Promoting Healthy Lifestyle Behaviors

Lifestyle, Healthy Clinical Trial

Official title:

Promote Healthy Lifestyle Behaviors for Adolescents With Mental Health Conditions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05675020
• Other study ID #: STUDY00003072
• Status: Completed
• Phase: N/A
• Start date: October 7, 2022
• Est. completion date: January 13, 2023

Study information

• Verified date: January 2023
• Source: Florida State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: January 13, 2023
• Est. primary completion date: January 13, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

• 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

Related Conditions & MeSH terms

• Lifestyle, Healthy
• Mental Disorders
• Problem Behavior

Intervention

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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Florida State University

Country where clinical trial is conducted

United States, 

References & Publications (24)

Al-Khudairy L, Loveman E, Colquitt JL, Mead E, Johnson RE, Fraser H, Olajide J, Murphy M, Velho RM, O'Malley C, Azevedo LB, Ells LJ, Metzendorf MI, Rees K. Diet, physical activity and behavioural interventions for the treatment of overweight or obese adolescents aged 12 to 17 years. Cochrane Database Syst Rev. 2017 Jun 22;6(6):CD012691. doi: 10.1002/14651858.CD012691. — View Citation

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Loewen OK, Maximova K, Ekwaru JP, Faught EL, Asbridge M, Ohinmaa A, Veugelers PJ. Lifestyle Behavior and Mental Health in Early Adolescence. Pediatrics. 2019 May;143(5):e20183307. doi: 10.1542/peds.2018-3307. Epub 2019 Apr 19. — View Citation

Merlo CL, Jones SE, Michael SL, Chen TJ, Sliwa SA, Lee SH, Brener ND, Lee SM, Park S. Dietary and Physical Activity Behaviors Among High School Students - Youth Risk Behavior Survey, United States, 2019. MMWR Suppl. 2020 Aug 21;69(1):64-76. doi: 10.15585/mmwr.su6901a8. — View Citation

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Nigg CR, Wunsch K, Nigg C, Niessner C, Jekauc D, Schmidt SCE, Woll A. Are Physical Activity, Screen Time, and Mental Health Related During Childhood, Preadolescence, and Adolescence? 11-Year Results From the German Motorik-Modul Longitudinal Study. Am J Epidemiol. 2021 Feb 1;190(2):220-229. doi: 10.1093/aje/kwaa192. — View Citation

Riehm KE, Feder KA, Tormohlen KN, Crum RM, Young AS, Green KM, Pacek LR, La Flair LN, Mojtabai R. Associations Between Time Spent Using Social Media and Internalizing and Externalizing Problems Among US Youth. JAMA Psychiatry. 2019 Dec 1;76(12):1266-1273. doi: 10.1001/jamapsychiatry.2019.2325. — View Citation

Rippe JM. Lifestyle Medicine: The Health Promoting Power of Daily Habits and Practices. Am J Lifestyle Med. 2018 Jul 20;12(6):499-512. doi: 10.1177/1559827618785554. eCollection 2018 Nov-Dec. — View Citation

Rodriguez-Ayllon M, Cadenas-Sanchez C, Estevez-Lopez F, Munoz NE, Mora-Gonzalez J, Migueles JH, Molina-Garcia P, Henriksson H, Mena-Molina A, Martinez-Vizcaino V, Catena A, Lof M, Erickson KI, Lubans DR, Ortega FB, Esteban-Cornejo I. Role of Physical Activity and Sedentary Behavior in the Mental Health of Preschoolers, Children and Adolescents: A Systematic Review and Meta-Analysis. Sports Med. 2019 Sep;49(9):1383-1410. doi: 10.1007/s40279-019-01099-5. — View Citation

Schwartz BS, Glass TA, Pollak J, Hirsch AG, Bailey-Davis L, Moran TH, Bandeen-Roche K. Depression, its comorbidities and treatment, and childhood body mass index trajectories. Obesity (Silver Spring). 2016 Dec;24(12):2585-2592. doi: 10.1002/oby.21627. Epub 2016 Nov 2. — View Citation

Skelton JA, Buehler C, Irby MB, Grzywacz JG. Where are family theories in family-based obesity treatment?: conceptualizing the study of families in pediatric weight management. Int J Obes (Lond). 2012 Jul;36(7):891-900. doi: 10.1038/ijo.2012.56. Epub 2012 Apr 24. — View Citation

Williams YV, Cowan PA, Graff JC. Depressive Symptoms, Body Mass Index, and Physical Activity Self-Efficacy in African American Children. J Child Fam Stud. 2020;29(9):2580-2589. doi: 10.1007/s10826-020-01761-x. Epub 2020 Jun 27. — View Citation

Wu X, Bastian K, Ohinmaa A, Veugelers P. Influence of physical activity, sedentary behavior, and diet quality in childhood on the incidence of internalizing and externalizing disorders during adolescence: a population-based cohort study. Ann Epidemiol. 2018 Feb;28(2):86-94. doi: 10.1016/j.annepidem.2017.12.002. Epub 2017 Dec 11. — View Citation

* Note: There are 24 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	One Month
Primary	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).	One Month

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