61 Clinical Trials for Various Conditions
This study is the pilot of a 12 - week positive food parenting intervention focused on structure-based and autonomy promoting practices. The intervention aims to give parents the tools to promote healthy child growth and improve diet quality. The investigators are piloting to assess feasibility and efficacy of the intervention through examining participant retention, impact on parent feeding practices, and impact on parent and child diet quality.
This proposal uses an innovative methodological framework, the multiphase optimization strategy (MOST), to design an effective and efficient responsive feeding (RF) intervention that promotes child appetite self-regulation among a high-risk sample: families with preschoolers living in rural poverty. The principles of MOST emphasize efficiency, allowing identification of the most efficacious intervention components (i.e., components that contribute to treatment effects) while minimizing participant burden and cost. ONE PATH will intervene on \~768 dyads recruited from 56 classrooms serving largely low-income, rural populations.
This is a single-group feasibility pilot trial of a peer-based, social media intervention to prevent obesity in infants.
The goal of this community-based randomized trial in elementary-aged children and a caregiver (parent/guardian) is to test the effect of providing families with produce and grocery store gift cards (family support) in conjunction with an after-school program for physical activity and healthy eating on improving children's overall diet, in comparison to the child only attending the after-school program without the family support. Participating families will: * receive weekly produce bags delivered to their home, recipes, and gift cards to a local grocery store (family support) * the child will attend the after-school program during the school year Researchers will compare the child's diet and eating scores with those in the after-school program alone.
The goal of this study is to demonstrate that healthy term babies who are fed Bobbie's study formula grow at the same rate as those fed with an existing cow's milk formula. Breastfeeding is the ultimate reference for infant nutrition. Therefore, this study also includes a group of breastfed babies for additional comparison.
The aim of the study is to assess age-appropriate growth of healthy infants fed a new organic milk-based infant formula.
The aim of the study is to compare growth of healthy infants fed an infant formula supplemented with a human milk oligosaccharide to that of infants on standard formula.
The goal of this clinical trial is to examine the effects of a nutrition education program on preschool children's food literacy and food acceptance, and to examine the added influence of a healthy eating curriculum and parent education on children's food knowledge and healthful food choices. The project will be evaluated with 450 children ages 3 to 5 years in center-based childcare programs serving predominantly Supplemental Nutrition Assistance Program (SNAP)-eligible families in Pennsylvania. Outcomes for children who receive the added healthy eating curriculum will be compared to children in classrooms that only receive the nutrition education program.
This study will investigate the effects of breastfeeding and breastmilk composition on infant gut microbiome development as well as obesity and cognitive outcomes. Breast milk contains certain natural sugars that can promote the growth of 'good' bacteria in the intestines and reduce the growth of harmful bacteria. The purpose of this study is to look at the effects of these natural sugars in breast milk on the infant's bacteria and the impact of this on development of obesity and cognitive outcomes by 2 years of age with plans for longer term follow up contingent upon funding.
The primary objective is to determine if the weight gain of healthy term infants fed a commercially available term infant formula supplemented with DHASCO® is similar to that of infants fed the same formula supplemented with a new product, DHASCO®-B.
The purpose of the study is to determine if by using MRI changes can be identified changes early on in the knees of young children that may be at risk for developing osteochondritis dissecans. If MRI can identify changes then better council can be offered about the risks of future activity and treatment options.
A 4 month growth monitoring study of healthy term infants fed iron fortified infant formula. Infants will be fed ad-libitum for 16 weeks and growth will be evaluated in terms of weight gain over the 16 weeks.
This clinical trial will compare the growth and tolerance of infants who consume an investigational cow's milk-based infant formula to those who consume a marketed cow's milk-based infant formula through approximately 4 months of age.
The objective of this study is to evaluate the effect of two experimental milk-based infant formulas on the growth and gastrointestinal (GI) tolerance of term infants.
The purpose of this trial is to examine the short-term effects of Growth Hormone Releasing Hormone (GHRH, tesamorelin) administration in healthy men. We hypothesize that GHRH will increase GH pulse height and will not affect insulin sensitivity.
The purpose of the research study is to better understand how beta-cells (cells in the pancreas that make insulin and help regulate blood sugar) respond to growth hormone in people with a family history of type 2 diabetes at the University of Missouri. Our aim is to advance understanding of how growth hormone affects beta-cells and risk factors for developing gestational diabetes and type 2 diabetes.
The purpose of the research study is to better understand how beta-cells (cells in the pancreas that make insulin and help regulate blood sugar) respond to growth hormone in people with a personal history of gestational diabetes (high blood sugar in pregnancy) at the University of Missouri. The aim of the study is to advance understanding of how growth hormone affects beta-cells and risk factors for developing gestational diabetes and type 2 diabetes.
