School-Based Intervention to Increase Physical Activity Among Adolescent Females

Obesity Clinical Trial

Official title:

Interventions to Increase Adolescent Physical Activity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00296101
• Other study ID #: 359
• Secondary ID: R01HL063861-05
• Status: Completed
• Phase: N/A
• First received: February 23, 2006
• Last updated: August 5, 2016
• Start date: February 2000
• Est. completion date: May 2005

Study information

• Verified date: February 2006
• Source: National Heart, Lung, and Blood Institute (NHLBI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: May 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 13 Years to 15 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Obesity

Intervention

Behavioral:
• Physical Activity

Locations

Country	Name	City	State
United States	University of Maryland	College Park	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physical activity
Primary	Cardiorespiratory fitness (measured at follow-up evaluation 2 1/2 years after study entry)
Secondary	Sedentary behaviors
Secondary	Cardiovascular risk factors (measured by blood pressure, lipoproteins, and BMI)
Secondary	Psychosocial factors (measured at follow-up evaluation 2 1/2 years after study entry)