Ongoing & Completed Clinical Studies

Principal Investigator:  Leanne Redman, PhD
Co-Investigators:  Daniel Hsia, MD, Abby Duhé, MS, Eric Ravussin, PhD

Objective:  This pilot study intends to establish the feasibility of completing metabolism measurements in infants using the doubly labeled water method and the new infant metabolic chamber at Pennington Biomedical.

Design: Up to 40 infants aged 1 to 3 months will be enrolled in this observational pilot study which includes two study visits to be completed within 5‐7 days.

Subjects:  Up to 40 healthy, full‐term infants aged 1 to 3 months who are exclusively fed breast milk and/or infant formula will be recruited to Pennington Biomedical Research Center to participate in this study.

Measurements:  Infant outcome data includes length, weight, head circumference, abdominal circumference, PEAPOD, skinfold thickness, physical activity, and energy expenditure measured by doubly labeled water and infant metabolic chamber monitoring.

Results:  Coming soon!

Funding:  Pennington Biomedical Research Center Nutrition and Obesity Research Center (NORC)

Clinical Trials Identifier:  NCT02683473

Principal Investigator:  Amanda Staiano
Co-Investigators:  Peter Katzmarzyk, Robert Newton, Stephanie Broyles, Catherine Champagne
Medical Investigator:  Daniel Hsia

Objective:  This study will establish a prospective pediatric cohort to identify health intervention targets based on the location, timing, barriers, and facilitators of current physical activity and sedentary behavior in a child’s day.

Design:  A prospective epidemiological design will be used to determine the effect of body mass on physical activity, sedentary behavior, and cardiometabolic risk factors among African American and White children and adolescents. Physical activity, sedentary behavior, cardiometabolic risk factors, and body composition will be assessed in each participant using gold standard, objective measures, with the first assessment (Year 0) in 2016-17 and the second assessment (Year 2) in 2018-19.

Participants:  The study will enroll 340 African American and White girls and boys aged 10 to 16 years, including half who are classified as severely obese.

Measurements:  We will use state-of-the-art technology including accelerometry to quantify physical activity, magnetic resonance imaging and dual energy x-ray absorptiometry to quantify fat accumulation, and geographic position system and ecological momentary assessment to identify environmental and socio-emotional barriers and facilitators. Dietary recall will be measured on two weekdays and one weekend day. Validated instruments will be used to collect self-reported and parent-reported data on family environment, neighborhood environment, body image, and mood. All measures will be taken at Year 0 and again at Year 2.

Results:  Results are anticipated in 2019.

Funding:  United States Department of Agriculture (3092-51000-056-04A)

Principal Investigator:  Amanda Staiano
Community Co-Principal Investigator: Andrew Allen (Mayor’s Healthy City Initiative)
Co-Investigator:  Corby Martin

Objective: Louisiana’s Department of Education (DOE) is implementing new regulations for children in childcare settings in 2015 to comply with national recommendations: 1) physical activity of at least 1 hour/day and 2) screen-time limited to 2 hours/day. Together with the Mayor’s Healthy City Initiative, we propose the following aims: 1) to examine the physical activity and screen-time environment of licensed childcare centers before and after the enactment of new state regulations; 2) to examine the physical activity and screen-time behaviors of children enrolled in childcare centers before and after the enactment of new state regulations; and 3) to establish community strategies to improve young children’s health behaviors.

Design:  Specific Aims 1 and 2 will be achieved through a prospective observational epidemiological approach before and after enactment of new regulations. We randomly selected 10 childcare centers licensed in East Baton Rouge Parish, and we trained our staff to use standardized behavioral observation scales to objectively quantify the physical activity and screen-time environment of the centers and the children’s behaviors both in and outside the center. Preliminary data collection will occur in 2016, with one-year follow-up data collected in 2017.

Participants:  Two hundred sixty-six children in ten childcare centers will be recruited for the classroom observation study. An additional thirty childcare center directors and parents of preschool-aged children will participate in focus groups.

Measurements:  The Environment and Policy Assessment and Observation tool will be used to observe children’s behaviors and the childcare center environment, and directors will complete a childcare center policies and practices survey. Children’s height, weight, and physical activity (via accelerometry) will be measured, and parents will complete a survey on children’s demographics. Focus groups will be held of parents and directors, along with ongoing advisory board meetings of the Mayor’s Healthy City Initiative, to strategize ways to increase young children’s physical activity and decrease screen-time in childcare centers and other settings.

Results:  Results are anticipated in 2017.

Funding:  National Institutes of Health / National Institute of Minority Health and Disparities / Gulf States Health Policy Center (U54 MD 008602)

Clinical Trials Identifier:  In Process.

Principal Investigator:  Amanda Staiano
Co-Investigator:  Robert Newton Jr.
Medical Investigator: Daniel Hsia

Objective:  The goal of the proposed randomized controlled trial is to test the efficacy of exergaming (i.e. video gaming that involves physical activity) to reduce adiposity in overweight and obese children.

Design:  The GameSquad study is a 6-month, 2-arm randomized controlled trial among 46 overweight/obese children (aged 10 to 12 years) assigned to: 1) 3 hours/week of in-home exergaming or 2) a control group. An innovative aspect is the inclusion of a fitness trainer who regularly video chats with the participant and virtually monitor gameplay.

Participants:  The study enrolled 46 overweight and obese children (ages 10-12 years; BMI ≥ 85th percentile on CDC growth chart). 

