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6 Study Matches

A Multicenter Access and Distribution Protocol for Unlicensed Cryopreserved Cord Blood Units (CBUs)

Lisa Erickson, MPH - 10-CBA@ndmp.org

McCarty, John, M.
NCT01351545
HM13913
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Inclusion Criteria:
* Disorders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment * Signed informed consent (and signed assent, if applicable) obtained prior to study enrollment * Pediatric and adult patients of any age
Exclusion Criteria:
* Patients who are receiving only licensed CBUs * Cord blood transplant recipients at international transplant centers * Patients who are enrolled on another IND protocol to access the unlicensed CBU(s) * Patients whose selected unlicensed CBU(s) will be more than minimally manipulated
DRUG: A multicenter access and distribution protocol for unlicensed cryopreserved cord blood units (CBUs)
Hematologic Malignancies, Inherited Disorders of Metabolism, Inherited Abnormalities of Platelets, Histiocytic Disorders, Acute Myelogenous Leukemia (AML or ANLL), Acute Lymphoblastic Leukemia (ALL), Other Acute Leukemia, Chronic Myelogenous Leukemia (CML), Myelodysplastic (MDS) / Myeloproliferative (MPN) Diseases, Other Leukemia, Hodgkin Lymphoma, Non-Hodgkin Lymphoma, Multiple Myeloma/ Plasma Cell Disorder (PCD), Inherited Abnormalities of Erythrocyte Differentiation or Function, Disorders of the Immune System, Autoimmune Diseases, Severe Aplastic Anemia
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Study Locations

