Trial Outcomes & Findings for Promoting Healthy Lifestyle Behaviors (NCT NCT05675020)

NCT ID: NCT05675020

Last Updated: 2024-11-15

Results Overview

Evaluate knowledge on healthy lifestyle behaviors before and one month after a 45-minute online educational session using a questionnaire (the same questionnaire for before and after intervention).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

86 participants

Primary outcome timeframe

One Month

Results posted on

2024-11-15

Participant Flow

This project enrolled 86 parent-adolescent dyads total (1 parent and 1 adolescent per dyad), and nine parent-adolescent dyads total completed the study. The setting was the Intensive Outpatient Behavioral Health Program (IOP), the Partial Hospitalization Program (PHP), and the Bridge Program at Wolfson Children Hospital in Jacksonville, Fl. Recruitment included posting approved project flyers on social media platforms such as Facebook and Instagram.

Participant milestones

Participant milestones
Measure
Parent-Adolescent Dyad
Each parent-adolescent dyad will receive the intervention (educational program delivered via a 45-minute presentation via Zoom). The educational program will promote healthy lifestyle knowledge and behaviors through education evidenced by the CDC, WHO, and the American Academy of Pediatrics. Educational sessions will include the importance of healthy lifestyle modifications in the adolescent population with a mental health condition(s), lifestyle recommendations versus reality, nutrition, physical activity, screen time, and sleep recommendations and guidelines. The educational presentation will include 5-10 minutes of education regarding recommendations versus reality for nutrition, PA, screen time, and sleep, 20-25 minutes of education regarding ways to improve healthy lifestyle knowledge and behaviors, 10 minutes for questions and discussion. Zoom Intervention * The educational presentation will be recorded and emailed to participants within 1 week of intervention to re-watch/review. * Educational sessions will include the importance of healthy lifestyle modifications in the adolescent population with a mental health condition(s), lifestyle recommendations versus reality, nutrition, physical activity, screen time, and sleep recommendations and guidelines. * We will compare the effects of an educational program on healthy lifestyle knowledge and behaviors pre-and post-program (after one month) via a REDCap survey for the adolescent and their parent/legal guardian.
Overall Study
STARTED
86
Overall Study
COMPLETED
9
Overall Study
NOT COMPLETED
77

