Behavioral / Psychiatric DisorderNCT05675020

Promoting Healthy Lifestyle Behaviors

A study testing Zoom Intervention in people with Behavioral / Psychiatric Disorder and Lifestyle, Healthy, run by Florida State University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 12 to 17 yearsHealthy volunteers can take part
Conditions the study is for: Behavioral / Psychiatric Disorder, Lifestyle, Healthy
What is being tested?: Zoom Intervention
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 86 participants
Where: 1 siteUnited States
Study dates: 7 Oct 2022to 13 Jan 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 12 to 17 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Wolfson Children's Hospital- Intensive Outpatient Behavioral Health Program (IOP) and the Partial Hospitalization Program (PHP) and Bridge Program
Jacksonville, Florida, 32207

Other trials in United States

About this study

Official title: Promote Healthy Lifestyle Behaviors for Adolescents With Mental Health Conditions

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.

Read the 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.

Conditions: Behavioral / Psychiatric Disorder, Lifestyle, Healthy
Being tested: Zoom Intervention
Keywords: Adolescent, Behavioral Health Condition, Behavioral / Psychiatric Disorder, Lifestyle Modification, Lifestyle, Healthy
Medical subject headings: Behavior, Mental Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Zoom InterventionBehavioural
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.

Study groups in NCT05675020
Study group	Role	What they receive
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. Receives: Behavioral: Zoom Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 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.
Measured: One Month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Oct 202213 Jan 2023

First posted9 Jan 2023
Study start7 Oct 2022
Primary completion13 Jan 2023
Study completion13 Jan 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (24)Papers the sponsor has linked to this study.
Other trials for Behavioral / Psychiatric DisorderStudies of the same condition, open and under way.
More trials run by Florida State UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
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)
Enrolment: 86 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05675020
Sponsor's protocol ID: STUDY00003072
Status last verified: Nov 2024
First submitted: 14 Dec 2022
Last updated: 15 Nov 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 28639320
Barnett ER, Trepman AZ, Fuson HA, Acquilano SC, McLaren JL, Woloshin S, Leyenaar JK. Deprescribing psychotropic medications in children: results of a national qualitative study. BMJ Qual Saf. 2020 Aug;29(8):655-663. doi: 10.1136/bmjqs-2019-010033. Epub 2019 Dec 13.
PubMed 31836627
Bean MK, Caccavale LJ, Adams EL, Burnette CB, LaRose JG, Raynor HA, Wickham EP 3rd, Mazzeo SE. Parent Involvement in Adolescent Obesity Treatment: A Systematic Review. Pediatrics. 2020 Sep;146(3):e20193315. doi: 10.1542/peds.2019-3315.
PubMed 32839242
Blasco BV, Garcia-Jimenez J, Bodoano I, Gutierrez-Rojas L. Obesity and Depression: Its Prevalence and Influence as a Prognostic Factor: A Systematic Review. Psychiatry Investig. 2020 Aug;17(8):715-724. doi: 10.30773/pi.2020.0099. Epub 2020 Aug 12.
PubMed 32777922
Faught EL, Ekwaru JP, Gleddie D, Storey KE, Asbridge M, Veugelers PJ. The combined impact of diet, physical activity, sleep and screen time on academic achievement: a prospective study of elementary school students in Nova Scotia, Canada. Int J Behav Nutr Phys Act. 2017 Mar 9;14(1):29. doi: 10.1186/s12966-017-0476-0.
PubMed 28274260
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.
PubMed 30165751
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.
PubMed 32817610
Jacka FN. Nutritional Psychiatry: Where to Next? EBioMedicine. 2017 Mar;17:24-29. doi: 10.1016/j.ebiom.2017.02.020. Epub 2017 Feb 21.
PubMed 28242200
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.
PubMed 33511092
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.
PubMed 33180751
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.
PubMed 32079538
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.
PubMed 31004047
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.
PubMed 32817612
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.
PubMed 25451390
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.
PubMed 30951586

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 15 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Promote Healthy Lifestyle Behaviors for Adolescents With Mental Health Conditions
ClinicalTrials.gov ID: NCT05675020
Acronym / sponsor ID: STUDY00003072
Conditions: Behavioral / Psychiatric Disorder, Lifestyle, Healthy
Keywords: Adolescent, Behavioral Health Condition, Behavioral / Psychiatric Disorder, Lifestyle Modification, Lifestyle, Healthy
Study type: Interventional
Recruitment status: Completed
Enrolment: 86 participants (actual)
Lead sponsor: Florida State UniversityUniversity, hospital or other
Study start: 7 Oct 2022 (actual)
Primary completion: 13 Jan 2023 (actual)
Study completion: 13 Jan 2023 (actual)
First posted: 9 Jan 2023 (actual)
Results: Posted 15 Oct 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
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.

Arm	Type	Receives
Parent-Adolescent Dyad	Experimental	Behavioral: Zoom InterventionEach 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.

Who may qualify

Ages: 12 to 17 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (4 listed)

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

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Zoom InterventionThis 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.	Behavioural	Parent-Adolescent Dyad

Primary outcome

Percent of Participants With Correct Responses for Healthy Lifestyle Behavior Knowledge Survey Questions.
Time frame: One Month
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).
Median Score on a Scale of Participants Responses for Healthy Lifestyle Behavior Knowledge Survey Questions
Time frame: One Month
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.

Results and safety

Results posted to the registry on 15 Oct 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Parent-Adolescent Dyad	86	9

Primary outcome: Percent of Participants With Correct Responses for Healthy Lifestyle Behavior Knowledge Survey Questions.

