Physical ActivityNDGameSquadNCT03665415
Expanded Game Squad for Neurodiverse Youth
A study testing NDGameSquad in people with Physical Activity and Mental Health Issue (E.G., Depression, Psychosis, Personality Disorder, Substance Abuse), run by Merrimack College at 2 sites in United States.
Trial summary
The proposed study will pilot the use of an adapted Game Squad intervention aimed at improving physical activity and other important health behaviors (nutrition, sleep hygiene, screen time habits) for children and adolescents receiving special education supports for behavioral health challenges, or who are served by… Read more about this study
- Who is it for?
- Ages 11 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Activity, Mental Health Issue (E.G., Depression, Psychosis, Personality Disorder, Substance Abuse), Health Behavior
- What is being tested?
- NDGameSquad
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 2 sitesUnited States
- Study dates
- 6 Nov 2018to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 11 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Receiving services either through the BMC-DBP or TIDES programs
- Wi-Fi and TV available in their home environment
Who cannot join
- Intellectual disability
- Chronic or physically disabling conditions for which strenuous physical activity is contra-indicated or not feasible
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Boston Medical Center Developmental and Behavioral Pediatrics Clinic
Boston, Massachusetts, 02118
Marblehead Public Schools
Marblehead, Massachusetts, 01945
About this study
Official title: Engaging Children With Mental Health and Developmental Disabilities and Their Parents to Adopt a Healthy Lifestyle: Piloting the Game Squad Home Exergaming & Virtual Health Coaching Intervention
The proposed study will pilot the use of an adapted Game Squad intervention aimed at improving physical activity and other important health behaviors (nutrition, sleep hygiene, screen time habits) for children and adolescents receiving special education supports for behavioral health challenges, or who are served by the Boston Medical Center Developmental and Behavioral Pediatrics (BMC-DBP) clinic.
Read the detailed description
The significant health disparities that exist among people with mental health conditions (MH) and developmental disabilities (DD), including autism spectrum disorder (ASD), have been documented through research and clinical practice. The majority of studies have focused on adults with these conditions, but due to the efforts of agencies such as the Maternal Child Health Bureau, the health disparities experienced by youth with MH and DD are increasingly recognized. These youth are more likely to be overweight and obese than their typically developing (TD) counterparts, have higher cardio-metabolic risk factors, and have lower levels of health-related fitness. These conditions can be partly attributed to the low physical activity levels and poor diet quality that have been observed in these populations. Multiple barriers that operate at the individual, community, and societal levels limit opportunities for these youth to achieve good health, and thus there is an urgent need for health promotion interventions to address these disparities. One novel way to address these barriers is to explore the use of virtual methods adapted specifically for this population to reach these children and families in their homes, while also investigating viable venues through which such interventions can be delivered and supported if necessary.
This study seeks to pilot a virtual health coaching and exercise program aimed at addressing modifiable lifestyle factors that can lead to improved health and well-being for youth with MH and DD. The Game Squad Home Exergaming program, originally developed by the Pennington Biomedical Research Center, is a theoretically-guided and evidence-based intervention that has shown effectiveness at engaging parents and children with overweight/obesity in regular physical activity and virtual health counseling. Game Squad utilizes home exergaming consoles (i.e., Kinect for Xbox video games that require physical activity for gameplay) for both caregiver and child exercise sessions, as well as to deliver virtual health counseling sessions to participants. These virtual health counseling sessions were aimed at improving non-exergame related physical activity. Importantly, during a recent RCT involving a socio-economically and racially diverse population over a six-month period, the intervention yielded clinically significant reductions in BMI z-score and cardiovascular disease risk factors, as well as increased moderate to vigorous physical activity (MVPA).
The proposed project seeks to determine whether the Game Squad intervention is acceptable and engaging to children and adolescents with MH and DD, adapt the health counseling sessions to encompass additional health behaviors and meet the needs of this population, as well as to assess feasibility of implementation through both a school-based program and a specialized clinic for children with MH/DD. This is achieved through innovative partnerships with several key collaborators: Merrimack College; the Pennington Biomedical Research Center; the Therapeutic Intervention Designed for Educational Success Program (TIDES) program, a public school special education collaborative in several north shore communities in Massachusetts; and the developmental-behavioral pediatrics clinic at Boston Medical Center (BMC-DBP), a clinical site associated with the MCHB-funded Developmental Pediatrics Research Network (DBP-NET).
