for helping overweight/obese pregnant women to achieve appropriate gestational weight gain (GWG) for their prepregnancy body mass index (BMI). The goal of the intervention is to help women achieve the lower bound of the GWG range recommended by the Institutes of Medicine (IOM) for a given prepregnancy BMI category (i.e., 11 lbs for obese women and 15 lbs for overweight women). The lifestyle intervention will be delivered via 2 in-person counseling sessions and 11 telephone contacts with study dieticians trained in motivational interviewing techniques. The lifestyle intervention will be compared to usual medical care. Outcomes will be assessed by trained study personnel at approximately 10 weeks and 32 weeks gestation, within several days of delivery and at 6 months and 12 months postpartum.
Individuals have a significant capacity to adapt to different environments by changing their core metabolic pathways. This adaptation is especially important in regards to diet. Epidemiological research over the last several decades have shown that diets high in saturated fats have a greater ability to cause insulin resistance and the 'metabolic syndrome' while diets low in saturated fats (or a so called 'Mediterranean Diet), reduces the risk for cardiovascular disease. In humans, experimental diets high in unsaturated fats, as compared to high carbohydrate or high saturated fat diets, result in increased insulin sensitivity and improved lipid profiles. In this application, the investigators propose to systematically assess the effects of two diets enriched in either saturated or unsaturated fatty acids and determine the cellular and molecular mechanisms of the apparent increase in insulin sensitivity. The investigators hypothesize that individuals will 'adapt' to the different diets and the investigators will be able to generate predictive alterations in gene expression and metabolites that underlie the alterations in metabolism. In parallel, the investigators will test the ability of these different diets to affect the release of gastrointestinal hormones that may be critical to modulation of appetite.
A goal of this study is to use a novel methodology to determine whether insulin resistance in women with polycystic ovary syndrome (PCOS) is related to the accumulation of proteins with modifications. This could lead to future research to determine if these modifications interfere with their proper function. Additionally, the investigators will determine how protein quality is affected by exercise training. Aerobic exercise enhances the endogenous oxidant buffering systems which may minimize oxidative damage to proteins. The investigators propose that aerobic exercise minimizes the accrual of modified proteins by increasing the synthesis of new proteins, but also by increasing the degradation and removal of old and damaged proteins. Based on our previous studies the investigators observed that insulin affects plasma protein synthesis and aerobic exercise improves insulin sensitivity not only in muscle but also in liver. The investigators therefore propose that aerobic exercise and related increase in insulin sensitivity (and decline in insulin levels) will reduce accumulation of old and modified skeletal muscle and plasma proteins leading to improved function.
This is a multicenter randomized clinical trial of 828 overweight and obese individuals with gestational diabetes designed to compare standard to intensive glycemic targets.
Maternal and childhood obesity have dramatically increased and continue to present a significant health problem. Studies show that offspring of overweight (body mass index, BMI \>25-29.9) and obese (BMI ≥30) women are at increased risk of newborn and age 1-year adiposity, and infant adiposity predicts childhood and adult obesity. The investigators hypothesize that infants of overweight/obese (OW/OB) mothers have both relative hyperphagia and are provided human milk with increased caloric composition, leading to obesity. The investigators propose an intervention study to calibrate milk or formula intake in infants of OW/OB mothers so as to avoid overweight infants at 6 months of age.
The purpose of the study was to evaluate whether LIK066 can be developed for the treatment of polycystic ovary syndrome (PCOS) in overweight and obese women.
The overall purpose of this study is to determine the efficacy of a pre-pregnancy lifestyle intervention to reduce the recurrence of gestational diabetes mellitus in multiethnic women with overweight or obesity.
The purpose of this study is to test the hypothesis that an intervention of lifestyle modification will positively impact women with breast cancer who are overweight and/or obese. To that end, our primary endpoint is to examine the effects of a practical lifestyle intervention that can be implemented by overweight or obese women (BMI greater or equal to 25) with early stage breast cancer (I-III) on outcomes such as body weight and change in BMI over the course of the study.
