65 Clinical Trials for Various Conditions
Healthy for Two, Healthy for You (H42/H4U) is an innovative evidence-based pregnancy/postpartum health coach intervention that is remotely-delivered (phone coaching using motivational interviewing, web-based platform, mobile phone behavioral tracking). The aim of this randomized controlled trial (RCT) is to embed H42/H4U into Johns Hopkins prenatal care clinics that serve a racially and economically diverse population, leveraging existing staff as trained health coaches to test its effectiveness and implementation. The investigators hypothesize that women in the H42/H4U arm will have lower gestational weight gain and lower rates of gestational diabetes, without an increase in low birth weight infants, and that implementation into the investigators' prenatal care clinics will be feasible and scalable.
In this study, the investigators aimed to have pregnant women use a hand-held device to track increases in daily caloric needs during pregnancy. Weight gain was assessed over time with the goal of reducing excessive gestational weight gain relative to a group of pregnant women who received standard prenatal care.
The study will test the effectiveness of a smartphone-based behavior modification program adapted for use in Women, Infants, and Children program in a state-wide, randomized controlled trial in 432 low-income women enrolled in the Louisiana Women, Infants, and Children program.
The purpose of this study is to determine the effect of an antenatal obesity treatment on gestational weight gain when integrated into Philadelphia WIC.
The primary purpose of this study is to assess the responses of pregnant women and their social network to six videos about health in pregnancy. Our goal is to assess a) acceptability and b) understanding of core messages about healthy eating, exercise and weight gain during pregnancy. We will also assess c) non-clinical sources of health information during pregnancy.
The study will use a comprehensive behavioral intervention adapted for pregnant women to change dietary intake, eating behavior and physical activity. The central hypothesis of this study is that the intervention will reduce excess gestational weight gain and achieve clinical and metabolic benefits in obese and overweight pregnant women and their infants over the first year of life.
Low back and posterior pelvic pain are common in pregnant females. Previous studies have demonstrated disability and it is estimated that all women experience some degree of musculoskeletal discomfort during pregnancy. Borg-Stein et. al. found 25% of pregnant females have temporarily disabling symptoms. There is demonstrated controversy over the mechanism of low back pain in pregnancy. The biomechanical theory implies that the enlarging uterus causes the maternal center of gravity to move anteriorly causing stress on the low back. Jensen et. al. demonstrated that weight gain correlated with biomechanical changes. The changes were measured by weight gain in segmental regions of the body and in principal moments of inertia from the sit to stand movement. Literature does not demonstrate a specific correlation between weight gain and the biomechanical changes of sway rate, lumbosacral angle and center of gravity. These three measurements may have a correlating effect on the underlying cause of low back pain in pregnant women. This study aims to determine the correlation between weight gain of pregnant females and the biomechanical changes of sway rate, lumbosacral angle and center of gravity. The change in weight over the last two trimesters will be correlated with the sway rate, lumbosacral angle and center of gravity. The degree of symptomatic low back pain as measured by the Oswestry Low Back Pain Scale will also be correlated with the sway rate, lumbosacral angle and center of gravity.
The prevalence of overweight and obesity is increasing among pregnant women in the United States. More than one-third of women of reproductive age in the US are overweight or obese, and two thirds of women gain more weight in pregnancy than is recommended by the Institute of Medicine guidelines. Maternal obesity during pregnancy increases the risk of complications to both mother and child. Minority women (Blacks and Hispanics) have higher rates of overweight and obesity when they become pregnant, experience higher rates of excessive weight gain during pregnancy, and experience higher rates of maternal and neonatal complications after adjusting for sociodemographic characteristics and comorbidities than Caucasian women. Epidemiologic studies indicate that lifestyle modification programs based on diet and exercise are promising approaches in controlling weight gain as well as in preventing type 2 diabetes in populations at risk. We hypothesize that overweight/obese minority women (Blacks and Hispanics) assigned to a culturally-grounded lifestyle intervention program based on diet and moderate exercise will result in higher compliance with Institute of Medicine guidelines for weight gain than women receiving standard care. Such lifestyle modifications should reduce risk of maternal and neonatal complications. We propose 1) to determine whether a lifestyle intervention program, based on diet and moderate physical activity implemented shortly after first recognition of pregnancy, will result in higher compliance with Institute of Medicine guidelines for weight gain compared to women receiving standard care; 2) to determine the occurrence of carbohydrate intolerance and GDM at 24-28 weeks gestation (after the first 10-12 weeks of intervention) and at 6 weeks postpartum between women in the lifestyle intervention group and women receiving standard care; and 3) to explore the impact of the lifestyle intervention on the development of maternal and fetal complications during pregnancy. By limiting excessive weight gain, the lifestyle intervention program may prevent the burden of obesity-related complications during pregnancy and reduce risk of subsequently developing overt diabetes.
