Ignite Creation Date:
2025-12-24 @ 7:11 PM
Ignite Modification Date:
2026-01-04 @ 2:30 PM
Study NCT ID:
NCT00788203
Status:
COMPLETED
Last Update Posted:
2011-07-25
First Post:
2008-11-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevention of Childhood Obesity
Sponsor:
Stanford University
Organization:
Study Overview
Official Title:
The Development of an Early Intervention for the Prevention of Childhood Obesity
Status:
COMPLETED
Status Verified Date:
2011-07
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 is conducting preliminary testing to find out whether a particular educational program can alter parental overcontrol of their children's eating. There is evidence from previous studies that children who are irritable, cry a lot, tend to be overcontrolled and are at high risk for developing overweight. If the education program can change parental behavior the next study would examine whether this affects children's weight over a longer period of time.
Detailed Description:
There are two main studies in this project. For both studies families with a child between 2 and 4-years will be entered to the study although only the parents will participate. At least one parent will be overweight with a BMI\>27.5, and the child will have a reactive temperament assessed by the Children's Behavior Questionnaire (CBQ) completed by the parent with a combined score on the approach/impulsivity scales of 4.65 (possible range 1 - 7). The cut-points for parental BMI and their child's temperament derive from our previous prospective risk factor study. Screening will consist of a brief telephone screen to ascertain willingness to participate in further screening and self-reported BMI. Both parents will be invited to the laboratory to ascertain whether they meet BMI criteria. In Study 1 parents with a child with either reactive or non-reactive temperament patterns will be entered to this study. In Study 2 only parents with a child with a reactive temperament will be admitted to the study. There will be no randomization in Study 1. There will also be 2 focus groups each lasting 90-minutes to ascertain typical child feeding problems, and a pilot administration of the interventions. In Study 2 parents will be randomized to receive either the experimental intervention or a health education program aimed at enhancing their children's health. Each group session will last 90-minutes and there will be 10 group sessions at weekly intervals. Assessments in both studies will be similar and will consist of questionnaires aimed at assessing family and children's feeding behaviors and parental attitudes and behaviors concerning their own weight/shape and dieting. We estimate that the assessments will take approximately 60-minutes to complete in Study 1 and 45-minutes each in Study 2 because extraneous questions will be removed as a result of findings in Study 1.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| R21HD055637 | NIH | None | https://reporter.nih.gov/quic… | View |