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Telephone Physical Activity Intervention in Obese Youth (TPAI)

Primary Purpose

Obesity

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

physical activity

About this trial

This is an interventional treatment trial for Obesity focused on measuring physical activity, obesity, adolescents, telephone, BMI, body mass index

Eligibility Criteria

12 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

ECU Pediatric Comprehensive Healthy Weight Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Physical Activity

Standard Medical Care

Arm Description

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.

Participants will receive standard medical care

Outcomes

Primary Outcome Measures

physical activity

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

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

Full Information

NCT ID

NCT01162512

First Posted

July 13, 2010

Last Updated

May 23, 2016

Sponsor

East Carolina University

1. Study Identification

Unique Protocol Identification Number

NCT01162512

Brief Title

Telephone Physical Activity Intervention in Obese Youth

Acronym

TPAI

Official Title

Telephone-Based Physical Activity Intervention in Obese Youth

Study Type

Interventional

2. Study Status

Record Verification Date

May 2016

Overall Recruitment Status

Completed

Study Start Date

July 2010 (undefined)

Primary Completion Date

October 2011 (Actual)

Study Completion Date

April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

East Carolina University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

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

Obesity

Keywords

physical activity, obesity, adolescents, telephone, BMI, body mass index

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Physical Activity

Arm Type

Experimental

Arm Description

Arm Title

Standard Medical Care

Arm Type

No Intervention

Arm Description

Participants will receive standard medical care

Intervention Type

Behavioral

Intervention Name(s)

physical activity

Intervention Description

physical activity counseling sessions will occur by telephone weekly for 2 months

Primary Outcome Measure Information:

Title

physical activity

Description

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

Time Frame

4 months

Secondary Outcome Measure Information:

Title

BMI

Description

Time Frame

4 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Katrina D DuBose, PhD

Organizational Affiliation

East Carolina University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

David Collier, MD, PhD

Organizational Affiliation

East Carolina University

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Lesley Lutes, PhD

Organizational Affiliation

East Carolina University

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Amy Gross-McMillan, PT, PhD

Organizational Affiliation

East Carolina University

Official's Role

Study Chair

Facility Information:

Facility Name

ECU Pediatric Comprehensive Healthy Weight Clinic

City

Greenville

State/Province

North Carolina

ZIP/Postal Code

27858

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Telephone Physical Activity Intervention in Obese Youth

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