A Primary Care Behavioral Approach for Addressing Childhood Overweight

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Anne Lang Dunlop, MD, MPH, Emory University
ClinicalTrials.gov Identifier:
NCT00284557
First received: January 30, 2006
Last updated: June 29, 2012
Last verified: June 2012
Results First Received: May 25, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Obesity
Intervention: Behavioral: Group-based behavioral intervention

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Group-based Behavioral Intervention The group-based behavioral intervention targets eating behaviors, physical activity, and "screen time", and is delivered to participating children and their parent/caregiver over the course of 4 weeks. Maintenance sessions occur every 3 months thereafter.
Health Education Materials Only Parent-child dyads allocated to Group 2 were provided with a standardized packet of health education materials addressing the recommended items from the expert committee guidelines (e.g., dietary recommendations using the Food Guide Pyramid and the Traffic Light Diet, a general prescription to increase physical activity to 60 minutes daily). They were also given a community resource list that provides contact and program information for community-based obesity treatment activities in their area.

Participant Flow:   Overall Study
    Group-based Behavioral Intervention     Health Education Materials Only  
STARTED     67     63  
COMPLETED     58     50  
NOT COMPLETED     9     13  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Group-based Behavioral Intervention The group-based behavioral intervention targets eating behaviors, physical activity, and "screen time", and is delivered to participating children and their parent/caregiver over the course of 4 weeks. Maintenance sessions occur every 3 months thereafter.
Health Education Materials Only Parent-child dyads allocated to Group 2 were provided with a standardized packet of health education materials addressing the recommended items from the expert committee guidelines (e.g., dietary recommendations using the Food Guide Pyramid and the Traffic Light Diet, a general prescription to increase physical activity to 60 minutes daily). They were also given a community resource list that provides contact and program information for community-based obesity treatment activities in their area.
Total Total of all reporting groups

Baseline Measures
    Group-based Behavioral Intervention     Health Education Materials Only     Total  
Number of Participants  
[units: participants]
  67     63     130  
Age  
[units: participants]
     
<=18 years     67     63     130  
Between 18 and 65 years     0     0     0  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  9.5  ± 1.7     9.3  ± 1.4     9.4  ± 1.5  
Gender  
[units: participants]
     
Female     49     45     94  
Male     18     18     36  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     0     0     0  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     67     63     130  
White     0     0     0  
More than one race     0     0     0  
Unknown or Not Reported     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     67     63     130  



  Outcome Measures
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1.  Primary:   BMI Z-score(for Gender and Age)at 6-months   [ Time Frame: 6-months post-intervention ]

2.  Primary:   BMI Z-score(for Gender and Age)at 12-months   [ Time Frame: 12-months post-intervention ]

3.  Secondary:   Change in Eating Behaviors (Consumption of WHOA Foods), Physical Activity, and "Screen Time"   [ Time Frame: 6- and 12-months post-intervention ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Anne L. Dunlop, MD, MPH
Organization: Emory University
phone: 404-712-8520
e-mail: amlang@emory.edu


No publications provided


Responsible Party: Anne Lang Dunlop, MD, MPH, Emory University
ClinicalTrials.gov Identifier: NCT00284557     History of Changes
Other Study ID Numbers: 416-2005
Study First Received: January 30, 2006
Results First Received: May 25, 2012
Last Updated: June 29, 2012
Health Authority: United States: Institutional Review Board