Measurements:  The primary study outcome is change in body mass index z-score (BMIz) from baseline to post-intervention. Secondary outcomes include changes in body fat as measured via dual energy x-ray absorptiometry; cardiovascular health metrics including blood pressure, blood glucose, and cholesterol levels; physical activity, diet, and lifestyle habits.

Results:  Results are anticipated in 2016.

Funding:  American Heart Association (15GRNT24480070)

Clinical Trials Identifier:  NCT02560493

Principal Investigator:  Amanda Staiano
Co-Investigators:  Peter Katzmarzyk, Robert Newton Jr., Daniel Hsia, Savarra Mantzor
Medical Investigator: Patrice Tyson (Our Lady of the Lake Regional Medical Center)

Objective:  The project aims to evaluate and adapt a 10-week pediatric obesity program delivered in a primary care provider clinical setting to increase the efficacy of achieving clinically significant weight loss in overweight and obese children.

Design: Eight cohorts of approximately 10 to 15 children each will complete a 10-week family-based weight management program conducted by staff from OLOL and PBRC, including physicians, a clinical psychologist, dietitians, and fitness trainers. Each ninety minute session includes dietary counseling with cooking demonstrations, interactive physical activity lessons, and goal-setting and barrier reduction counseling.

Participants:  Participants are pediatric patients referred by OLOL physicians to the Pediatric Specialty Clinic of Our Lady of the Lake Children’s Hospital. Participants are aged 8 to 17 years old with BMI ≥ 95th percentile or have a BMI ≥ 85th percentile with comorbidities (e.g. hypertension, heart disease, type 2 diabetes, insulin resistance, sleep apnea, orthopedic problems, or fatty liver disease).

Measurements:  Main study outcomes are change in weight and body mass index (BMI) z-score. Secondary outcome variables include improvements in physical activity, quality of life, and physical activity enjoyment.

Results:  Results are anticipated in 2016.

Funding:  American Council on Exercise and the Franciscan Missionaries of Our Lady

Principal Investigator: Tiffany Stewart
Co-Investigators: Carolyn Becker, Terrence Wilson

Given the cost of treating eating disorders (EDs) and the substantial morbidity and mortality associated with these disorders, prevention of EDs has considerable public health significance.  Research supports the use of a Healthy Weight (HW) program targeting small lifestyle modifications in the prevention of ED onset and in the reduction of ED risk factors. Studies show that HW can be tailored for specific social systems (e.g., sororities) which can facilitate dissemination and that undergraduate peer-leaders can implement these programs. Interventions that can be administered affordably by endogenous providers are more likely to be disseminated, as indicated by the large scale dissemination of a peer-led ED prevention program by a national sorority.  Another target social system for dissemination of ED prevention is collegiate athletics. Research suggests that disordered eating among female athletes is prevalent, and that this group is often at greater risk for developing EDs than non-athlete females. Disordered eating is especially dangerous in female athletes because it increases risk for the Female Athlete Triad (i.e., low energy availability/disordered eating, menstrual disorders, and decreased bone mineral density/osteoporosis) and subsequent injury. Moreover, the triad puts athletes at risk for serious long-term health consequences, such as osteoporosis, reproductive disorders, and cardiovascular disease. Despite this, efforts aimed at prevention of EDs among this group remain surprisingly limited. A pilot study with female athletes suggests that a modified version of HW can be successfully implemented by peer-leaders within the constraints of a competitive athletics program with positive effects at 12- month follow-up. The proposed study is a randomized controlled trial of the HW intervention among female athletes. 500 female collegiate athletes from three sites will be randomized to either the HW prevention program or a brochure waitlist control condition utilizing group (cluster) randomization. Participants will complete surveys and telephone interviews at pretest, posttest, and at 6, 12, and 18- month follow-ups. We will examine; (1) the efficacy of HW in reducing empirically supported ED risk factors relative to a waitlist brochure control condition at 18 months, (2) whether HW impacts secondary outcomes, including knowledge and identification of the female athlete triad, treatment seeking for the triad, affect, and health care utilization, and (3) the underlying mechanisms (mediators) of the HW intervention effects.

The goal of the present study is to test the efficacy of an intervention, called Healthy Weight (HW), designed to improve body satisfaction, promote awareness of the Female Athlete Triad, reduce eating disorder (ED) risk factors, and reduce the risk of obesity among female collegiate athletes. Given the cost of treating EDs and the substantial morbidity and mortality associated with these disorders, the results of this investigation will have substantial public health significance for the prevention of EDs in a critical population.

Funding: NIH 1 RO1 MH094448-01

Principle Investigator: John Apolzan
Co-Investigators: Corby Martin and Daniel Hsia

Objective: The aim of the proposed study is to provide important data on weight loss efficacy in overweight and obese adolescents on an isocaloric higher protein diet vs a lower protein diet utilizing the U.S. Department of Agriculture (USDA) MyPlate nutrition guide.

Design: Adolescents received a nutritional and behavior weight loss intervention. Participants meet for an individual session then group sessions occur every other week for the remaining 12 weeks. They are (in no order so participants may drop into the rotation): 1) dairy 2) fruits 3) vegetables 4) grains 5) oils and beverages 6) physical activity. Participants received an individualized dietary meal plan. Dietary counseling is based on the USDA MyPlate guidelines with extra attention and focus on appropriate protein food choice and energy restriction. Specifically, the meal plan is designed to meet 75% of energy requirements and the protein, carbohydrate, and fat percentages for the participants assigned group(s). Thus, the lower protein group is instructed to consume 15% of energy as protein, with 25% and 60% of energy from fat and carbohydrate, respectively. The higher protein group is instructed to consume 30% of energy as protein, with 25% and 45% of energy from fat and carbohydrate, respectively. Assessments were performed at baseline and week 12.

