Pilot Program for Targeted Prevention of Child or Adolescent Weight Gain

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT00263536
• Date of registration: 08/12/2005
• Prospective Registration: No
• Primary sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Public title: Pilot Program for Targeted Prevention of Child or Adolescent Weight Gain
• Scientific title: Pilot Program for Targeted Prevention of Child or Adolescent Weight Gain
• Date of first enrolment: December 5, 2005
• Target sample size: 147
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00263536
• Study type: Interventional
• Study design: Primary purpose: Treatment.
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: Jack A Yanovski, M.D.
• Affiliation: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Key inclusion & exclusion criteria

- 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.



Age minimum: 8 Years
Age maximum: 13 Years
Gender: All

Health Condition(s) or Problem(s) studied

Overweight Adolescents

Overweight

Intervention(s)

Procedure: Interpersonal Psychotherapy

Secondary ID(s)

06-CH-0039

060039

Source(s) of Monetary Support

Please refer to primary and secondary sponsors