Parents As The Agent Of Change For Childhood Obesity (PAAC)

Obesity Clinical Trial

— PAAC  

Official title:

Parents As The Agent Of Change For Childhood Obesity (PAAC)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01066910
• Other study ID #: 0611M96906
• Status: Completed
• Phase: N/A
• First received: February 9, 2010
• Last updated: July 9, 2012
• Start date: December 2006
• Est. completion date: April 2009

Study information

• Verified date: July 2012
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to test and evaluate the effectiveness of a parent-only treatment for childhood obesity. This study provides state-of-the-art treatment for childhood obesity. Parents and children will participate in treatment groups for 6 months. These treatment groups include recommendations to decrease overall caloric intake (by increasing fruits and vegetables), increasing physical activity, decreasing sedentary behavior and changing the home food environment. We are currently implementing this treatment in the Healthy Choices Program which is part of the Childhood Obesity Clinic at the University of Minnesota. Len Epstein at the University of Buffalo has been publishing on this treatment protocol for 30 years.

Description:

The objective of this study is to pilot test and evaluate the efficacy of a parent-only treatment for childhood obesity. The central working hypothesis is that the parent-only treatment will result in greater weight loss for the overweight child as compared to the parent + child treatment. The specific aims of this application focus on comparing a behavioral parent-only intervention to a parent + child intervention for childhood obesity.

The primary aim of the proposed study is to compare the efficacy of the parent-only treatment to the parent + child treatment for childhood obesity.

The secondary aim is to compare treatment groups on change in the child and parent diet and exercise behavior, change in the home food environment, and parent weight post-treatment and at 6-months post-treatment.

This study is a randomized, clinical pilot trial evaluating two 6-month treatments for childhood obesity; parent + child and parent-only groups, with 6-months of post-treatment follow-up. The two treatments will differ in terms of the designated recipient of treatment, which will be delivered either to parents-only or to parents and children separately. Study outcomes will be assessed at baseline, immediately post-treatment, and 6-months post-treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 12 Years

Eligibility

Inclusion Criteria:

• An overweight child (>95th%) in the family who is between the ages of 8-12.

• A parent willing to participate and attend all treatment meetings.

• Family willing to commit to 6 months of treatment attendance, and follow-up for 6 months post-treatment.

• Family willing to submit the $60 deposit.

Exclusion Criteria:

• Child psychiatric disorder diagnoses (based on parent report).

• Child diagnoses of a serious current physical disease (such as diabetes) for which physician supervision of diet and exercise prescription are needed.

• Family with restrictions on types of food, such as food allergies, or religious or ethnic practices that limit the foods available in the home.

• Child with physical difficulties that limit the ability to exercise.

• Child with an active eating disorder.

All exclusionary and inclusionary criteria are similar to those in previous studies of Epstein and colleagues and Golan and colleagues.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity
• Pediatric Obesity

Intervention

Behavioral:
• Behavioral treatment for childhood obesity
Behavioral treatment for childhood obesity includes nutrition and physical activity recommendations, and behavior therapy skills for parent and child.
• Behavioral treatment for childhood obesity
Behavioral treatment for childhood obesity includes nutrition and physical activity recommendations, and behavior therapy skills for parent and child.

Locations

Country	Name	City	State
United States	KDWB University Pediatrics Family Center (UMP Stand alone clinic)	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota - Clinical and Translational Science Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Child BMI percentile, Child BMI, Child BMI_Z		11 months	No
Secondary	Parent BMI, Child nutritional intake, Child physical activity		11 months	No