Our Research

Actively Enrolling Research

Research Studies Closed to Enrollment


 

Actively Enrolling Research


 

MomEE”

Determinants of gestational weight gain in obese pregnant women

In the U.S. the number of obese women entering pregnancy has more than doubled in the past 30 years. Pregravid obesity alone however is not the only cause for concern since two-thirds of obese women gain weight in excess of the 2009 IOM recommendations and attempts to manage gestational weight gain to date have failed. To improve weight management of obese pregnant women, there is a critical need to deliver specific evidence-based recommendations on energy intake and energy expenditure (physical activity); the two primary determinants of weight gain in non-pregnant individuals. As an ancillary study to LIFE-Moms (Lifestyle Interventions in Expectant Moms Study) we will evaluate energy intake and energy expenditure during pregnancy (13 to 37 weeks) and 12 months postpartum in 80 obese women enrolled in a LIFE-Moms study.

Visit the Pennington website for more information or to screen online.

Visit clinicaltrials.gov for more information on this study.


 

"BabyEE" Pilot

Measurement of Energy Metabolism in Infants

Metabolism is a major component of health especially infant health. Scientists are not sure how metabolism is inherited or what factors after birth may influence metabolism, so researchers at Pennington Biomedical are working to better understand the factors that impact metabolism development in infants. The BabyEE Pilot research study will observe and collect information about metabolism, body composition, physical activity, food intake, and feeding behavior of infants during the first three months of life. See our cutting-edge facility below.

 

Visit the Pennington Biomedical website (www.pbrc.edu/babyee) for more information. 

Visit clinicaltrials.gov for more information on this study.


 

ART Survey

Assisted Reproductive Technology Survey

The National Institutes of Health has asked scientists to study the health and development of children conceived with the help of in vitro fertilization. Researchers at Pennington Biomedical would like to help! In preparation for a new study, the ART Survey is trying to collect information from families who have conceived with or without the help of IVF in our community.

 

Please help us learn more about children in Louisiana by completing the ART survey (www.pbrc.edu/ARTsurvey)!
This survey takes about 3 minutes to complete.

Visit clinicaltrials.gov for more information on this study.


 

Participate While Pregnant Survey

Understanding feelings of participating in research studies while pregnant

Researchers at Pennington Biomedical Research Center would like to better understand how women feel about participating in reserach studies while they are pregnant. 

 

Please help us learn more about your feelings on participating in research studies by taking our survey (www.pbrc.edu/ParticipateWhilePregnant)!
This survey takes about 5 minutes to complete
.

Visit clinicaltrials.gov for more information on this study.

 

 

Research Studies Closed to Enrollment


 

"Mom2Baby" Pilot

Understanding the Influence of Pregnancy on Breast Milk

In 2010, more than a third of children in the U.S. aged two to five were overweight or obese. Obese youth are more likely to have risk factors for cardiovascular disease (high cholesterol and high blood pressure) and increased risk for diabetes. Maternal behaviors, especially those related to nutrition, should be targets for investigations to link early life biological factors to future obesity. Gestational health, incidence of breastfeeding, maternal food intake, and quality of breast milk should be evaluated for their effects on infant health and obesity risk throughout childhood. In the Mom2Baby Pilot study, we intend to enroll pregnant women who are planning to breastfeed their infants until the infants are at least 2 months old. The purpose of this study is to identify the influences of pregnancy on breast milk and the effects of these on the health of the babies during the first 2 months of life.

Visit the Pennington website for more information on this study or to screen online.

Visit clinicaltrials.gov for more information on this study


 

"PULSE" Study

Effect of Weight and Insulin Sensitivity on Reproductive Function in PCOS

K99 HD060762/R00 awarded |R00HD060762

Up to 10% of women of reproductive age are affected by polycystic ovary syndrome (PCOS), an endocrinopathy characterized by excessive androgen production and reproductive dysfunction.  Since weight gain and excess adiposity exacerbate the androgen excess and reproductive dysfunction, weight loss by dietary restriction and exercise is the recommended treatment for infertility in overweight women with PCOS.  Our preliminary data indicate that exercise, independent of weight loss, restores menstrual cyclicity in obese women with PCOS. Moreover, treatment of PCOS patients with insulin sensitizers improved both androgen excess and ovulatory function without weight change.  We plan to conduct a randomized controlled clinical trial in 52 obese women with PCOS to determine the effects of: a) exercise training, b) 25% dietary restriction and c) metformin in comparison to d) a control group with no intervention.  In these subjects, we will measure: 1) neuroendocrine function (pulsatile LH secretion), 2) reproductive function (ovulation rate) and 3) ovarian function.

Visit the Pennington website for more information or to screen online.

Visit clinicaltrials.gov for more information on this study.


 

"PULSE Ancillary"

Effect of Weight and Insulin Sensitivity on Reproductive Function in PCOS: Studies in Skeletal Muscle and Adipose Tissue

The overall objective of this ancillary study is to test in PULSE participants (overweight and obese women with polycystic ovary syndrome) the effect of 6 months of treatment with either: exercise training, 25% dietary restriction or metformin in comparison to a control group receiving no intervention on the functions of the skeletal muscle and adipose tissue. We will compare metabolic outcomes in the tissue samples between women randomized to a control group receiving no intervention and to those in the intervention groups.  We will also importantly evaluate, regardless of the assigned intervention, the association between weight loss, improvements in whole body insulin sensitivity (measured by the euglycemic hyperinsulinemic clamp) and changes tissue-specific substrate oxidation, insulin sensitivity and insulin signaling and mitochondrial function.