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Parent-Adolescent Dyad is presented separately to distinguish parent participants from adolescent participants.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Pre-Intervention
n=18 Participants
Participants (Dyads) who completed the pre-survey
Age, Categorical
Parents/Legal Guardians · <=18 years
9 Participants
n=9 Participants • The Parent-Adolescent Dyad is presented separately to distinguish parent participants from adolescent participants.
Age, Categorical
Parents/Legal Guardians · Between 18 and 65 years
0 Participants
n=9 Participants • The Parent-Adolescent Dyad is presented separately to distinguish parent participants from adolescent participants.
Age, Categorical
Parents/Legal Guardians · >=65 years
0 Participants
n=9 Participants • The Parent-Adolescent Dyad is presented separately to distinguish parent participants from adolescent participants.
Age, Categorical
Adolescents · <=18 years
0 Participants
n=9 Participants • The Parent-Adolescent Dyad is presented separately to distinguish parent participants from adolescent participants.
Age, Categorical
Adolescents · Between 18 and 65 years
9 Participants
n=9 Participants • The Parent-Adolescent Dyad is presented separately to distinguish parent participants from adolescent participants.
Age, Categorical
Adolescents · >=65 years
0 Participants
n=9 Participants • The Parent-Adolescent Dyad is presented separately to distinguish parent participants from adolescent participants.
Age, Continuous
24 years
n=18 Participants
Age, Customized
Parent/Legal Guardians
30 years
n=9 Participants • The Parent-Adolescent Dyad is presented separately to distinguish parent participants from adolescent participants.
Age, Customized
Adolescents
14 years
n=9 Participants • The Parent-Adolescent Dyad is presented separately to distinguish parent participants from adolescent participants.
Sex/Gender, Customized
Parent/Legal Guardians · Male
6 Participants
n=9 Participants • Separate parent/legal guardians from adolescents.
Sex/Gender, Customized
Parent/Legal Guardians · Female
3 Participants
n=9 Participants • Separate parent/legal guardians from adolescents.
Sex/Gender, Customized
Adolescents · Male
6 Participants
n=9 Participants • Separate parent/legal guardians from adolescents.
Sex/Gender, Customized
Adolescents · Female
3 Participants
n=9 Participants • Separate parent/legal guardians from adolescents.
Sex: Female, Male
Female
6 Participants
n=18 Participants
Sex: Female, Male
Male
12 Participants
n=18 Participants
Ethnicity (NIH/OMB)
Parents/Legal Guardians · Hispanic or Latino
3 Participants
n=9 Participants • The Parent-Adolescent Dyad is presented separately to distinguish parent participants from adolescent participants.
Ethnicity (NIH/OMB)
Parents/Legal Guardians · Not Hispanic or Latino
4 Participants
n=9 Participants • The Parent-Adolescent Dyad is presented separately to distinguish parent participants from adolescent participants.
Ethnicity (NIH/OMB)
Parents/Legal Guardians · Unknown or Not Reported
2 Participants
n=9 Participants • The Parent-Adolescent Dyad is presented separately to distinguish parent participants from adolescent participants.
Ethnicity (NIH/OMB)
Adolescents · Hispanic or Latino
6 Participants
n=9 Participants • The Parent-Adolescent Dyad is presented separately to distinguish parent participants from adolescent participants.
Ethnicity (NIH/OMB)
Adolescents · Not Hispanic or Latino
3 Participants
n=9 Participants • The Parent-Adolescent Dyad is presented separately to distinguish parent participants from adolescent participants.
Ethnicity (NIH/OMB)
Adolescents · Unknown or Not Reported
0 Participants
n=9 Participants • The Parent-Adolescent Dyad is presented separately to distinguish parent participants from adolescent participants.
Race (NIH/OMB)