Time frame: One Month. Number. Unit: percentage of participants

Measure	Parent/Legal Guardian (LG) Pre-Intervention Knowledge Changes n = 9	Parent/Legal Guardian (LG) Post-Intervention Knowledge Changes n = 9	Adolescent Pre-Intervention Knowledge Changes n = 9	Adolescent Post-Intervention Knowledge Changes n = 9
Carbohydrates per day	33	44	56	33
Cups of fruit per day	44	67	56	33
Cups of Veggies per day	44	56	33	44
Cups of water per day	22	44	22	33
Healthy snack	44	44	44	56
Aerobic Exercise per week	44	44	44	89
Example of Aerobic Activity	33	44	22	56
Example of BS Activity	33	0	0	11

Population analysed: 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.

Primary outcome: Median Score on a Scale of Participants Responses for Healthy Lifestyle Behavior Knowledge Survey Questions

Time frame: One Month. Median (Full Range). Unit: score on a scale

Measure	Parent/Legal Guardian (LG) Pre-Intervention Behavioral Changes n = 9	Parent/Legal Guardian (LG) Post-Intervention Behavioral Changes n = 9	Adolescent Pre-Intervention Behavioral Changes n = 9	Adolescent Post-Intervention Behavioral Changes n = 9
Drink Water	5 (1 to 7)	5 (1 to 7)	4 (1 to 7)	5 (1 to 7)
Eat Breakfast	5 (1 to 8)	6 (1 to 8)	4 (1 to 8)	5 (1 to 8)
Eat Dairy Products	4 (1 to 7)	6 (1 to 7)	5 (1 to 7)	5 (1 to 7)
Eat Family Dinner	5 (1 to 8)	5 (1 to 8)	5.5 (1 to 8)	6 (1 to 8)
Eat Fruit	4 (1 to 7)	4 (1 to 7)	3.5 (1 to 7)	5 (1 to 7)
Eat Whole Grains	5 (1 to 7)	6 (1 to 7)	4 (1 to 7)	5 (1 to 7)
Where do You Eat Dinner	4 (1 to 7)	3.5 (1 to 7)	2.5 (1 to 7)	2 (1 to 7)
Eat Vegetables	3 (1 to 7)	4 (1 to 7)	4 (1 to 7)	5 (1 to 7)

Population analysed: WHO-5 Analysis for Adolescent participants only.

Adverse events

Time frame: All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events
Parent/Legal Guardian (LG) Pre-Intervention Knowledge Changes	0 of 0	0 of 0
Parent/Legal Guardian (LG) Post-Intervention Knowledge Changes	0 of 0	0 of 0
Adolescent Pre-Intervention Knowledge Changes	0 of 0	0 of 0
Adolescent Post-Intervention Knowledge Changes	0 of 0	0 of 0

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 28639320Al-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.
Background: PubMed 31836627Barnett ER, Trepman AZ, Fuson HA, Acquilano SC, McLaren JL, Woloshin S, Leyenaar JK. Deprescribing psychotropic medications in children: results of a national qualitative study. BMJ Qual Saf. 2020 Aug;29(8):655-663. doi: 10.1136/bmjqs-2019-010033. Epub 2019 Dec 13.
Background: PubMed 32839242Bean MK, Caccavale LJ, Adams EL, Burnette CB, LaRose JG, Raynor HA, Wickham EP 3rd, Mazzeo SE. Parent Involvement in Adolescent Obesity Treatment: A Systematic Review. Pediatrics. 2020 Sep;146(3):e20193315. doi: 10.1542/peds.2019-3315.
Background: PubMed 32777922Blasco BV, Garcia-Jimenez J, Bodoano I, Gutierrez-Rojas L. Obesity and Depression: Its Prevalence and Influence as a Prognostic Factor: A Systematic Review. Psychiatry Investig. 2020 Aug;17(8):715-724. doi: 10.30773/pi.2020.0099. Epub 2020 Aug 12.
Background: PubMed 28274260Faught EL, Ekwaru JP, Gleddie D, Storey KE, Asbridge M, Veugelers PJ. The combined impact of diet, physical activity, sleep and screen time on academic achievement: a prospective study of elementary school students in Nova Scotia, Canada. Int J Behav Nutr Phys Act. 2017 Mar 9;14(1):29. doi: 10.1186/s12966-017-0476-0.
Background: PubMed 30165751Gidugu 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.
Background: PubMed 32817610Ivey-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.
Background: PubMed 28242200Jacka FN. Nutritional Psychiatry: Where to Next? EBioMedicine. 2017 Mar;17:24-29. doi: 10.1016/j.ebiom.2017.02.020. Epub 2017 Feb 21.
Background: PubMed 33511092Kansra 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.
Background: PubMed 33180751Leeb 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.
Background: PubMed 32079538Lindberg 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.
Background: PubMed 31004047Loewen 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.
Related InfoLink provided by the sponsor.
Related InfoLink provided by the sponsor.
Related InfoLink provided by the sponsor.
Related InfoLink provided by the sponsor.
Related InfoLink provided by the sponsor.
Related InfoLink provided by the sponsor.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Mary Livings study chair

Florida State University

Rachel L Sharp, BSN principal investigator

Florida State University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Zoom Intervention in people with Behavioral / Psychiatric Disorder and Lifestyle, Healthy, run by Florida State University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent of Participants With Correct Responses for Healthy Lifestyle Behavior Knowledge Survey Questions. (time frame: One Month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05675020, which also lists 24 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2024.