Status:
COMPLETED
Pilot Program for Targeted Prevention of Child or Adolescent Weight Gain
Lead Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Overweight Adolescents
Overweight
Eligibility:
All Genders
8-13 years
Phase:
PHASE1
Brief Summary
This study will examine whether family-based interpersonal psychotherapy (FB-IPT) is an effective tool for helping pre-adolescent girls and boys at risk for become obese to reduce weight gain. IPT is ...
Detailed Description
The most prevalent disordered eating pattern described in overweight youth is loss of control (LOC) eating, during which individuals experience an inability to control the amount of food they are cons...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Volunteers will qualify if they meet the following criteria:
- Good general health. A normal history and physical examination with the exception of overweight will be required.
- Age greater than or equal to 12 and \< 18 years at the start of the study.
- Female.
- Body mass index measured at the NIH is within the 75th 97th percentile for age, gender, and race.
- English speaking.
- Ability to complete study procedures including the ability to participate in a group.
- Individuals will be individually assessed to determine their suitability for group treatment. School placement (e.g. special education) will be used as an estimate of cognitive functioning.
- \- As assessed by the Eating Disorder Examination structured clinical interview (see methods), a history of LOC eating (objective or subjective bulimic episodes, or both) or no reports of LOC eating.
- EXCLUSION CRITERIA:
- Volunteers will be excluded (and referred to non-experimental treatment programs as needed) for the following reasons:
- Presence of major illnesses: renal, hepatic, gastrointestinal, most endocrinologic (e.g., Cushing syndrome, hyper- or hypothyroidism), hematological problems or pulmonary disorders (other than asthma not requiring continuous medication). Nonserious medical illnesses, such as seasonal allergies, will be reviewed on a case-bycase basis.
- Presence of an obesity-related medical complication that would require a more aggressive weight loss intervention approach. Such comorbidities include hyperlipidemia (LDL-cholesterol \> 130 mg/dL), hypertension (defined by age- sexand height- specific standards (115) fasting hyperglycemia (fasting glucose \> 126 mg/dL) and nonalcoholic steatohepatitis (ALT above NIH Clinical Center laboratory norms with consistent radiologic findings and absence of another cause such as infectious hepatitis).
- Regular use of prescription medications. Oral contraceptive use will be permitted, provided the contraceptive has been used for at least two months before starting study medication. Individuals taking medications for most conditions will be excluded, but medication use for non-serious conditions (e.g., acne) will be considered on a caseby- case basis. In particular, participants currently prescribed SSRI s, neuroleptics, tricyclics, stimulants, or any medication known to affect body weight or eating will be excluded.
- Current involvement in psychotherapy or a structured weight loss program,
- Weight loss during the past 2 months for any reason exceeding 3% of body weight.
- Pregnant or recently pregnant girls (within 1 year of delivery).
- History of an eating disorder or a current eating disorder (other than binge eating disorder) as determined by medical history or if uncovered during the study s structured clinical interviews. Subjects found to have an eating disorder other than binge eating disorder at baseline will be referred to mental health specialists for further evaluation and treatment.
- Current pregnancy or breast feeding. A negative pregnancy test before starting the study will be required. Because pregnancy is a state in which weight gain is expected and appropriate, pregnant individuals would not be suitable for this study. Sexually active females must be using an effective form of birth control. These methods include total abstinence (no sex), oral contraceptives ( the pill ), an intrauterine device (IUD), levonogestrol implants (Norplant), or medroxyprogesterone acetate injections (Depo-provera shots). If one of these cannot be used, contraceptive foam with a condom is recommended.
- Individuals who have DSM-IV-TR major depressive disorder, psychoses, current substance or alcohol abuse, conduct disorder, or a diagnosed psychiatric disorder that, in the opinion of the investigators, would impede competence or compliance or possibly hinder completion of the study. Individuals whose parents or guardians have current substance abuse or a diagnosed psychiatric disorder or other condition that, in the opinion of the investigators, would impede adherence with the study
- Each participant will receive a written explanation of the purposes, procedures, and potential hazards of the study. Communication of this information and of the participant s assent, as well as the consent of the parent or guardian, will be documented in the medical record. All participants will be informed of their right to withdraw from the study.
Exclusion
Key Trial Info
Start Date :
December 5 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 16 2016
Estimated Enrollment :
147 Patients enrolled
Trial Details
Trial ID
NCT00263536
Start Date
December 5 2005
End Date
August 16 2016
Last Update
October 6 2017
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892