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Location Contacts
AdventHealth Orlando Orlando, Florida Rushang Patel, MD - (rushang.patel.md@adventhealth.com)
Advocate Lutheran General Hospital Park Ridge, Illinois
All Children's Hospital St. Petersburg, Florida Deepakbabu Chellapandian, MD - (dchella2@jhmi.edu)
Amarillo Blood and Marrow Transplant Program Amarillo, Texas
Ann & Robert H. Lurie Children's Hospital of Chicago Chicago, Illinois Sonali Chaudhury, MD - (schaudhury@luriechildrens.org)
Arkansas Children's Hospital Little Rock, Arkansas Jason Farrar, MD - (JEFarrar@uams.edu)
Avera Transplant Institute Sioux Falls, South Dakota Waqas Jehangir, MD, FACP - (waqas.jehangir@avera.org)
Banner MD Anderson Cancer Center Gilbert, Arizona September Mitchell, RN - (september.mitchell@bannerhealth.com) Rajneesh Nath, MD - (rajneesh.nath@bannerhealth.com)
Beth Israel Deaconess Boston, Connecticut
Cardinal Glennon Children's Medical Center St Louis, Missouri Deepika Bhatla, MD - (dbhatla@slu.edu)
Children's Healthcare of Atlanta Atlanta, Georgia Ann Haight, MD - (Ann.haight@choa.org)
Children's Hospital Colorado Aurora, Colorado Michael Verneris, MD - (MICHAEL.VERNERIS@CUANSCHUTZ.EDU)
Children's Hospital and Research Center of Oakland Oakland, California Mark Walters, MD - (mwalters@mail.cho.org)
Children's Hospital at Montefiore The Bronx, New York Mahvish Rahim, MD - (mrahim@montefiore.org)
Children's Hospital of Los Angeles Los Angeles, California Neena Kapoor, MD - (nkapoor@chla.usc.edu)
Children's Hospital of Michigan Detroit, Michigan Sureyya Savasan, MD - (ssavasan@med.wayne.edu)
Children's Hospital of New Orleans/LSUHSC New Orleans, Louisiana Lolie Yu, MD - (lyu@lsuhsc.edu)
Children's Hospital of Orange County (CHOC) Orange, California Rishikesh Chavan, MD - (rishikesh.chavan@choc.org)
Children's Hospital of Philadelphia Philadelphia, Pennsylvania Nancy Bunin, MD - (buninn@email.chop.edu)
Children's Hospital of Pittsburgh Pittsburgh, Pennsylvania Paul Szabolcs, MD - (Paul.szabolcs@chp.edu)
Children's Hospital of Wisconsin Milwaukee, Wisconsin David Margolis, MD - (dmargoli@mcw.edu)
Children's Medical Center Dallas Dallas, Texas Victor Aquino, MD - (Victor.aquino@utsouthwestern.edu)
Children's Mercy Hospital and Clinics Kansas City, Missouri
Children's National Medical Center Washington D.C., District of Columbia David Jacobsohn, MD - (dajacobs@childrensnational.org)
Childrens Hospital Medical Center of Akron Akron, Ohio Megan Sampson, MD - (msampson@akronchildrens.org)
Cincinnati Children's Hospital Cincinnati, Ohio Stella Davies, MD - (stella.davies@cchmc.org)
City of Hope Duarte, California Monzr Al Malki, MD - (malmalki@coh.org)
Cleveland Clinic Cleveland, Ohio Craig Sauter, MD - (sauterc@ccf.org)
Cohen Children's Medical Center of New York New Hyde Park, New York Jonathan Fish, MD - (jfish1@nshs.edu)
Columbia University Medical Center - Morgan Stanley Children's Hospital New York, New York Monica Bhatia, MD - (mb2476@columbia.edu)
Cook Children's Hospital Fort Worth, Texas Gretchen Eames, MD - (gretchen.eames@cookchildrens.org)
Dana Farber Cancer Institute Boston, Massachusetts Corey Cutler, MD - (cscutler@partners.org)
Duke University Medical Center Durham, North Carolina Joanne Kurtzberg, MD - (kurtz001@mc.duke.edu)
Emory University Hospital Atlanta, Georgia
Florida Center for Pediatric Cellular Therapy Orlando, Florida Susan Kelly, MD - (susan.kelly.md@flhosp.org)
Fred Hutchinson Cancer Research Center Seattle, Washington Ann Dahlberg, MD - (adahlber@fredhutch.org)
Greenebaum Cancer Center - University of Maryland Baltimore, Maryland
H Lee Moffitt Cancer Center Tampa, Florida
Hackensack University Medical Center Hackensack, New Jersey Alfred Gillio, MD - (agillio@humed.com)
Helen DeVos Children's Hospital Grand Rapids, Michigan Troy Quigg, MD - (troy.quigg@spectrumhealth.org)
Henry Ford Health System Jackson, Michigan Nalini Janakiraman, MD - (njanaki1@hfhs.org)
Indiana Blood & Marrow Transplantation Beech Grove, Indiana Luke Akard, MD - (lakard@ibmtindy.com)
Indiana University/Riley Hospital for Children Indianapolis, Indiana Jodi Skiles, MD - (jskiles@iu.edu)
Johns Hopkins Baltimore, Maryland Allen Chen, MD, PhD - (allenchen@jhmi.edu)
Kapiolani Medical Center for Women and Children Honolulu, Hawaii Randal Wada, MD - (randalw@hawaii.edu)
Karmanos Cancer Institute Detroit, Michigan
