Pilot Program for Targeted Prevention of Child or Adolescent Weight Gain

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 consuming. LOC eating is associated cross-sectionally with greater adiposity in
children and adolescents, and appears to predispose youth to gain weight or body fat above
that expected due to normal growth, thus likely contributing to obesity in susceptible
individuals. No prior studies have examined whether LOC eating can be decreased by
interventions in children or adolescents, or whether programs reducing LOC eating affect
weight gain. Interpersonal Psychotherapy (IPT), a form of psychotherapy that has been adapted
for the treatment of eating disorders, has demonstrated efficacy in reducing binge eating
episodes and inducing modest weight losses (or at least weight stabilization) among adults
diagnosed with binge eating disorder. In Study 1, we proposed a pilot study of the efficacy
of group IPT as an intervention to slow the trajectory of weight gain in 36 overweight or
at-risk for overweight youth who report symptoms of LOC eating. We hypothesized that
reductions in LOC eating among adolescents who engage in such episodes and who are at risk
for obesity will decrease the likelihood of inappropriate weight gain. In this pilot study,
changes in body composition of adolescent girls participating in a 12-week IPT group
intervention were compared with those of girls participating in a health education program at
6 month and 1 year follow-up visits. Significantly more girls who participated in IPT
stabilized their weight compared to girls who participated in health education. These
promising preliminary data were the basis for an adequately powered trial of adolescent IPT
for the prevention of excessive weight gain that is currently underway (NICHD Protocol
08-CH-0139). In Study 2, we wish to pilot an excess weight gain prevention program targeting
LOC eating behaviors in middle childhood youth and in their parents. In Study 2 the
prevention programs will be delivered in a parent-child dyadic format instead of an
adolescent group format. Enrolling children and their parents will also allow pilot exome
sequencing genetic analyses to be conducted.

- 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.