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

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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Behavioral: Behavioral treatment for childhood obesity

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • KDWB University Pediatrics Family Center (UMP Stand alone clinic)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 12 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Parent-only	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.
ACTIVE_COMPARATOR: Parent and child	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Child BMI percentile, Child BMI, Child BMI_Z	11 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Parent BMI, Child nutritional intake, Child physical activity	11 months

Collaborators and Investigators

• Sponsor: University of Minnesota
• Investigators: Principal Investigator: Kerri N Boutelle, Ph.D., L.P., University of Minnesota - Dept of Pediatrics

Study record dates

Study Major Dates

• Study Start: December 1, 2006
• Primary Completion (ACTUAL): April 1, 2009
• Study Completion (ACTUAL): April 1, 2009

Study Registration Dates

• First Submitted: February 9, 2010
• First Submitted That Met QC Criteria: February 9, 2010
• First Posted (ESTIMATE): February 10, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): July 10, 2012
• Last Update Submitted That Met QC Criteria: July 9, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Keywords: Exercise; Obesity; Childhood Obesity; Nutrition
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Pediatric Obesity
• Other Study ID Numbers: 0611M96906