Active clinical trials for "Body Weight"

Time restricted feeding (TRF) is a novel form of intermittent fasting that involves confining the period of food intake to 8 h/d (e.g. 10 am to 6 pm) without calorie counting. TRF is effective for weight loss and cardio-protection in obese adults. It is of great interest to see whether subjects can adhere to TRF for longer periods of time, and to see what degree of weight loss that can be achieved with TRF. Accordingly, the aims of this trial are: Aim 1: To determine if TRF can be implemented to facilitate weight loss in obese adults, and Aim 2: To determine if TRF can produce clinically meaningful reductions in plasma lipids, blood pressure, insulin resistance, and inflammatory markers.

This study is being conducted to assess the impact of promoting community initiated Kangaroo Mother Care (ciKMC) for low birth weight babies on post enrolment neonatal mortality and mortality post enrolment upto 6 months of age. This large individually randomized controlled trial will enroll 10500 low birth weight babies. The secondary objectives are examining the impact of the intervention on exclusive breast feeding and growth at 1 and 3 months, infections and hospitalizations in the neonatal period and from 1 to 5 months of age, recognition of illnesses and early care seeking from appropriate sources, motor and mental development in a subsample. Newborns weighing >=1500 to <=2250gm are being enrolled into the study within 3 days of birth. Eligible babies are randomized to intervention or control arms. Mothers in the intervention arm are supported for KMC and breastfeeding by study ANM (Auxiliary Nurse Midwife) and study ASHA (Accredited Social Health Activist) like workers . Routine home visits are conducted in both intervention and control arms by government workers according to the existing government program. Survival will be ascertained in all enrolled infants through contacts at 1, 3 and 6 months. The data safety and monitoring committee (DSMC) conducted two interim analyses, first in September 2017 when about half of the infants had been enrolled, and second in June 2018, when almost three quarters of the enrolled babies had been followed till 28 days of age. Following the second interim analysis, the DSMC concluded that a sufficient number of infants would be enrolled by the end to September 2018 to clearly answer the study question concerning the impact of ciKMC on both neonatal and early infant mortality. The DSMC recommended that data collection be completed by the end of October 2018.

Colostrum, mothers' early breastmilk, contains multiple factors that provide immune protection to very low birth weight (VLBW) infants, a population at high risk for hospital-acquired infections. However, critical illness during the first few days of life often prevents the initiation of enteral feeds, placing these infants at even higher risk for morbidities including feeding intolerance and infection. Oropharyngeal administration has been proposed as an alternative route of delivery for colostrum and the immune benefits it provides. Research from animal and adult human models supports oropharyngeal administration as a potentially safe and effective mode of delivery for immune therapies. Immune components of colostrum, such as secretory IgA, may have both direct and indirect effects on the immune system. The purpose of this proposed randomized, placebo-controlled pilot study is to determine the effect of oropharyngeally administered colostrum (OAC) on immune stimulation in VLBW infants, as measured by secretory IgA (sIgA) levels. In addition to measuring sIgA response to OAC the investigators will also collect clinical data to determine if OAC has effects on tolerance of enteral feedings and rates of infection. The investigators hypothesize OAC will have a moderate effect on salivary secretory IgA concentration in VLBW infants. If proven efficacious, utilization of OAC in VLBW infants could have far reaching consequences for these highly fragile babies including lower rates of infection, improved tolerance of enteral feedings, and shorter NICU stays.

The main hypothesis for this study is that increased Body Mass Index (BMI) alters oral contraceptive metabolism in a manner which results in decreased effectiveness in obese women.

The goal of the current study is to determine the role of dairy in similarly preventing weight and fat re-gain in obese adults who have successfully completed a weight loss diet program.240 obese subjects will undergo a meal-replacement-based weight loss plan designed to produce a 10 kg weight loss in 8-12 weeks. Upon achieving the weight loss goal, subjects will be randomly assigned to either a low-dairy or high-dairy eucaloric weight maintenance diet for two years. Macronutrient distribution will be maintained constant and set at approximately the U.S. average. Primary outcomes include changes in body weight, body fat and anatomical distribution of fat (via dual x-ray absorptiometry) and resting metabolic rate and substrate oxidation (via respiratory calorimetry); Secondary outcomes include blood pressure, circulating glucose, insulin, lipids and calcitrophic hormones. on prevention of weight regain in humans has not yet been assessed in clinical trials.

The purpose of this study was to determine the effects of providing supplements containing alternative combinations of micronutrients during pregnancy on birth weight and other infant and maternal health and nutritional outcomes in a rural area of Nepal.

This study aims to evaluate effects of a 16-week supplementation with a polyphenol rich extract, Sinetrol® Xpur, on fat mass accumulation and body weight management improvement.Subjects were overweight or obese and received polyphenol supplement or placebo. A 4-week follow-up as performed to evaluate its effect after supplementation stop.

This study is a randomized controlled clinical trial of two arms, which included 60 women survivors of breast cancer of the state of Sonora, Mexico.The intervention is for 8 months and includes home visits every 15 days for the first four months and monthly for the last four months.The objective was to evaluate the effect of a diet and physical activity intervention program using the motivational interviewing (MI) strategy compared to an orientation with a traditional educational approach to improve anthropometric variables such as body weight, fat, muscle mass and bone mineral density, as well as biomarkers of the disease such as mammographic density, telomere length, telomerase activity, DNA methylation, ceramide-1-phosphate transport protein (CPTP), vascular endothelial growth factor (VEGF), C-reactive protein (CRP), interlucin 6 (IL-6) , interlucin 8 (IL-8), tumor necrosis factor alpha (TNF-α), leptin and adiponectin. Finally, the study also aims to improve psychological variables such as quality of life, sleep quality, anxiety and optimism.

The hypothesis is to be tested that eating carbohydrate-reduced bread over three months leads to a significant weight difference compared to conventional, carbohydrate-rich bread.

This study will test the feasibility (i.e., acceptability, demand) of a 12-week prenatal yoga intervention on excessive gestational weight gain (GWG) in pregnant women in the second trimester (enrolled at 12-24 weeks). Participants will be randomized into the prenatal yoga intervention or a pregnancy education (e.g., information on preparing for motherhood, labor and delivery etc.) control group. Participants in both groups will be asked to attend one 75 minute class per week. The investigators hypothesize that prenatal yoga intervention will be feasible for pregnant women. The study aims are as follows: Primary Aim: Determine the feasibility (i.e., acceptability, demand) of a 12-week prenatal yoga intervention in pregnant women. In a randomized controlled pilot study comparing prenatal yoga to a pregnancy education control condition, the investigators will assess 1) acceptability (defined as satisfaction, intent to continue use, perceived appropriateness) and 2) demand (defined as attendance/adherence). Exploratory Aim 1: Ascertain the preliminary effects of prenatal yoga on excessive GWG [i.e., weight gain exceeding Institute of Medicine (IOM) recommendations]. The investigators will compare weight change between intervention and control groups. Exploratory Aim 2: Explore the potential mediators (i.e., mindfulness, self-regulation) on the effect of prenatal yoga on excessive GWG.