- Conditions
- Physical Activity, Mental Health Issue (E.G., Depression, Psychosis, Personality Disorder, Substance Abuse), Health Behavior, Developmental Disorder
- Being tested
- NDGameSquad
- Medical subject headings
- Motor Activity, Depression, Psychotic Disorders, Personality Disorders, Substance-Related Disorders, Health Behavior, Developmental Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NDGameSquadBehavioural
The intervention will be delivered within participants' homes. Participants will be provided a gaming console and exergames. Participants will be encouraged to meet a goal of 60 minutes/day of MVPA for the duration of the intervention by playing the exergames at least three times per week and engaging in non-screen based physical activity on other days. Participants will receive a booklet that includes a curriculum for playing weekly challenges. Participants will wear a FitBit during their exergaming sessions. Participants and parents meet bi-weekly with a health coach via video-chat using the exergame console. Sessions will identify and encourage specific physical activity, healthy eating, and healthy sleep habits. At the school site, participants will receive additional check-ins, engagement support, and health curricula from classroom teachers during the first 10 weeks of the intervention.
| Study group | Role | What they receive |
|---|---|---|
| Formative | Other | This stage represents an initial formative phase to implement the NDGame Squad intervention with small samples of youth in order to make any modifications necessary before embarking on the full pilot in both sites in the next phase. Three (n=3) participants from the school site only will participate in an initial 4-week Game Squad intervention in the first formative phase. Participant feedback including barriers to engagement and suggestions for improvements will be obtained via parent/caregiver and child interviews post-intervention. Receives: Behavioral: NDGameSquad |
| Pilot Intervention | Experimental | Participants in the pilot intervention arm will receive either 10 or 14 weeks of the NDGameSquad intervention. School site participants will receive 10 weeks during the school year, followed by another 4 weeks during summer vacation. Clinic site participants will receive 10 weeks only. Receives: Behavioral: NDGameSquad |
| Pilot Waitlist Control | Other | Participants at both sites randomized to the waitlist control arm will be asked to maintain current physical activity levels during the first 10-week period. They will then be provided the intervention equipment and training. School site control arm participants will then participate in a 4-week, unsupported summer NDGame Squad intervention. Clinic site control arm participants will not be required to participate in the NDGameSquad intervention. Receives: Behavioral: NDGameSquad |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline 7-day Actigraph MVPA after 10 weeks of intervention
Change in moderate to vigorous physical activity measured via hip-worn Actigraph accelerometer
Measured: Collected within 14 days of intervention start (baseline) and end (follow-up after 10 week intervention)
Secondary outcomes (6)
Change from baseline BMI after 10 weeks of intervention
Child body mass index change
Measured: Collected within 14 days of intervention start (baseline) and end (follow-up after 10 week intervention)
Change from baseline blood pressure after 10 weeks of intervention
Child systolic and diastolic blood pressure change
Measured: Collected within 14 days of intervention start (baseline) and end (follow-up after 10 week intervention)
Change from baseline parent perceptions of child health habits after 10 weeks of intervention
Change in parent report of child sleep, meal-time, screen and physical activity behaviors
Measured: Collected within 14 days of intervention start (baseline) and end (follow-up after 10 week intervention)
Change from baseline child anxiety symptoms after 10 weeks of intervention
Change in parent and child reported Screen for Childhood Anxiety Related Emotional Disorder (SCARED) questionnaire. The full scale range is 0-82, with five sub-scales (panic disorder range 0-26; generalized anxiety disorder range 0-18; separation anxiety disorder range 0-16; social anxiety disorder range 0-14; school avoidance range 0-8). Higher score values indicate greater experience of symptoms. Total score is the sum of all sub-scores.
Measured: Collected within 14 days of intervention start (baseline) and end (follow-up after 10 week intervention)
Change in child depression symptoms after 10 weeks of intervention
Change in child reported modified Patient Health Questionnaire for Adolescents (PHQ-A) questionnaire, which assesses symptoms of depression. The scale has a total score range of 0-27 and there are no sub-scales. Greater values indicate greater experience of symptoms.
Measured: Collected within 14 days of intervention start (baseline) and end (follow-up after 10 week intervention)
Change in child video game use habits
Change in child reported video game use questionnaire
Measured: Collected within 14 days of intervention start (baseline) and end (follow-up after 10 week intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2018
- Study start6 Nov 2018
- Primary completion15 Aug 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (33)Papers the sponsor has linked to this study.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The project will be carried out in three phases: 1) Formative research to implement the intervention with n=6 youth in order to make any modifications necessary before embarking on the full pilot in both sites in the next phase; 2) The pilot intervention comprised of a randomized wait-list controlled pilot intervention at two sites (school and clinic) during the school year; 3) an unsupported follow up period where participants in the school-based intervention will be offered the intervention during the summer months without school staff support. Wait-listed school site participants will also receive the unsupported intervention in this phase.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merrimack College
- Sponsor type
- University, hospital or other
- Collaborators
- University of Massachusetts, Worcester, Pennington Biomedical Research Center, Boston Medical Center Developmental and Behavioral Pediatrics Clinic, Marblehead Public Schools
- Responsible party
- Principal investigator, April Bowling, Merrimack College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03665415
- Sponsor's protocol ID
- IRB-FY18-19-1
- Acronym
- NDGameSquad
- Status last verified
- Feb 2020
- First submitted
- 5 Sep 2018
- Last updated
- 19 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared.
Publications
Anderson SE, Must A, Curtin C, Bandini LG. Meals in Our Household: reliability and initial validation of a questionnaire to assess child mealtime behaviors and family mealtime environments. J Acad Nutr Diet. 2012 Feb;112(2):276-84. doi: 10.1016/j.jada.2011.08.035.