The purpose of this study is to develop an endometrial biopsy screening program for endometrial cancer and its precursor lesions in overweight and obese women. There is a BMI threshold at and above which optimal screening parameters exist for identifying endometrial cancer and its precursor lesions in overweight and/or obese women. Prevention, diagnosis and treatment of endometrial cancer and its precursor lesions in overweight and/or obese women offers substantial health benefits.
The WalkMore study will help find out how walking interventions can help overweight/obese postmenopausal women with increased risk of cardiovascular disease lower their blood pressure.
The purpose of this study is to determine the effects of stress reduction on glucose, blood pressure, quality of life and overall health and well-being in overweight or obese women, either with Polycystic Ovary Syndrome (PCOS) or without PCOS (non-PCOS). Stress reduction treatment sessions will include one or more of the following activities: breathing exercises, meditation, stretching exercises or health education activities.
Employees in developed societies are becoming increasingly sedentary at work and at home due to technological advances. Physical inactivity coupled with excess intake of calorie-rich foods are responsible for the epidemic of obesity. In population cohorts, physical inactivity and obesity increase the risk of cardiovascular disease and death. Because of the impact on productivity and health care costs, many businesses and other organizations have initiated "wellness" programs, often with facilities at the work site to encourage exercise. Although these programs have often resulted in improved fitness for participants, weight loss has been more difficult to achieve. In this regard, in our initial study of NIH employees participating in NHLBI's Keep the Beat program--two-thirds of whom were overweight or obese--we found improved exercise fitness after 3 months of participation, with exercise averaging 20 minutes each work day, but no significant weight loss. Associated with greater fitness in our participants was improvement in endothelial function, an important biomarker of cardiovascular risk. Because level of fitness is a strong predictor of cardiovascular (and total) mortality in population studies, some investigators and thought leaders have proposed that it is acceptable to be "fat and fit." We found in our study, however, that exercise alone has little effect on insulin sensitivity and other biomarkers of risk, including C-reactive protein, which could limit further improvement in endothelial function and even greater risk reduction. We propose to test in this protocol whether weight loss through supervised nutritional counseling and daily exercise at worksite facilities confers health benefits beyond those achieved with improved fitness alone, such as improvement in endothelial function, arterial compliance, insulin sensitivity, markers of inflammation in blood and high-density lipoprotein (HDL) structure and function. Because obesity in a sedentary workforce environment is especially prevalent among women, with additional contribution of menopause to obesity, our study will be restricted to overweight and obese women to allow appropriate analysis in a cohort of manageable size for our testing resources. The primary endpoint will be differential improvement in endothelial function, as determined by brachial artery reactivity to shear stress, from baseline to 6 months in participants randomized to exercise coupled with weight-loss intervention versus subjects randomized to exercise alone. Secondary analyses will include comparisons of adiposity, arterial stiffness, insulin sensitivity, HDL subparticles and function, and markers of inflammation and adipokines in blood, with exploratory analyses of minorities and age/hormonal interactions. Demonstration of improved vascular function and other biomarkers of cardiovascular risk with improved fitness combined with weight loss may serve as an incentive for greater participation in organization-initiated wellness programs with emphasis both on exercise and on personalized nutritional counseling.
The goal of this study is to examine the impact of a diet high in fresh lean pork, compared to a plant-based diet, on cardiovascular function and vasomotor symptoms in perimenopausal women with overweight and obesity. The main questions it aims to answer are: 1. How does a diet high in pork, compared to a plant-based diet, affects blood lipids, endothelial function, and blood pressure? 2. How does a diet high in pork, compared to a plant-based diet, affects blood nitrate, cardiometabolic biomarkers, inflammatory biomarkers, and vasomotor symptoms? Researchers will compare the diet high in pork to a plant-based diet to see if pork helps improve cardiovascular and mesopause symptoms. Participants will: * Consume both of the diets, each for 4 weeks, with a washout period between 2 and 6 weeks in between the diets trials * Visit the clinic 5 times with weekly meal pick ups during the diet trials * Undergo testing procedures including: weight and body composition, blood pressure and pulse, endothelial function using ultrasound of upper arm, microvascular blood flow, blood draws, physical activity measurements, and questionnaires.
