Lifestyle and Bone Study
A Brief Description

Exercise and Bone Health Video
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Flexibility is important throughout the life span.

Bones are formed early in life.

Osteoporosis. Microscopically, normal bone (top) is much stronger than osteoporotic bone (bottom).

Principal Investigators:
Margaret Schneider Jamner, Ph.D., Assistant Researcher, School of Social Ecology, UC Irvine

Dan Cooper, M.D., Pediatrician, Clinical Researcher, UC Irvine

Associated Staff:
Stan Bassin, Ed.D., Adjunct Professor of Medicine, UC Irvine

Christie Rose-Gottron, M.A., Research Assistant, UC Irvine

Primary Study Aims:
1. To develop an intervention that will effectively motivate adolescent females to exercise.
2. To examine the effect of increased exercise on osteoporosis risk among these females.

Study Design (Year One):

• Participants: 40 sedentary female adolescents (9th grade)
• Calcium supplementation: all participants will be requested to ingest calcium supplement tablets daily to ensure a minimum daily intake of 1200 mg. Dosages will be tailored based on the amount of calcium received through dietary sources (assessed at baseline).
• Educational Intervention: Participants will attend a summer class of 3-5 weeks duration (to be determined in cooperation with the collaborating school). Topics will include the health benefits of physical activity and the role of nutrition in osteoporosis (detailed curriculum to be provided).
• Group Assignment: participants will be randomly assigned to either a training or a control group.
• Exercise Training: During the summer session, participants in the training group will engage in supervised exercise sessions for approximately one hour per day. Of this time, 10 minutes will be spent in warming up, 40 minutes in physical activity designed to elevate the heart rate to about 60-70% of heart rate maximum (based on fitness testing), and 10 minutes in cool-down. Activities will be varied, and will be designed to be fun and engaging to encourage participation. At the end of the summer session, participants in the training group will attend supervised exercise sessions after school 3 times per week for the school year (i.e., approximately 9 months), and will record their weekly activity via the internet.
• Control Group Activities: During the summer session, study participants assigned to the control group will be excused from the exercise sessions; during this time they will engage in a non-physically active pursuit (computer skills instruction).
• Degree of Flexibility within the study Design: Depending on the information provided by Teacher- coordinator, parents, students, and school administrators, some aspects of the study design may be modified. These aspects may include: the specific nature of the physical activity program (i.e., types of sports, team vs. individual); the specific nature of the computer skills instruction; and the location of the after-school activity sessions.

Assessments:

• Students will be assessed 4 times during the study: at baseline (prior to the summer program); at the end of the summer session, midway through the school year, and at the end of the school year.
• Assessments will take place at the UC Irvine Medical School, and will be conducted by physicians and qualified medical staff working under physician supervision. All testing will be conducted by employees of the University of California, Irvine Medical School.
• Medical Assessments: At each assessment, participants will provide a blood and a urine sample and will complete a cardiovascular fitness test conducted on a stationary bicycle. At baseline, midway through the school year, and at the end of the intervention, students will undergo a DEXA scan, which is a whole-body scan designed to measure bone density and body composition (i.e., lean and fat body mass).
• Other Assessments: Participants will also be asked to complete questionnaires assessing diet, physical activity, and perceived benefits and barriers to physical activity.
• A subset of study participants (10 from each group) may be asked to wear an activity monitor (i.e., a device that is worn on the belt and is a motion sensor that will record the amount of physical activity) for a 3-day period at the beginning, middle, and end of the intervention period.

Incentives for Participation:

• Various incentives will be offered to students and parents to encourage participation in the study. The specific nature of these incentives will be decided in collaboration with school representatives, teachers, parent representatives, and student focus groups.
• Incentives will be offered to participants to encourage adherence to the self-monitoring activities via computer. Participants will accumulate points for completion of the weekly exercise logs, and will be able to exchange these points for rewards (to be determined based on focus groups).
• Ideally, some type of academic credit will be provided to participants in recognition of the education received during the summer class (pending school approval).
• In addition, students will receive monetary compensation for the time they spend in testing.

Benefits to Participating Schools:

The Lifestyle and Bone study will be a collaborative effort between the UCI-based researchers and participating schools. Each participating school will be asked to designate a Teacher-Coordinator to act as a liaison between the school and the UCI researchers, and this individual will be considered a member of the research team. The Teacher-Coordinator, who will be compensated for her time, will be asked to assist the team in designing a research project the is both maximally effective and minimally burdensome on the school. Information will be solicited through interviews and focus groups from parents, students, teachers, and school administrators to further ensure these goals.

As mentioned above, a project-specific curriculum will be administered to study participants during a summer session, followed by regular supervised physical activity during the school year (for students assigned to the training group). A training program for interested teachers will be offered to share the specifics of the curriculum and physical activity program with participating schools.

