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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01004341
Other study ID # K23HD057299
Secondary ID
Status Completed
Phase N/A
First received October 20, 2009
Last updated June 18, 2013
Start date June 2009
Est. completion date May 2012

Study information

Verified date June 2013
Source University of California, San Diego
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the role of different parenting skills and parenting styles in the success of children enrolled in a family-based behavioral weight control program and to compare these skills and styles to those used by families with normal weight children.


Description:

Pediatric overweight has nearly tripled in the past several decades and while family-based behavioral weight control programs are the mainstay of treatment, there is considerable variability in their outcomes. Parents play an important role in the success of their children, particularly by implementing new behavioral skills. However recent evidence has also suggested that parenting style, or the way a parent interacts with their child and provides emotional support and discipline, may be another key element in pediatric weight control. Our goal is to evaluate the role of specific parenting (behavioral) skills and parenting style in the success of children enrolled in a standard family-based behavioral weight control intervention. Our goal is to examine whether specific parenting (behavioral) skills and parenting style change during the intervention and whether or not this change is related to changes in the child's BMI z-score.


Recruitment information / eligibility

Status Completed
Enrollment 44
Est. completion date May 2012
Est. primary completion date May 2012
Accepts healthy volunteers No
Gender Both
Age group 8 Years to 12 Years
Eligibility Inclusion Criteria:

- children between and including the ages of 8-12 years old

- child BMI >= 85th percentile

- parent willing to attend all treatment meetings

- parent and child must be able to speak, read, and understand English

Exclusion Criteria:

- a family member who is participating in another weight loss program

- the child has any serious medical problem that would limit his/her participation in the study, for example, gastrointestinal diseases, cardiac disease, immune compromised state, chronic steroid use or other medication that impacts weight, developmental delays.

- child with serious food allergies that would compromise adherence to dietary recommendations

- any family member has a major psychiatric disease or organic brain syndrome

- family is going to move outside the metropolitan area within the time frame of the study

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
Family-based behavioral weight control intervention
Standard behavioral weight control program for children ages 8-12 years old and their parents in a family-based intervention.

Locations

Country Name City State
United States University of California, San Diego La Jolla California

Sponsors (3)

Lead Sponsor Collaborator
University of California, San Diego Brown University, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Rhee KE, Lumeng JC, Appugliese DP, Kaciroti N, Bradley RH. Parenting styles and overweight status in first grade. Pediatrics. 2006 Jun;117(6):2047-54. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change in parenting skills and parenting style 0 and 6 months No
Secondary Change in child BMI z-score 0 and 6 months No
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