Pilot Program for Targeted Prevention of Child or Adolescent Weight Gain
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|ClinicalTrials.gov Identifier: NCT00263536|
Recruitment Status : Completed
First Posted : December 8, 2005
Last Update Posted : October 6, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Overweight Adolescents Overweight||Procedure: Interpersonal Psychotherapy||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||147 participants|
|Official Title:||Pilot Program for Targeted Prevention of Child or Adolescent Weight Gain|
|Study Start Date :||December 5, 2005|
|Actual Primary Completion Date :||August 16, 2016|
|Actual Study Completion Date :||August 16, 2016|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00263536
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Jack A Yanovski, M.D.||Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)|