Parents/Legal Guardians · American Indian or Alaska Native
0 Participants
n=9 Participants • The Parent-Adolescent Dyad is presented separately to distinguish parent participants from adolescent participants.
Race (NIH/OMB)
Parents/Legal Guardians · Asian
0 Participants
n=9 Participants • The Parent-Adolescent Dyad is presented separately to distinguish parent participants from adolescent participants.
Race (NIH/OMB)
Parents/Legal Guardians · Native Hawaiian or Other Pacific Islander
0 Participants
n=9 Participants • The Parent-Adolescent Dyad is presented separately to distinguish parent participants from adolescent participants.
Race (NIH/OMB)
Parents/Legal Guardians · Black or African American
6 Participants
n=9 Participants • The Parent-Adolescent Dyad is presented separately to distinguish parent participants from adolescent participants.
Race (NIH/OMB)
Parents/Legal Guardians · White
2 Participants
n=9 Participants • The Parent-Adolescent Dyad is presented separately to distinguish parent participants from adolescent participants.
Race (NIH/OMB)
Parents/Legal Guardians · More than one race
0 Participants
n=9 Participants • The Parent-Adolescent Dyad is presented separately to distinguish parent participants from adolescent participants.
Race (NIH/OMB)
Parents/Legal Guardians · Unknown or Not Reported
1 Participants
n=9 Participants • The Parent-Adolescent Dyad is presented separately to distinguish parent participants from adolescent participants.
Race (NIH/OMB)
Adolescents · American Indian or Alaska Native
0 Participants
n=9 Participants • The Parent-Adolescent Dyad is presented separately to distinguish parent participants from adolescent participants.
Race (NIH/OMB)
Adolescents · Asian
0 Participants
n=9 Participants • The Parent-Adolescent Dyad is presented separately to distinguish parent participants from adolescent participants.
Race (NIH/OMB)
Adolescents · Native Hawaiian or Other Pacific Islander
0 Participants
n=9 Participants • The Parent-Adolescent Dyad is presented separately to distinguish parent participants from adolescent participants.
Race (NIH/OMB)
Adolescents · Black or African American
6 Participants
n=9 Participants • The Parent-Adolescent Dyad is presented separately to distinguish parent participants from adolescent participants.
Race (NIH/OMB)
Adolescents · White
2 Participants
n=9 Participants • The Parent-Adolescent Dyad is presented separately to distinguish parent participants from adolescent participants.
Race (NIH/OMB)
Adolescents · More than one race
0 Participants
n=9 Participants • The Parent-Adolescent Dyad is presented separately to distinguish parent participants from adolescent participants.
Race (NIH/OMB)
Adolescents · Unknown or Not Reported
1 Participants
n=9 Participants • The Parent-Adolescent Dyad is presented separately to distinguish parent participants from adolescent participants.
Region of Enrollment
United States · Parents/Legal Guardians
9 Participants
n=18 Participants • The Parent-Adolescent Dyad is presented separately to distinguish parent participants from adolescent participants.
Region of Enrollment
United States · Adolescents
9 Participants
n=18 Participants • The Parent-Adolescent Dyad is presented separately to distinguish parent participants from adolescent participants.
Age of Diagnosis for Adolescent Participants Only
12 years
n=9 Participants • The Parent-Adolescent Dyad is presented separately to distinguish parent participants from adolescent participants.
Parent/Legal Guardian Mood
4 Units on a scale
n=9 Participants • The Parent-Adolescent Dyad is presented separately to distinguish parent participants from adolescent participants.
Adolescent Weight
106 lbs
n=9 Participants • The Parent-Adolescent Dyad is presented separately to distinguish parent participants from adolescent participants.