Levine Children's Hospital Charlotte, North Carolina Jeffrey Huo, MD - (Jeffrey.Huo@carolinashealthcare.org) Michelle Hyland - (Michelle.Hyland@carolinashealthcare.org)
Loma Linda University Cancer Center Loma Linda, California Hisham Abdel-Azim, MD - (habdelazim@llu.edu)
Loyola University Medical Center Maywood, Illinois Patrick Stiff, MD - (pstiff@lumc.edu)
M.D. Anderson Cancer Center Houston, Texas Elizabeth Shpall, MD - (eshpall@mdanderson.org)
Massachusetts General Hospital Boston, Massachusetts
Mayo Clinic - Jacksonville Jacksonville, Florida Vivek Roy, MD - (roy.vivek@mayo.edu)
Mayo Clinic Arizona (adults) Phoenix, Arizona James Slack, MD - (slack.james@mayo.edu)
Mayo Clinic Rochester Rochester, Minnesota
Medical City Dallas Dallas, Texas Vikas Bhushan, MD - (vikas.bhushan@usoncology.com)
Medical College of Georgia Augusta, Georgia Claude Sportes, MD - (csportes@gru.edu)
Medical College of Wisconsin Milwaukee, Wisconsin Hamadani Mehdi, MD - (mhamadani@mcw.edu)
Medical University of South Carolina Charleston, South Carolina Michelle Hudspeth, MD - (hudspeth@musc.edu)
Memorial Sloan-Kettering Cancer Center New York, New York Ioannis Politikos, MBBS - (politiki@mskcc.org)
Methodist Healthcare Blood and Marrow Transplant Center Memphis, Tennessee Fnu Kaweeta, MD - (fnu.kaweeta@mlh.org) Joshua Boss, RN - (fnu.kaweeta@westclinic.com)
Methodist Healthcare System of San Antonio/Texas Transplant Institute San Antonio, Texas Jose Cruz, MD - (josecarlos.cruz@hcahealthcare.com)
Midwestern Regional Medical Center Zion, Illinois
Mount Sinai Medical Center Miami Beach, Florida Alla Keyzner, MD - (alla.keyzner@mssm.edu)
NIH/NCI Bethesda, Maryland
Nationwide Children's Hospital Columbus, Ohio Rolla Abu-Arja, MD - (rolla.abu-arja@nationwidechildrens.org)
Nemours - Alfred I. duPont Hospital for Children Brandywine, Delaware Emi Caywood, MD - (ecaywood@nemours.org)
Nemours Children's Hospital - Mayo Jacksonville Jacksonville, Florida Michael Joyce, MD - (mjoyce@nemours.org)
New York Presbyterian Hospital at Cornell New York, New York Tsiporah Shore, MD - (tbs2001@med.cornell.edu)
New York University Langone Medical Center New York, New York A. Samer Al-Homsi, MD - (Samer.Al-Homsi@nyumc.org) Kelli Cole - (Kelli.cole@nyumc.org)
Nih/Nhlbi Bethesda, Maryland Richard Childs, MD - (childsr@nih.gov)
Nih/Niaid Bethesda, Maryland Elizabeth Kang, MD - (ekang@niaid.nih.gov)
Niklaus Children's Hospital Miami, Florida Jorge Galvez-Silva, MD - (jorgericardo.galvezsilva@nicklaushealth.org)
North Shore University Hospital Manhasset, New York Ruthee L Bayer, MD - (rbayer@nshs.edu)
Northside Hospital Atlanta, Georgia Scott Solomon, MD - (ssolomon@bmtga.com)
Northwestern Memorial Hospital Chicago, Illinois Kehinde Adekola, MD - (kehinde-adekola@northwestern.edu)
Oregon Health & Science University/Doernbecher Children's Hospital Portland, Oregon Eneida Nemecek, MD - (nemeceke@ohsu.edu)
Orlando Health Bone Marrow Transplant and Cellular Therapy Orlando, Florida Yasser Khaled, MD - (yasser.khaled@orlandohealth.com)
Penn State Milton S. Hershey Cancer Center Hershey, Pennsylvania Shin Mineishi, MD - (smineishi@pennstatehealth.psu.edu)
Phoenix Children's Hospital Phoenix, Arizona
Presbyterian St. Luke's/Colorado Blood Cancer Institute Denver, Colorado Alireza Eghtedar, MD - (alireza.eghtedar@healthonecares.com)
Rady Children's Hospital San Diego San Diego, California Eric Anderson, MD - (eanderson@rchsd.org)
Robert Wood Johnson/Cancer Institute of New Jersey New Brunswick, New Jersey Matthew Matasar, MD, MS - (mm3511@cinj.rutgers.edu)
Roger Williams Medical Center Providence, Rhode Island Todd Roberts, MD - (todd.roberts@chartercare.org)
Roswell Park Cancer Institute Buffalo, New York Philip McCarthy, MD - (philip.mccarthy@roswellpark.org)
Rush University Medical Center Chicago, Illinois
Sarah Cannon BMT Program Nashville, Tennessee
Scripps Green Hospital La Jolla, California Jeffrey W Andrey, MD - (andrey.jeffrey@scrippshealth.org)
Southwest Cancer Treatment & Research Center Lubbock, Texas
Spectrum Health Grand Rapids, Michigan Aly Abdel-Mageed, MD - (aly.mageed@helendevoschildrens.org)
St. Jude Childrens Research Hospital Memphis, Tennessee Renee Madden, MD - (renee.madden@stjude.org)
St. Louis University Medical Center St. Louis, Missouri Sagun Goyal, MD - (sgoyal3@slu.edu)
Stanford University Medical Center Palo Alto, California Andrew Rezvani, MD - (arezvani@stanford.edu)
Stony Brook University Hospital Stony Brook, New York Michael Schuster, MD - (mschuster@notes.cc.sunysb.edu)