Subjects: We recruited 32 boys and girls 12 – 17 years of age who were at or above the 85th percentile for body mass index.

Measurements: The main study endpoint was change in BMI z-score. Secondary endpoints included change in: body weight change (kg), % weight change, blood pressure, waist/hip circumference, self-report measures to quantify constructs associated with appetite and body weight (retrospective VAS, Eating Inventory, Food Craving Inventory), food intake (measured with the Remote Food Photography Method, RFPM), accelerometry, and fasting blood parameters (glucose, insulin, cholesterol, and triglycerides).

Results: Coming soon!

Funding: Pennington Biomedical Nutrition Obesity Research Center (NORC) Pilot and Feasibility Award (NIH P30 DK072476)

Clinical Trial Identifier: NCT02079831

Principle Investigator: Jenelle Shanley, Georgia State University
Principle Investigator of PBRC site: Corby Martin
Co-Investigators at PBRC: John Apolzan and Daniel Hsia

Objective: The aim of this study was to test the efficacy of the DRIVE curriculum at promoting weight management in children.

Design: Participants were randomly assigned to either the control group, in which participants received health information via mail only, or the DRIVE group.  DRIVE included 15 in-person sessions and a home-based program for families to promote a healthy environment around eating, physical activity, and parent-child interactions.

Subjects: The study enrolled 16 young children who exhibit elevated weights (at or above the 75th percentile) between the ages of 2-6 years old.

Measurements: The child’s and a parent’s height, weight, and waist circumference; parent report of attitudes towards health and nutrition; parent and child food consumption; and parent and child physical activity levels were assessed.

Results: Coming soon!

Funding: Board of Regents of the University System of Georgia

Clinical Trials Identifier: NCT02160847

Principal Investigator:  Amanda Staiano
Co-Investigators:  Corby Martin, Daniel Hsia

Objective:  To determine the influence of screen-based peer modeling on children’s vegetable consumption and preference.

Design:  Children were randomly assigned to individually view a DVD segment of peers consuming a modeled vegetable (bell pepper) vs. a non-food DVD segment vs. no DVD. Analysis of covariance models examined bell pepper preference and consumption during initial DVD exposure (Day 1) and without DVD exposure (Days 2 and 7), adjusted for age, sex, body mass index, and initial bell pepper consumption.

Participants:  Forty-two children aged 3 to 5 years were recruited from childcare centers.

Measurements:  Parent surveys assessed child demographic information, dietary habits and purchasing trends, and home availability of fruits and vegetables. Children’s food consumption was measured directly following the food selection task. Food preference was captured with a 3-point Likert Scale.

Results:  Children in the vegetable condition ate more bell peppers than the control condition at Day 7, without differences at Days 1 or 2. Among children who ate the modeled vegetable, those in the vegetable DVD condition reported higher preference towards eating the vegetable again. Screen-based peer modeling is a promising tool to influence children’s vegetable consumption

Staiano AE, Marker AM, Frelier JM, Hsia DS, Martin CK. Influence of screen-based peer modeling on preschool children’s vegetable consumption and preferences. Journal of Nutrition Education and Behavior. 2016; in press. NIHMS763194.

Funding:  Pennington Biomedical Research Center

Principal Investigator:  Henry Nuss, PhD
Co-Investigators:  Leanne Redman, PhD, Abby Duhé, MS, Melinda Sothern, PhD, Jovanny Zabaleta PhD, Daniel Hsia, MD

Objective:  This pilot study evaluated the relationship between inflammatory biomarkers and hormones in maternal serum blood and breast milk in normal weight versus overweight and obese mothers.

Design:  Pregnant women who were considered normal weight prior to pregnancy were enrolled in the study. The overweight and obese group was previously enrolled in the Expecting Success study at Pennington Biomedical (NCT01610752).  Infants born to the mothers were enrolled after they were born. Study outcomes were assessed on mothers in the 3rd trimester of pregnancy, and 4-8 weeks postpartum, and study outcomes were assessed on infants within 1 week of birth and at 4-8 weeks old.

Subjects:  The study enrolled 18 pregnant women who were considered normal weight prior to pregnancy in the 3rd trimester of pregnancy. The 18 infants born to these women were enrolled after birth. All participants (18 women and 18 infants) successfully completed the study.

Measurements:  Maternal outcome data included height, weight, circumferences, vital signs, adverse event reporting, current medication reporting, BODPOD, skinfold thickness, energy intake (RFPM), physical activity, questionnaires, blood collection, and breast milk collection.  Infant outcome data included length, weight, head circumference, abdominal circumference, PEAPOD, and skinfold thickness.

Results:  Coming soon!

Funding:  Pennington Biomedical Research Center Nutrition Obesity Research Center (NORC) Pilot and Feasibility Pilot Grant

Clinical Trials Identifier:  NCT02317653

Principal Investigator:  Amanda Staiano
Co-Investigators:  Peter Katzmarzyk, Robert Newton Jr., Daniel Hsia

Objective:  This pilot study tested the feasibility and efficacy of an exergaming intervention for weight loss among overweight and obese adolescent girls.

