144 Clinical Trials for Various Conditions
The goal of this clinical trial is to test if a regulation of craving training intervention in the form of a mobile phone app can increase fruit and vegetable intake in adolescent girls ages 14-18 years of age. The main questions it aims to answer are: 1. What is the effect of a mobile app version of the regulation of craving training intervention on healthy eating index scores over one year? 2. What is the effect of a mobile app version of the regulation of craving training intervention on body mass index, waist circumference, and blood glucose over one year? Researchers will compare the active regulation of craving training arm to a control fun food fact arm to see if the regulation of craving training improves HEI scores, BMI, and blood glucose over a year. Participants will be asked to play the regulation of craving training mobile app twice a week for a year.
Resistant starch (RS), a type of dietary fiber, was shown to have beneficial effects on human health through its impact on microbes present in the intestine. However, the effects of RS on the gut microbiota and in turn, on human health, can vary between individuals. Consequently, everyone may not reap the same health benefits by eating high amounts of RS. Factors predicting how an individual's gut microbes as well as the beneficial metabolites produced by these microbes respond to RS supplementation would be helpful in developing precision nutrition approaches that maximize the benefits of dietary fiber intake. The objective of this study was to evaluate candidate predictors of gut microbiota response to RS supplementation.
Black Girls Move is a school-linked daughter/mother physical activity and dietary behavior program, with 9th and 10th grade students. This program is designed to prevent obesity in Black adolescent females and thus aligns with the NIH mission to enhance health, lengthen life, and reduce illness and disability. This project is relevant to public health because it holds the potential to reduce population health disparities impacted by structural racism.
Background: Sickle Cell Disease (SCD) causes blood cells form a crescent shape. It is caused by a genetic mutation in the hemoglobin gene. People with SCD are at increased risk for illnesses like stroke, chronic pain, and heart problems, as well as decreased overall health and well-being. Researchers want to learn more about how nutrition and diet can help relieve or reduce the symptoms of SCD. Objective: To understand how diet, dietary patterns and behaviors, nutrition, and other related factors in adults with SCD affect their overall health. Eligibility: Adults aged 18 and older with SCD. Design: Participants will be screened with a review of their medical records. They will take a pregnancy test if needed. Participants will have a physical exam and medical history. Their height, weight, and waist and hip circumference will be measured. They can complete this exam (1) via telehealth along with a visit to an outpatient laboratory center or (2) by going to the NIH Clinical Center. Participants will complete 2 interviews about their diet. They will talk about the foods they ate in the past 24 hours. They will also complete 1 interview about diet-related behaviors such as food shopping and cooking. They can complete the interviews in person, by phone, or by telehealth visit. Participants will complete surveys about their demographics (such as age and gender), SCD pain, mood, stress, diet, and nutrition. It may take about 1 hour to complete all of the surveys. Participants will give blood and urine samples. They will need to fast for at least 8 hours overnight before giving blood samples. Participation will last for about 2 weeks.
Background: Diet is one of the most modifiable behaviors affecting health. But diet assessment measures that are based on self-report can be inaccurate. Researchers want better ways to address the role of diet in chronic disease. They want to see if stable isotopes can be used to better assess what people eat. Objective: To see if stable isotopes can help scientists identify things people eat. Eligibility: Healthy adults ages 18 to 65 Design: Participants will be screened with a medical history and physical exam. They will have blood and urine tests. These tests will be repeated during the study. Participants will stay in the inpatient unit of the NIH in Phoenix, Arizona, for 13 weeks. For 7 days, participants will eat a diet prepared by the NIH kitchen. They will get balanced meals that are 50% carbohydrates, 20% protein, and 30% fat. Then participants will be randomly placed on one of 3 diets containing different percentages of carbohydrates from soda. Participants height and weight will be measured. The amount of fat and muscle in their body will be measured by body scans that are similar to x-rays. Participants will have oral glucose tolerance tests. They will consume a sugar drink and then give blood samples over 3 hours. Participants will give hair and stool samples. Participants will complete a diet questionnaire. It assesses their food intake over 24 hours. Participants will complete behavioral questionnaires and computer performance tests. Participants will have fat biopsies taken from their stomach and thigh. Participants will have three 24-hour stays in a metabolic chamber. It is used to measure metabolism.
The aim of this research is to collect dietary intake, physical activity, mood and stress data during and after the Illinois shelter-in-place and social distancing orders for the COVID-19 pandemic. The study's intent is to capture data during this unprecedented time to understand the non-infection consequences of social distancing and shelter-in-place, including duration of affect after orders are lifted.
