School-Based Intervention to Increase Physical Activity Among Adolescent Females

This study has been completed.
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00296101
First received: February 23, 2006
Last updated: March 6, 2006
Last verified: February 2006
  Purpose

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.


Condition Intervention
Cardiovascular Diseases
Obesity
Behavioral: Physical Activity

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Interventions to Increase Adolescent Physical Activity

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Primary Outcome Measures:
  • Physical activity
  • Cardiorespiratory fitness (measured at follow-up evaluation 2 1/2 years after study entry)

Secondary Outcome Measures:
  • Sedentary behaviors
  • Cardiovascular risk factors (measured by blood pressure, lipoproteins, and BMI)
  • Psychosocial factors (measured at follow-up evaluation 2 1/2 years after study entry)

Estimated Enrollment: 300
Study Start Date: February 2000
Estimated Study Completion Date: May 2005
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   13 Years to 15 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  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: NCT00296101

Locations
United States, Maryland
University of Maryland
College Park, Maryland, United States, 20742
Sponsors and Collaborators
Investigators
Principal Investigator: Deborah R. Young University of Maryland
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00296101     History of Changes
Other Study ID Numbers: 359, R01 HL063861-05
Study First Received: February 23, 2006
Last Updated: March 6, 2006
Health Authority: United States: Federal Government

Keywords provided by National Heart, Lung, and Blood Institute (NHLBI):
Physical Inactivity

Additional relevant MeSH terms:
Cardiovascular Diseases
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on August 18, 2014