NCT00263536

Pilot Program for Targeted Prevention of Child or Adolescent Weight Gain

Completed Phase 1 Last updated 6 October 2017

What this trial tests

Phase 1 trial testing Interpersonal Psychotherapy in Overweight Adolescents in 147 participants. Completed in 16 August 2016.

Timeline

5 December 2005

Primary endpoint
16 August 2016

16 August 2016

Quick facts

Lead sponsor	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Primary purpose	treatment
Enrollment	147
Start date	5 December 2005
Primary completion	16 August 2016
Estimated completion	16 August 2016
Sites	1 location across United States

Drugs / interventions tested

• Interpersonal Psychotherapy

Conditions studied

• Overweight Adolescents — all drugs for Overweight Adolescents →
• Overweight — all drugs for Overweight →

Sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Who can join

Adults 8 to 13, any sex, with Overweight Adolescents or Overweight. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Sexual dimorphisms in the associations of BMI and body fat with indices of pubertal development in girls and boys.
   Crocker MK, Stern EA, Sedaka NM, Shomaker LB, et al · · 2014 · cited 78× · PMID 24780051 · DOI 10.1210/jc.2014-1384
2. Attentional bias to food cues in youth with loss of control eating.
   Shank LM, Tanofsky-Kraff M, Nelson EE, Shomaker LB, et al · · 2015 · cited 36× · PMID 25435490 · DOI 10.1016/j.appet.2014.11.027
3. Serum leptin and loss of control eating in children and adolescents.
   Miller R, Tanofsky-Kraff M, Shomaker LB, Field SE, et al · · 2014 · cited 33× · PMID 23835660 · DOI 10.1038/ijo.2013.126
4. Metabolic characteristics of youth with loss of control eating.
   Radin RM, Tanofsky-Kraff M, Shomaker LB, Kelly NR, et al · · 2015 · cited 32× · PMID 26210388 · DOI 10.1016/j.eatbeh.2015.07.002
5. A randomized, comparative pilot trial of family-based interpersonal psychotherapy for reducing psychosocial symptoms, disordered-eating, and excess weight gain in at-risk preadolescents with loss-of-control-eating.
   Shomaker LB, Tanofsky-Kraff M, Matherne CE, Mehari RD, et al · · 2017 · cited 31× · PMID 28714097 · DOI 10.1002/eat.22741
6. Pediatric Loss of Control Eating and High-Sensitivity C-Reactive Protein Concentrations.
   Shank LM, Tanofsky-Kraff M, Kelly NR, Schvey NA, et al · · 2017 · cited 29× · PMID 27732055 · DOI 10.1089/chi.2016.0199
7. Examination of the interpersonal model of loss of control eating in the laboratory.
   Shank LM, Crosby RD, Grammer AC, Shomaker LB, et al · · 2017 · cited 28× · PMID 28410467 · DOI 10.1016/j.comppsych.2017.03.015
8. Self-efficacy beliefs and eating behavior in adolescent girls at-risk for excess weight gain and binge eating disorder.
   Glasofer DR, Haaga DA, Hannallah L, Field SE, et al · · 2013 · cited 28× · PMID 23881587 · DOI 10.1002/eat.22160