The Nutrition Study of the GA2LEN Follow-Survey was designed to investigate the association between usual dietary intake and allergic and respiratory outcomes in adults across Europe. Within this framework, a food frequency questionnaire (FFQ) was designed to ascertain usual dietary intake of 250 food items, which was translated into the languages of the participant centres. Information on daily intake of foods, nutrients, and flavonoids was derived.
The present record represents a secondary data analysis of the Modification of Diet in Renal Disease (MDRD) Study. For this analysis, the MDRD study data and specimens were retrieved from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Central Repository. A global, untargeted, metabolomic profile was used to investigate biomarkers of dietary intake as well as biomarkers of kidney disease progression.
Brief Summary: This randomized clinical pilot will test the feasibility of having individuals self-monitor for 12 weeks and based on what the participants record be given feedback messages. The investigator will use this information to refine the questions and data collection procedures for the larger study. Participants will be randomized into 3 groups * self-monitoring only * self-monitoring w/ feedback messages * self-monitoring w/feedback messages and group sessions Feedback messages will be delivered up to 4 times per day using a different schedule. The group sessions will be held in the 2nd, 4th and 8th week of the 12-week study. All participants will be asked to complete questionnaires and 2 assessment visits at baseline and 12 weeks.
Childhood obesity is a major area of concern for health care and public health. Overweight children are more likely overweight and obese adults. Chronic health problems associated with adult obesity are now occurring more frequently in children. Because of the associated health problems and potential for long term struggles with obesity, intervention early in life is essential for addressing the obesity epidemic. Some intervention work in this area has focused on the pediatric primary care setting in order to utilize the influence and credibility of medical providers. Unfortunately, primary care visits are often too short to spend a significant amount of time on issues of diet, weight and nutrition. There has been very little work exploring the potential of alternative care settings, such as the pediatric Emergency Department (ED) in addressing childhood obesity. While provider time is also limited in the ED, there is often a considerable amount of downtime during emergency department visits that could be valuable time for patient and parent education. There may also be an opportunity to reach parents and children in the ED who do not regularly utilize primary care. In order to explore the possibility of pediatric obesity interventions in Children's Pediatric Emergency Department, we will need to measure the prevalence of obesity in the population that utilizes the Children's ED. The height of patients seen in the ED is not routinely measured, which makes calculating BMI to determine obesity impossible. This study, establishing the prevalence of obesity in Children's Emergency Department will lay the groundwork for future work addressing obesity in the ED.
This study will examine the influence of dietary intake of tryptophan on response to metformin. The investigators hypothesize that dietary tryptophan alteration will influence metformin response.
The investigators are conducting this research study to find out if eating low or high levels of specific amino acids changes the levels of these same amino acids in the blood. Amino acids are the building blocks of protein that are normally found in food. The amino acids the investigators are studying are called branched chain amino acids. The investigators will look at the levels (amount) of branched chain amino acids in blood before and after consumption of specially prepared meals. The investigators hypothesize that circulating branch chain amino acid (BCAA) levels will be lower following a low BCAA-content diet compared with a high BCAA-content diet.
Bone loss is not only a well-documented effect of spaceflight on astronauts, but also a condition that affects millions of men and women on Earth each year. Many countermeasures to bone loss have been proposed, and many have been evaluated to some degree. To date, those showing potential have focused on either exercise or pharmacological interventions, but none have targeted dietary intake alone as a factor to predict or minimize bone loss during spaceflight. The investigators proposed to document how the ratio of acid precursors to base precursors in the diet is related to directional changes in markers of bone resorption and formation during flight and recovery from flight. There is a high likelihood for success in predicting the extent of bone loss from dietary intake patterns of astronauts during spaceflight, given that this concept is strongly anchored in data obtained from ground-based experiments in our laboratory and others. The notion of manipulating diet to minimize bone loss could also have significant social and economic impacts for NASA and for the general public - especially given the increasing trends for diets that are high in animal protein and low in fruits and vegetables. The results of the proposed experiments will lead to development of a dietary countermeasure for bone loss consisting of a balanced diet with no associated risks for side effects that might be present with pharmaceuticals or supplements, no requirement for payload mass, and no additional crew time necessary during flight.
Examine the effect of three different dietary messages on dietary intake and the health of parents and their children.
The proposed study will be a randomized, double-blind, parallel-arm study. Participants will incorporate snack foods (bar/yogurt) containing 16 grams of fiber (fructooligosaccharide) or similar snack foods without the added fiber into their usual diets. The study period will include a 2-week pre-baseline assessment period and an 8-week treatment period. During the 2-week pre-baseline period no study foods will be consumed however dietary intake will be assessed using a 24-hour online diet recall program. The first week of the 8-week treatment will serve as an acclimation period where only one serving of the study foods will be given (8 grams of fiber) per day. Participants will receive two servings (16 grams of fiber) per day for weeks 2 through 8 of the treatment period and 24-hour online diet recalls will be completed during weeks 4, 6 and 8. Hypothesis: Adults aged 18 to 50 years consuming their usual diet modified by incorporating yogurt and snack bars containing 16 grams of chicory root fiber (Frutalose®) will decrease their usual dietary intake to a greater extent compared to participants who receive similar snack foods without the added fiber.