The purpose of this study is to determine if twice monthly interaction with a registered dietitian from 6-16 weeks gestation through 6 months postpartum will help women who are overweight or obese gain weight during pregnancy closer to the Institute of Medicine (IOM)guidelines and lose weight more effectively within the 6 month postpartum period than those who do not receive twice monthly interaction with a registered dietitian during this period. Overweight/obesity can lead to a number of adverse pregnancy, delivery and birth outcomes, including increased risk of hypertension, eclampsia, and diabetes during pregnancy, miscarriage, premature delivery, birth injuries, neural tube defects, and prenatal death. More than half of women of childbearing age are overweight or are obese. Women of color and low-income women are affected disproportionately. Unfortunately, women know little, if anything, about the impact of overweight and obesity on pregnancy and health care providers are unsure how to effectively address the problem with their patients. A limited number of programs have tested ways to effectively address weight gain management during pregnancy. None have been successful in addressing weight gain in women who are obese or overweight at the start of pregnancy. The 2-year Revere Health Center Pregnancy Weight Management Study will test the feasibility and efficacy of providing pregnant women who are overweight or obese with regular access to a registered dietitian during and after pregnancy to help achieve total weight gain closer to recommended guidelines and to ensure the best outcomes for the mother and her newborn.
The purpose of this study is to determine if an organized, consistent program of dietary and lifestyle counseling will prevent excessive gestational weight gain.
Multiple studies have demonstrated a very low prevalence of women meeting physical activity and weight gain recommendations during pregnancy. The aim of this study is to provide a lifestyle intervention to increase physical activity, reduce carbohydrate intake, prevent excessive gestational weight gain, decrease postpartum weight retention, and improve mental well-being compared to "usual care" using a randomized controlled design in pregnant women. Participants in the intervention group will receive behavioral lifestyle counseling and take part in monthly one-on-one visits with a registered dietitian (RDN) from approximately week 14 of their pregnancy to child birth. Participants in the "usual care" group (control) will not receive any lifestyle counseling. Data collected from this group will be used to compare the effectiveness of the lifestyle intervention. Unlike many studies examining diet and physical activity factors alone, this study evaluates additional psychosocial factors such as psychological health, self-efficacy, competence, motivation and barriers that may influence excessive gestational weight gain. In addition, the Self-Determination Theory framework will be used to measure how motivation and motivational interviewing strategies can help explain changes in volitional behavior.
The purpose of this study is to determine how to help manage weight gain during pregnancy. This study is part of the National Consortium 'LIFE-Moms: Lifestyle interventions in expectant moms'. LIFE-Moms is 7 studies funded to test different lifestyle interventions in overweight and obese pregnant women.
The IBEP study is a randomized control trial of a healthy lifestyle intervention program for women with gestational diabetes. The primary aim of the study is to evaluate whether women with gestational diabetes enrolled in an intensive behavioral educational program (IBEP) demonstrate lower mean fasting glucose levels measured by 2 hour 75 gram oral glucose tolerance test (OGTT) at 6 weeks postpartum compared to women with gestational diabetes who undergo routine gestational diabetes education and counseling.