PRIMARY outcome

Timeframe: One Month

Population: This project included nine parent-adolescent dyads. Examples of eligible diagnosed mental health conditions include major depressive disorder (MDD), generalized anxiety disorder (GAD), attention-deficit disorder (ADD)/ attention deficit hyperactivity disorder (ADHD), and bipolar disorder (BPD). Participants' exclusion criteria include children under 12 years old or older than 18 years old. Non-legal guardians were unable to participate in the project.

Evaluate knowledge on healthy lifestyle behaviors before and one month after a 45-minute online educational session using a questionnaire (the same questionnaire for before and after intervention).

Outcome measures

Outcome measures
Measure
Parent/Legal Guardian (LG) Pre-Intervention Knowledge Changes
n=9 Participants
Parent/legal guardians of adolescents 12-17 years old with a clinical diagnosis of a mental health condition(s)
Parent/Legal Guardian (LG) Post-Intervention Knowledge Changes
n=9 Participants
Parent/legal guardians of adolescents 12-17 years old with a clinical diagnosis of a mental health condition(s)
Adolescent Pre-Intervention Knowledge Changes
n=9 Participants
Adolescents 12-17 years old with a clinical diagnosis of a mental health condition(s)
Adolescent Post-Intervention Knowledge Changes
n=9 Participants
Adolescents 12-17 years old with a clinical diagnosis of a mental health condition(s)
Percent of Participants With Correct Responses for Healthy Lifestyle Behavior Knowledge Survey Questions.
Carbohydrates per day
33 percentage of participants
44 percentage of participants
56 percentage of participants
33 percentage of participants
Percent of Participants With Correct Responses for Healthy Lifestyle Behavior Knowledge Survey Questions.
Cups of fruit per day
44 percentage of participants
67 percentage of participants
56 percentage of participants
33 percentage of participants
Percent of Participants With Correct Responses for Healthy Lifestyle Behavior Knowledge Survey Questions.
Cups of Veggies per day
44 percentage of participants
56 percentage of participants
33 percentage of participants
44 percentage of participants
Percent of Participants With Correct Responses for Healthy Lifestyle Behavior Knowledge Survey Questions.
Cups of water per day
22 percentage of participants
44 percentage of participants
22 percentage of participants
33 percentage of participants
Percent of Participants With Correct Responses for Healthy Lifestyle Behavior Knowledge Survey Questions.
Healthy snack
44 percentage of participants
44 percentage of participants
44 percentage of participants
56 percentage of participants
Percent of Participants With Correct Responses for Healthy Lifestyle Behavior Knowledge Survey Questions.
Aerobic Exercise per week
44 percentage of participants
44 percentage of participants
44 percentage of participants
89 percentage of participants
Percent of Participants With Correct Responses for Healthy Lifestyle Behavior Knowledge Survey Questions.
Example of Aerobic Activity
33 percentage of participants
44 percentage of participants
22 percentage of participants
56 percentage of participants
Percent of Participants With Correct Responses for Healthy Lifestyle Behavior Knowledge Survey Questions.
Example of BS Activity
33 percentage of participants
0 percentage of participants
0 percentage of participants
11 percentage of participants
Percent of Participants With Correct Responses for Healthy Lifestyle Behavior Knowledge Survey Questions.
Example of MS Activity
67 percentage of participants
33 percentage of participants
33 percentage of participants
33 percentage of participants
Percent of Participants With Correct Responses for Healthy Lifestyle Behavior Knowledge Survey Questions.
Exercise per day
33 percentage of participants
44 percentage of participants
22 percentage of participants
44 percentage of participants
Percent of Participants With Correct Responses for Healthy Lifestyle Behavior Knowledge Survey Questions.
Average screen time
11 percentage of participants
22 percentage of participants
0 percentage of participants
11 percentage of participants
Percent of Participants With Correct Responses for Healthy Lifestyle Behavior Knowledge Survey Questions.
Recommended screen time
22 percentage of participants
11 percentage of participants
11 percentage of participants
0 percentage of participants
Percent of Participants With Correct Responses for Healthy Lifestyle Behavior Knowledge Survey Questions.
Reduce screen time
33 percentage of participants
11 percentage of participants
44 percentage of participants
22 percentage of participants
Percent of Participants With Correct Responses for Healthy Lifestyle Behavior Knowledge Survey Questions.
Recommended hours of sleep
44 percentage of participants
11 percentage of participants
11 percentage of participants
22 percentage of participants
Percent of Participants With Correct Responses for Healthy Lifestyle Behavior Knowledge Survey Questions.
Risk of poor sleep
33 percentage of participants
22 percentage of participants
33 percentage of participants
22 percentage of participants
Percent of Participants With Correct Responses for Healthy Lifestyle Behavior Knowledge Survey Questions.
Sleep quality
67 percentage of participants
56 percentage of participants
33 percentage of participants
56 percentage of participants