Background: - Researchers who study health and nutrition are interested in developing more accurate methods of determining what people eat from day to day and how it affects their general health. In particular, better methods are needed to determine if people are accurately remembering what they ate. One possible method involves the use of biomarkers, or indicators in urine, blood, saliva, fat, and hair, which are related to the intake of a particular food in a consistent way. One set of biomarkers in blood samples and hair may be used to determine the relative amount of meat, fish, and soda (corn/sugar cane) in a person s diet. However, more research is needed to study the effectiveness of using these biomarkers to accurately track dietary intake. Objectives: - To validate the use of biomarkers as representative of specific dietary intake patterns (meat/fish/soda). Eligibility: - Healthy, nondiabetic men between 18 and 65 years of age. Design: * This study involves an initial screening visit and a 12-13 week inpatient dietary study period. * Participants will be screened with a medical history and physical examination, as well as blood and urine samples and a glucose tolerance test to exclude individuals who have diabetes. * After 3 days of a standard weight-maintaining diet, participants will have a glucose tolerance test and a body fat scan; provide hair, blood, and fat tissue samples; and complete questionnaires and performance tests. * Participants will spend one day in a metabolic chamber to measure their energy expenditure and general metabolism. * Participants will then be randomized into one of eight carefully designed diets for 12 weeks. The diets will differ in the amount of meat, fish, and soda, including one diet where none of the three biomarker-related foods will be permitted. Blood samples will be collected throughout the study diet period. * At the end of the 12-week study diet period, participants will provide additional hair, blood, and fat tissue samples, and will have a second metabolism assessment in the metabolic chamber.
The purpose of this study is to determine whether or not energy and macronutrient intake changes when comparing habitually active and habitually sedentary college-aged males in two different sessions of one resting and one exercise.
The purpose of this study is to evaluate the influence of dietary restraint, social desirability, and food type on the accuracy of dietary intake reported during a 24-hour recall.
to study the dietary intake and eating behaviors of adolescents who undergo bariatric surgery
This trial examines the effects of grapefruit or grapefruit juice on anthropometry, dietary intakes, appetite, and metabolic profile in overweight and obese young and middle-aged adults.
"The goal of this study is to evaluate whether the addition of spices and herbs to the vegetables served to military personnel on a large military base can increase vegetable intake as compared to typical vegetable offerings without spices and herbs. A two-phase intervention will be conducted on base at Naval Station Activity Bethesda (NSAB) to evaluate whether the addition of spices and herbs to vegetable dishes can increase vegetable intake amongst military service members. Phase I will involve extensive engagement with key stakeholders involved in current vegetable consumption at NSAB, including military service members, staff dietitians, the health promotion specialist on base, barracks managers, military culinary specialist, unit leaders, morale welfare and recreations/single sailor program leaders, base senior enlisted leaders, and the base commander. Questionnaires will be administered evaluating current barriers to vegetable intake at NSAB, familiarity with and liking of a variety of spices and herbs, and sensory testing of several vegetables with and without spices and herbs. The recipes in the vegetable sensory testing comparisons will be identical other than spices and herbs content. Phase II will involve will focus upon the direct measurement of vegetable intake (primary outcome) and vegetable linking (secondary outcome) among active-duty service members with spices and herbs and without spices and herbs. The vegetables will be provided as part of an entire meal on a "grab and go" plate. The other foods in the meal (proteins, starches, etc.) accompanying the vegetables will be kept consistently paired to vegetable recipes to minimize confounding. Vegetable intake will be assessed via cell phone pictures and liking will be assessed by a single 5-point Likert scale question."
This project will pilot test a new app for self-monitoring food intake using natural spoken language (by voice recognition or text) to provide daily estimates of energy and nutrient intakes with a phone app.
the purpose of this study is to identify how the body responds to increased dietary protein (that includes pork and eggs) and meal-frequency in adult men. During this study, the changes in blood glucose, hormones, appetite, and energy expenditure will be examined.
With funding through USDA and Tufts University's Telehealth Intervention Strategies for WIC (THIS-WIC) project, the South Carolina WIC department will be implementing a telehealth solution for nutrition and breastfeeding support. The purpose of this study is to evaluate this telehealth solution. The research/evaluation involves completing online surveys. The evaluation will focus on participant satisfaction, usage of the telehealth solution, and use of information collected on the WIC participant through the WIC management information system (MIS). It is hypothesized that the telehealth solution will increase WIC participant's satisfaction with nutrition and breastfeeding support while also reducing the burden of attending in-person care.