Design:  Overweight and obese adolescent girls were randomly assigned to an exergaming condition or a control condition.  Participants in the exergaming condition attended 60-minute gaming sessions, 3 times a week for 12 weeks.  During these sessions, exergaming participants played dance video games, including Just Dance and Dance Central, in a social environment.  Participants were allowed to self-select many aspects of the exergaming intervention, including game and song selections, intensity level, and playing partners.  Participants self-monitored their activity, and interventionists provided motivation and support at each visit.  Participants in the control condition were asked to maintain their current lifestyle for 12 weeks.

Participants:  The study enrolled 42 overweight and obese adolescent girls (ages 14-18 years; BMI ≥ 85th percentile on CDC growth chart).  Forty participants (95%) successfully completed the study. 

Measurements:  Outcome data, including body weight, BMI, waist circumference, blood pressure, body composition (DXA, MRI), clinical chemistry (total cholesterol, HDL, LDL, glucose, insulin, and triglycerides), exercise transfer effects, habitual physical activity, and lifestyle/psychosocial behaviors, were assessed at baseline and 12-week follow-up.  Body weight, attendance, and self-reported activity and enjoyment were collected at each session for the exergaming condition.

Results:  Using analysis of covariance controlling for baseline value, age, and race, there were no significant condition differences in body composition or cardiovascular risk factors. Per protocol (attended >75%), the intervention group significantly decreased abdominal subcutaneous adiposity and increased trunk and spine BMD (ps < 0.05). Per protocol (> 2600 steps/session), the intervention group significantly decreased leg %fat and decreased abdominal subcutaneous and total adiposity (ps < 0.05). Psychosocial and physical activity outcome data are being analyzed.
Staiano AE, Marker AM, Beyl RA, Hsia DS, Katzmarzyk PT, Newton RN. A randomized controlled trial of dance exergaming for exercise training in overweight and obese adolescent girls. Pediatric Obesity. 2016. [Advance Online Publication February 26, 2016].
Funding:  Pennington Biomedical Research Center / Pediatric Pilot Project

Clinical Trials Identifier:  NCT02003963

Principal Investigator: William Cefalu
Co-Investigators: Daniel Hsia

Each year in the U.S. an average of more than 15,000 young people under the age of 20 years are diagnosed with type 1 diabetes mellitus (T1DM).  These people are dependent upon multiple daily insulin injections or an infusion of insulin via an insulin pump to maintain blood sugars in the normal range.  Studies have shown that the closer blood sugars are to the normal range, the less likely a patient will develop complications from diabetes such as blindness, kidney failure, and neuropathy.  Many of the challenges involved in the care of diabetes patients revolve around trying to achieve tight blood sugar control while avoiding low blood sugars (hypoglycemia). 

LX4211 is a novel, orally delivered, small molecule dual inhibitor of sodium-glucose cotransporters SGLT1/SGLT2, designed to reduce glucose absorption in the gastrointestinal tract via SGLT1 inhibition and renal glucose reabsorption via SGLT2 inhibition.  Inhibiting SGLT2 in the kidney has many advantages: glucose is cleared from the circulation without the need for insulin; glucose clearance decreases as blood glucose levels decrease, which limits risk of severe hypoglycemia; urinary glucose excretion (UGE) may lower blood pressure; and UGE may lead to weight loss.  Inhibiting SGLT1 in the intestines may improve glucose control by: reducing intestinal glucose absorption and stimulating gastrointestinal peptides such as GLP-1 and PYY that assist in glycemic and appetite control.  There have a been a number of studies targeting the type 2 diabetes population, but this is the first study to use this drug in type 1 diabetes patients.  LX4211 has the potential to help patients with type 1 diabetes achieve tight glucose control while decreasing the amount of insulin needed and decreasing the risk of hypoglycemia.

Objectives: The primary objective of the study is to assess the effect of LX4211 on the total daily bolus amount of exogenous insulin required to maintain or improve glycemic control. 
Secondary objectives include: to assess the effect of LX4211 on the total daily amount of insulin required to maintain or improve glycemic control; to assess blood glucose via 24-hour continuous glucose monitoring (CGM) during and after treatment with LX4211; to assess the effect of LX4211 on fasting plasma glucose (FPG); and to assess the pharmacokinetics and pharmacodynamics of LX4211 when administered for 29 days in patients with T1DM.

Funding: Lexicon Pharmaceuticals

Principal Investigator: Daniel Hsia
Co-Investigators: Frank Greenway, William Cefalu

Lixisenatide is a novel selective Glucagon-like peptide-1 (GLP-1) receptor agonist with a receptor binding affinity to the GLP-1 receptor approximately 4-times greater than human GLP-1 produced by our own bodies.  GLP-1 has several benefits: suppression of glucagon secretion from pancreatic α-cells, which decreases hepatic glucose production leading to improved hepatic insulin resistance and glycemic control; slowing of gastric emptying and gut motility, causing delayed nutrient absorption and decreased post-prandial glucose excursion; and increased postprandial satiety leading to a lower food intake, weight loss, and improved insulin resistance.  This class of medications is currently being used to treat type 2 diabetes and there have been several studies demonstrating the safety and efficacy of lixisenatide in adult patients.

Coinciding with the increasing prevalence of obesity in children, the incidence of type 2 diabetes in children and adolescents has increased dramatically to the point that it accounts for as many as one third of all the new cases of diabetes diagnosed in adolescents.  Moreover, progression of type 2 diabetes in this younger population seems to be more rapid and there are few treatments approved in the pediatric age range.  Thus, it is important to find new therapies and study existing therapies in children and adolescents in order to improve the care of these patients.  Up till now there have not been any studies in children with type 2 diabetes using lixisenatide.