Primary objective is to determine the bioavailability of and characterize the kinetic profile of target polyphenol metabolites of potatoes over 6 hour postprandial period. Secondary objective is to assess the influence of potatoes' bioavailability and kinetic profiles on markers of chronic diseases.
The purpose of this research is to compare two healthy diet styles during pregnancy. Sixty pregnant women between 8 and 16 weeks will participate. Participates will be randomly assigned (like flipping a coin) to either receive routine healthy diet advice and counseling, or to receive advice and counseling for the Mediterranean style diet. Our current routine healthy diet program follows the recommendations provided by the American College of Obstetricians and Gynecologists (ACOG). It recommends the consumption of grains, fruits, vegetables, protein foods, and dairy foods during pregnancy. The Mediterranean diet (MedDiet) is a well-known healthy diet that consists of a large amount of plant-based foods such as fruits, vegetables, beans, and nuts with olive oil as the principal source of fat. Dairy, fish, and poultry are consumed in moderation and red meat only eaten occasionally. Throughout their pregnancy, participants will receive free food and be assessed to determine how will they are following to the diet plan they were randomized to.
Moms Are Worth It is a lifestyle behavior intervention study aims to prevent excessive gestational weight gain in overweight or obese pregnant women through promotion of the stress management, healthy eating, and physical activity. Eligible women will be randomly assigned to a usual care or an intervention plus usual care group. The intervention will last 20 weeks and will be delivered via weekly web and individual health coaching session (10 of them)
Women with a history of gestational diabetes (GDM) are at substantially increased risk of type 2 diabetes mellitus (T2DM). Compared with the general population, these women are more likely to be overweight or obese. Moreover, weight gain after GDM is significantly associated with T2DM, independent of baseline body weight. Weight gain, particularly increased central adiposity after delivery, is strongly associated with deterioration of β-cell compensation for insulin resistance. Taken together, our findings and other studies support increased abdominal fat as the strongest factor associated with declining B-cell compensation for insulin resistance in prior GDM women at high risk for T2DM. Dapagliflozin is a novel highly selective SGLT2 inhibitor that improves glycemic control by reducing renal glucose reabsorption leading to urinary glucose excretion. Its efficacy and safety has been studied in multiple randomized controlled trials including an add-on to metformin compared with a placebo. To the extent that glucotoxicity contributes to the demise in β-cell function in subjects with impaired glucose, SGLT2 inhibitors also may prove useful in the treatment of "prediabetes." An additional secondary benefit of SGLT2 inhibition is the elimination of calories in the form of glucose. The loss of glucose with attendant caloric loss contributes to weight loss; in addition, improvements in β cell function have been seen. Weight loss seen with SGLT2 inhibitors is similar to that seen with glucagon-like peptide 1 analogs, and may be more acceptable because they are oral agents. A consistent finding in all dapagliflozin studies has been a reduction in blood pressure. The investigators hypothesize that combination dapagliflozin -metformin treatment over a 24-week period will have a greater positive impact on body weight, anthropometric measurements and glycemic and cardiometabolic parameters than dapagliflozin or metformin monotherapy in overweight/obese at-risk women with a history of GDM.
