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

NCT ID: NCT01066910

Last Updated: 2012-07-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-12-31
• Study Completion Date: 2009-04-30

Brief 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.

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.

Conditions

Obesity

Keywords

Obesity; Childhood Obesity; Exercise; Nutrition

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Parent-only

Group Type: EXPERIMENTAL

Behavioral treatment for childhood obesity

Intervention Type: BEHAVIORAL

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

Parent and child

Group Type: ACTIVE_COMPARATOR

Behavioral treatment for childhood obesity

Intervention Type: BEHAVIORAL

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

Interventions

Behavioral treatment for childhood obesity

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

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kerri N Boutelle, Ph.D., L.P.

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota - Dept of Pediatrics

Locations

KDWB University Pediatrics Family Center (UMP Stand alone clinic)

Minneapolis, Minnesota, United States

Countries

United States

Other Identifiers

0611M96906

Identifier Type: -

Identifier Source: org_study_id