Objectives: The primary objective of this study is to investigate the effects of a single subcutaneous lixisenatide dose of 5 μg and 10 μg as compared to placebo in reducing postprandial glucose (PPG) assessed as area under the plasma glucose concentration curve (AUC) after a standardized liquid meal (breakfast) in type 2 diabetic pediatric population (10-17 years old).

Secondary objectives include evaluating:  the pharmacokinetic parameters of lixisenatide in plasma after single subcutaneous ascending doses; the maximum PPG excursion, changes in insulin, C-peptide, and glucagon following a standardized breakfast; and safety and tolerability.

Funding: Sanofi

Principal Investigators: Catrine Tudor-Locke, PhD, William Johnson, PhD
Co-Investigators: Daniel Hsia, MD

Objective: The primary aim of this study was to identify and evaluate objectively monitored cadence (steps/min) cut points associated with markers of increasing intensity across age in children and adolescents.

Design: CADENCE-Kids was across-sectional study that identified and recruited approximately 10 children (5 boys, 5 girls) from each age-year between 6- 20 years to a lab-based study of cadence.

Subjects: The study enrolled 122 children and adolescents 6 to 20 years of age.

Measurements: This study involved treadmill tests in the laboratory which simultaneously measured cadence (steps/minute), heart rate and oxygen uptake at several pre-defined workloads. In addition, cadence, heart rate and oxygen uptake were also measured during free-living conditions using portable analysis equipment.     

Results: Coming soon!

Funding: NIH 1R21HD073807-01A1

Clinical Trials Identifier: NCT01989104

Principal Investigator: Robert L. Newton, Jr.
Co-Investigators: Timothy Church, Stephanie Broyles, Catrine Tudor-Locke

Mobile-phone based interventions have the potential to be delivered long-term, and at lower cost, and therefore will likely assist in behavior maintenance.  We propose to deliver a family-based physical activity promotion program to parents through mobile phones.  The mobile application will provide a website with theoretically based behavioral change strategies, tools to monitor physical activity, and will also make use of the short message service capabilities to provide automated motivational messages and behavioral prompts.  To date, the use of a mobile phone intervention has not been applied to family-based physical activity promotion programs for children.  Therefore, our pilot study represents a novel application of mobile phone technology. 

We randomize 30 families into either a control group or a mobile-phone based physical activity pilot study.  Families randomized into the control group will be asked to monitor their child’s physical activity but will not receive an intervention to increase physical activity.  Families randomized into the mobile-phone based physical activity intervention will receive an intervention delivered to the parents via mobile phone, with the goal of increasing their child’s physical activity to 6000 steps above baseline.  We will recruit families who have a designated child between the ages of 6 and 10 year old, who is either overweight or obese, and is sedentary.  The intervention will be conducted over the course of 3 months.

The primary outcome variable is objectively measured physical activity.  We will assess changes in physical activity utilizing pedometers.  Our secondary outcomes will be changes in waist circumference, body mass index, percent body fat, and blood pressure.  In addition, physical activity enjoyment, neighborhood environment, sedentary behavior, psychological well-being and parental physical activity will be assessed.  All assessments will be measured at baseline and 12 weeks. 

Aims:

1. To determine if a mobile phone based intervention will be utilized by parents of 6-10 year old children.
2. To determine if a mobile phone based intervention will result in increases in steps/day in children as measured by pedometers.

Funding: Private Foundation

Principal Investigator: Corby Martin
Co-Investigators:Catherine Champagne, William D. Johnson
Subcontract Pricinpal Investigator: Bahadir Gunturk, Monique M. LeBlanc

Objective: During this project, the Remote Food Photography Method (RFPM) was modified for adolescents. The RFPM and pen-and-paper food records will then be used by a sample of 50 adolescents. The accuracy of each method will be examined by comparing food intake to three gold standards: 1) Doubly Labeled Water (DLW; energy intake only), 2) a laboratory-based test meal, and 3) food intake during lunch in a school cafeteria.

Design: The RFPM was modified by developing a Smartphone application (“app”) called SmartIntake.  SmartIntake streamlines the data collection process for the RFPM and reduces participant and staff burden (cost-effectiveness of SmartIntake will be empirically determined in this study).  A pilot sample of 4 adolescents is currently being recruited, and these adolescents will complete the study procedures sequentially. This pilot group is critical to determining if we adequately customized the methodology and technology to address the challenges of collecting food intake data from adolescents.

Following completion of this pilot phase and subsequent modifications to our methods, we will recruit a sample of 50 adolescents to complete the protocol. Briefly, during screening participants will record daily weights at home to establish weight stability (< 1.1 pound change based on regressed daily body weights) over one week (if one week of weight stability is not achieved in 2 weeks, the participant will be excluded). Participants who enroll will then be dosed with DLW and will use the RFPM to measure food intake for one week and food records for another week (the order will be balanced across participants and methods will be changed at Day 7 of the DLW dosing period). Participants’ food intake will also be measured at lunch in their school cafeteria using the validated Digital Photography of Foods Method for one day during each assessment period (Days 6 and 13). They also will complete laboratory-based food intake tests after the DLW period on Days 16 ± 1 (they will use the RFPM and food records during the food test). Hence, food intake estimated with the RFPM and food records will be compared to: 1) DLW measured EI, 2) food intake measured in the laboratory, and 3) food intake measured in the school cafeteria.