In addition, a parent education program will be offered in conjunction with the study. This element will be designed initially to educate and inform the parents of potential study participants, but will continue periodically as a general education program that will provide all interested parents with information about physical activity and osteoporosis.

In the event that the research team works out an arrangement with a participating school to administer the after-school supervised exercise sessions on school grounds, financial resources and other compensation will be offered to the school to offset the use of facilities.

Summary

In Year One, the Lifestyle and Bone Study aims to recruit 40 sedentary female adolescents, who will be assigned to either an exercise or a control group. Participants will be enrolled in the study for a period of one year, with a long-term follow-up to occur one year after the termination of the intervention. Benefits to students will include increased knowledge regarding the importance of physical activity to health and well-being, possible increases in cardiovascular and bone health resulting from greater levels of physical activity, monetary compensation, and involvement in a rigorous scientific study funded by the National Institutes of Health. Benefits to participating schools will include strengthened ties between the school and UCI, teacher training in a specialized curriculum designed to increase physical activity participation among female adolescents, a parent education program focusing on the links between physical activity and health, and financial resources and other compensation will be offered to offset facilities use, time provided by the Teacher-Coordinator, and any additional administrative burden placed on the school.

Pilot Study Results

Impact of a Pilot School-based Intervention to Promote Physical Activity among Sedentary Adolescent Females

Margaret Schneider Jamner', Dan Michael Cooper, Debby Ford, John Johansen2, and Stan Bassin3. (1) University of California, Irvine, Orange, CA, (2) El Toro High School, Mission Viejo, CA, (3) University of California, Irvine, Irvine, CA

Amid growing evidence that American youth are not sufficiently active to promote health and prevent disease, a call has been issued for innovative programs that will stimulate adolescents to engage in increased levels of exercise. Adolescent females, in particular, stand to benefit from successful interventions for a number of reasons; namely, that they tend to participate in lower levels of physical activity as compared to adolescent males, and they are at higher risk for several conditions associated with sedentary behavior (e.g., osteoporosis, obesity). One current focus in intervention research has been on testing the utility of identified correlates of exercise as mechanisms for change in exercise behavior. Specifically, a number of psychosocial factors have been put forth as possible mediators of exercise behavior, including perceived self-efficacy for exercise, social support for exercise, perceived benefits of and barriers to exercise, and enjoyment of exercise. The present study analyzes data from a pilot of a school-based intervention designed to promote physical activity among sedentary adolescent females. The study was designed to determine first whether the intervention brought about an increase in physical fitness and secondly whether the participants demonstrated the expected changes in the set of psychosocial variables described above. Twenty-two sedentary adolescent females were recruited from a local high school. Criteria for inclusion in the study included the following: 1) currently exercising fewer than 3 times per week; and 2) a score at or below the 70th percentile for age-adjusted cardiovascular fitness. Participants were primarily Caucasian (n=16), with 3 Hispanic and 3 Asian. At Baseline and Follow-up, study participants completed a questionnaire containing standardized scales to assess psychosocial variables and performed a ramp-type progressive cycle ergometer test to assess cardiovascular fitness. Following baseline testing, participants were randomly assigned to a specially designed physical education class (n=9) or to a wait-list control condition (n=13). Analysis of Variance revealed that the intervention had a significant effect on cardiovascular fitness (F=4.94, p < .03), with intervention participants achieving a greater increase in fitness. In contrast, none of the psychosocial variables were significantly impacted by the intervention. This study presents evidence that contradicts the popular assumption that interventions should strive to modify psychosocial influences on exercise as a means for bringing about increased cardiovascular fitness.
Keyword(s): exercise/fitness, high school issues, wellness/disease prevention

Study Activities in Subsequent Years
The Lifestyle and Bone Study is a four-year effort, in which new student participants will be recruited each year. The following describes the study activities for years 2-4, although adjustments may be made based on experiences in Year One.

• Participants: 80 sedentary female adolescents (9th grade) recruited each year
• Calcium supplementation: Same as Year One
• Educational Intervention: Same as Year One
• Group Assignment: participants will be randomly assigned to either a training, an enhanced training, or a control group.
• Training Group Activities: Same as Year One
• Enhanced Training Group Activities: The enhanced training group will receive motivational information via the internet each time that they record their weekly physical activity via the computer. The motivational information will be in the form of role model stories depicting the stories of adolescent females incorporating physical activity into their lives.
• Control Group Activities: Same as Year One
• Assessments: Same as Year One

Long-Term Follow-up

Each student participant will be asked to return for a full assessment (including all physiological and questionnaire assessments) one year after the conclusion of their active participation in the study. Thus, the full duration of individual involvement in the study may be considered to be approximately two years.