This is a prospective, randomized, placebo controlled study with three parallel arms examining the effects of magnesium supplementation in the second trimester of pregnancy. Recent research has shown that supplemental magnesium can have beneficial effects, especially in overweight individuals. Not only do many people have a magnesium deficient diet, there is also evidence that magnesium can improve blood sugar levels. Due to the growing concern of obesity with pregnancy and its associated complications, such as diabetes and abnormal fetal growth, magnesium therapy could have novel and beneficial effects on pregnancy outcomes. In this study, 60 overweight and obese pregnant patients in their first trimester will be enrolled and randomized. The first group (A) will receive oral magnesium citrate (300mg elemental Magnesium), group B will receive dietary counseling about following a magnesium rich diet from a nutritionist, and group C will receive a placebo (control). Blood and urine specimens will be collected at three time points during the pregnancy to analyze changes in levels of metabolic markers, inflammatory markers, and protein expression profiles. Fetal and maternal complications of pregnancy will be noted, including maternal weight gain. At delivery, patients will have a placental cord blood specimen and placental biopsy collected for gene expression patterns and further analysis.
50-70% of adolescents gain too much weight during pregnancy, and this excess gain significantly increases their risk of high postpartum weight retention and long-term obesity. In this randomized controlled pilot study, the investigators are evaluating the feasibility and acceptability of a relatively brief interpersonal psychotherapy program for reducing excess gestational weight gain during adolescent pregnancy. Compared to treatment-as-usual prenatal care delivered in an adolescent maternity clinic, the investigators will estimate the added benefit of an interpersonal psychotherapy program's effectiveness for reducing excess gestational weight gain, improving maternal postpartum insulin sensitivity, and decreasing maternal and infant adiposity.
The purpose of this study is to measure energy intake and energy expenditure during and after pregnancy. The investigators hypothesize that obese pregnant women with weight gain above the Institute of Medicine (IOM) guidelines, 'High Gainers', will have increased energy intake but no evidence for changes in energy expenditure after adjustment for the weight gained when compared to women with appropriate gestational weight gain, 'Normal Gainers'. Additionally, the investigators will measure the babies born to the pregnant women enrolled in MomEE at one time point before 10 days of life.
The purpose of this study is to evaluate pedometer use by overweight women during pregnancy. The study will show if a pedometer will help women to limit weight gain during pregnancy. It will also show if it there are other benefits such as decreased diabetes, decreased high blood pressure, decreased rates of cesarean section, and decreased complications for the baby.
There are set guidelines for weight gain developed by the Institute of Medicine in pregnancy but about three quarters of women gain an inappropriate weight during pregnancy. Many studies have assessed ways to decrease weight gain in these women who gain excess weight, usually through a combination of diet and exercise. Still, often these interventions are difficult to implement, expensive, or have low acceptability. Wearable Fitbit devices have been on the market for years and slowly becoming more inexpensive and easier to use. Previous studies on non-pregnant women have shown that using the device can help reduce weight gain. In addition, small studies in pregnant women have shown they are accurate for measuring steps and have high acceptability and retention rates. The ability of the Fitbit to assess metrics of sleep including sleep duration and quality will also be assessed. This project aims to provide overweight and obese pregnant women at the beginning of their pregnancy with the Fitbit device and with regular follow-up to assess if there is effectiveness in increasing the rate of women who meet weight gain guidelines compared to women without the device along with measuring aspects of sleep.
In the United States, severe obesity (body mass index (BMI) ≥ 40.0 kg/m2) affects approximately 10% of females of reproductive age with Black females disproportionately burdened (16%). Severe obesity is a significant predictor of adverse perinatal outcomes including gestational diabetes mellitus, pre-eclampsia, premature birth, and at its most severe, fetal death, birth defects and a three-fold greater risk of maternal mortality - outcomes that also disproportionately affect Black females. Observational studies suggest weight maintenance and even modest body fat loss and altering the maternal metabolic milieu (availability of glucose and lipids) in the gestational period may be important to reducing perinatal health risks among pregnant females with severe obesity. The proposed research aims to assess time-restricted eating in the 2nd and 3rd trimesters of pregnancy to explore the effects on maternal weight, and perinatal health outcomes compared to standard clinical care.
The purpose of this study is to compare the effectiveness of H42-HV integrated into home visiting compared with usual home visiting services in reducing postpartum weight retention (difference between pre-pregnancy weight and weight at 6 months postpartum) among pregnant and postpartum people. The intervention is tailored for Black and Latinx pregnant and postpartum people and, ultimately, aims to address inequities in cardiometabolic health.
This project will increase knowledge about how a simple intervention, grocery delivery, impacts weight gain and diet among low-income pregnant young women. Results can then be used to support other pregnant young women.
