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Telephone Physical Activity Intervention in Obese Youth (TPAI)

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ClinicalTrials.gov Identifier: NCT01162512
Recruitment Status : Completed
First Posted : July 14, 2010
Last Update Posted : May 25, 2016
Sponsor:
Information provided by (Responsible Party):
Katrina D DuBose, East Carolina University

Brief Summary:
The purpose of this study is to examine the effectiveness of a telephone-based physical activity (PA) intervention in obese adolescents attending a Health Weight Comprehensive Clinic. Secondary aims focus on increasing the amount of change in obesity markers, namely waist circumference and BMI z-scores. The investigators hypothesize the following: 1.The telephone-based PA intervention will increase PA levels above the mail group; and 2. The telephone-based PA intervention will provide changes in waist circumference and BMI z-scores above the mail group.

Condition or disease Intervention/treatment Phase
Obesity Behavioral: physical activity Not Applicable

Detailed Description:
Obesity rates in youth have tripled over the past 20 years. Physical activity aids in weight loss and is critical for weight maintenance. Further, physical activity has other physiological and psychological benefits. Obese youth often see specialists for weight loss treatment. Treatment in a pediatric population uses a multi-component approach, but physical activity if often overlooked. Combining physical activity information with physician care and nutritional information could improve weight loss and the overall health of these obese children.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Telephone-Based Physical Activity Intervention in Obese Youth
Study Start Date : July 2010
Actual Primary Completion Date : October 2011
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Physical Activity
Participants will receive 7 weeks of weekly news letters and phone calls. The news letters and phone calls will include information about physical activity and ways to increase physical activity levels. This is in addition the standard medical care.
Behavioral: physical activity
physical activity counseling sessions will occur by telephone weekly for 2 months
No Intervention: Standard Medical Care
Participants will receive standard medical care



Primary Outcome Measures :
  1. physical activity [ Time Frame: 4 months ]
    physical activity levels during the 2 month intervnetion will be measured and then physical activity will also be measured during a 2 month follow up period


Secondary Outcome Measures :
  1. BMI [ Time Frame: 4 months ]
    waist circumference and weight and height will be measured. BMI will be calculated. After the 2 month intervention period the amount of change in waist circumference and BMI will be quantified. These measures will also be examined after a 2 month follow up period



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Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 12 to 18 years old
  • attending the ECU Pediatric Comprehensive Healthy Weight Clinic

Exclusion Criteria:

  • must be able to read and write in English
  • must be able to participate in physical activity

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 ClinicalTrials.gov identifier (NCT number): NCT01162512


Locations
United States, North Carolina
ECU Pediatric Comprehensive Healthy Weight Clinic
Greenville, North Carolina, United States, 27858
Sponsors and Collaborators
East Carolina University
Investigators
Principal Investigator: Katrina D DuBose, PhD East Carolina University
Study Chair: David Collier, MD, PhD East Carolina University
Study Chair: Lesley Lutes, PhD East Carolina University
Study Chair: Amy Gross-McMillan, PT, PhD East Carolina University

Responsible Party: Katrina D DuBose, Associate Professor, East Carolina University
ClinicalTrials.gov Identifier: NCT01162512     History of Changes
Other Study ID Numbers: ECU-2010-01
First Posted: July 14, 2010    Key Record Dates
Last Update Posted: May 25, 2016
Last Verified: May 2016

Keywords provided by Katrina D DuBose, East Carolina University:
physical activity
obesity
adolescents
telephone
BMI
body mass index