Researchers are looking for a better way to treat people who have advanced non-small cell lung cancer (NSCLC) with specific genetic changes called EGFR and HER2 mutations. Advanced NSCLC refers to a type of lung cancer that has spread from the lungs to nearby tissues or other body parts. People with advanced NSCLC may have changes in certain proteins like EGFR and HER2, that cause uncontrolled cell growth and increased spread of cancer. In this study, participants will be healthy and will not benefit from taking the study treatment, BAY2927088. However, the study will provide information about how to test BAY2927088 in future studies with people who have advanced NSCLC with EGFR or HER2 mutations. BAY2927088 is under development for the treatment of advanced NSCLC with EGFR or HER2 mutations. It is expected to work against these changed proteins, which might slow down the spread of cancer. BAY2927088 is broken down by an enzyme called CYP3A4 inside the body. Itraconazole is a drug that inhibits the activity of CYP3A4 while carbamazepine is a drug that enhances the activity of CYP3A4. Giving these drugs together will allow researchers to learn how the blood levels of BAY2927088 change when the CYP3A4 activity is inhibited or enhanced. The main purpose of this study is to find out how itraconazole and carbamazepine may affect the blood levels of BAY2927088. For this, researchers will measure the following for BAY2927088 when it is given with and without itraconazole and carbamazepine * Area under the curve (AUC): a measure of the total amount of BAY2927088 in participants' blood over time * Maximum observed concentration (Cmax): the highest amount of BAY2927088 in participants' blood The study will have 2 treatment groups. In Group 1, participants will take: * BAY2927088 as a single dose on Days 1 and 8. * Itraconazole once daily on Days 5 to 11. In Group 2, participants will take: * BAY2927088 as a single dose on Days 1 and 14. * Different doses of carbamazepine two times a day on Days 3 to 15. Participants will be in this study for about 7 weeks in Group 1 and 8 weeks in Group 2. Participants will visit the study clinic: * at least once, 2 to 28 days before the treatment starts in both groups, to confirm they can take part in this study * on Day 1, and will stay at the clinic until Day 12 in Group 1 and Day 16 in Group 2 * once, 7 to 10 days later from last dose of BAY2927088 in both groups, for a health check up During the study, the doctors and their study team will: * perform physical examinations * collect blood samples from the participants to measure the levels of BAY2927088 * check participants' health by performing tests such as blood and urine tests, and checking heart health using an electrocardiogram (ECG) * ask the participants questions about how they are feeling and what adverse events they are having An adverse event is any medical problem that a participant has during a study. The study doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatment.
The aim of the study is to investigate the growth of healthy toddlers fed with Toddler almond based nutritional drink (test) vs. a. formula that has been shown to support growth (control) in Healthy Toddlers
This is a pilot study to test how a growing-up formula (GUF) compares to a common nutritional supplement (NS), which is regularly used to help toddlers (ages 12-36 months) gain weight. This study will look at whether GUF helps to increase solid food intake for children who are thought to be "picky eaters" and see the effects on growth compared with the NS. To date, it is not clear if GUFs help to increase intake of solid foods. Participants will be placed into one of the two study arms: Enfagrow (GUF) or Pediasure (standard NS).
Background. Unprecedented rates of overweight and obesity are seen in childhood1 with evidence suggesting that infancy may be a critical period for the development of this high weight trajectory. This has led to a call for proposals for "understanding factors in infancy and early childhood (birth to 24 months) that influence obesity development (PA-18-032)." Objectives. The current study seeks to recruit a sample of mother-infant dyads to pilot a responsive parenting focused obesity prevention program delivered by behavior and development specialists in pediatric primary care. Methods. Approximately 80 mother-infant dyads will be recruited in pediatric primary care at their newborn visit and randomly assigned to one of two groups: a) Healthy Growth (new intervention) or b) Healthy Steps (as usual). We will obtain assessments of growth, feeding, and sleep throughout the study period for infants across five clinic visits and at-home measure completion. Research clinic visits will take place at their regularly scheduled well-child check visits at ages 1, 2, 4, and 6 mos and in-home measures will be completed monthly. The intervention program is hypothesized to show efficacy in both breast and formula fed infants as measured by the primary (i.e., BMI percentile and BMI z-score) and secondary outcomes (e.g., awareness of infant cues, use of alternative soothing strategies, when it is not time for a feeding).
A goal of infant formula development is to mimic human milk (HM) both in nutrient composition as well as physiologic outcomes. investigators have developed an infant formula for term infants that more closely resembles the composition of human milk. The purpose of this study is to demonstrate that this formulation meets nutritional requirements and supports age appropriate growth of healthy term infants.
The purpose of this two-month follow-up study is to continue to follow growth, safety, and other health outcomes of infants fed a new infant formula for term infants or comparator formula. A reference group of human milk-fed infants will also be followed. This study is designed in accordance with Good Clinical Practice guidelines.
