Clincosm LogoSign in Get a demo

Promoting Healthy Lifestyle Behaviors

Sponsor
Florida State University (Other)
Overall Status
Completed
CT.gov ID
NCT05675020
Collaborator
(none)
9
Enrollment
1
Location
1
Arm
3.2
Actual Duration (Months)
2.8
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Zoom Intervention
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
9 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention 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.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)
Primary Purpose:
Treatment
Official Title:
Promote Healthy Lifestyle Behaviors for Adolescents With Mental Health Conditions
Actual Study Start Date :
Oct 7, 2022
Actual Primary Completion Date :
Jan 13, 2023
Actual Study Completion Date :
Jan 13, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Behavioral: Zoom Intervention
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.

Outcome Measures

Primary Outcome Measures

  1. Evaluate a change in healthy lifestyle behavior knowledge with a questionnaire. [One Month]

    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).

  2. Evaluate a change in healthy lifestyle behaviors with a questionnaire. [One Month]

    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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
12 Years to 17 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes

  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Wolfson Children's Hospital- Intensive Outpatient Behavioral Health Program (IOP) and the Partial Hospitalization Program (PHP) and Bridge Program Jacksonville Florida United States 32207

Sponsors and Collaborators

  • Florida State University

Investigators

  • Study Chair: Mary Livings, Florida State University
  • Principal Investigator: Rachel L Sharp, BSN, Florida State University

Study Documents (Full-Text)

More Information

Additional Information:

Publications

Responsible Party:
Rachel Sharp, Principal Investigator, Florida State University
ClinicalTrials.gov Identifier:
NCT05675020
Other Study ID Numbers:
  • STUDY00003072
First Posted:
Jan 9, 2023
Last Update Posted:
Feb 1, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Rachel Sharp, Principal Investigator, Florida State University
Adolescent
Behavioral Health Condition
Behavioral / Psychiatric Disorder
Lifestyle Modification
Lifestyle
Healthy
Additional relevant MeSH terms:
Mental Disorders
Problem Behavior

Study Results

No Results Posted as of Feb 1, 2023