Subjects: Fifty-four adolescents will be recruited. Inclusion criteria include: 1) boy or girl of any race, 2) age 12 to 18 years, inclusive, 3) willing to use the RFPM for one week and pen-and-paper food records for one week, 4) willing to complete two laboratory-based food tests during week 3, and 5) willing to use the RFPM during one laboratory-based test and food records during the other. Exclusion criteria include: 1) chronic diseases that affect body weight, appetite, or metabolism (e.g., diabetes), 2) use of prescriptions or over-the-counter medications or herbal products that affect appetite, body weight, or metabolism (e.g., certain antipsychotic medications, ephedrine), and 3) weight unstable (>1.1 pounds weight change in one week based on regressed daily body weights). We expect 50% of the sample to be female, and 15% to be minority, primarily African American.

Measurements: Daily energy intake will be measured using DLW, the RFPM, and pen-and-paper food records.  The RFPM and pen-and-paper records will also be used to estimate food intake during a laboratory-based food intake test.  Daily body weights will be recorded during the DLW dosing period.  Finally, participants will complete a user-satisfaction survey at the end of their participation in the study.

Funding: NIH R01 DK089051
Clinical Trials Identifier: NCT01719445

Principal Investigator: Nikhil V. Dhurandhar
Co-Investigators: Frank Greenway, William Johnson

The objective of this pilot study was to determine in preschool children and teenagers, if an egg breakfast will induce greater satiety and reduce lunch-time food intake, compared to a bagel breakfast of matched energy density (ED). 

Experiment 1: To determine if an egg breakfast will reduce lunch time food intake in preschool children, compared to a bagel breakfast matched for ED. The study was conducted in school.

Preschool children (age range 4 – 6y) from one class participated in the study.  Consent of the preschool for this participation was obtained. The children are routinely served breakfasts and lunch prepared at the school cafeteria and are closely monitored by teachers at all times.  Either an egg breakfast (EB) or a bagel breakfast (BB) was provided, which are of equal ED. The breakfasts were assembled as usual in the school kitchen (under the supervision of PBRC staff). Children were offered EB or BB as determined by a random order.  Care was taken to sit all children with similar breakfast at each table, to avoid comparison of their individual breakfasts.  Children were required to consume the entire breakfast meal and were asked to rate how they liked the taste of the meal. A standardized lunch (pasta) was offered ad libitum and their food intake (at breakfast and lunch) was covertly monitored. A week later, the study was repeated by reversing the order of the breakfast.  We expected the children to eat less at lunch after the EB than after the BB.

Experiment 2:  To determine if an egg breakfast (vs an ED matched bagel breakfast) will increase satiety, reduce hunger, reduce lunch time food intake, and modulate PYY, GLP1 and acylated ghrelin levels in teenage boys and girls.  This study was conducted at the PBRC clinic.

Children from 14-17 years of age participated in this study.  For screening visit, their eligibility was determined and consent was obtained. Next, on the test day, upon arrival at PBRC clinic after an overnight fast, a blood sample was drawn and either EB or BB was offered (determined by random order, which was reversed when they repeated the study a week later) at 8 AM. Children were required to consume the entire breakfast meal.  Blood was drawn again 30 min and 180 min after stopping breakfasts.  After 180 min, they were offered a standardized lunch and the food intake was covertly determined. Between breakfast and lunch, children remained in the clinic and were allowed to watch TV (free of food commercials).  They were asked to rate their feelings of hunger and fullness periodically using visual analog scales. The EB is expected to increase satiety scores, decrease hunger and the lunch time food intake, compared to the BB.  We expect that PYY and GLP1 levels will rise higher and remain elevated after the EB, and the acylated ghrelin levels will rise higher between the BB and lunch time.

Funding: The American Egg Board

The primary aim of the International Study of Childhood Obesity, Lifestyle and the Environment (ISCOLE) is to determine the relationship between lifestyle characteristics and obesity in children, and to investigate the influence of behavioural settings and physical, social and policy environments on the observed relationships within and between countries. The targeted sample includes 6000 10-year old children from twelve countries in all major geographic regions of the world (Asia, Africa, Europe, South America, North America, and Oceania). The protocol includes procedures to collect data at the individual level (lifestyle, diet and physical activity questionnaires, accelerometry), family and neighborhood level (parental questionnaires and Geographic Information System (GIS) analyses), and the school environment (school administrator questionnaire and school audit tool). A standard study protocol has been developed for implementation in all regions of the world. Quality control is addressed through the training and certification of personnel, active monitoring of remote data entry, and site visits. A rigorous system of training and certification of study personnel has been developed and implemented, including web-based training modules and regional in-person training meetings. Unique features of the ISCOLE study include the global representation of study sites with a range of low to high income countries at different stages of nutritional and epidemiological transition, robust, standardized training and data collection methods, and the multi-level nature of data being collected, including individual, family, neighborhood, and school levels. The results of this study will provide a robust examination of the correlates of body weight and obesity in children, focusing on both sides of the energy balance equation. The results will also provide important new information that will inform the development of lifestyle, environmental, and policy interventions to address childhood obesity that can be culturally adapted for implementation around the world. ISCOLE represents an international collaboration among all world regions, and represents a global effort to increase research capacity and infrastructure in childhood obesity.

