Telephone Physical Activity Intervention in Obese Youth (TPAI)

May 23, 2016 updated by: Katrina D DuBose, East Carolina University

Telephone-Based Physical Activity Intervention in Obese Youth

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Greenville, North Carolina, United States, 27858
        • ECU Pediatric Comprehensive Healthy Weight Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 14 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

July 13, 2010

First Submitted That Met QC Criteria

July 13, 2010

First Posted (Estimate)

July 14, 2010

Study Record Updates

Last Update Posted (Estimate)

May 25, 2016

Last Update Submitted That Met QC Criteria

May 23, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ECU-2010-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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