Preventing Excessive Weight Gain in Adolescent Girls at High-Risk for Adult Obesity
Condition: Obesity; Overweight; Binge Eating
MeSH terms: Obesity; Overweight; Weight Gain; Bulimia; Binge-Eating Disorder
Study type: Interventional
Phase: Phase 2

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.
    

Intervention name(s): Interpersonal Psychotherapy; Health Education
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Prevention; Obesity; Binge Eating; Adolescents; Overweight; Weight Gain