Preventing Excessive Weight Gain in Adolescent Girls at High-Risk for Adult Obesity

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 appears to be 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. 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 loss (or at least weight stabilization)
among adults diagnosed with binge eating disorder. We adapted group IPT for the targeted
prevention of excessive weight gain (IPT-WG) among adolescent girls. Our pilot data support
the feasibility and acceptability of a 12-week group IPT-WG trial among adolescent girls at
high risk for obesity who report LOC eating, and preliminary findings suggest that IPT-WG has
the potential to prevent excessive weight gain. We now propose an adequately powered clinical
trial to evaluate the efficacy of IPT-WG compared to a standard-of-care health education for
stabilizing weight and body fat gain trajectories in 117 adolescent girls at high risk for
adult obesity who report LOC eating. Participants will be randomly assigned to a 12-week
group IPT-WG or health education group; anthropometric variables will be measured at
baseline, immediately after, and for up to 1 year following the initiation of treatment. We
will assess the efficacy of IPT-WG in improving social functioning and reducing negative
mood, disturbed eating patterns, and emotional distress. We also aim to determine the impact
of IPT-WG on objective measures of LOC eating during a test meal and on appetitive hormones.

- 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.