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

NCT01704768 | Unknown DMC

• 2 other identifiers: 5R01NR0121711R01NR012171-01A2
• Study Type: interventional
• Target: 1,219
• Locations: 1 country
• Sites: 1

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).

Conditions

Healthy Lifestyle Behaviors; Depressive/Anxiety Symptoms

Keywords

Randomized Controlled Trial; School-Based Intervention

Outcome Measures

Primary Outcomes (9)

• 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

• 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

• 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

• 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

• Academic Performance

  Academic performance is measured utilizing the student's health class grades

  15-Week Post

• 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

• 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

• 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

• 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

Secondary Outcomes (14)

• Change in Healthy Lifestyles Beliefs

  Change from Baseline to 15-Week Post intervention

• Change in Perceived Difficulty of Leading a Healthy Lifestyle

  Change from Baseline to 15-Week Post intervention

• Change in Triglycerides (Lipid Panels)

  Change from Baseline to 15-Week Post Intervention

• Change in Healthy Lifestyles Beliefs

  Change from Baseline to 6-Months Post intervention

• Change in Healthy Lifestyles Beliefs

  Change from Baseline to 12-Month Post intervention

Study Arms (2)

COPE/Healthy Lifestyles TEEN Program

EXPERIMENTAL

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.

Behavioral: COPE/Healthy Lifestyles TEEN Program.

Healthy Teens Attention Control Program

PLACEBO COMPARATOR

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.

Behavioral: Healthy Teens Attention Control Program

Interventions

COPE/Healthy Lifestyles TEEN Program. 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.

Also known as: Cognitive-Behavioral Skills Building

COPE/Healthy Lifestyles TEEN Program

Healthy Teens Attention Control Program 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).

Also known as: Educational

Healthy Teens Attention Control Program

Eligibility Criteria

• Age: 14 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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).

Sponsors & Collaborators

• Arizona State University: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

Arizona State University

Phoenix, Arizona, 85044, United States

Location

Related Publications (3)

• 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.

  PMID: 33518442 DERIVED

• 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.

  PMID: 29941235 DERIVED

• 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.

  PMID: 24050416 DERIVED

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

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

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2012
• First Posted: October 11, 2012
• Study Start: January 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: June 1, 2013
• Last Updated: October 11, 2012

Record last verified: 2012-10

Locations

US (1)