Visit clinicaltrials.gov for more information on this study.


 

"E-Moms" Study

E-Moms: A personalized telehealth intervention for health and weight loss in postpartum women

United States Department of Agriculture (through UCLA Small Grants Program)

Pre-pregnancy maternal overweight/obesity and excessive weight gain during pregnancy lead to significant morbidities in mothers and their offspring. Mothers who never return to their pre-pregnancy weight begin later pregnancies at a greater weight and have a larger possibility for excess gestational weight gain and postpartum weight retention. This vicious cycle is contributing to increased obesity among reproductive-aged women. Motherhood is increasingly recognized as a “teachable moment” for adopting a healthier lifestyle. While mothers are believed to be a highly motivated population for behavior change, pregnant women and new moms face several barriers to traditional in-person weight management programs.  Application of telehealth technologies to women during pregnancy and postpartum may successfully address these barriers and facilitate weight management. The objective of this study, titled “E-Moms: A personalized telehealth intervention for health and weight loss in postpartum women”, is to implement a personalized weight management program to overweight and obese postpartum women delivering health information based on the Women, Infants and Children periconceptional nutrition program. 

Visit clinicaltrials.gov for more information on this study.


 

"E-MECHANIC Ancillary"

Effect of exercise-induced weight loss on energy metabolism

The purpose of the E-MECHANIC Ancillary Study is to measure changes in daily energy expenditure with 24 weeks of exercise training (the metabolic adaptation to exercise training) and to determine if the metabolic adaptation to exercise is different between individuals who lost the predicted amount of weight (non-compensators) and individuals that did not lose the predicted amount of weight (compensators).    The E-MECHANIC study sponsored by the National Institutes of Health is conducting a randomized parallel arm study to understand the mechanisms that may explain exercise-induced weight change.  A total of 198 individuals overweight/obese individuals will be randomized into one of three groups for 24 weeks; non-exercise control group, low dose exercise training (exercise training dose will be set at 8 calories per kg of body weight per week, 8KKW) and high dose exercise training (exercise training dose will be set at 20 calories per kg of body weight per week, 20KKW). The primary outcome variables of E-MECHANIC are energy intake and the discrepancy between expected weight loss and observed weight loss. The secondary outcome variables include assessment of changes in resting metabolic rate and activity levels as potential mechanisms to explain differences in predicted and observed weight loss.  In the E-MECHANIC ancillary study, 24 hour energy expenditure and spontaneous physical activity will be measured in the metabolic chamber in a subset of 60 obese individuals (BMI: ≥30 kg/m2) enrolled in the main study.

Visit clinicaltrials.gov for more information on this study.

Visit Pennington's website for more information on how to participate.


 

"Expecting Success"

Personalized Management of Body Weight During Pregnancy

3U01DK094481-01S1

More than 60% of reproductive age women in the US are overweight or obese and more than half exceed weight gain guidelines during pregnancy as recommended by the Institute of Medicine (IOM). Although pregnant women are believed to be a highly motivated population for accepting behavior change, they face several barriers to traditional in-person clinic weight management programs. The objective of this study is to implement a personalized gestational weight management program to overweight and obese pregnant women that focuses on healthy eating and achieving national physical activity recommendations.  We plan to enroll 306 overweight and obese pregnant women and randomly assign them to receive either usual care (Physician Directed Group) or a personalized lifestyle program for weight management called SmartMoms, delivered either in a traditional clinical setting (SmartMoms-Clinic) or remotely via a Smartphone (SmartMoms-Phone). 

Visit clinicaltrials.gov for more information on this study.


 

"ECCENTRIC"

Effect of Cinnamon Extract on Insulin Resistance in Polycystic Ovary Syndrome

Botanical Research Center Pilot Award

 

In vivo studies in skeletal muscle biopsies obtained from women with PCOS during fasted and insulin-stimulated (euglycemic hyperinsulinemic clamp) conditions indicate several post-insulin receptor defects in insulin signaling. Cinnamon, the bark of Cinnamoni Cassae is a potential mimetic of insulin action.  The molecular mechanisms by which cinnamon can influence glucose uptake are largely unknown.  Studies in laboratory animals and stable cells lines however, suggest that cinnamon can potentiate the action of insulin.  The objective of this study therefore is to evaluate for the first time, the effects of cinnamon on whole-body insulin-stimulated glucose uptake using the gold standard, euglycemic hyperinsulinemic clamp and insulin signaling in skeletal muscle.

Visit clinicaltrials.gov for more information on this study.


 

"Baby Bottle"

Remote Food Photography with Infants: A Pilot Study

Food intake is crucial during the first two years of life because it is a time of constant growth and development. Measuring food intake in infants is challenging due to constant changes in eating patterns and large variability in food selection. Establishing accurate methods to estimate food intake in infants is important for establishing effective feeding practices, supporting adequate growth and development and to help understand the role of food intake in the development of childhood obesity. Digital photography and the Remote Food Photography Method (RFPM) is used to measure energy and nutrient intake in adults, but these methods have not been used to measure energy and nutrient intake in infants from birth to 12 months. The primary objective of this study is to determine the reliability and validity of the RFPM to assess food intake in formula fed infants.

Visit clinicaltrials.gov for more information on this study


 

“MAX”

Max II Metabolic Cart Validation

The objective of this study, “MAX,” is to establish the accuracy and reliability of Max II metabolic cart (AEI Technologies, Naperville, II) for measuring resting metabolic rate in humans in comparison to the Deltatrac II metabolic cart, a widely accepted metabolic measurement system which is no longer serviceable.

Visit clinicaltrials.gov for more information on this study.

 

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