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Telephone Physical Activity Intervention in Obese Youth (TPAI)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Katrina D DuBose, East Carolina University
ClinicalTrials.gov Identifier:
NCT01162512
First received: July 13, 2010
Last updated: May 23, 2016
Last verified: May 2016
  Purpose
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 Intervention
Obesity
Behavioral: physical activity

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Telephone-Based Physical Activity Intervention in Obese Youth

Resource links provided by NLM:


Further study details as provided by East Carolina University:

Primary Outcome Measures:
  • physical activity [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    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:
  • BMI [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    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


Enrollment: 60
Study Start Date: July 2010
Study Completion Date: April 2013
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Genders Eligible for Study:   Both
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Responsible Party: Katrina D DuBose, Associate Professor, East Carolina University
ClinicalTrials.gov Identifier: NCT01162512     History of Changes
Other Study ID Numbers: ECU-2010-01 
Study First Received: July 13, 2010
Last Updated: May 23, 2016
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 28, 2016