School-Based Intervention to Increase Physical Activity Among Adolescent Females

NCT ID: NCT00296101

Last Updated: 2016-08-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-02-29

Study Completion Date

2005-05-31

Brief Summary

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Physical inactivity is a major public health problem in the United States. Research has shown that physical activity levels decline during adolescence, and the decline is greater in females than males. The purpose of this study is to evaluate a life-skills oriented physical activity intervention at increasing activity levels and decreasing cardiovascular risk factors in adolescent females.

Detailed Description

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Physical activity levels decline dramatically during adolescence, particularly among females, with the decline most apparent among African Americans. The health benefits of regular physical activity are well-known; individuals who are active have lower rates of obesity and less incidence of cardiovascular disease. Because physical activity behaviors often develop during childhood, it is important to develop programs specifically for adolescents to encourage them to adopt and maintain a physically active lifestyle. Unfortunately, few programs have been developed that specifically focus on adolescents, and the long-term effectiveness of these programs is unknown. This study will evaluate the effectiveness of a life-skills oriented Comprehensive Physical Activity Program (CAP) at increasing activity levels in adolescents. Participants in the CAP program will develop new behavioral skills, which will assist them to continue a physically active lifestyle once the program ends. The purpose of this study is to compare CAP versus a standard physical education (PE) class at increasing physical activity levels and decreasing cardiovascular risk factors in adolescent African American and Caucasian females.

This study will enroll 9th grade female students who attend a high school in Baltimore, Maryland. They will be randomly assigned to participate in either a standard PE class or CAP. Participants in the CAP program will also receive support from a family member to ensure that they receive encouragement for engaging in exercise. Baseline assessments will include physical activity level; cardiorespiratory fitness; cardiovascular risk factors, including blood pressure, lipoproteins, and body mass index (BMI); and psychosocial factors. Participants will attend follow-up visits at the end of each school year in the 9th, 10th, and 11th grades.

Conditions

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Cardiovascular Diseases Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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Physical Activity

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Enrolled in 9th grade at the participating high school in Baltimore, Maryland

Exclusion Criteria

* Has a chronic medical disorder
* Currently taking medications that affect the cardiovascular or metabolic systems (e.g., beta adrenergic blockers)
* Excused from the State of Maryland's PE requirement
* Planning on leaving the area prior to the end of the study
* Has a sibling enrolled in the study
* Pregnant or breast-feeding
Minimum Eligible Age

13 Years

Maximum Eligible Age

15 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role lead

Principal Investigators

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Deborah R. Young

Role: PRINCIPAL_INVESTIGATOR

University of Maryland

Locations

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University of Maryland

College Park, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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R01HL063861-05

Identifier Type: NIH

Identifier Source: secondary_id

View Link

359

Identifier Type: -

Identifier Source: org_study_id

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