Status:
COMPLETED
Preventing Excessive Weight Gain in Adolescent Girls at High-Risk for Adult Obesity
Lead Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Obesity
Overweight
Eligibility:
FEMALE
12-17 years
Phase:
PHASE2
Brief Summary
This study will examine whether interpersonal psychotherapy (IPT) can help reduce excessive weight gain in adolescent girls. It will compare the effectiveness of IPT with a teen health education progr...
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.
- Female.
- Age 12 17 years.
- BMI between 75th and 97th percentile.
- English speaking.
- Good general health.
- Participants must have normal laboratory testing, including negative urine glucose and normal electrolytes, hepatic, and thyroid function, or they will be referred for treatment.
- EXCLUSION CRITERIA:
- Individuals will be excluded (and referred to non-experimental treatment programs as needed):
- 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). Non-serious medical illnesses, such as seasonal allergies, will be reviewed on a case-by-case basis.
- Presence of an obesity-related medical complication that would require a more aggressive weight loss intervention approach. Such comorbidities include hyperlipidemia (LDL-cholesterol greater than 160 mg/dL), hypertension (defined by age-, sex-, and height- specific standards fasting hyperglycemia (fasting glucose greater than 100 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. Individuals taking medications for most conditions will be excluded, but medication use for non-serious conditions (e.g., acne) will be considered on a case-by-case basis. In particular, participants currently prescribed SSRIs, 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 per cent 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. Should a participant in the IPT-WG group become pregnant during the 12 weeks of therapy, she will be excluded from the group sessions. The girl s IPT-WG therapists will closely assist her in obtaining an appropriate referral to a community mental healthcare provider. The IPT-WG leaders will request a release of information so that they may communicate with the community therapist in order to facilitate a smooth transition for the girl.
- 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.
- Inability to participate in a group due to psychiatric or cognitive functioning. School placement (e.g. grade level) will be used as an estimate of cognitive functioning. The decision to include or exclude subjects for this reason is left entirely to the discretion of the investigators.
- Any other condition in the adolescent or her parents or guardians that, in the opinion of the investigators, would impede compliance or possibly hinder completion of the study.
Exclusion
Key Trial Info
Start Date :
May 15 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 16 2015
Estimated Enrollment :
166 Patients enrolled
Trial Details
Trial ID
NCT00680979
Start Date
May 15 2008
End Date
April 16 2015
Last Update
October 1 2019
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
United States Uniformed Health Service
Bethesda, Maryland, United States, 20889
2
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892