Funding: The Coca-Cola Company
Clinical Trials Identifier: NCT01722500

Principal Investigator: Peter T. Katzmarzyk
Co-Investigators: Stephanie Broyles, Melinda Sothern, Alok Gupta

The goal of this project is to identify and determine the clinical utility of the most accurate anthropometric measurements for the assessment of total and intra-abdominal visceral adipose tissue in children and adolescents. The increasing prevalence of childhood obesity is placing an increasing economic toll on health care. Abdominal fat, in particular intra-abdominal visceral adipose tissue, is considered to be the most dyslipidemic and atherogenic fat depot in the human body. Waist circumference shows some promise as a reliable marker of both intra-abdominal visceral adipose tissue and total body fat among adults; however, this relationship has not been studied as extensively among children. Further, the effect of biological maturation and its interaction with race on the relationship between waist circumference and intra-abdominal visceral adipose tissue and total body fat has not been determined. Finally, there is currently no consensus as to the best protocol or anatomic site of measurement of waist circumference in children and adolescents, thus early identification of those most at risk is not possible without advanced, costly imaging techniques. 

We recruited and assessed 92 African American boys, 104 Caucasian boys, 125 African American girls, and 90 Caucasian girls 5 to 18 years of age to a cross-sectional study of the relationship between waist circumference and intra-abdominal visceral adipose tissue and total body fat. Waist circumference was measured at the four common anatomic sites used in pediatric research: 1) superior border of the iliac crest, 2) midpoint between the iliac crest and the lowest rib, 3) umbilicus, and 4) minimal waist. Additional anthropometric measurements were obtained in order to determine the clinical utility of combining waist circumference with other measurements. Total and regional (limbs, trunk) body fat mass were assessed using dual energy x-ray absorptiometry (DXA), and abdominal total, subcutaneous and visceral adipose tissue were assessed using magnetic resonance imaging (MRI). Biological maturity status was assessed using multiple techniques in order to determine the influence of individual differences in maturation on the observed relationships. Inter- and intra-rater reliability of each anthropometric measurement was estimated with replicate measurements on a 10% sub-sample of participants within one week.

The specific aims of this project are as follows:

• Specific Aim 1: Identify reliable landmarks and methodology for the measurement of pediatric waist circumference that are associated with intra-abdominal visceral adipose tissue and total body fat across the pediatric age, total body adiposity, and maturity range among African American and Caucasian children and adolescents.
• Specific Aim 2: Determine if waist circumference in combination with other anthropometric indices is a better predictor of intra-abdominal visceral adipose tissue and total body fat than waist circumference alone across the pediatric age, total body adiposity, and maturation range.
• Specific Aim 3: Develop and determine the clinical utility of pediatric race-sex-specific waist circumference thresholds for the identification of elevated chronic disease risk factors across the pediatric age, total body adiposity, and maturation range.

Funding: NIH 1RC1DK086881-01 (Katzmarzyk); AHA 11GRNT7750027 (Broyles)

Principle Investigator: Frank Greenway
Co-Investigators: Aixin Hou, Nikhil Dhurandhar, Kayanush Aryana, Richard Tulley, Roy Martin

This pilot study was designed to develop the necessary pilot data demonstrating the expertise and cooperation of the Resistant Starch group in studying the effect of resistant starch in growing children. 

Hypothesis: Resistant starch feeding in a yogurt vehicle will change the bacterial microflora in the gut of children causing a drop in stool pH and an increase in stool butyrate.

Specific Aims:

1. Develop a tasty yogurt vehicle carrying resistant starch.
   
   
2. Collect 3 daily stool specimens from 4 growing children at baseline and after 4 weeks of RS feeding for characterizing the stool microflora and measuring stool butyrate and stool pH.

Methods: This study consisted of 5 visits and enrolled 4 healthy children.  On the first visit, consent was obtained from the parent and assent was obtained from the child. The parent was given stool collection “pilgrim hats” that fit inside the toilet to collect stool, zip lock plastic bags into which each stool specimen can be placed and a container in which to carry the zip lock bags.  The parents were given pilgrim hats to collect 3 daily stool specimens at baseline when the child is on their usual diet.  The parent returned each baseline stool sample the day it was collected.  They transferred the stool from the pilgrim hat into a zip lock plastic bag and put the plastic bag on ice in a cooler for transfer to the lab.   After the 3 baseline stool samples were returned, the parents received the first week of yogurt containing resistant starch for the child to consume with breakfast and dinner.  The dose for an adult is 8 ounces of yogurt twice a day.  The dose was scaled to the children based upon surface area dosing charts, but did not exceed a resistant starch load of 1 gram per year of age plus 10 grams.  The parent returned at the end of the first, second and third weeks to pick up more yogurts and return the empty containers.  During the last 3 days of 4 weeks while still consuming the yogurt supplements, 3 daily stool samples were collected in the same manner as the baseline stool collections.  The parent and child were seen for the final visit at the end of week 4 when the empty yogurt containers were returned from the prior week.

Funding: Pennington Biomedical Research Center

Principal Investigator: Don Williamston
Co-Investigators: Donna Ryan, Catherine Champagne, David Harsha, Tiffany Stewart, Corby Martin, H. Raymond Allen, Robert Newton, Jr., Lisa Colvin, Monique LeBlanc

Objective: This randomized controlled trial tested the efficacy of an internet-based lifestyle behavior modification program for weight management in African-American girls.

Design: African-American girls were randomly assigned to an interactive behavioral internet program or an internet health education program, the control condition. The behavioral intervention included internet counseling and was highly interactive. The control intervention was a passive (non-interactive) educational program. Parents were also participants in the study. Participants in both treatment groups met in face-to-face sessions on four occasions over the first 12 weeks of a 6-month intervention.