With funding through the United States Department of Agriculture (USDA) and Tufts University's Telehealth Intervention Strategies for WIC (THIS-WIC) project, North Carolina (NC) WIC department will be implementing new, nutrition education telehealth in NC's WIC program. The purpose of this study is to evaluate the impact of the telehealth platform. The evaluation will focus on NC WIC clients as the study population. The North Carolina WIC department would be implementing this education platform, regardless of the evaluation research. The North Carolina WIC department is responsible for implementing this new intervention, while the Tufts University research team is responsible for the evaluation of this platform through surveys and analysis of administrative data. An online survey will be used to gauge WIC clients' satisfaction with the telehealth solution and the impact of the telehealth solution compared to usual care on breastfeed duration, dietary intake, attendance at scheduled appointments, attitudes to breastfeeding and nutrition education, and barriers encountered. Survey data will be combined with previously collected data on clients and their families from the NC Management Information Systems (MIS), and aggregate level data from the telehealth solution about utilization.
With funding through USDA and Tufts University's Telehealth Intervention Strategies for WIC (THIS-WIC) project, the Georgia WIC department will be implementing a telehealth solution for nutrition and breastfeeding support. The purpose of this study is to evaluate this telehealth solution. The research/evaluation involves completing online surveys. The evaluation will focus on participant satisfaction, usage of the telehealth solution, and use of information collected on the WIC participant through the WIC management information system (MIS). It is hypothesized that the telehealth solution will increase WIC participant's satisfaction with nutrition and breastfeeding support while also reducing the burden of attending in-person care.
With funding through the United States Department of Agriculture (USDA) and Tufts University's Telehealth Intervention Strategies for WIC (THIS-WIC), Michigan's (MI) WIC department will pilot telehealth opportunities as a means of delivering services to WIC Clients. This video conferencing pilot looks to improve and/or remove barriers. Implementing a pilot program in select local agencies to utilize technology would allow clients to connect with a WIC Registered Dietitian (RD) or an International Board-Certified Lactation Consultant (IBCLC). Videoconferencing could open new opportunities for leveraging the extensive expertise of the nutrition and lactation workforce in WIC agencies to address rural and remote locations and travel considerations. The purpose of this study will be to evaluate the effectiveness of this telehealth solution.
With funding through the United States Department of Agriculture (USDA) and Tufts University's Telehealth Intervention Strategies for WIC (THIS-WIC) project, Wisconsin's (WI) WIC department will be implementing a new, customized, mobile-friendly nutrition education platform called ONE (Online Nutrition Education) in WI's WIC program. The purpose of this study is to evaluate the impact of the ONE platform. The evaluation will focus on WIC clients as the study population. The Wisconsin WIC department would be implementing this education platform, regardless of the evaluation research. The Wisconsin WIC department is responsible for implementing this new intervention, while the Tufts University research team is responsible for the evaluation of this platform through surveys and analysis of administrative data. An online survey will be used to gauge WIC clients' satisfaction with ONE, and the impact of the telehealth solution compared to usual care on breastfeed duration, dietary intake, attendance at scheduled appointments, attitudes to breastfeeding and nutrition education, and barriers encountered. Survey data will be combined with previously collected data on clients and their families from the WI Management Information Systems (MIS), and aggregate level data from the ONE telehealth solution about ONE utilization.
Hispanic men and children experience health disparities for overweight and obesity-related medical conditions, and therefore family level obesity prevention programs for Hispanic populations are needed. 'Healthy Dads Healthy Kids' is the first program to primarily target fathers for obesity prevention for themselves and their children, with significant and clinically relevant treatment effects. This is an efficacy trial to assess a culturally adapted 'Healthy Dads Healthy Kids' for Hispanic families.
The goal of this study is to determine the feasibility and acceptability of two food preference learning approaches for toddlers that could serve as alternatives to mere repeated exposure to new or previously disliked foods. The target population is toddlers who score higher on food fussiness. The study is a two-group randomized controlled trial. Families will be randomized to 1 of 2 study groups: associative conditioning, or the child tasting vegetables alongside a palatable dip, or modeling, in which the child and parent taste vegetables together. Both groups will attend two laboratory visits, one before and one after a 4-week exposure period, and will be asked to complete 8 vegetable tastings in accordance with their assigned condition across the 4 intervention weeks. Key questions to be addressed are: * summarizing the feasibility and acceptability of the intervention strategies * assessing whether children's liking and intake of the target food increase from baseline to post-intervention