Childhood Obesity Treatment Targeting Specific Behaviors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00259324
Recruitment Status : Completed
First Posted : November 29, 2005
Last Update Posted : April 20, 2012
National Institutes of Health (NIH)
University of Tennessee
Information provided by (Responsible Party):
The Miriam Hospital

Brief Summary:
The US is in the midst of an obesity epidemic, affecting young children. The pediatric primary care setting is an ideal place to address this problem since most families have frequent contact with their pediatrician and a child's health status is regularly assessed in this setting. Recommendations for treating children with a body mass index (BMI) over the 85th percentile in the primary care setting have been developed by an Expert Committee on childhood. Programs are needed that meet the recommendations from the Committee, which include: 1) beginning treatment as young as possible; 2) focusing on the family, with the parent being the primary change agent for treatment; 3) using behavior modification techniques to change eating and activity behaviors; and 4) making 2 or 3 very specific changes in diet and activity at one time. Thus, the aim of this R21 application is to develop, implement, and evaluate a 6-month behavioral childhood obesity intervention that meets the Committee's recommendations and can be implemented in a primary care setting. A second aim of this project is to determine which eating and activity behaviors should be targeted in the intervention. One hundred thirty-five children, aged 4 to 9 years with a BMI > 85th percentile, assessed and referred by their pediatricians, will be randomized to one of three conditions: 1) a newsletter condition; 2) a Behavioral Parenting Program that increases physical activity (60 min/day) and decreases sweetened drink consumption (< 3 servings/week) (Traditional); or 3) a Behavioral Parenting Program that reduces TV watching (< 2 hours/day) and increases low-fat milk consumption (2 servings/day) (Substitutes). Follow-up assessments on weight, height, and standardized BMI (z-BMI), the primary dependent variable, will be conducted at 3, 6, 9, and 12 months. Pediatricians will provide follow-up letters to families, regarding weight and height status, following the assessments. This pilot study allows us to determine the feasibility and efficacy of a pediatric obesity intervention that optimizes the role of the pediatrician and meets the Committee's recommendations for treatment in a primary care setting. Moreover, by comparing the effects of targeting the traditional or substitute behaviors, data will be obtained for a power analysis for a full-scale trial of the effects of these two approaches on long-term weight loss.

Condition or disease Intervention/treatment Phase
Childhood Obesity Behavioral: Diet and Activity Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 81 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Childhood Obesity Treatment Targeting Specific Behaviors
Study Start Date : September 2005
Actual Primary Completion Date : February 2009
Actual Study Completion Date : February 2009

Arm Intervention/treatment
Experimental: 1
Diet and Activity
Behavioral: Diet and Activity
Diet and Activity

Experimental: 2
Diet and Activity
Behavioral: Diet and Activity
Diet and Activity

Placebo Comparator: 3
Behavioral: Diet and Activity
Diet and Activity

Primary Outcome Measures :
  1. Z-BMI in children [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Eating and activity behaviors [ Time Frame: 12 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   4 Years to 9 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • 1) Age between 4 and 9 years. We propose to use this age group since parents are in control of the eating and exercise choices of such children, and thus a program that focuses on parenting behaviors (i.e., positive reinforcement, stimulus control, parental modeling) should be developmentally appropriate. This age group also meets the Expert Committee's goal of intervening early5; moreover children aged 4 to 8 years have similar nutritional needs.

    2) Body mass index (BMI) > 85th percentile BMI. Based upon the Expert Committee recommendations,5 children > 2 years of age who are identified as being at risk for overweight (85th to 94th percentile BMI) or overweight (> 95th percentile BMI) should focus on weight maintenance as height continues to increase. These recommendations are aimed at reducing z-BMI.

    3) Tanner stage 1 (prepubertal) sexual maturation status. 4) Self-report at least one of the following problematic behaviors:

    1. Consume > 1 serving of sweetened drink per day.
    2. Consume < 2 servings of low-fat milk per day.
    3. Watch > 2 hours of TV per day.
    4. Engage in physical activity that makes them sweat or breath hard < 5 days per week.

      These behaviors have been selected because each has been associated with childhood obesity.

      5) A parent willing to attend treatment meetings. 6) Parent and child speak English.

      Exclusion Criteria:

      Participants will be excluded if they:

      1. Report a family member participating in another weight loss program.
      2. Report that the child or parent planning to attend the treatment meetings has a major psychiatric disease or organic brain syndrome.
      3. Report that the child or parent planning to attend the treatment meetings has dietary or physical activity restrictions.
      4. Intend to move outside of the metropolitan area within the time frame of the investigation.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00259324

United States, Rhode Island
The Weight Control and Diabetes Research Center
Providence, Rhode Island, United States, 02903
Sponsors and Collaborators
The Miriam Hospital
National Institutes of Health (NIH)
University of Tennessee
Principal Investigator: Hollie A Raynor University of Tennessee

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: The Miriam Hospital Identifier: NCT00259324     History of Changes
Other Study ID Numbers: 1-R21-DK07491901
First Posted: November 29, 2005    Key Record Dates
Last Update Posted: April 20, 2012
Last Verified: December 2007

Additional relevant MeSH terms:
Pediatric Obesity
Nutrition Disorders
Body Weight
Signs and Symptoms