Healthy Lifestyle BehaviorsNCT01704768
COPE/Healthy Lifestyles for Teens: A School-Based RCT
A study testing COPE/Healthy Lifestyles TEEN Program. in people with Healthy Lifestyle Behaviors and Depressive/Anxiety Symptoms, run by Arizona State University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 14 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Lifestyle Behaviors, Depressive/Anxiety Symptoms
- What is being tested?
- COPE/Healthy Lifestyles TEEN Program.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,219 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Jun 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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).
Read the 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.
- Being tested
- COPE/Healthy Lifestyles TEEN Program., Healthy Teens Attention Control Program
- Keywords
- Randomized Controlled Trial, School-Based Intervention
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COPE/Healthy Lifestyles TEEN Program.Behavioural
Also called Cognitive-Behavioral Skills Building
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 ProgramBehavioural
Also called Educational
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Healthy Teens Attention Control Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 15-Week Post
Academic Performance
Academic performance is measured utilizing the student's health class grades
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change from Baseline to 12-Month Post intervention
Secondary outcomes (14)
Change in Healthy Lifestyles Beliefs
Healthy Lifestyles Beliefs are measured utilizing the Healthy Lifestyle Beliefs Scale (HLBS). The HLBS is a 16-item instrument that taps beliefs about various facets of maintaining a healthy lifestyle.
Measured: Change from Baseline to 15-Week Post intervention
Change in Perceived Difficulty of Leading a Healthy Lifestyle
Perceived Difficulty is measured utilizing the Perceived Difficulty Scale. This instrument is a 12-item questionnaire that measures one's perceived difficulty in living a healthy lifestyle.
Measured: Change from Baseline to 15-Week Post intervention
Change in Triglycerides (Lipid Panels)
Participants whose BMI is at or above the 85th percentile are recruited to participate in the Lipid Panels. Participants who provide consent to participate in the Lipid Panels provide a blood sample through a finger stick which is tested for the participant's Triglycerides.
Measured: Change from Baseline to 15-Week Post Intervention
Change in Healthy Lifestyles Beliefs
Healthy Lifestyles Beliefs are measured utilizing the Healthy Lifestyle Beliefs Scale (HLBS). The HLBS is a 16-item instrument that taps beliefs about various facets of maintaining a healthy lifestyle.
Measured: Change from Baseline to 6-Months Post intervention
Change in Healthy Lifestyles Beliefs
Healthy Lifestyles Beliefs are measured utilizing the Healthy Lifestyle Beliefs Scale (HLBS). The HLBS is a 16-item instrument that taps beliefs about various facets of maintaining a healthy lifestyle.
Measured: Change from Baseline to 12-Month Post intervention
Change in Perceived Difficulty of Leading a Healthy Lifestyle
Perceived Difficulty is measured utilizing the Perceived Difficulty Scale. This instrument is a 12-item questionnaire that measures one's perceived difficulty in living a healthy lifestyle.
Measured: Change from Baseline to 6-Month Post intervention
Change in Perceived Difficulty of Leading a Healthy Lifestyle
Perceived Difficulty is measured utilizing the Perceived Difficulty Scale. This instrument is a 12-item questionnaire that measures one's perceived difficulty in living a healthy lifestyle.
Measured: Change from Baseline to 12-Month Post intervention
Change in Total Cholesterol (Lipid Panels)
Participants whose BMI is at or above the 85th percentile are recruited to participate in the Lipid Panels. Participants who provide consent to participate in the Lipid Panels provide a blood sample through a finger stick which is tested for the participant's Total Cholesterol.
Measured: Change from Baseline to 15-Week Post Intervention
Change in High-Density Lipoprotein (HDL)(Lipid Panels)
Participants whose BMI is at or above the 85th percentile are recruited to participate in the Lipid Panels. Participants who provide consent to participate in the Lipid Panels provide a blood sample through a finger stick which is tested for the participant's High-Density Lipoprotein (HDL).
Measured: Change from Baseline to 15-Week Post Intervention
Change in Low-Density Lipoprotein (LDL) (Lipid Panels)
Participants whose BMI is at or above the 85th percentile are recruited to participate in the Lipid Panels. Participants who provide consent to participate in the Lipid Panels provide a blood sample through a finger stick which is tested for the participant's Low-Density Lipoprotein (LDL).
Measured: Change from Baseline to 15-Week Post Intervention
Change in Triglycerides (Lipid Panels)
Participants whose BMI is at or above the 85th percentile are recruited to participate in the Lipid Panels. Participants who provide consent to participate in the Lipid Panels provide a blood sample through a finger stick which is tested for the participant's Triglycerides.
Measured: Change from Baseline to 6-Month Post Intervention
Change in Total Cholesterol (Lipid Panels)
Participants whose BMI is at or above the 85th percentile are recruited to participate in the Lipid Panels. Participants who provide consent to participate in the Lipid Panels provide a blood sample through a finger stick which is tested for the participant's Total Cholesterol.
Measured: Change from Baseline to 6-Month Post Intervention
Change in High-Density Lipoprotein (HDL) (Lipid Panels)
Participants whose BMI is at or above the 85th percentile are recruited to participate in the Lipid Panels. Participants who provide consent to participate in the Lipid Panels provide a blood sample through a finger stick which is tested for the participant's High-Density Lipoprotein (HDL).
Measured: Change from Baseline to 6-Month Post Intervention
Change in Low-Density Lipoprotein (LDL) (Lipid Panels)
Participants whose BMI is at or above the 85th percentile are recruited to participate in the Lipid Panels. Participants who provide consent to participate in the Lipid Panels provide a blood sample through a finger stick which is tested for the participant's Low-Density Lipoprotein (LDL).