Strong Memorial Hospital/University of Rochester Rochester, New York Omar Aljitawi, MD - (omar_aljitawi@urmc.rochester.edu)
Sutter Medical Center Sacramento, California Michael Carroll, MD - (carrolmp@sutterhealth.org)
Texas Children's Hospital - Baylor Medical Center Houston, Texas Robert Krance, MD - (rakrance@txch.org)
The Arthur G. James Cancer Hospital/The Ohio State University Medical Center Columbus, Ohio Sumithira Vasu, MD - (sumithira.vasu@osumc.edu)
The Children's Hospital of San Antonio San Antonio, Texas Martin Andreansky, MD, PhD - (martin.andreansky@bcm.edu) Mark Schambura - (Mark.schambura@christushealth.org)
The Jewish Hospital Cincinnati, Ohio
Tufts Medical Center Boston, Massachusetts Andreas Klein, MD - (aklein2@tuftsmedicalcenter.org)
Tulane Medical Center New Orleans, Louisiana Hana Safa, MD - (hsafah@tulane.edu)
UCLA Santa Monica, California Gary Schiller, MD - (gschiller@mednet.ucla.edu)
UCSF (adults) San Francisco, California
UCSF (peds) San Francisco, California
Univeristy of Mississippi Medical Center Jackson, Mississippi Carolyn Bigelow, MD - (cbigelow@umc.edu)
University Hospitals Case Medical Center Cleveland, Ohio Hillard Lazarus, MD - (hillard.lazarus@case.edu)
University of Alabama at Birmingham Birmingham, Alabama Joseph Chewning, MD - (jchewning@peds.uab.edu)
University of Arizona Medical Center - Tucson Tucson, Arizona Emmanuel Katsanis, MD - (katsanis@peds.arizona.edu)
University of California San Diego San Diego, California Edward Ball, MD - (tball@ucsd.edu)
University of Chicago Chicago, Illinois James LaBelle, MD, PhD - (jlabelle@peds.bsd.uchicago.edu)
University of Colorado Hospital Aurora, Colorado Jonathan Gutman, MD - (jonathan.gutman@ucdenver.edu)
University of Florida Shands Medical Center Gainesville, Florida Jordan Milner, MD - (jordan.milner@ufl.edu)
University of Illinois at Chicago Chicago, Illinois Damiano Rondelli, MD - (drond@uic.edu)
University of Iowa Iowa City, Iowa Margarida Silverman, MD - (margarida-silverman@uiowa.edu)
University of Kansas Westwood, Kansas Joseph McGuirk, DO - (jmcguirk@kumc.edu)
University of Louisville Hospital - James Brown Cancer Center Louisville, Kentucky William Tse, MD - (w0tse002@louisville.edu)
University of Massachusetts Worcester, Massachusetts Jan Cerny, MD - (Jan.Cerny@umassmemorial.org)
University of Miami (adult) Miami, Florida
University of Miami (peds) Miami, Florida
University of Michigan Ann Arbor, Michigan Jessica Yu - (jjxyu@med.umich.edu)
University of Nebraska Medical Center Omaha, Nebraska Phyllis Warkenton, MD - (pwarkent@unmc.edu)
University of North Carolina at Chapel Hill Chapel Hill, North Carolina
University of Oklahoma Health Science Center Oklahoma City, Oklahoma Adam Asch, MD - (adam-asch@ouhsc.edu)
University of Pennsylvania/Thomas Jefferson Pittsburg, Pennsylvania Elizabeth Hexner, MD - (elizabeth.hexner@uphs.upenn.edu)
University of Pittsburgh Medical Center Pittsburgh, Pennsylvania Alison Sehgal, MD - (sehgalar@upmc.edu)
University of Texas Southwestern Medical Center Dallas, Texas
University of Utah Salt Lake City, Utah Ahmad Rayes, MD - (ahmad.rayes@hsc.utah.edu)
University of Virginia Charlottesville, Virginia Karen Ballen, MD - (KB3TC@hscmail.mcc.virginia.edu)
University of Wisconsin - Madison Madison, Wisconsin Kenneth DeSantes, MD - (kbdesantes@pediatrics.wisc.edu)
VA Puget Sound HCS Seattle, Washington
VA Tennessee Valley Healthcare System Nashville, Tennessee
Vanderbilt University Nashville, Tennessee Michael Byrne, MD - (michael.byrne@vumc.org)
Virginia Commonwealth University Richmond, Virginia John McCarty, MD - (jmccarty@vcu.edu)
Wake Forest University Winston-Salem, North Carolina
Washington University St. Louis St Louis, Missouri Geoffrey Uy, MD - (guy@wustl.edu)
Washington University/St. Louis Children's Hospital St Louis, Missouri Geoffrey Uy, MD - (guy@wustl.edu)
West Virginia University Morgantown, West Virginia Lauren Veltri, MD - (lveltri@hsc.wvu.edu)
Westchester Medical Center Valhalla, New York Mitchell Cairo, MD - (mitchell_cairo@nymc.edu)
Western Penn Hospital Pittsburg, Pennsylvania John Lister, MD - (Jlister@wpahs.org)
Yale New Haven Hospital New Haven, Connecticut Aaron Flagg, MD - (aron.flagg@yale.edu)
Zachary & Elizabeth Fisher Bone Marrow Transplant Program (Brooke Army Medical Center) Fort Sam Houston, Texas Bradley Beeler, MD - (bradley.w.beeler.mil@health.mil)

