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Completed Phase 1 Interventional Accepts healthy volunteers

Pilot Program for Targeted Prevention of Child or Adolescent Weight Gain

ClinicalTrials.gov ID: NCT00263536

Public ClinicalTrials.gov record NCT00263536. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 8, 2026, 5:34 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 a time-limited group therapy for preventing and treating depression in children. It is also effective for treating binge eating disorder in adults and has resulted in weight maintenance or modest weight loss in obese adults. IPT focuses on improving how people relate to one another by relating symptoms to personal problem areas and then developing strategies for dealing with these problems. Girls and boys between the ages of 8-13 years of age who are in good general health with the exception of being overweight and whose body mass index (BMI) is above the 85th percentile for their age and sex may be eligible for this study. Candidates are screened with a physical examination, measurement of their height and weight, blood and urine tests, a DEXA scan (x-ray scan that measures body fat, muscle and bone mineral content), and questionnaires and an interview to obtain information about the child's general health, social and psychological function, and eating patterns. Parents are also screened for their health and are asked to give blood samples for genetic studies and participate in a few questionnaires and interviews. Participants are randomly assigned to participate in FB-IPT or a health education program. Both programs involve 12 weekly visits. At the end of the study, the body weight and mood of the girls and boys in both groups are compared. Participants (a parent and their child) meet individually with the therapist for 12 sessions (each approximately an 45 minutes ). Girls and boys offered FB-IPT have meetings in which they develop strategies for dealing with the problems girls struggle with that may lead to increased eating. Girls and boys in the health education group have meetings that focus on teaching teens children to live healthier lives and review topics related to developing and maintaining healthy eating and exercise. All participants are evaluated at the end of the 12-week program and asked to return to the NIH for follow-up visits at post treatment, 6 and 12 months following initiation of the program. Each child and parent will be compensated for their time and inconvenience with $40 for completing all pre-program assessments, $40 for attending the 12 week follow-up visit, $40 for the 6 month follow-up visit, and $40 for the 1-year follow-up. Therefore, each child may receive up to $160, and the participating parent may receive up to $160. If a child's second biological parent is also willing to give a genetic sample and undergo interviews, the second parent can also receive $40 for a single visit to the NIH.

Study identification

NCT ID
NCT00263536
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Enrollment
147 participants

Conditions and interventions

Eligibility (public fields only)

Age range
8 Years to 13 Years
Sex
All
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Dec 4, 2005
Primary completion
Aug 15, 2016
Completion
Aug 15, 2016
Last update posted
Oct 5, 2017

2005 – 2016

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
National Institutes of Health Clinical Center, 9000 Rockville Pike Bethesda Maryland 20892

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00263536, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Oct 5, 2017 · Synced Sep 8, 2026

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The complete protocol, eligibility criteria, and contact information for NCT00263536 live on ClinicalTrials.gov.

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