NCT01162512

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Jul 2010

Typical duration for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

July 13, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 14, 2010

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

May 25, 2016

Status Verified

May 1, 2016

Enrollment Period

1.3 years

First QC Date

July 13, 2010

Last Update Submit

May 23, 2016

Conditions

Keywords

physical activityobesityadolescentstelephoneBMIbody mass index

Outcome Measures

Primary Outcomes (1)

  • 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

    4 months

Secondary Outcomes (1)

  • BMI

    4 months

Study Arms (2)

Physical Activity

EXPERIMENTAL

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

Standard Medical Care

NO INTERVENTION

Participants will receive standard medical care

Interventions

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

Physical Activity

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ECU Pediatric Comprehensive Healthy Weight Clinic

Greenville, North Carolina, 27858, United States

Location

MeSH Terms

Conditions

ObesityMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Katrina D DuBose, PhD

    East Carolina University

    PRINCIPAL INVESTIGATOR
  • 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 CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 13, 2010

First Posted

July 14, 2010

Study Start

July 1, 2010

Primary Completion

October 1, 2011

Study Completion

April 1, 2013

Last Updated

May 25, 2016

Record last verified: 2016-05

Locations