Subjects: The study enrolled 57 African-American adolescent girls (ages 11 to 15 years) who were overweight or obese and had at least one biological parent who was obese [body mass index (BMI) >30 kg/m2]. Of the 57 participants, 50 (88%) completed the 6-month trial.

Measurements: Outcome data, including BMI, body weight, body composition, dietary intake, and weight loss behaviors were collected at baseline and 6-months later. A computer server tracked utilization of the websites. Participation in the program was measured by number of "hits" on the website.

Results: Compared to the control condition, adolescents in the behavioral treatment lost more body fat (group difference =1.6% body fat) and parents lost significantly more body weight (group difference =2.1 kg). Utilization of the behavioral website by adolescents and parents was associated with positive outcome. Dietary fat intake was lowered for adolescents and parents in the behavioral treatment group.

Conclusion: An internet-based behavioral intervention was superior to internet-based health education and yielded decreased body fat for adolescent girls and decreased body weight for parents.

Funding: NIH 5 R01 HD39104-03

Principal Investigator: Don Williamston
Co-Investigators: Donna Ryan, David Harsha, Pamela Martin, Geraldine Holmes, Stewart Gordon, George Bray, Jennifer Lovejoy, Corby Martin, Robert Newton, Jr., Tiffany Stewart

Objective: This randomized controlled trial tested the efficacy of an internet-based lifestyle behavior modification program for weight management in African-American girls.

Design: African-American girls were randomly assigned to an interactive behavioral internet program or an internet health education program, the control condition. The behavioral intervention included internet counseling and was highly interactive. The control intervention was a passive (non-interactive) educational program. Parents were also participants in the study. Participants in both treatment groups met in face-to-face sessions on four occasions over the first 12 weeks of a 6-month intervention.

Subjects: The study enrolled 57 African-American adolescent girls (ages 11 to 15 years) who were overweight or obese and had at least one biological parent who was obese [body mass index (BMI) >30 kg/m2]. Of the 57 participants, 50 (88%) completed the 6-month trial.

Measurements: Outcome data, including BMI, body weight, body composition, dietary intake, and weight loss behaviors were collected at baseline and 6-months later. A computer server tracked utilization of the websites. Participation in the program was measured by number of "hits" on the website.

Results: Compared to the control condition, adolescents in the behavioral treatment lost more body fat (group difference =1.6% body fat) and parents lost significantly more body weight (group difference =2.1 kg). Utilization of the behavioral website by adolescents and parents was associated with positive outcome. Dietary fat intake was lowered for adolescents and parents in the behavioral treatment group.

Conclusion: An internet-based behavioral intervention was superior to internet-based health education and yielded decreased body fat for adolescent girls and decreased body weight for parents.

Funding: NIH 5 R01 HD39104-03

Principle Investigator: Don Williamson
Co-Investigators: Donna Ryan, Pam Martin, Betty Kennedy, Amy Copeland, Catherine Champage, Melinda Sothern, Ray Allen

Objective: The Wise Mind pilot study compared the efficacy of an environmental approach for prevention of inappropriate weight gain in children with an active control condition that used an environmental approach for modifying expectancies related to the use of alcohol, tobacco, and drugs.

Research Methods and Procedures: A total of 670 second to sixth grade students from four schools were enrolled in the study. The study spanned 2 academic years, and 586 students were available for evaluation at the end of the study. Two schools were randomly assigned to each treatment arm. The environmental approach for weight gain prevention focused on modification of eating habits and physical activity, and the active control group focused on modification of expectancies related to substance use.

Results: Using an intention to treat design, the study found no differences in weight gain prevention between the two interventions. The weight gain prevention program was associated with reduction of total caloric intake, reduction of dietary fat intake, reduction of protein intake, and increased physical activity in comparison with the active control group and relative to baseline. These changes in food intake were attributed to changes in food selections that resulted from modification of school cafeteria menus and food preparation.

Discussion: The Wise Mind school-based weight gain prevention program induced behavioral changes in healthy eating and physical activity but did not induce significant changes in body weight in comparison with the control arm.

Funding: R01 DK063453-01

Principle Investigator: George A. Bray
Co-Investigators: James DeLany, Catherine Champagne, David Harsha

The subjects for this study were children recruited from the Baton Rouge, LA, public school system. With the approval of the Superintendent of Schools, the East Baton Rouge School Board, the Louisiana State University Institutional Review Board, and the principals of the 8 schools included, a letter describing the screening study was sent to all children in the 5th grade. An equal number of African Americans and whites and an equal number of boys and girls were selected from the screening cohort by sampling from each end of the sum of the triceps plus subscapular skinfold-thickness distribution, which provided a bi-modally distributed sample. The final selected sample consisted of 33 white boys, 32 white girls, 32 African American boys, and 32 African American girls who volunteered for the study and whose parents signed a second consent form, which was also approved by the Institutional Review Board.

Body fat was measured with use of dual-energy X-ray absorptiometry (DXA), underwater weighing (densitometry), isotope dilution (H2 18O), bioelectrical impedance, skinfold thicknesses, corporal diameters, and circumferences.  Energy expenditure was measured at age 10 and again at age 12 using doubly-labeled water.  Resting Energy Expenditure and the thermic response to food were also measured at these times using a van equipped with metabolic carts.

Funding: NIH RO1 HD-28020