Improving Transition Care for Adolescents and Young Adults With Type 1 Diabetes (SHIFT2)

Sarah Farthing - sarah.malone@vcuhealth.org

NCT05639088
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Inclusion Criteria:
AYA:
• Type 1 Diabetes diagnosis for at least 1 year (as documented in medical record)
• 16-22 years old
• English speaking
• Children's Hospital of Richmond patient (Division of Pediatric Endocrinology)
• must have a caregiver willing to participate Caregiver:
• Age greater than 18 years
• Provides care to AYA and willing to participate
Exclusion Criteria:
AYA:
• Non-English speaking
• Significant psychiatric, cognitive, medical or developmental conditions that would impair their ability to complete assessments and/or engage in diabetes self-care behaviors (e.g., malignancies, psychosis, intellectual disability
• Hospitalization for depression, suicidal ideation or other psychiatric disorder within the past 12 months. Life time history of psychotic disorder
• Medically-induced diabetes or diagnosis of diabetes other than type 1 diabetes.
• Currently pregnant, pregnant within the past 6 months, currently breastfeeding or planning to become pregnant within the next 12 months.
• Another member of the household (other than the participating parent) is a participant or staff member on this study.
• Participation in another research study that may interfere with this study.
• Previous participation in the SHIFT pilot study Caregiver:
• Non-English speaking
• Significant psychiatric, cognitive, developmental conditions that would impair their ability to complete assessments and/or engage in supporting the AYA with diabetes self-care behaviors (e.g., psychosis, intellectual disability)
• Another member of the home (not AYA) is a participant/staff member on current study
• Participation in another research study that may interfere with current study
• Previous participation in SHIFT pilot study
BEHAVIORAL: Transition preparation program, OTHER: Educational materials
Type 1 Diabetes
Diabetes Management, Transition
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Virginia Commonwealth University Richmond, Virginia

