COPE/Healthy Lifestyles for Teens: A School-Based RCT
试验速览
- 阶段
- 不适用
- 入组人数
- 1,219
- 试验地点
- 2
- 主要终点
- Change in Body Mass Index Percentile (%)
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 14 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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).
结局指标
主要结局
Change in Body Mass Index Percentile (%)
时间窗: Change from Baseline to 6-Month post intervention
Information regarding the participants age, gender, weight and height at time of data collection provide information to track BMI overtime.
Change in Body Mass Index Percentage (BMI%)
时间窗: Change from Baseline to 12-Month Post intervention
Information regarding the participants age, gender, weight and height at time of data collection provide information to track BMI overtime.
Change in Healthy Lifestyle Behaviors
时间窗: Change from Baseline to 6-Month Post intervention
Healthy lifestyle behaviors will be measured with the Healthy Lifestyle Behaviors Scale developed for use in our preliminary studies. we also will employ pedometers to objectively quantify activity. Teens will be trained in the use of the pedometer. Pedometers provide a valid and reliable means to measure habitual physical activity in youth to be used as a measure of the students Healthy Lifestyles Behaviors.
Change in Depression and Anxiety Symptoms
时间窗: Change from Baseline to 12-Month Post intervention
Depression and Anxiety is measured utilizing the Beck Youth Inventory (2nd edition; BYI-II). This 100-item instrument for youth 7 to 18 years of age is a commercial product widely used in research and clinical settings that has well-established reliability, validity, and age, gender, and diagnostic-adjusted norms. It measures five constructs: (a) depressive symptoms, (b) anxiety symptoms, (c) anger, (d) disruptive behavior, and (e) self-concept.
Social Skills
时间窗: 15-Week Post
Social Skills are measured utilizing the Social Skills Rating System (SSRS), a commercial tool that is commonly utilized in research. The SSRS is completed by the student's health teacher.
Academic Performance
时间窗: 15-Week Post
Academic performance is measured utilizing the student's health class grades
次要结局
- Change in Healthy Lifestyles Beliefs(Change from Baseline to 12-Month Post intervention)
- Change in Perceived Difficulty of Leading a Healthy Lifestyle(Change from Baseline to 12-Month Post intervention)
- Change in Triglycerides (Lipid Panels)(Change from Baseline to 6-Month Post Intervention)
- Change in Total Cholesterol (Lipid Panels)(Change from Baseline to 6-Month Post Intervention)
- Change in High-Density Lipoprotein (HDL)(Lipid Panels)(Change from Baseline to 15-Week Post Intervention)
- Change in Low-Density Lipoprotein (LDL) (Lipid Panels)(Change from Baseline to 6-Month Post Intervention)
- Change in High-Density Lipoprotein (HDL) (Lipid Panels)(Change from Baseline to 6-Month Post Intervention)