Protocol Number: 06-CH-0039

Title:

Pilot Program for Targeted Prevention of Adolescent Weight Gain

Number:

06-CH-0039

Summary:

This study will examine whether interpersonal psychotherapy for preventing weight gain (IPT-WG) is an effective tool for helping adolescent girls at risk for become obese to reduce weight gain. ITP is a time-limited group therapy for preventing and treating depression in adolescents. 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-WG 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.

Adolescent girls between 12 and 17 years of age who are in good general health with the exception of being overweight and whose body mass index (BMI) is within the 75th to 97th percentile for their age and gender 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.

Participants are randomly assigned to participate in IPT-WG or a health education group. Both programs involve 12 weekly visits. At the end of the study, the body weight and mood of the girls in both groups are compared.

At the start of the study, participants meet individually with the therapist for one or two sessions (approximately an hour) so the therapist can learn about each girl's significant relationships or family health history and set goals for the program and so the participant can learn about group participation and format. At the end of the individual meeting(s), participants are given a pamphlet with standard information on healthy eating.

Girls in the IPT-WG group have 12 weekly 1 1/2-hour group meetings in which they develop strategies for dealing with the problems girls struggle with that may lead to increased eating. After about 6 weeks of group therapy, the therapists meet individually with each participant for about 15 minutes to review their progress and goals.

Girls in the health education group have 12 weekly 1 1/2-hour group meetings that focus on teens living healthier lives and include topics related to avoiding alcohol, drug and tobacco use, identifying signs of depression and suicide, improving nutrition, body image and exercise, and sun safety.

All participants are evaluated at the end of the 12-week group program and asked to return to the NIH for follow-up visits at 6 and 12 months following initiation of the program.

Sponsoring Institute:

National Institute of Child Health and Human Development (NICHD)

Recruitment Detail

Type: Completed Study; data analyses ongoing

Gender: Female

Referral Letter Required: No

Population Exclusion(s): Male

Eligibility Criteria: This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Special Instructions:

Currently Not Provided

Keyword(s):

Obesity

Adiposity

Binge Eating

Social Functioning

Eating Disorders

Prevention

Adolescence

Recruitment Keyword(s):

Adolescent Weight Gain

Overweight

Obesity

Condition(s):

Overweight Adolescents

Overweight

Investigational Drug(s):

None

Investigational Device(s):

None

Interventions:

Procedure/Surgery: Interpersonal Psychotherapy

Supporting Site:

National Institute of Child Health and Human Development

Contact(s):

This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Citation(s):

Hedley AA, Ogden CL, Johnson CL, Carroll MD, Curtin LR, Flegal KM. Prevalence of overweight and obesity among US children, adolescents, and adults, 1999-2002. JAMA. 2004 Jun 16;291(23):2847-50.

Freedman DS, Khan LK, Dietz WH, Srinivasan SR, Berenson GS. Relationship of childhood obesity to coronary heart disease risk factors in adulthood: the Bogalusa Heart Study. Pediatrics. 2001 Sep;108(3):712-8.

Freedman DS, Khan LK, Serdula MK, Dietz WH, Srinivasan SR, Berenson GS. Inter-relationships among childhood BMI, childhood height, and adult obesity: the Bogalusa Heart Study. Int J Obes Relat Metab Disord. 2004 Jan;28(1):10-6.

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department Clinical Research Informatics, CC.

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