Measured: Change from Baseline to 6-Month Post Intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2012 (estimated)
- Study startJan 2010
- Primary completionDec 2012 (estimated)
- Study completionJun 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Healthy Lifestyle BehaviorsStudies of the same condition, open and under way.
- More trials run by Arizona State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,219 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arizona State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Sponsor
- Investigators
- Bernadette M Melnyk, PhD, RN, CPNP/PMHNP, FNAP FAAN, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01704768
- Sponsor's protocol ID
- 5R01NR012171
- Other IDs
- 1R01NR012171-01A2
- Status last verified
- Oct 2012
- First submitted
- 12 Sep 2012
- Last updated
- 11 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 33518442McGovern 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.
PubMed 29941235Melnyk 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.
PubMed 24050416
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COPE/Healthy Lifestyles for Teens: A School-Based RCT
- ClinicalTrials.gov ID
- NCT01704768
- Acronym / sponsor ID
- 5R01NR012171
- Keywords
- Randomized Controlled Trial, School-Based Intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,219 participants (actual)
- Lead sponsor
- Arizona State UniversityUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- Jan 2010
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Jun 2013 (estimated)
- First posted
- 11 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COPE/Healthy Lifestyles TEEN Program | Experimental | Behavioral: 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. |
| Healthy Teens Attention Control Program | Placebo comparator | Behavioral: Healthy Teens Attention Control ProgramHealthy 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. |
Who may qualify
- Ages
- 14 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (6 listed)
- Teens who are under age 14 will be excluded because:
- Teens who are over age 16 will be excluded for two key reasons:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COPE/Healthy Lifestyles TEEN Program.Also: Cognitive-Behavioral Skills BuildingThe 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. | Behavioural | COPE/Healthy Lifestyles TEEN Program |
| Healthy Teens Attention Control ProgramAlso: EducationalThe 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). | Behavioural | Healthy Teens Attention Control Program |
Primary outcome
Change in Body Mass Index Percentage (BMI%)
Time frame: Change from Baseline to 12-Month Post intervention
Information regarding the participants age, gender, weight and height at time of data collection provide information to track BMI overtime.
Change in Healthy Lifestyle Behaviors
Time frame: Change from Baseline to 12-Month Post intervention
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 in Depression and Anxiety Symptoms
Time frame: Change from Baseline to 15-Week Post intervention
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.
Social Skills
Time frame: 15-Week Post
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.
Academic Performance
Time frame: 15-Week Post
Academic performance is measured utilizing the student's health class grades
Change in Body Mass Index Percentile (%)
Time frame: Change from Baseline to 6-Month post intervention
Information regarding the participants age, gender, weight and height at time of data collection provide information to track BMI overtime.
Change in Healthy Lifestyle Behaviors
Time frame: Change from Baseline to 6-Month Post intervention
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 in Depression and Anxiety Symptoms
Time frame: Change from Baseline to 6-Month Post intervention
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 in Depression and Anxiety Symptoms
Time frame: Change from Baseline to 12-Month Post intervention
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.
14 secondary outcomes
Change in Healthy Lifestyles Beliefs
Time frame: Change from Baseline to 15-Week Post intervention
Change in Perceived Difficulty of Leading a Healthy Lifestyle
Time frame: Change from Baseline to 15-Week Post intervention
Change in Triglycerides (Lipid Panels)
Time frame: Change from Baseline to 15-Week Post Intervention
Change in Healthy Lifestyles Beliefs
Time frame: Change from Baseline to 6-Months Post intervention
Change in Healthy Lifestyles Beliefs
Time frame: Change from Baseline to 12-Month Post intervention
Change in Perceived Difficulty of Leading a Healthy Lifestyle
Time frame: Change from Baseline to 6-Month Post intervention
Change in Perceived Difficulty of Leading a Healthy Lifestyle
Time frame: Change from Baseline to 12-Month Post intervention
Change in Total Cholesterol (Lipid Panels)
Time frame: Change from Baseline to 15-Week Post Intervention
Change in High-Density Lipoprotein (HDL)(Lipid Panels)
Time frame: Change from Baseline to 15-Week Post Intervention
Change in Low-Density Lipoprotein (LDL) (Lipid Panels)
Time frame: Change from Baseline to 15-Week Post Intervention
Change in Triglycerides (Lipid Panels)
Time frame: Change from Baseline to 6-Month Post Intervention
Change in Total Cholesterol (Lipid Panels)
Time frame: Change from Baseline to 6-Month Post Intervention
Change in High-Density Lipoprotein (HDL) (Lipid Panels)
Time frame: Change from Baseline to 6-Month Post Intervention
Change in Low-Density Lipoprotein (LDL) (Lipid Panels)
Time frame: Change from Baseline to 6-Month Post Intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2012.
- Derived from this study: PubMed 33518442Melnyk 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.
- Derived from this study: PubMed 29941235McGovern 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.
- Derived from this study: PubMed 24050416Melnyk 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bernadette M Melnyk, PhD, RN, CPNP/PMHNP, FNAP FAAN principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing COPE/Healthy Lifestyles TEEN Program. in people with Healthy Lifestyle Behaviors and Depressive/Anxiety Symptoms, run by Arizona State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Body Mass Index Percentage (BMI%) (time frame: Change from Baseline to 12-Month Post intervention). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01704768, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2012.