The purpose of this study is to find out whether a technology-base healthy lifestyle program is an acceptable and effective way for African-American mothers to improve their eating and activity during pregnancy, compared to usual obstetric care. The goal of the program is to enhance the health of African-American mothers and their babies.
The prevalence of maternal overweight and obesity has nearly doubled in the United States since 1976. In 2004-2005, 42% of pregnant women had body mass index (BMI) above 25 versus 23% in 1993. Most American women are overweight/ obese (OW/OB) at conception, especially within certain racial, ethnic, and lower socioeconomic groups leading to increased adverse maternal and birth outcomes. This study will recruit, randomize and test in 300 ethnically diverse OW/OB pregnant women a behavioral intervention aimed at controlling gestational weight gain (GWG) through recommended diet, activity and lifestyle changes that are to be maintained postpartum. Outcomes include anthropometric (height, weight, percent body fat) metabolic (blood pressure, fasting glucose, insulin, HbA1c, lipids and C-reactive protein) and behavioral measures (diet. physical activity, sleep and stress). In addition, babies will be measured for length, weight and percent body fat. The goal is to limit excessive gestational weight gain through improved maternal lifestyle that can be maintained and modelled for the family post partum and beyond.
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)
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.
The goal of this clinical trial is to see if the enhanced HMZ 2.0 intervention with new control system/digital platform to regulate gestational weight gain (GWG) and impact maternal-infant outcomes while collecting implementation data works and can be given to other pregnant women in various settings. The question this study aims to answer are: 1. Does the new intervention manage GWG? 2. Does the new intervention have any influence on sleep and eating behaviors and infant outcomes. 3. Does the new platform and other data collected help inform how well the research and information can be used in health care settings? 144 pregnant women with overweight/obesity will be randomized to either the HMZ 2.0 intervention or attention control groups from \~8-36 weeks gestation. All participants will be asked to: 1. Weight themselves and wear an activity monitor each day over the study. 2. Complete online surveys at either a weekly or monthly level about their thoughts, attitudes, and behaviors on GWG, physical activity, eating behaviors, sleep, their anxiety, depression, and stress. 3. Attend weekly sessions with a registered dietician. The weekly sessions will differ based on intervention group. The HMZ 2.0 intervention group will receive education, create and follow goal-setting and action plans, self-monitor their behaviors, and receive feature evidence and fetal growth facts. Education, goals, and self-monitoring will focus on GWG, physical activity, eating behaviors, sleep, self-regulating behaviors and emotions, and preparing for labor/delivery and postpartum. The attention control group will receive weekly sessions on preparing for labor/delivery and benefits of behavioral pain management strategies (e.g., mindfulness-based relaxation, imagery, music, massage, deep-breathing) to help with pain after childbirth without medicine.
This study is being done to assess the feasibility, acceptability, and preliminary impact of a meal delivery intervention designed to improve diet quality and promote appropriate gestational weight gain among predominantly Black and low-income pregnant women with overweight or obesity. This will be done by 1) assessing the feasibility and acceptability of the meal delivery intervention; 2) investigating changes in patient-reported diet quality, barriers to healthy eating, and food security; and 3) exploring the preliminary impact of the meal delivery intervention on gestational weight gain and blood pressure and estimate the effect size of the intervention relative to a de-identified non-randomized control group that will be derived from de-identified hospital records.
The purpose of this study is determine whether different antiretroviral therapy (ART) changes the effects on body fat and predict the weight change in Black and Hispanic females.
The purpose of this study is to enable the investigator to conduct proof of concept work related to the feasibility, acceptability, initial efficacy and mechanisms of action (focusing on maternal and infant modifiable factors) for a novel self-management intervention for pregnant women.
The aims of this randomized controlled trial are to determine the effects of a lifestyle program that supports weight maintenance and fat mass loss during pregnancy in women with obesity on changes in 1) maternal weight, fat mass, and cardiometabolic risk factors; 2) safety measures, including fetal and neonatal growth; 3) the mediators and moderators of the fat mass loss intervention and 4) the effects gestational fat mass loss has on reducing incidence of adverse obstetrical outcomes, including non-elective cesarean delivery, gestational diabetes, hypertension, and pre-eclampsia.