Pediatric Obesity Weight Evaluation Registry (POWER) Study (POWER)

Shelley Kirk, PhD, RD, LD - Shelley.Kirk@cchmc.org

NCT02121132
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Inclusion Criteria:

• age 18 years or younger
• overweight or obese patient
• initial medical evaluation in a pediatric weight management program between March 1, 2014-April 30, 2020.
Exclusion Criteria:

• no exclusion criteria
Overweight, Obesity
Overweight, Obesity
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Study Locations

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AdventHealth Orlando, Florida Mary Beth Vance - (mary.vance@adventhealth.com)
Advocate Children's Hospital Park Ridge, Illinois Susan Panek - (susan.panek@aah.org)
Ann & Robert H. Lurie Children's Hospital of Chicago Chicago, Illinois
Arkansas Children's Hospital Little Rock, Arkansas
Children's Healthcare of Atlanta Atlanta, Georgia
Children's Hospital Los Angeles Los Angeles, California
Children's Hospital and Medical Center Omaha Omaha, Nebraska Leslie Turner - (lturner@childrensomaha.org)
Children's Hospital of San Antonio San Antonio, Texas
Children's Medical Center at UT Southwestern Dallas, Texas
Children's Mercy Hospital Kansas City, Missouri
Cincinnati Children's Hospital Medical Center Cincinnati, Ohio
Cleveland Clinic Cleveland, Ohio Roy Kim - (kimr@ccf.org)
Connecticut Children's Medical Center Hartford, Connecticut
Cook Children's Medical Center Fort Worth, Texas
Dell Children's Medical Center Austin, Texas
Duke Children's Hospital & Health Center Durham, North Carolina
Eastern Maine Medical Center Bangor, Maine
Fit Kids of Arizona at Northern Arizona Healthcare Cottonwood, Arizona Dirk de Heer - (dirk.deheer@nau.edu)
Helen DeVos Children's Hospital Grand Rapids, Michigan
Maine Medical Center - Barbara Bush Children's Hospital Portland, Maine
Marshfield Clinic Marshfield, Wisconsin
Mayo Clinic in Minnesota Rochester, Minnesota
OSF Saint Francis Medical Center Peoria, Illinois
Our Lady of The Lake Baton Rouge, Louisiana Micah Klumpp - (micah.klumpp@fmolhs.org)
Penn State Hershey Children's Hospital Hershey, Pennsylvania
Riley Children's Hospital - IU Health Indianapolis, Indiana Emily Ragozzino - (emragozz@iu.edu)
Seattle Children's Hospital Seattle, Washington
St. Luke's Children's Hospital Boise, Idaho
The Medical University of South Carolina Charleston, South Carolina Christine San Giovanni - (sangiova@musc.edu)
UCSF Benioff Children's Hospital Oakland Oakland, California
University of California Los Angeles Los Angeles, California Jennifer Yee - (jyee@lundquist.org)
University of Florida Health Science Center Jacksonville, Florida
University of Michigan C.S. Mott Children's Hospital Ann Arbor, Michigan
University of Minnesota Amplatz Children's Hospital Minneapolis, Minnesota
University of Mississippi Medical Center Jackson, Mississippi
University of New Mexico Children's Hospital Albuquerque, New Mexico
University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma
VCU Health Richmond, Virginia Sarah Farthing - (sarah.malone@vcuhealth.org)

Exploring the Familial Reach of Adolescent Obesity Treatment

Sarah M Farthing, MS - sarah.malone@vcuhealth.org

NCT05780970
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Inclusion Criteria:

