NCT01066910

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Dec 2006

Typical duration for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2006

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

February 9, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 10, 2010

Completed
Last Updated

July 10, 2012

Status Verified

July 1, 2012

Enrollment Period

2.3 years

First QC Date

February 9, 2010

Last Update Submit

July 9, 2012

Conditions

Keywords

ObesityChildhood ObesityExerciseNutrition

Outcome Measures

Primary Outcomes (1)

  • Child BMI percentile, Child BMI, Child BMI_Z

    11 months

Secondary Outcomes (1)

  • Parent BMI, Child nutritional intake, Child physical activity

    11 months

Study Arms (2)

Parent-only

EXPERIMENTAL
Behavioral: Behavioral treatment for childhood obesity

Parent and child

ACTIVE COMPARATOR
Behavioral: Behavioral treatment for childhood obesity

Interventions

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

Parent-only

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KDWB University Pediatrics Family Center (UMP Stand alone clinic)

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

ObesityPediatric ObesityMotor Activity

Interventions

Behavior Therapy

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Kerri N Boutelle, Ph.D., L.P.

    University of Minnesota - Dept of Pediatrics

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2010

First Posted

February 10, 2010

Study Start

December 1, 2006

Primary Completion

April 1, 2009

Study Completion

April 1, 2009

Last Updated

July 10, 2012

Record last verified: 2012-07

Locations