The purpose of this study is to demonstrate that a new infant formula for term infants supports age-appropriate growth. This study is designed in accordance with Good Clinical Practice guidelines and the requirements of the Code of Federal Regulations, 21CFR106.96. In this randomized, controlled trial (RCT), healthy, term, formula-fed (FF) infants will be randomized to one of two infant formulas: a standard, commercially-available infant formula for term infants (CF) or the study formula for term infants (SF) for 16 weeks. A reference group of human milk-fed infants will also be enrolled. The primary efficacy objective is to compare the growth of infants randomized to the study infant formula (SF) versus growth of infants randomized to the standard commercial infant formula (CF).
A goal of infant formula development is to mimic human milk (HM) both in nutrient composition as well as physiologic outcomes. investigators have developed an infant formula for term infants that more closely resembles the composition of human milk. The purpose of this study is to demonstrate that this formulation meets nutritional requirements and supports age appropriate growth of healthy term infants.
The study is a Phase 1, randomized, double-blind, vehicle-controlled, single-dose, three dose levels study in healthy Caucasian and Japanese male volunteers. Following a 4-week screening period, eligible male subjects will be stratified by ethnic group and will be randomized to one of six groups. On dosing day, designated as Day 1, each subject will receive single SC injection of study medication according to group allocation and will be followed up for a month for safety monitoring.
Background: - Canagliflozin (sold as InvokanaTM) is a new medicine for diabetes. But it might increase the bone fracture risk in people with diabetes. Objective: - To see if Invokana has negative side effects on bone health. Eligibility: - Healthy men ages 18 45. Design: * Participants will be screened with a medical history, physical exam, and blood tests. A nutritionist will discuss their dietary history and the study dietary requirements. Participants will get a food diary to record what they eat and drink on 3 separate days. * Participants will have a DEXA scan x-ray test of bone health. Participants will lie still on a table while a small camera passes over the body. * Participants will have 2 stays in the clinic. They will be 1 week apart and each last 6 overnights starting on a Sunday. * Before each stay, participants will: * Pick up food each day for 7 days. They will get breakfast, lunch, dinner, and snacks. They must eat only the food provided during these times. * Collect their urine twice. * During the stays, participants will: * Be evaluated by a doctor and have blood drawn. * On each Monday, participants will: * Skip breakfast * At about 8 a.m. take a placebo pill in one stay, the study drug in the other stay. * Drink 6 ounces of water every 2 hours for 4 hours. * An intravenous (IV) catheter will be inserted into an arm. Blood will be drawn every 2 hours from 8 a.m. until noon. * Get lunch. * Have blood testing again at 8pm and midnight. * Repeat the testing days 2 5. * Have urine collected.
Background: - Studies show that many factors affect children s eating behavior and health. These include sleep, mood, thinking skills, and genetics. Studying children over time may identify children at higher risk for eating-related health concerns. Objective: - To understand how genes and environment influence eating behavior and health over time. Eligibility: - Children ages 8 17 in good general health. Design: * Screening visit 1: Medical history, physical exam, body measurements, and questions. * 14 days: Participants will wear a wrist monitor and answer smartphone prompts about eating and mood. They may give a stool sample. * Screening visit 2: * Body measurements. * Saliva, urine, and blood samples. * Heart tests. * Meals provided (after fasting overnight). * Questionnaires and interview. * Behavior, thinking, and exercise tests. * X-ray of left wrist and full body.\<TAB\> * Some parents may have medical history, physical exam, and questions at screening visits. They may answer questions at the yearly visits. * Participants will have up to 6 yearly visits. They will give a urine sample and body measurements, and repeat the X-rays. They will have questions and behavior and thinking tasks. They may give stool samples. Visits will range from 3 to 8 hours. * Participants may choose to participate in other studies: * Stress and Hormones, 1 visit: While resting, participants will give saliva samples and have their heart monitored. Then they will do math. They will repeat the resting part, then do a computer task. * Brain Imaging, 2 visits: Twice, participants will perform tasks with a magnetic cone on their head then answer questions. Once, they will have an MRI, lying still in a scanner with a coil on their head. Before the first visit, participants will collect at-home saliva samples once a day for three days. During both visits, participants will perform tasks and answer questions that gauge their thinking skills and mood. * Experiment 3 (sleep/fatigue): Participants will complete 2 additional visits. During these visits, participants will complete a task on the computer for 2 hours, or watch a movie for two hours. After completion of the task/movie, they will answer questions and be provided with food. Participants will be compensated for the time and inconvenience involved with completing study procedures.
The purpose of this study is to establish and follow longitudinally a cohort of ethnically diverse pregnant women and their offspring, in order to explore the hypothesis that fetal over-nutrition is associated with obesity, metabolic, and cardiovascular abnormalities in the offspring.
Progesterone amplifies estrogen-stimulated Growth Hormone (GH) secretion in postmenopausal women. Preliminary data are sought to estimate statistical power for more detailed studies of this hypothesis.