Clinical trial NCT01704768: COPE/Healthy Lifestyles for Teens: A School-Based RCT
Official title: COPE/Healthy Lifestyles for Teens: A School-Based RCT
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy Lifestyle Behaviors
Depressive/Anxiety Symptoms
Keywords: Randomized Controlled Trial
School-Based Intervention
Lead sponsor: Arizona State University
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2012-10-11
Enrollment: 1219
Sex: ALL
Minimum age (years): 14
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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).

Detailed 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Change in Body Mass Index Percentage (BMI%)
timeFrame: Change from Baseline to 12-Month Post intervention
measure: Change in Healthy Lifestyle Behaviors
timeFrame: Change from Baseline to 12-Month Post intervention
measure: Change in Depression and Anxiety Symptoms
timeFrame: Change from Baseline to 15-Week Post intervention
measure: Social Skills
timeFrame: 15-Week Post
measure: Academic Performance
timeFrame: 15-Week Post
measure: Change in Body Mass Index Percentile (%)
timeFrame: Change from Baseline to 6-Month post intervention
measure: Change in Healthy Lifestyle Behaviors
timeFrame: Change from Baseline to 6-Month Post intervention
measure: Change in Depression and Anxiety Symptoms
timeFrame: Change from Baseline to 6-Month Post intervention
measure: Change in Depression and Anxiety Symptoms
timeFrame: Change from Baseline to 12-Month Post intervention
Secondary outcomes:
measure: Change in Healthy Lifestyles Beliefs
timeFrame: Change from Baseline to 15-Week Post intervention
measure: Change in Perceived Difficulty of Leading a Healthy Lifestyle
timeFrame: Change from Baseline to 15-Week Post intervention
measure: Change in Triglycerides (Lipid Panels)
timeFrame: Change from Baseline to 15-Week Post Intervention
measure: Change in Healthy Lifestyles Beliefs
timeFrame: Change from Baseline to 6-Months Post intervention
measure: Change in Healthy Lifestyles Beliefs
timeFrame: Change from Baseline to 12-Month Post intervention
measure: Change in Perceived Difficulty of Leading a Healthy Lifestyle
timeFrame: Change from Baseline to 6-Month Post intervention
measure: Change in Perceived Difficulty of Leading a Healthy Lifestyle
timeFrame: Change from Baseline to 12-Month Post intervention
measure: Change in Total Cholesterol (Lipid Panels)
timeFrame: Change from Baseline to 15-Week Post Intervention
measure: Change in High-Density Lipoprotein (HDL)(Lipid Panels)
timeFrame: Change from Baseline to 15-Week Post Intervention
measure: Change in Low-Density Lipoprotein (LDL) (Lipid Panels)
timeFrame: Change from Baseline to 15-Week Post Intervention
measure: Change in Triglycerides (Lipid Panels)
timeFrame: Change from Baseline to 6-Month Post Intervention
measure: Change in Total Cholesterol (Lipid Panels)
timeFrame: Change from Baseline to 6-Month Post Intervention
measure: Change in High-Density Lipoprotein (HDL) (Lipid Panels)
timeFrame: Change from Baseline to 6-Month Post Intervention
measure: Change in Low-Density Lipoprotein (LDL) (Lipid Panels)
timeFrame: Change from Baseline to 6-Month Post Intervention
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona State University
state: Arizona
Study officials:
affiliation: Ohio State University
name: Bernadette M Melnyk, PhD, RN, CPNP/PMHNP, FNAP FAAN
role: PRINCIPAL_INVESTIGATOR
References:
citation: Melnyk BM, Kelly S, Tan A. Psychometric Properties of the Healthy Lifestyle Beliefs Scale for Adolescents. J Pediatr Health Care. 2021 May-Jun;35(3):285-291. doi: 10.1016/j.pedhc.2020.11.002. Epub 2021 Jan 29.
citation: McGovern CM, Militello LK, Arcoleo KJ, Melnyk BM. Factors Associated With Healthy Lifestyle Behaviors Among Adolescents. J Pediatr Health Care. 2018 Sep-Oct;32(5):473-480. doi: 10.1016/j.pedhc.2018.04.002. Epub 2018 Jun 22.
citation: Melnyk BM, Jacobson D, Kelly S, Belyea M, Shaibi G, Small L, O'Haver J, Marsiglia FF. Promoting healthy lifestyles in high school adolescents: a randomized controlled trial. Am J Prev Med. 2013 Oct;45(4):407-15. doi: 10.1016/j.amepre.2013.05.013.