• Untreated children: must be between 8-17 years of age and primarily living in the same household as the TEENS+ participants.
• Untreated caregiver: must be 18 years of age or older and primarily living in the same household as the TEENS+ participants.
• Treated caregivers: must have another individual in the household that meets the eligbility for an untreated child or untreated caregiver.
Exclusion Criteria:

• temporarily (<1yr) living in the home
• children with a BMI<5th%ile or caregivers with a BMI<18.5 kg/m2
• non-English speaking
• medical condition(s) that may be associated with unintentional weight change or significant disruption to eating behaviors (e.g., hypothalamic injury, Prader-Willi, G-tube placement, or malignancy
• clinically significant eating disorder (e.g., anorexia nervosa or bulimia nervosa)
• following a medically-supervised/prescribed diet
• psychiatric, cognitive, physical or developmental conditions that would impair the individual's ability to complete assessments.
Other: No intervention
Pediatric Obesity
Pediatric Obesity, Lifestyle Intervention, Family-Level Change, Family-based Intervention
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Children's Hospital of Richmond at VCU Healthy Lifestyles Center Henrico, Virginia Sarah M Farthing, MS - (sarah.malone@vcuhealth.org) Melanie K Bean, Ph.D. - (melanie.bean@vcuhealth.org)

Feasibility Study for the Comprehensive Overweight/Obesity Management Pre-Kidney Transplant (COMPKT) Program

Evan Sisson - emsisson@vcu.edu

NCT06688825
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Inclusion Criteria:
* on the waiting list for kidney transplant at VCUHS * BMI greater than 35 kg/m2
Exclusion Criteria:
* Children, prisoners, pregnant women
BEHAVIORAL: Education regarding Weight loss, BEHAVIORAL: Lifestyle tools for weight loss, BIOLOGICAL: Blood draw
Kidney Transplant, Complications, Obesity
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Virginia Commonwealth University Richmond, Virginia Evan Sisson - (emsisson@vcu.edu) Dana Burns - (dburns@vcu.edu)

Redefining BMI: The Body, Mind, and Inflammation Trial

Morgan Meyer - morgan.meyer@vcuhealth.org

NCT06532747
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Inclusion Criteria:
* Ages 18-25 years * Body mass index (BMI) 25-50 kg/m\^2 * Female
Exclusion Criteria:
* Currently pregnant or lactating * Current involvement in a weight loss program or current use of weight loss medication * Lost \>5% of their body weight in the previous 3 months * Uncontrolled medical conditions that may pose a safety issue given the recommendations for the diet and unsupervised physical activity * Diagnosis of type 2 diabetes and/or impaired fasting blood glucose * Diagnosis of type 1 diabetes * Rheumatologic and gastrointestinal conditions associated with severe systemic inflammation * Medical conditions resulting in known perturbations in the hypothalamic-pituitary-adrenal axis * Report of a heart condition, chest pain during periods of activity or rest, or loss of consciousness * Current or recent (during the past 3 months) use of medications that may impact weight or metabolic function * Current or recent (during the past 3 months) use of anti-inflammatory medications * Report of diagnosis or history of Anorexia Nervosa or Bulimia Nervosa, or any compensatory behaviors within the previous 3 months * Hospitalization for depression or other psychiatric disorder within the past 12 months * Uncontrolled bipolar disorder or psychotic disorder * Current suicidal intent * Planning to move from the area within the study period * Unwilling to be randomized to either study condition * Unable to read and speak English
BEHAVIORAL: Integrated Lifestyle Intervention (ILI), BEHAVIORAL: Monitoring with digital tools
Obesity, Adiposity
BMI, Emerging Adult (EA) Women, Lifestyle Intervention, Biomarker Inflammation Improvement
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Location Contacts
Virginia Commonwealth Universtity Richmond, Virginia Morgan Meyer, MS - (morgan.meyer@vcuhealth.org) Jessica LaRose - (jlarose@vcu.edu)