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Completed

NCT Number: NCT01066910

Parents As The Agent Of Change For Childhood Obesity (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.

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Key information

Conditions

Obesity Behavior Body Weight Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pediatric Obesity Signs and Symptoms

Age range

8 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

KDWB University Pediatrics Family Center (UMP Stand alone clinic)

Minneapolis, Minnesota, 55455, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Behavioral treatment for childhood obesity

Behavioral

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

Primary outcomes

  1. Child BMI percentile, Child BMI, Child BMI_Z

    Time frame: 11 months

Secondary outcomes

  1. Parent BMI, Child nutritional intake, Child physical activity

    Time frame: 11 months

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Acronym: PAAC

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Feb 10, 2010
Registry last updated
Jul 10, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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