Phase
Condition
Bulimia
Obesity
Healthy Volunteers
Treatment
N/AClinical Study ID
Ages 8-100 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
- Eligibility Criteria for Parents/Guardians of Child Participants:
INCLUSION CRITERIA:
Parents/Guardians will qualify if they meet the following criteria.
Age >=18 years
Have a child enrolled in this protocol (15-CH-0096).
Exclusion
EXCLUSION CRITERIA:
Parents/Guardians will be excluded for the following reasons:
If their child is not eligible to participate in the study (see below)
If they are believed by the medical study team to have a medical or psychiatricproblem that will not allow them to complete study procedures safely (these will bedetermined on a case-by-case basis) Eligibility Criteria for Child Participants: INCLUSION CRITERIA: Volunteers will qualify if they meet the following criteria.
Age 8-17 years (NB: children may continue to participate as adults duringfollow-up).
Weight, height and BMI >= 5th percentile for age and sex according to Centersfor Disease Control and Prevention 2000 US standards.
Cognitively capable of completing study procedures (FSIQ >= 70).
Good general health based on a normal history and physical examination (withthe exception of overweight and minor, well-controlled illnesses). EXCLUSION CRITERIA: Individuals will be excluded (and provided treatment referrals as needed) for thefollowing reasons:
History of major cardiovascular disease or any other serious obesity-relatedcomplication as assessed during history and physical exam. Individuals withuntreated or major illnesses relating to the endocrine and/or cardiovascularsystems are excluded because these illnesses will likely influence outcomes.Such obesity-related comorbidities include hypertension (defined by age- sex-and height- specific standards; and fasting hyperglycemia consistent withdiabetes (fasting glucose > 126 mg/dL).
Presence of other major illnesses: renal, hepatic, gastrointestinal, mostendocrinologic (e.g., Cushing syndrome, untreated hyper- or hypothyroidism),hematological problems or pulmonary disorders (other than asthma not requiringcontinuous medication). Non-serious medical illnesses, such as seasonalallergies, will be reviewed on a case-by-case basis.
Regular use of any medication known to affect body weight or eating behavior (e.g., many medications prescribed for attention deficit hyperactivitydisorder, or ADHD). Medication use for non-serious conditions (e.g., acne) willbe considered on a case-by-case basis.
Current pregnancy or a history of pregnancy. A negative pregnancy test beforestarting the study will be required for postmenarcheal girls.
Current and regular use of tobacco products and/or alcohol.
A significant reduction in weight during the past three months, for any reason,exceeding 5% of body weight.
A history of significant or recent brain injury that may considerably influenceperformance on neurocognitive measures (i.e., any history of loss ofconsciousness >=30 minutes associated with a head injury, any history of memoryloss or hospitalization associated with a head injury, or >=2 concussionswithin last year).
Presence of any significant, full-threshold psychiatric disorder based on DSMcriteria such as schizophrenia, bipolar disorder, alcohol or substance abuse,anorexia or bulimia nervosa, or any disorder that, in the opinion of theinvestigators, would impede competence or compliance or possibly hindercompletion of the study. These individuals will not be permitted to enroll inthe current study and will be referred for treatment. Individuals who presentwith other psychiatric disorders, including sub-threshold psychiatricdisorders, will be permitted to enroll in the study. Sub-threshold psychiatricdisorders include symptoms that do not meet diagnostic threshold based on theDSM criteria for mental disorders, but which are nevertheless significantlyimpairing or distressing. If, based on the opinion of the investigators, aparticipant requires treatment for his/her psychiatric symptoms, the individualwill be referred for treatment. Participants who develop any psychiatricdisorder or significant psychiatric symptoms at any follow-up assessment duringthe study will not be excluded, but will be provided with treatment referrals.
Any other condition in the child or parents/guardians that, in the opinion ofthe investigators, would impede compliance or possibly hinder completion of thestudy (e.g., significant Learning Disorder). Additional exclusions for (optional) stool sample collection include: Stool Sample only:
Diagnosis or history of inflammatory bowel disease, including ulcerativecolitis or Crohn's disease, celiac sprue, irritable bowel syndrome, or otherinflammatory disorders of the intestine.
Diarrhea within 1 week prior to sampling.
Antibiotic use within 4 weeks prior to sampling. In addition, Experiments 1 and 2 have specific additional exclusions: Experiment 1 only:
Regular use of medications that could influence autonomic or endocrinefunctioning, including alpha and beta blockers, oral contraceptives, orprescription pain medication.
Scoring as "highly active" on the International Physical Activity Questionnaire (due to decreased cortisol reactivity). Experiment 2 only:
Participants will be excluded if MRI and MEG is contraindicated (metal in/onbody, braces, presence of non-organic [e.g., cochlear] implants or cerebralclips, permanent tattooed makeup or general tattoos that are recent and/or in adangerous location on the body or made with colors whose content in iron cannotbe definitely ruled out.
Youth will be excluded if they are left-handed. All participants will receive a written explanation of the purposes, procedures, andpotential hazards of the study. Communication of this information and of theparticipant's assent as well as the consent of the parent or guardian will bedocumented in the medical record and copies of all signed documents given to eachfamily. All participants will be informed of their right to withdraw from the study.
Study Design
Study Description
Connect with a study center
National Institutes of Health Clinical Center
Bethesda, Maryland 20892
United StatesActive - Recruiting
National Institutes of Health Clinical Center
Bethesda 4348599, Maryland 4361885 20892
United StatesSite Not Available

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