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

Arizona State University (ASU)

Status: Unknown

Conditions: Healthy Lifestyle Behaviors; Depressive/Anxiety Symptoms

Treatments: Behavioral: COPE/Healthy Lifestyles TEEN Program.; Behavioral: Healthy Teens Attention Control Program

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01704768

5R01NR012171

1R01NR012171-01A2 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 1,219 patients

Sex: All

Ages: 14 to 16 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,219 participants in 2 patient groups, including a placebo group

COPE/Healthy Lifestyles TEEN Program

Experimental group

Description:

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.

Treatment:

Behavioral: COPE/Healthy Lifestyles TEEN Program.

Healthy Teens Attention Control Program

Placebo Comparator group

Description:

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.

Treatment:

Behavioral: Healthy Teens Attention Control Program