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Completed

NCT Number: NCT00296101

School-Based Intervention to Increase Physical Activity Among Adolescent Females

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.

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Key information

Age range

13 year–15 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Maryland

College Park, Maryland, 20742, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Physical activity

Behavioral

Primary outcomes

  1. Physical activity

  2. Cardiorespiratory fitness (measured at follow-up evaluation 2 1/2 years after study entry)

Secondary outcomes

  1. Sedentary behaviors

  2. Cardiovascular risk factors (measured by blood pressure, lipoproteins, and BMI)

  3. Psychosocial factors (measured at follow-up evaluation 2 1/2 years after study entry)

Sponsors and collaborators

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Nih

Registry information

Official study title

Interventions to Increase Adolescent Physical Activity

Important dates

Study start
2000
Study completion
2005
First posted
Feb 24, 2006
Registry last updated
Aug 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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