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Childhood Obesity Treatment Targeting Specific Behaviors

Primary Purpose

Childhood Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Diet and Activity
Sponsored by
The Miriam Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Childhood Obesity

Eligibility Criteria

4 Years - 9 Years (Child)All SexesAccepts Healthy Volunteers

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: Consume > 1 serving of sweetened drink per day. Consume < 2 servings of low-fat milk per day. Watch > 2 hours of TV per day. 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: Report a family member participating in another weight loss program. Report that the child or parent planning to attend the treatment meetings has a major psychiatric disease or organic brain syndrome. Report that the child or parent planning to attend the treatment meetings has dietary or physical activity restrictions. Intend to move outside of the metropolitan area within the time frame of the investigation.

Sites / Locations

  • The Weight Control and Diabetes Research Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

1

2

3

Arm Description

Diet and Activity

Diet and Activity

Education

Outcomes

Primary Outcome Measures

Z-BMI in children

Secondary Outcome Measures

Eating and activity behaviors

Full Information

First Posted
November 28, 2005
Last Updated
April 19, 2012
Sponsor
The Miriam Hospital
Collaborators
National Institutes of Health (NIH), University of Tennessee
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1. Study Identification

Unique Protocol Identification Number
NCT00259324
Brief Title
Childhood Obesity Treatment Targeting Specific Behaviors
Official Title
Childhood Obesity Treatment Targeting Specific Behaviors
Study Type
Interventional

2. Study Status

Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
February 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Miriam Hospital
Collaborators
National Institutes of Health (NIH), University of Tennessee

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
81 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Diet and Activity
Arm Title
2
Arm Type
Experimental
Arm Description
Diet and Activity
Arm Title
3
Arm Type
Placebo Comparator
Arm Description
Education
Intervention Type
Behavioral
Intervention Name(s)
Diet and Activity
Intervention Description
Diet and Activity
Primary Outcome Measure Information:
Title
Z-BMI in children
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Eating and activity behaviors
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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: Consume > 1 serving of sweetened drink per day. Consume < 2 servings of low-fat milk per day. Watch > 2 hours of TV per day. 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: Report a family member participating in another weight loss program. Report that the child or parent planning to attend the treatment meetings has a major psychiatric disease or organic brain syndrome. Report that the child or parent planning to attend the treatment meetings has dietary or physical activity restrictions. Intend to move outside of the metropolitan area within the time frame of the investigation.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hollie A Raynor
Organizational Affiliation
University of Tennessee
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Weight Control and Diabetes Research Center
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21774578
Citation
Hart CN, Raynor HA, Osterholt KM, Jelalian E, Wing RR. Eating and activity habits of overweight children on weekdays and weekends. Int J Pediatr Obes. 2011 Oct;6(5-6):467-72. doi: 10.3109/17477166.2011.590204. Epub 2011 Jul 20.
Results Reference
derived
PubMed Identifier
19922036
Citation
Raynor HA, Osterholt KM, Hart CN, Jelalian E, Vivier P, Wing RR. Evaluation of active and passive recruitment methods used in randomized controlled trials targeting pediatric obesity. Int J Pediatr Obes. 2009;4(4):224-32. doi: 10.3109/17477160802596189.
Results Reference
derived

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Childhood Obesity Treatment Targeting Specific Behaviors

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