Excessive weight gain during pregnancy, particularly in overweight and obese women, predisposes to adverse perinatal outcomes and has long term effects on maternal and neonatal health. With an inverse relationship between socioeconomic status and obesity, significant health disparities exist between obese and normal weight women. The Institute of Medicine (IOM) recently revised its gestational weight gain recommendations, targeted to pregravid body mass index (BMI), to minimize pregnancy complications. However, these recommendations are based on cross sectional observational studies and neither the ideal method to achieve weight gain goals nor whether perinatal outcome is optimized with active management of weight gain is known. The investigators propose to investigate a behavioral incentive-based intervention to improve compliance with IOM weight gain recommendations during pregnancy in low-income overweight and obese women. The investigators will evaluate if 1) gestational weight gain can be reliably targeted to the IOM recommendations and 2) active weight gain management during pregnancy improves perinatal outcomes. Two study groups will be compared in a prospective randomized trial; 1) those receiving standard obstetrical care and 2) those receiving behavioral weight management counseling plus financial incentives for achieving weight gain goals. The main outcome measure will be the percentage of women gaining within the IOM recommendations based on prepregnancy BMI. Secondary outcomes evaluated will include fetal growth and body composition changes, birth weight and the rate of cesarean delivery. The investigators hypothesize that 1) the behavioral intervention with incentives will result in greater compliance to IOM guidelines for gestational weight gain than standard care and 2) targeting weight gain to the IOM guidelines will lead to a reduction in the rates of fetal macrosomia and cesarean delivery. Finally, cost effectiveness of treatment conditions will be examined. This intervention, if efficacious and cost-effective, has the potential to improve compliance with gestational weight gain guidelines, optimize perinatal outcomes, and reduce health disparities.
This trial is conducted in the United States of America (USA). The aim of this trial is to investigate the safety, tolerability, efficacy and pharmacokinetics (the rate at which the trial drug is eliminated from the body) of NNC 0070-0002-0453 in overweight/obese, but otherwise healthy male and female volunteers. Selected subjects will continue in a follow-up period of up to 5 years.
RATIONALE: A low-calorie diet and/or exercise program may help lower an overweight or obese postmenopausal woman's risk of developing breast cancer. It is not yet known whether a low-calorie diet and/or exercise program are more effective than no diet or exercise program in lowering an overweight or obese postmenopausal woman's risk of developing breast cancer. PURPOSE: This randomized clinical trial is studying the effect of a low-calorie diet and/or exercise program on risk factors for developing breast cancer compared with no diet or exercise program in overweight or obese postmenopausal women.
Beta-amino isobutyric acid (BAIBA) is a myokine produced in skeletal muscle and has been shown to impact how our body metabolizes fuel. We seek to examine changes in body composition, weight loss, glucose control, and cardiometabolic risk factors after adding supplementation of BAIBA to exercise in overweight and obese men and women.
The goal of this intervention study is to examine changes in body composition, weight loss, and cardio-metabolic risk factors after adding supplementation of L-Beta aminoisobutyric acid (L-BAIBA) and Grains of Paradise to exercise in overweight and obese men and women. Participants will supplement for 8 weeks and complete a 8 week exercise protocol.
The overall goal of this randomized controlled trial is to test the efficacy of a culturally and linguistically modified, individually tailored lifestyle intervention to reduce excess gestational weight gain (GWG), increase postpartum weight loss, and improve maternal metabolic status among overweight/obese Hispanic women.
This trial will be conducted in the United States of America (USA). The aim of the trial is to investigate whether the drug is safe, well tolerated and to investigate the efficacy of NNC 0070-0002-0182 for the treatment of obesity. The subjects will be treated with drug and placebo. This registration covers the phase 2 part of a combined phase 1/phase 2 trial (phase 1 part of trial conducted between November 2007 and April 2008).
The investigators will measure plasma concentrations of the hormones insulin and testosterone as well as measures of insulin sensitivity in women with overweight or obesity who have insulin resistance (IR). Women who meet these criteria that also have elevated total or free testosterone will be eligible to participate in the diet intervention. The dietary intervention is designed to produce a 5% reduction in starting body weight to test whether weight loss will acutely lower fasting insulin and testosterone concentrations.