Clinical trial: A Family-Based Weight Loss Intervention for Youth With Intellectual Disability (NCT02033642)

Eligibility criteria:
Inclusion Criteria: Inclusion criteria for the adolescents with intellectual disability
        (ID) will be:

          1. Age 14-22 years

          2. Clinically overweight or obese, as indicated by BMI guidelines set by the Centers for
             Disease Control and Prevention

          3. Scores of ≤ 75 on the Kaufman Brief Intelligence Test (KBIT) and Vineland Adaptive
             Behavior Scales, 2nd Edition to establish criteria for the presence of an intellectual
             disability

          4. Living at home in a single- or two-parent family with no plans to leave home in the
             next year

          5. Verbal ability and necessary behavioral/social skills to participate in a group
             classroom-based educational program (determined by clinical observation and judgment
             accomplished through a structured interview during enrollment)

          6. Signed approval to participate by the adolescent's primary care provider (and by other
             specialists such as cardiologists or neurologists if the participant has a heart
             condition or neurological disorder).

        Exclusion Criteria: Exclusion criteria will be:

          1. Cardiac problems that preclude participation in moderate-to-vigorous-physical-activity
             (MVPA)

          2. Insulin-dependent diabetes

          3. An active seizure disorder not stabilized on medication

          4. Non-ambulatory, i.e. uses a wheelchair, or orthopedic injuries/deformities that
             prohibit moderate walking and other exercise

          5. Colitis, Crohn's Disease, and Inflammatory Bowel Disease

          6. Prader Willi syndrome

          7. Unwillingness to wear the accelerometer at screening or enrollment

          8. Recent history of disruptive, inappropriate or dangerous behaviors (e.g., self-injury,
             aggression/injury to others, property destruction, and extreme and ongoing use of
             inappropriate language).
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 14 Years old.
Subject must be at most 22 Years

Patient description (medical language): A 15-year-old boy with mild intellectual disability is brought to the office by his parents for a routine physical examination.  The boy is going to a school for students with learning disabilities.  The patient was adopted, and his immunizations are up to date.  Review of the patient's medical records is notable for cytogenetic studies that showed a small gap near the tip of the long arm of the X chromosome, which is consistent with fragile X syndrome, an X-linked disorder. The defect is an unstable expansion of trinucleotide repeats (CGG) in the fragile X mental retardation 1 (FMR1) gene, located on the long arm of the X chromosome. He is not using any medications and vital signs are within normal levels. His blood chemistry analysis as bellow:
Blood Chemistry Value      Normal Range     Patient Value
Glucose                    90-120 mg/dl     95 mg/dl
BUN (Blood Urea Nitrogen)  7-24 mg/dl       10 mg/dl
Creatinine                 0.7-1.4 mg/dl    0.8 mg/dl
Calcium                    8.5-10.5 mg/dl   9 mg/dl
Sodium                     134-143 mEq/L    135 mEq/L
Potassium                  3.5-4.5 mEq/L    3.7 mEq/L
Chloride                   95-108 mEq/L     98 mEq/L
CO2                        20-30 mEq/L      25 mEq/L
Blood pH                   7.38-7.42        7. 39

Patient description (patient's own words): My husband and I brought our 15-year-old son to the clinic for his routine exam. My son is going to school for special needs students. We adopted him a few years ago. His vaccinations are up to date. He already passed some chromosome testing and they found that he has a fragile X syndrome. The doctor told us that it comes from repeats in the fragile X chromosome. My son is not using any medication and his blood pressure temperature and breathing were normal during the exam. He also did a blood test. The results came back and showed that his blood sugar urea creatinine calcium sodium potassium chloride CO2 and blood pH were all within the normal range.

Does the patient match the trial criteria? 1