Pilot Program for Targeted Prevention of Child or Adolescent Weight Gain
Condition: Overweight Adolescents; Overweight
MeSH terms: Overweight; Weight Gain
Study type: Interventional
Phase: Phase 1

Summary: 
      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.
    

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 is 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. No prior studies have examined whether LOC eating can be decreased by
      interventions in children or adolescents, or whether programs reducing LOC eating affect
      weight gain. 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 losses (or at least weight stabilization) among adults
      diagnosed with binge eating disorder. In Study 1, we proposed a pilot study of the efficacy
      of group IPT as an intervention to slow the trajectory of weight gain in 36 overweight or
      at-risk for overweight youth who report symptoms of LOC eating. We hypothesized that
      reductions in LOC eating among adolescents who engage in such episodes and who are at risk
      for obesity will decrease the likelihood of inappropriate weight gain. In this pilot study,
      changes in body composition of adolescent girls participating in a 12-week IPT group
      intervention were compared with those of girls participating in a health education program at
      6 month and 1 year follow-up visits. Significantly more girls who participated in IPT
      stabilized their weight compared to girls who participated in health education. These
      promising preliminary data were the basis for an adequately powered trial of adolescent IPT
      for the prevention of excessive weight gain that is currently underway (NICHD Protocol
      08-CH-0139). In Study 2, we wish to pilot an excess weight gain prevention program targeting
      LOC eating behaviors in middle childhood youth and in their parents. In Study 2 the
      prevention programs will be delivered in a parent-child dyadic format instead of an
      adolescent group format. Enrolling children and their parents will also allow pilot exome
      sequencing genetic analyses to be conducted.
    

Intervention name(s): Interpersonal Psychotherapy
Intervention type(s): Procedure
Primary purpose: Treatment
Keywords: Obesity; Adiposity; Binge Eating; Social Functioning; Eating Disorders; Prevention; Adolescence; Adolescent Weight Gain; Overweight