Promoting Healthy Lifestyle Behaviors

NCT05675020 | Completed Results

• 1 other identifier: STUDY00003072
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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.

Conditions

Behavioral / Psychiatric Disorder; Lifestyle, Healthy

Keywords

Adolescent; Behavioral Health Condition; Behavioral / Psychiatric Disorder; Lifestyle Modification; Lifestyle; Healthy

Outcome Measures

Primary Outcomes (2)

• Percent of Participants With Correct Responses for Healthy Lifestyle Behavior Knowledge Survey Questions.

  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).

  One Month

• Median Score on a Scale of Participants Responses for Healthy Lifestyle Behavior Knowledge Survey Questions

  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.

  One Month

Study Arms (1)

Parent-Adolescent Dyad

EXPERIMENTAL

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

Interventions

Zoom Intervention BEHAVIORAL

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.

Parent-Adolescent Dyad

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Florida State University: lead

Study Sites (1)

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

Jacksonville, Florida, 32207, United States

Location

Related Publications (24)

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• Gidugu V, Jacobs ML. Empowering individuals with mental illness to develop healthy eating habits through mindful eating: results of a program evaluation. Psychol Health Med. 2019 Feb;24(2):177-186. doi: 10.1080/13548506.2018.1516295. Epub 2018 Aug 31.

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• Ivey-Stephenson AZ, Demissie Z, Crosby AE, Stone DM, Gaylor E, Wilkins N, Lowry R, Brown M. Suicidal Ideation and Behaviors Among High School Students - Youth Risk Behavior Survey, United States, 2019. MMWR Suppl. 2020 Aug 21;69(1):47-55. doi: 10.15585/mmwr.su6901a6.

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• Kansra AR, Lakkunarajah S, Jay MS. Childhood and Adolescent Obesity: A Review. Front Pediatr. 2021 Jan 12;8:581461. doi: 10.3389/fped.2020.581461. eCollection 2020.

  PMID: 33511092 BACKGROUND

• Leeb RT, Bitsko RH, Radhakrishnan L, Martinez P, Njai R, Holland KM. Mental Health-Related Emergency Department Visits Among Children Aged <18 Years During the COVID-19 Pandemic - United States, January 1-October 17, 2020. MMWR Morb Mortal Wkly Rep. 2020 Nov 13;69(45):1675-1680. doi: 10.15585/mmwr.mm6945a3.

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• Lindberg L, Hagman E, Danielsson P, Marcus C, Persson M. Anxiety and depression in children and adolescents with obesity: a nationwide study in Sweden. BMC Med. 2020 Feb 21;18(1):30. doi: 10.1186/s12916-020-1498-z.

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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.

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• Morrison KM, Shin S, Tarnopolsky M, Taylor VH. Association of depression & health related quality of life with body composition in children and youth with obesity. J Affect Disord. 2015 Feb 1;172:18-23. doi: 10.1016/j.jad.2014.09.014. Epub 2014 Sep 23.

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• Naar S, Ellis D, Idalski Carcone A, Jacques-Tiura AJ, Cunningham P, Templin T, Hartlieb KB, Jen KC. Outcomes From a Sequential Multiple Assignment Randomized Trial of Weight Loss Strategies for African American Adolescents With Obesity. Ann Behav Med. 2019 Aug 29;53(10):928-938. doi: 10.1093/abm/kaz003.

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MeSH Terms

Conditions

Behavior; Mental Disorders

Results Point of Contact

• Title: Rachel Sharp
• Organization: Florida State University

rls14c@fsu.edu

850-865-4443

Study Officials

• Mary Livings

  Florida State University

  STUDY CHAIR

• Rachel L Sharp, BSN

  Florida State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: * 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.

Study Record Dates

• First Submitted: December 14, 2022
• First Posted: January 9, 2023
• Study Start: October 7, 2022
• Primary Completion: January 13, 2023
• Study Completion: January 13, 2023
• Last Updated: November 15, 2024
• Results First Posted: October 15, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)