PRIMARY outcome

Timeframe: One Month

Population: WHO-5 Analysis for Adolescent participants only.

Evaluate healthy lifestyle behaviors before and one month after a 45-minute online educational session using a questionnaire (the same questionnaire for before and after intervention). The scale was adapted from 2021 United States Census Bureau Questionnaire, 2001 PHQ-9, 2021 National Youth Physical Activity and Nutrition Study, and 2021 Youth Risk Behavior Surveillance System Questionnaire. High scores represent better outcomes. The subscale range for each question is as follows: Drink Water 1-7, Eat Breakfast 1-8, Eat dairy products 1-7, eat family dinner 1-8, eat fruit 1-7, eat whole grains 1-7, where do you eat dinner 1-7, eat vegetables 1-7, active 60min/day 1-8, aerobic activity 1-8, Muscle Strengthening Activity 1-8, sports teams 1-4, Bed at Same Time 1-6, Bedtime 7-12, Hours of Sleep 3-12, Nap during day 1-6, restless sleep 1-6, Tired during day 1-6, where do you sleep 1-7, awaken during night 1-6, WHO final score 0-25, afford food 1-3, family dinner 1-8, family exercise 1-8.

Outcome measures

Outcome measures
Measure
Parent/Legal Guardian (LG) Pre-Intervention Knowledge Changes
n=9 Participants
Parent/legal guardians of adolescents 12-17 years old with a clinical diagnosis of a mental health condition(s)
Parent/Legal Guardian (LG) Post-Intervention Knowledge Changes
n=9 Participants
Parent/legal guardians of adolescents 12-17 years old with a clinical diagnosis of a mental health condition(s)
Adolescent Pre-Intervention Knowledge Changes
n=9 Participants
Adolescents 12-17 years old with a clinical diagnosis of a mental health condition(s)
Adolescent Post-Intervention Knowledge Changes
n=9 Participants
Adolescents 12-17 years old with a clinical diagnosis of a mental health condition(s)
Median Score on a Scale of Participants Responses for Healthy Lifestyle Behavior Knowledge Survey Questions
Drink Water
5 score on a scale
Interval 1.0 to 7.0
5 score on a scale
Interval 1.0 to 7.0
4 score on a scale
Interval 1.0 to 7.0
5 score on a scale
Interval 1.0 to 7.0
Median Score on a Scale of Participants Responses for Healthy Lifestyle Behavior Knowledge Survey Questions
Eat Breakfast
5 score on a scale
Interval 1.0 to 8.0
6 score on a scale
Interval 1.0 to 8.0
4 score on a scale
Interval 1.0 to 8.0
5 score on a scale
Interval 1.0 to 8.0
Median Score on a Scale of Participants Responses for Healthy Lifestyle Behavior Knowledge Survey Questions
Eat Dairy Products
4 score on a scale
Interval 1.0 to 7.0
6 score on a scale
Interval 1.0 to 7.0
5 score on a scale
Interval 1.0 to 7.0
5 score on a scale
Interval 1.0 to 7.0
Median Score on a Scale of Participants Responses for Healthy Lifestyle Behavior Knowledge Survey Questions
Eat Family Dinner
5 score on a scale
Interval 1.0 to 8.0
5 score on a scale
Interval 1.0 to 8.0
5.5 score on a scale
Interval 1.0 to 8.0
6 score on a scale
Interval 1.0 to 8.0
Median Score on a Scale of Participants Responses for Healthy Lifestyle Behavior Knowledge Survey Questions
Eat Fruit
4 score on a scale
Interval 1.0 to 7.0
4 score on a scale
Interval 1.0 to 7.0
3.5 score on a scale
Interval 1.0 to 7.0
5 score on a scale
Interval 1.0 to 7.0
Median Score on a Scale of Participants Responses for Healthy Lifestyle Behavior Knowledge Survey Questions
Eat Whole Grains
5 score on a scale
Interval 1.0 to 7.0
6 score on a scale
Interval 1.0 to 7.0
4 score on a scale
Interval 1.0 to 7.0
5 score on a scale
Interval 1.0 to 7.0
Median Score on a Scale of Participants Responses for Healthy Lifestyle Behavior Knowledge Survey Questions
Where do You Eat Dinner
4 score on a scale
Interval 1.0 to 7.0
3.5 score on a scale
Interval 1.0 to 7.0
2.5 score on a scale
Interval 1.0 to 7.0
2 score on a scale
Interval 1.0 to 7.0
Median Score on a Scale of Participants Responses for Healthy Lifestyle Behavior Knowledge Survey Questions
Eat Vegetables
3 score on a scale
Interval 1.0 to 7.0
4 score on a scale
Interval 1.0 to 7.0
4 score on a scale
Interval 1.0 to 7.0
5 score on a scale
Interval 1.0 to 7.0
Median Score on a Scale of Participants Responses for Healthy Lifestyle Behavior Knowledge Survey Questions
Active 60min/day
4 score on a scale
Interval 1.0 to 8.0
5 score on a scale
Interval 1.0 to 8.0
4 score on a scale
Interval 1.0 to 8.0
5 score on a scale
Interval 1.0 to 8.0
Median Score on a Scale of Participants Responses for Healthy Lifestyle Behavior Knowledge Survey Questions
Aerobic Activity
5 score on a scale
Interval 1.0 to 8.0
5 score on a scale
