COPE/Healthy Lifestyles for Teens: A School-Based RCT

Healthy Lifestyle Behaviors Clinical Trial

Official title:

COPE/Healthy Lifestyles for Teens: A School-Based RCT

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01704768
• Other study ID #: 5R01NR012171
• Secondary ID: 1R01NR012171-01A
• Status: Active, not recruiting
• Phase: N/A
• First received: September 12, 2012
• Last updated: October 10, 2012
• Start date: January 2010
• Est. completion date: June 2013

Study information

• Verified date: October 2012
• Source: Arizona State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1219
• Est. completion date: June 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 14 Years to 16 Years

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Depressive/Anxiety Symptoms
• Healthy Lifestyle Behaviors

Intervention

Behavioral:
• COPE/Healthy Lifestyles TEEN Program.
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.
• Healthy Teens Attention Control Program
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).

Locations

Country	Name	City	State
United States	Arizona State University	Phoenix	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Arizona State University	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Body Mass Index Percentage (BMI%)	Information regarding the participants age, gender, weight and height at time of data collection provide information to track BMI overtime.	Change from Baseline to 12-Month Post intervention	No
Primary	Change in Healthy Lifestyle Behaviors	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 from Baseline to 12-Month Post intervention	No
Primary	Change in Depression and Anxiety Symptoms	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.	Change from Baseline to 15-Week Post intervention	No
Primary	Social Skills	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.	15-Week Post	No
Primary	Academic Performance	Academic performance is measured utilizing the student's health class grades	15-Week Post	No
Primary	Change in Body Mass Index Percentile (%)	Information regarding the participants age, gender, weight and height at time of data collection provide information to track BMI overtime.	Change from Baseline to 6-Month post intervention	No
Primary	Change in Healthy Lifestyle Behaviors	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 from Baseline to 6-Month Post intervention	No
Primary	Change in Depression and Anxiety Symptoms	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.	Change from Baseline to 6-Month Post intervention	No
Primary	Change in Depression and Anxiety Symptoms	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.	Change from Baseline to 12-Month Post intervention	No
Secondary	Change in Healthy Lifestyles Beliefs	Healthy Lifestyles Beliefs are measured utilizing the Healthy Lifestyle Beliefs Scale (HLBS). The HLBS is a 16-item instrument that taps beliefs about various facets of maintaining a healthy lifestyle.	Change from Baseline to 15-Week Post intervention	No
Secondary	Change in Perceived Difficulty of Leading a Healthy Lifestyle	Perceived Difficulty is measured utilizing the Perceived Difficulty Scale. This instrument is a 12-item questionnaire that measures one's perceived difficulty in living a healthy lifestyle.	Change from Baseline to 15-Week Post intervention	No
Secondary	Change in Triglycerides (Lipid Panels)	Participants whose BMI is at or above the 85th percentile are recruited to participate in the Lipid Panels. Participants who provide consent to participate in the Lipid Panels provide a blood sample through a finger stick which is tested for the participant's Triglycerides.	Change from Baseline to 15-Week Post Intervention	No
Secondary	Change in Healthy Lifestyles Beliefs	Healthy Lifestyles Beliefs are measured utilizing the Healthy Lifestyle Beliefs Scale (HLBS). The HLBS is a 16-item instrument that taps beliefs about various facets of maintaining a healthy lifestyle.	Change from Baseline to 6-Months Post intervention	No
Secondary	Change in Healthy Lifestyles Beliefs	Healthy Lifestyles Beliefs are measured utilizing the Healthy Lifestyle Beliefs Scale (HLBS). The HLBS is a 16-item instrument that taps beliefs about various facets of maintaining a healthy lifestyle.	Change from Baseline to 12-Month Post intervention	No
Secondary	Change in Perceived Difficulty of Leading a Healthy Lifestyle	Perceived Difficulty is measured utilizing the Perceived Difficulty Scale. This instrument is a 12-item questionnaire that measures one's perceived difficulty in living a healthy lifestyle.	Change from Baseline to 6-Month Post intervention	No
Secondary	Change in Perceived Difficulty of Leading a Healthy Lifestyle	Perceived Difficulty is measured utilizing the Perceived Difficulty Scale. This instrument is a 12-item questionnaire that measures one's perceived difficulty in living a healthy lifestyle.	Change from Baseline to 12-Month Post intervention	No
Secondary	Change in Total Cholesterol (Lipid Panels)	Participants whose BMI is at or above the 85th percentile are recruited to participate in the Lipid Panels. Participants who provide consent to participate in the Lipid Panels provide a blood sample through a finger stick which is tested for the participant's Total Cholesterol.	Change from Baseline to 15-Week Post Intervention	No
Secondary	Change in High-Density Lipoprotein (HDL)(Lipid Panels)	Participants whose BMI is at or above the 85th percentile are recruited to participate in the Lipid Panels. Participants who provide consent to participate in the Lipid Panels provide a blood sample through a finger stick which is tested for the participant's High-Density Lipoprotein (HDL).	Change from Baseline to 15-Week Post Intervention	No
Secondary	Change in Low-Density Lipoprotein (LDL) (Lipid Panels)	Participants whose BMI is at or above the 85th percentile are recruited to participate in the Lipid Panels. Participants who provide consent to participate in the Lipid Panels provide a blood sample through a finger stick which is tested for the participant's Low-Density Lipoprotein (LDL).	Change from Baseline to 15-Week Post Intervention	No
Secondary	Change in Triglycerides (Lipid Panels)	Participants whose BMI is at or above the 85th percentile are recruited to participate in the Lipid Panels. Participants who provide consent to participate in the Lipid Panels provide a blood sample through a finger stick which is tested for the participant's Triglycerides.	Change from Baseline to 6-Month Post Intervention	No
Secondary	Change in Total Cholesterol (Lipid Panels)	Participants whose BMI is at or above the 85th percentile are recruited to participate in the Lipid Panels. Participants who provide consent to participate in the Lipid Panels provide a blood sample through a finger stick which is tested for the participant's Total Cholesterol.	Change from Baseline to 6-Month Post Intervention	No
Secondary	Change in High-Density Lipoprotein (HDL) (Lipid Panels)	Participants whose BMI is at or above the 85th percentile are recruited to participate in the Lipid Panels. Participants who provide consent to participate in the Lipid Panels provide a blood sample through a finger stick which is tested for the participant's High-Density Lipoprotein (HDL).	Change from Baseline to 6-Month Post Intervention	No
Secondary	Change in Low-Density Lipoprotein (LDL) (Lipid Panels)	Participants whose BMI is at or above the 85th percentile are recruited to participate in the Lipid Panels. Participants who provide consent to participate in the Lipid Panels provide a blood sample through a finger stick which is tested for the participant's Low-Density Lipoprotein (LDL).	Change from Baseline to 6-Month Post Intervention	No