Ignite Creation Date:
2024-05-05 @ 12:10 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00263536
Status:
COMPLETED
Last Update Posted:
2017-10-06
First Post:
2005-12-08
Brief Title:
Pilot Program for Targeted Prevention of Child or Adolescent Weight Gain
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Pilot Program for Targeted Prevention of Child or Adolescent Weight Gain
Status:
COMPLETED
Status Verified Date:
2016-08-16
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 childs 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 childs 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
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 childs 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 06-CH-0039 | None | None | None |