Interval 1.0 to 8.0
4 score on a scale
Interval 1.0 to 8.0
5 score on a scale
Interval 1.0 to 8.0
Median Score on a Scale of Participants Responses for Healthy Lifestyle Behavior Knowledge Survey Questions
Muscle Strengthening Activity
5 score on a scale
Interval 1.0 to 8.0
6 score on a scale
Interval 1.0 to 8.0
5 score on a scale
Interval 1.0 to 8.0
5 score on a scale
Interval 1.0 to 8.0
Median Score on a Scale of Participants Responses for Healthy Lifestyle Behavior Knowledge Survey Questions
Sports Teams
2 score on a scale
Interval 1.0 to 4.0
3 score on a scale
Interval 1.0 to 4.0
2 score on a scale
Interval 1.0 to 4.0
3 score on a scale
Interval 1.0 to 4.0
Median Score on a Scale of Participants Responses for Healthy Lifestyle Behavior Knowledge Survey Questions
Bed at Same Time
3 score on a scale
Interval 1.0 to 6.0
3 score on a scale
Interval 1.0 to 6.0
4 score on a scale
Interval 1.0 to 6.0
4 score on a scale
Interval 1.0 to 6.0
Median Score on a Scale of Participants Responses for Healthy Lifestyle Behavior Knowledge Survey Questions
Bedtime
8 score on a scale
Interval 7.0 to 12.0
8 score on a scale
Interval 7.0 to 12.0
8 score on a scale
Interval 7.0 to 12.0
8 score on a scale
Interval 7.0 to 12.0
Median Score on a Scale of Participants Responses for Healthy Lifestyle Behavior Knowledge Survey Questions
Hours of Sleep
6 score on a scale
Interval 3.0 to 12.0
6 score on a scale
Interval 3.0 to 12.0
6 score on a scale
Interval 3.0 to 12.0
7.5 score on a scale
Interval 3.0 to 12.0
Median Score on a Scale of Participants Responses for Healthy Lifestyle Behavior Knowledge Survey Questions
Nap During Day
3 score on a scale
Interval 1.0 to 6.0
3 score on a scale
Interval 1.0 to 6.0
3.5 score on a scale
Interval 1.0 to 6.0
4 score on a scale
Interval 1.0 to 6.0
Median Score on a Scale of Participants Responses for Healthy Lifestyle Behavior Knowledge Survey Questions
Restless Sleep
3 score on a scale
Interval 1.0 to 6.0
4 score on a scale
Interval 1.0 to 6.0
4 score on a scale
Interval 1.0 to 6.0
4 score on a scale
Interval 1.0 to 6.0
Median Score on a Scale of Participants Responses for Healthy Lifestyle Behavior Knowledge Survey Questions
Tired During Day
4 score on a scale
Interval 1.0 to 6.0
4 score on a scale
Interval 1.0 to 6.0
4 score on a scale
Interval 1.0 to 6.0
4 score on a scale
Interval 1.0 to 6.0
Median Score on a Scale of Participants Responses for Healthy Lifestyle Behavior Knowledge Survey Questions
Where do You Sleep
2 score on a scale
Interval 1.0 to 7.0
2 score on a scale
Interval 1.0 to 7.0
2 score on a scale
Interval 1.0 to 7.0
1 score on a scale
Interval 1.0 to 7.0
Median Score on a Scale of Participants Responses for Healthy Lifestyle Behavior Knowledge Survey Questions
Awaken During Night
4 score on a scale
Interval 1.0 to 6.0
4 score on a scale
Interval 1.0 to 6.0
3.5 score on a scale
Interval 1.0 to 6.0
4 score on a scale
Interval 1.0 to 6.0
Median Score on a Scale of Participants Responses for Healthy Lifestyle Behavior Knowledge Survey Questions
WHO-5 Final Score
13 score on a scale
Interval 0.0 to 25.0
16 score on a scale
Interval 0.0 to 25.0
Median Score on a Scale of Participants Responses for Healthy Lifestyle Behavior Knowledge Survey Questions
Afford Food
2 score on a scale
Interval 1.0 to 3.0
2 score on a scale
Interval 1.0 to 3.0
2 score on a scale
Interval 1.0 to 3.0
2 score on a scale
Interval 1.0 to 3.0
Median Score on a Scale of Participants Responses for Healthy Lifestyle Behavior Knowledge Survey Questions
Family Dinner
4 score on a scale
Interval 1.0 to 8.0
5 score on a scale
Interval 1.0 to 8.0
4.5 score on a scale
Interval 1.0 to 8.0
6 score on a scale
Interval 1.0 to 8.0
Median Score on a Scale of Participants Responses for Healthy Lifestyle Behavior Knowledge Survey Questions
Family Exercise
5 score on a scale
Interval 1.0 to 8.0
5 score on a scale
Interval 1.0 to 8.0
3 score on a scale
Interval 1.0 to 8.0
5 score on a scale
Interval 1.0 to 8.0

Adverse Events

Parent/Legal Guardian (LG) Pre-Intervention Knowledge Changes

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Parent/Legal Guardian (LG) Post-Intervention Knowledge Changes

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Adolescent Pre-Intervention Knowledge Changes

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Adolescent Post-Intervention Knowledge Changes

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Rachel Sharp

Florida State University

Phone: 850-865-4443

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place