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

NCT ID: NCT01704768

Last Updated: 2012-10-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 1219 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2013-06-30

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.

Conditions

Healthy Lifestyle Behaviors; Depressive/Anxiety Symptoms

Keywords

Randomized Controlled Trial; School-Based Intervention

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

COPE/Healthy Lifestyles TEEN Program

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.

Group Type: EXPERIMENTAL

COPE/Healthy Lifestyles TEEN Program.

Intervention Type: BEHAVIORAL

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

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.

Group Type: PLACEBO_COMPARATOR

Healthy Teens Attention Control Program

Intervention Type: BEHAVIORAL

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).

Interventions

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.

Intervention Type: BEHAVIORAL

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).

Intervention Type: BEHAVIORAL

Other Intervention Names

Cognitive-Behavioral Skills Building; Educational

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).

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Nursing Research (NINR)

NIH

Sponsor Role: collaborator

Arizona State University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bernadette M Melnyk, PhD, RN, CPNP/PMHNP, FNAP FAAN

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

Arizona State University

Phoenix, Arizona, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 33518442 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 29941235 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 24050416 (View on PubMed)

Other Identifiers

1R01NR012171-01A2

Identifier Type: NIH

Identifier Source: secondary_id

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5R01NR012171

Identifier Type: NIH

Identifier Source: org_study_id

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