Clinical trial NCT01066910: Parents As The Agent Of Change For Childhood Obesity (PAAC)
Official title: Parents As The Agent Of Change For Childhood Obesity (PAAC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Obesity
Childhood Obesity
Exercise
Nutrition
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2010-02-10
Enrollment: 80
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Child BMI percentile, Child BMI, Child BMI_Z
timeFrame: 11 months
Secondary outcomes:
measure: Parent BMI, Child nutritional intake, Child physical activity
timeFrame: 11 months
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: KDWB University Pediatrics Family Center (UMP Stand alone clinic)
state: Minnesota
Study officials:
affiliation: University of Minnesota - Dept of Pediatrics
name: Kerri N Boutelle, Ph.D., L.P.
role: PRINCIPAL_INVESTIGATOR
References: