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Promoting Healthy Lifestyle Behaviors

Primary Purpose

Behavioral / Psychiatric Disorder, Lifestyle, Healthy

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Zoom Intervention
Sponsored by
Florida State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Behavioral / Psychiatric Disorder focused on measuring Adolescent, Behavioral Health Condition, Behavioral / Psychiatric Disorder, Lifestyle Modification, Lifestyle, Healthy

Eligibility Criteria

12 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

Adolescents, 12-17 years old, with a clinical diagnosis of a mental health condition(s) and their parent/legal guardian. 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), bipolar disorder (BPD). Adolescents that score below 13 on the World Health Organization (Five) Well-Being Index survey or if the adolescent has answered 0 to 1 to any of the five items, they will not be allowed to complete the REDCap survey or participate in the project unless they are currently enrolled in outpatient mental health services (Ex: counseling, therapy, partial hospitalization). Parent(s)/legal guardian(s), 18 years old or older, live with adolescents diagnosed with a mental health condition(s) Inclusion Criteria: Individuals who are not yet adults (Adolescents 12-17 years old) With diagnosed mental health condition (ex: Depression, Anxiety, ADD/ADHD) more than one year ago. Adolescent eligibility determined with WHO-5 screening prior to pre-intervention survey. o Parent(s)/legal guardian(s), 18 years old or order, live with adolescents diagnosed with mental health condition(s) Be able to read/write in English Exclusion Criteria: Children <12 years old or >18 years old Children 12-17 that are wards of the state or any other agency, institution, or entity Adolescent scoring <13 and not currently enrolled in mental health services, or if the adolescent has answered 0 to 1 to any of the five items, on the WHO-5, and not currently enrolled in mental health services. Female participants that report they are pregnant before or after the start of the study will be excluded from the study. Parent(s)/legal guardian(s) < 18 years old Non-legal guardians

Sites / Locations

  • Wolfson Children's Hospital- Intensive Outpatient Behavioral Health Program (IOP) and the Partial Hospitalization Program (PHP) and Bridge Program

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Parent-Adolescent Dyad

Arm Description

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.

Outcomes

Primary Outcome Measures

Evaluate a change in healthy lifestyle behavior knowledge with a questionnaire.
Evaluate a change in 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).
Evaluate a change in healthy lifestyle behaviors with a questionnaire.
Evaluate a change in 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).

Secondary Outcome Measures

Full Information

First Posted
December 14, 2022
Last Updated
January 30, 2023
Sponsor
Florida State University
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1. Study Identification

Unique Protocol Identification Number
NCT05675020
Brief Title
Promoting Healthy Lifestyle Behaviors
Official Title
Promote Healthy Lifestyle Behaviors for Adolescents With Mental Health Conditions
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
October 7, 2022 (Actual)
Primary Completion Date
January 13, 2023 (Actual)
Study Completion Date
January 13, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Florida State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study's purpose is to identify factors that may aid in answering the clinical question: Among adolescents 12-17 years old who are diagnosed with a mental health condition(s), does a family-based educational intervention improve healthy lifestyle knowledge and behaviors, including nutrition, PA, screen time, and sleep? The specific aims are to: Aim 1: To educate adolescents with mental health conditions and their family members about ways to improve healthy lifestyle behaviors. Aim 2: To evaluate an increase in knowledge on healthy lifestyle behaviors after a 45-minute online education session. Aim 3: To evaluate an increase in healthy lifestyle behaviors after the intervention. This project utilizes a one-group pretest-posttest design study for 30 adolescents (aged 12-17 years) diagnosed with a mental health condition(s) and their parent/legal guardian. This project will implement best practices to promote healthy lifestyle knowledge and behaviors to adolescents and their parent(s)/legal guardian(s). This will be a 45-minute educational presentation delivered via Zoom. Participants will have option to select between 2-3 dates and times for educational presentation. The investigators 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. The survey will utilize an adapted version of the 2021 National Youth Risk Behavior Survey (YRBS) and the 2020 National Survey of Children's Health (NSCH-T3). The analysis of this project will compare changes in healthy lifestyle knowledge and behaviors using a paired t-test. The educational presentation will be recorded and emailed to participants within 1 week of intervention to re-watch/review.
Detailed Description
The pediatric population faces a public health crisis involving children and adolescents with overweight or obesity. Childhood obesity has become the most disconcerting and predominant pediatric nutritional disorder worldwide. From 2017 to 2018, 19.3% of the children and adolescents in the United States (US) were diagnosed with obesity. Childhood obesity has been linked to psychological conditions such as depression and anxiety. Children that are overweight or obese are more commonly diagnosed with depression than children with a healthy weight. In 2019, 13.6% of children five to seventeen years old received mental health treatment in twelve months, and 8.4% of that population had taken psychotropic medication for their mental health condition. Healthy lifestyle behaviors impact short and long-term health and quality of life among children with depression. Physical activity (PA), healthy nutritional habits, and maintaining a healthy weight can improve children's quality of life with depression and overweight or obesity. Parents have the most significant influence on their children's health. Thus, family-based intervention studies have been conducted to promote children's healthy lifestyle behaviors. Behavioral interventions that combine nutritional, physical, and behavioral components and parental involvement have proven to be the best and most effective practice for treating and preventing childhood obesity among adolescents 12-17 years old. Although there is evidence to support that adolescents benefit from peer and family support and group education, there are few in-depth studies documenting lifestyle modifications that can improve this population's overall physical and mental health. Given this lack of implementation into practice, this project aims to improve healthy lifestyle knowledge and behaviors among adolescents with a mental health condition(s) through preventative and detailed nutritional, physical activity, screen time, and sleep education. This study's purpose is to identify factors that may aid in answering the clinical question: Among adolescents 12-17 years old who are diagnosed with a mental health condition(s), does a family-based educational intervention improve healthy lifestyle knowledge and behaviors, including nutrition, PA, screen time, and sleep? The specific aims are to: Aim 1: To educate adolescents with mental health conditions and their family members about ways to improve healthy lifestyle behaviors. Aim 2: To evaluate an increase in knowledge on healthy lifestyle behaviors after a 45-minute online education session. Aim 3: To evaluate an increase in healthy lifestyle behaviors after the intervention.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Behavioral / Psychiatric Disorder, Lifestyle, Healthy
Keywords
Adolescent, Behavioral Health Condition, Behavioral / Psychiatric Disorder, Lifestyle Modification, Lifestyle, Healthy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This project utilizes a one-group pretest-posttest design study for 9 adolescents (aged 12-17 years) diagnosed with a mental health condition(s) and their parent/legal guardian. This educational program will be delivered via a 45-minute presentation via Zoom. Participants will have the option to select between multiple dates and times for educational presentation The educational presentation will be recorded and emailed to participants within 1 week of intervention to re-watch/review. The educational program will promote healthy lifestyle knowledge and behaviors through education evidenced by the Centers for Disease Control (CDC), World Health Organization (WHO), and the American Academy of Pediatrics. 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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Parent-Adolescent Dyad
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Zoom Intervention
Intervention Description
This educational program will be delivered via a 45-minute presentation via Zoom. The educational presentation will be recorded and emailed to participants within 1 week of intervention to re-watch/review. The educational program will promote a 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. 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.
Primary Outcome Measure Information:
Title
Evaluate a change in healthy lifestyle behavior knowledge with a questionnaire.
Description
Evaluate a change in 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).
Time Frame
One Month
Title
Evaluate a change in healthy lifestyle behaviors with a questionnaire.
Description
Evaluate a change in 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).
Time Frame
One Month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Adolescents, 12-17 years old, with a clinical diagnosis of a mental health condition(s) and their parent/legal guardian. 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), bipolar disorder (BPD). Adolescents that score below 13 on the World Health Organization (Five) Well-Being Index survey or if the adolescent has answered 0 to 1 to any of the five items, they will not be allowed to complete the REDCap survey or participate in the project unless they are currently enrolled in outpatient mental health services (Ex: counseling, therapy, partial hospitalization). Parent(s)/legal guardian(s), 18 years old or older, live with adolescents diagnosed with a mental health condition(s) Inclusion Criteria: Individuals who are not yet adults (Adolescents 12-17 years old) With diagnosed mental health condition (ex: Depression, Anxiety, ADD/ADHD) more than one year ago. Adolescent eligibility determined with WHO-5 screening prior to pre-intervention survey. o Parent(s)/legal guardian(s), 18 years old or order, live with adolescents diagnosed with mental health condition(s) Be able to read/write in English Exclusion Criteria: Children <12 years old or >18 years old Children 12-17 that are wards of the state or any other agency, institution, or entity Adolescent scoring <13 and not currently enrolled in mental health services, or if the adolescent has answered 0 to 1 to any of the five items, on the WHO-5, and not currently enrolled in mental health services. Female participants that report they are pregnant before or after the start of the study will be excluded from the study. Parent(s)/legal guardian(s) < 18 years old Non-legal guardians
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary Livings
Organizational Affiliation
Florida State University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Rachel L Sharp, BSN
Organizational Affiliation
Florida State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wolfson Children's Hospital- Intensive Outpatient Behavioral Health Program (IOP) and the Partial Hospitalization Program (PHP) and Bridge Program
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
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Promoting Healthy Lifestyle Behaviors

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