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

Phase 2

Completed

• Conditions: Obesity; Binge Eating; Overweight

• Registration Number: NCT00680979
• Lead Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Brief Summary

This study will examine whether interpersonal psychotherapy (IPT) can help reduce excessive weight gain in adolescent girls. It will compare the effectiveness of IPT with a teen health education program in preventing weight gain.

Adolescent girls between 12 and 17 years of age who are at risk for becoming overweight adults, by virtue of being above average weight and experiencing episodes of loss of control over eating, may be eligible for this study. Candidates are screened in two visits with the following procedures:

Visit 1

* Height and weight measurements.

* Interview and questionnaires about the child s general health, social and psychological functioning and eating patterns and behaviors.

Visit 2

* Physical examination, blood and urine tests.

* DXA scan to measure body fat, muscle and bone mineral content.

* Laboratory test meal. The child fills out a rating scale about her level of hunger and is then given a food buffet from which she is instructed to eat as much as she wants. Immediately after eating, the child again completes the hunger rating forms.

* Interview about the child s mood and psychological functioning.

Participants are assigned at random to either the IPT or teen health education program. All participants have a 1- to 1 1/2-hour individual session with a therapist, followed by 12 weekly group sessions of 1 1/2 hours each in their assigned program. They are assessed at the end of the program with questionnaires and body measurements. They return to the clinic after 6 months for body measurements, blood test, DXA scan, questionnaires, interview and a test meal, and again at 1 year for body measurements, questionnaires and a DXA scan.

Detailed Description

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.

Study Timeline

• Study Start: 2008-05-15
• Study First Submitted: 2008-05-17
• Study First Submitted QC: 2008-05-17
• Study First Posted: 2008-05-20
• Primary Completion: 2015-04-16
• Study Completion: 2015-04-16
• Status Verified: 2015-08-20
• Last Update Submitted: 2019-09-28
• Last Update Posted: 2019-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 166

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Girls with LOC eating will be randomly assigned to IPT-WG or HE to examine their expected BMI change based upon CDC BMI growth chart data versus their actual in BMI over the course of two years.	1 year

Secondary Outcome Measures

Name	Time	Method
Efficacy of IPT-WG in improving socia	1 year

Trial Locations

Locations (2)

United States Uniformed Health Service; 🇺🇸 Bethesda, Maryland, United States

National Institutes of Health Clinical Center, 9000 Rockville Pike; 🇺🇸 Bethesda, Maryland, United States