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

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Behavioral treatment for childhood obesity
Behavioral treatment for childhood obesity
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Obesity, Childhood Obesity, Exercise, Nutrition

Eligibility Criteria

8 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • KDWB University Pediatrics Family Center (UMP Stand alone clinic)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Parent-only

Parent and child

Arm Description

Outcomes

Primary Outcome Measures

Child BMI percentile, Child BMI, Child BMI_Z

Secondary Outcome Measures

Parent BMI, Child nutritional intake, Child physical activity

Full Information

First Posted
February 9, 2010
Last Updated
July 9, 2012
Sponsor
University of Minnesota
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1. Study Identification

Unique Protocol Identification Number
NCT01066910
Brief Title
Parents As The Agent Of Change For Childhood Obesity (PAAC)
Acronym
PAAC
Official Title
Parents As The Agent Of Change For Childhood Obesity (PAAC)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
April 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Obesity, Childhood Obesity, Exercise, Nutrition

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Parent-only
Arm Type
Experimental
Arm Title
Parent and child
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Behavioral treatment for childhood obesity
Intervention Description
Behavioral treatment for childhood obesity includes nutrition and physical activity recommendations, and behavior therapy skills for parent and child.
Intervention Type
Behavioral
Intervention Name(s)
Behavioral treatment for childhood obesity
Intervention Description
Behavioral treatment for childhood obesity includes nutrition and physical activity recommendations, and behavior therapy skills for parent and child.
Primary Outcome Measure Information:
Title
Child BMI percentile, Child BMI, Child BMI_Z
Time Frame
11 months
Secondary Outcome Measure Information:
Title
Parent BMI, Child nutritional intake, Child physical activity
Time Frame
11 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kerri N Boutelle, Ph.D., L.P.
Organizational Affiliation
University of Minnesota - Dept of Pediatrics
Official's Role
Principal Investigator
Facility Information:
Facility Name
KDWB University Pediatrics Family Center (UMP Stand alone clinic)
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States

12. IPD Sharing Statement

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