Overview

This trial is active, not recruiting.

Conditions healthy lifestyle behaviors, depressive/anxiety symptoms
Treatments cope/healthy lifestyles teen program., healthy teens attention control program
Sponsor Arizona State University
Collaborator National Institute of Nursing Research (NINR)
Start date January 2010
End date December 2012
Trial size 1219 participants
Trial identifier NCT01704768, 1R01NR012171-01A2, 5R01NR12171

Summary

The prevention and treatment of obesity and mental health disorders in adolescence are two major public health problems in the United States today. To address the increasing incidence and adverse health outcomes associated with both obesity and mental health problems, a theory-based 15 session intervention program entitled COPE (Creating Opportunities for Personal Empowerment)/ Healthy Lifestyles TEEN(Thinking, Feeling, Emotions & Exercise), will be delivered within high school health classes in order to improve the physical and mental health outcomes of 800 culturally diverse adolescents (14 to 16 years of age).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose prevention
Arm
(Experimental)
COPE is a manualized 15-session educational and cognitive-behavioral skills building program guided by Cognitive Behavioral Theory with physical activity as a component of each session.
cope/healthy lifestyles teen program. Cognitive-Behavioral Skills Building
The COPE Program is the intervention curriculum delivered to one arm of the study. Each session of COPE contains 15 to 20 minutes of physical activity (e.g., walking, dancing), not as an exercise training program, but rather to build beliefs/confidence in the teens that they can engage in and sustain some level of physical activity on a regular basis. Those healthy lifestyle intervention programs that have employed exercise interventions only have not led to sustained changes in healthy lifestyle behaviors. Our program is designed to enhance healthy lifestyle behaviors and sustain them because life-long cognitive-behavioral skills are taught in the program. Because the COPE TEEN program is completely manualized for the teens and instructors, it can be easily implemented by health teachers in high school settings.
(Placebo Comparator)
Healthy Teens is an attention control program that controls for the time spent with the adolescents in the COPE group is essential to determining the efficacy of the experimental program.
healthy teens attention control program Educational
The Healthy Teens program is an attention control program that will assist in ruling out alternative explanations of the mechanism by which the intervention works. It will be standardized like the COPE program to insure that it can be evaluated. It will be administered in a format like that of the COPE intervention program, and will include the same number and length of sessions, except for that it will not include the theoretical active components of CBT and will not include theoretical mechanisms to produce our hypothesized changes in outcomes. Teens in the attention control group also will receive the sessions in their required health class. The difference between the two programs will lie in the content of the sessions, with the Healthy Teens program being focused on safety and common health topics/issues for teens (e.g., road safety, skin care, acne, sun safety).

Primary Outcomes

Measure
Change in Body Mass Index Percentage (BMI%)
time frame: Change from Baseline to 12-Month Post intervention
Change in Healthy Lifestyle Behaviors
time frame: Change from Baseline to 12-Month Post intervention
Change in Depression and Anxiety Symptoms
time frame: Change from Baseline to 15-Week Post intervention
Social Skills
time frame: 15-Week Post
Academic Performance
time frame: 15-Week Post
Change in Body Mass Index Percentile (%)
time frame: Change from Baseline to 6-Month post intervention
Change in Healthy Lifestyle Behaviors
time frame: Change from Baseline to 6-Month Post intervention
Change in Depression and Anxiety Symptoms
time frame: Change from Baseline to 6-Month Post intervention
Change in Depression and Anxiety Symptoms
time frame: Change from Baseline to 12-Month Post intervention

Secondary Outcomes

Measure
Change in Healthy Lifestyles Beliefs
time frame: Change from Baseline to 15-Week Post intervention
Change in Perceived Difficulty of Leading a Healthy Lifestyle
time frame: Change from Baseline to 15-Week Post intervention
Change in Triglycerides (Lipid Panels)
time frame: Change from Baseline to 15-Week Post Intervention
Change in Healthy Lifestyles Beliefs
time frame: Change from Baseline to 6-Months Post intervention
Change in Healthy Lifestyles Beliefs
time frame: Change from Baseline to 12-Month Post intervention
Change in Perceived Difficulty of Leading a Healthy Lifestyle
time frame: Change from Baseline to 6-Month Post intervention
Change in Perceived Difficulty of Leading a Healthy Lifestyle
time frame: Change from Baseline to 12-Month Post intervention
Change in Total Cholesterol (Lipid Panels)
time frame: Change from Baseline to 15-Week Post Intervention
Change in High-Density Lipoprotein (HDL)(Lipid Panels)
time frame: Change from Baseline to 15-Week Post Intervention
Change in Low-Density Lipoprotein (LDL) (Lipid Panels)
time frame: Change from Baseline to 15-Week Post Intervention
Change in Triglycerides (Lipid Panels)
time frame: Change from Baseline to 6-Month Post Intervention
Change in Total Cholesterol (Lipid Panels)
time frame: Change from Baseline to 6-Month Post Intervention
Change in High-Density Lipoprotein (HDL) (Lipid Panels)
time frame: Change from Baseline to 6-Month Post Intervention
Change in Low-Density Lipoprotein (LDL) (Lipid Panels)
time frame: Change from Baseline to 6-Month Post Intervention

