COPE/Healthy Lifestyles for Teens: A School-Based RCT
NCT01704768 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1219
Last updated 2012-10-11
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
Interventions
- 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.
- 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).
Sponsors & Collaborators
-
National Institute of Nursing Research (NINR)
collaborator NIH -
Arizona State University
lead OTHER
Principal Investigators
-
Bernadette M Melnyk, PhD, RN, CPNP/PMHNP, FNAP FAAN · Ohio State University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 14 Years
- Max Age
- 16 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2010-01-31
- Primary Completion
- 2012-12-31
- Completion
- 2013-06-30
Countries
- United States
Study Locations
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