Eligibility Criteria

Male or female participants from 14 years up to 16 years old.

Inclusion Criteria: - Teens and parents of any gender, ethnicity/race, or socioeconomic status. - Teens 14 to 16 years of age who are freshmen and sophomores taking a health class at one of the participating high schools. - Teens who assent to participation. - Teens with a custodial parent who consents for themselves and their teen's participation in the study. - Teens who can speak and read in English (educational instruction in Arizona High Schools is conducted in English) Exclusion Criteria: - Teens who are under age 14 will be excluded because: - They are not likely to be enrolled in high school, and - They are unlikely to have sufficient cognitive development to benefit from the proposed intervention - Teens who are over age 16 will be excluded for two key reasons: - We believe that the cognitive development of and social expectations for older teens requires a more complex and flexible intervention than that proposed, and - Teens need to be available for 12 month follow-up sessions (our pilot studies indicated that this becomes less likely once teens are old enough to leave/graduate from high school, emancipate from parents, and/or leave home).

Additional Information

Official title COPE/Healthy Lifestyles for Teens: A School-Based RCT
Principal investigator Bernadette M Melnyk, PhD, RN, CPNP/PMHNP, FNAP FAAN
Description The prevention and treatment of obesity and mental health disorders in adolescence are two major public health problems in the United States (U.S.) today. The incidence of adolescents who are overweight or obese has increased dramatically over the past 20 years, with approximately 17.1 percent of teens now being overweight or obese. Furthermore, approximately 15 million children and adolescents (25 percent) in the U.S. have a mental health problem that is interfering with their functioning at home or at school, but less than 25 percent of those affected receive any treatment for these disorders. The prevalence rates of obesity and mental health problems are even higher in Hispanic teens, with studies suggesting that the two conditions often coexist in many youth. However, despite the rapidly increasing incidence of these two public health problems with their related health disparities and adverse health outcomes, there has been a paucity of theory based intervention studies conducted with adolescents in high schools to improve their healthy lifestyle behaviors as well as their physical and mental health outcomes. Unfortunately, physical and mental health services continue to be largely separated instead of integrated in the nation's healthcare system, which often leads to inadequate identification and treatment of these significant adolescent health problems. Therefore, the goal of the proposed randomized controlled trial is to test the efficacy of the COPE(Creating Opportunities for Personal Empowerment)/Healthy Lifestyles TEEN (Thinking, Feeling, Emotions & Exercise) Program, an educational and cognitive-behavioral skills building intervention guided by cognitive behavior theory, on the healthy lifestyle behaviors and depressive symptoms of 800 culturally diverse adolescents enrolled in Phoenix, Arizona high schools. The specific aims of the study are to: (1) Use a randomized controlled trial to test the short- and more long-term efficacy of the COPE TEEN Program on key outcomes, including healthy lifestyles behaviors, depressive symptoms and body mass index percentage, (2) Examine the role of cognitive beliefs and perceived difficulty in leading a healthy lifestyle in mediating the effects of COPE on healthy lifestyle behaviors and depressive symptoms; and (3) Explore variables that may moderate the effects of the intervention on healthy lifestyle behaviors and depressive symptoms, including race/ethnicity, gender, SES, acculturation, and parental healthy lifestyle beliefs and behaviors. Six prior pilot studies support the need for this full scale clinical trial and the use of cognitive-behavioral skills building in promoting healthy lifestyles beliefs, behaviors and optimal mental health in teens.
Trial information was received from ClinicalTrials.gov and was last updated in October 2012.
Information provided to ClinicalTrials.gov by Arizona State University.