PubMed 22741169Baglioni C, Nanovska S, Regen W, Spiegelhalder K, Feige B, Nissen C, Reynolds CF, Riemann D. Sleep and mental disorders: A meta-analysis of polysomnographic research. Psychol Bull. 2016 Sep;142(9):969-990. doi: 10.1037/bul0000053. Epub 2016 Jul 14.
PubMed 27416139Barnett A, Cerin E, Baranowski T. Active video games for youth: a systematic review. J Phys Act Health. 2011 Jul;8(5):724-37. doi: 10.1123/jpah.8.5.724.
PubMed 21734319Biddiss E, Irwin J. Active video games to promote physical activity in children and youth: a systematic review. Arch Pediatr Adolesc Med. 2010 Jul;164(7):664-72. doi: 10.1001/archpediatrics.2010.104.
PubMed 20603468Blaine B. Does depression cause obesity?: A meta-analysis of longitudinal studies of depression and weight control. J Health Psychol. 2008 Nov;13(8):1190-7. doi: 10.1177/1359105308095977.
PubMed 18987092Bowling A, Slavet J, Miller DP, Haneuse S, Beardslee W, Davison K. Cybercycling Effects on Classroom Behavior in Children With Behavioral Health Disorders: An RCT. Pediatrics. 2017 Feb;139(2):e20161985. doi: 10.1542/peds.2016-1985. Epub 2017 Jan 9.
PubMed 28069663Broder-Fingert S, Brazauskas K, Lindgren K, Iannuzzi D, Van Cleave J. Prevalence of overweight and obesity in a large clinical sample of children with autism. Acad Pediatr. 2014 Jul-Aug;14(4):408-14. doi: 10.1016/j.acap.2014.04.004.
PubMed 24976353Brown SA. Measuring perceived benefits and perceived barriers for physical activity. Am J Health Behav. 2005 Mar-Apr;29(2):107-16. doi: 10.5993/ajhb.29.2.2.
PubMed 15698978Cook BG, Li D, Heinrich KM. Obesity, Physical Activity, and Sedentary Behavior of Youth With Learning Disabilities and ADHD. J Learn Disabil. 2015 Nov-Dec;48(6):563-76. doi: 10.1177/0022219413518582. Epub 2014 Jan 21.
PubMed 24449262Cortese S, Morcillo Penalver C. Comorbidity between ADHD and obesity: exploring shared mechanisms and clinical implications. Postgrad Med. 2010 Sep;122(5):88-96. doi: 10.3810/pgm.2010.09.2205.
PubMed 20861592TRUE Consortium. Recommended standards for assessing blood pressure in human research where blood pressure or hypertension is a major focus. J Hum Hypertens. 2017 Aug;31(8):487-490. doi: 10.1038/jhh.2017.10. Epub 2017 Apr 13. No abstract available.
PubMed 28406234Davis C, Levitan RD, Smith M, Tweed S, Curtis C. Associations among overeating, overweight, and attention deficit/hyperactivity disorder: a structural equation modelling approach. Eat Behav. 2006 Aug;7(3):266-74. doi: 10.1016/j.eatbeh.2005.09.006. Epub 2005 Oct 17.
PubMed 16843230DE Hert M, Correll CU, Bobes J, Cetkovich-Bakmas M, Cohen D, Asai I, Detraux J, Gautam S, Moller HJ, Ndetei DM, Newcomer JW, Uwakwe R, Leucht S. Physical illness in patients with severe mental disorders. I. Prevalence, impact of medications and disparities in health care. World Psychiatry. 2011 Feb;10(1):52-77. doi: 10.1002/j.2051-5545.2011.tb00014.x.
PubMed 21379357Gao Z, Chen S, Pasco D, Pope Z. A meta-analysis of active video games on health outcomes among children and adolescents. Obes Rev. 2015 Sep;16(9):783-94. doi: 10.1111/obr.12287. Epub 2015 May 6.
PubMed 25943852Gariepy G, Nitka D, Schmitz N. The association between obesity and anxiety disorders in the population: a systematic review and meta-analysis. Int J Obes (Lond). 2010 Mar;34(3):407-19. doi: 10.1038/ijo.2009.252. Epub 2009 Dec 8.
PubMed 19997072
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Engaging Children With Mental Health and Developmental Disabilities and Their Parents to Adopt a Healthy Lifestyle: Piloting the Game Squad Home Exergaming & Virtual Health Coaching Intervention
- ClinicalTrials.gov ID
- NCT03665415
- Acronym / sponsor ID
- NDGameSquad / IRB-FY18-19-1
- Conditions
- Physical Activity, Mental Health Issue (E.G., Depression, Psychosis, Personality Disorder, Substance Abuse), Health Behavior, Developmental Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Merrimack CollegeUniversity, hospital or other
- Collaborators
- University of Massachusetts, Worcester, Pennington Biomedical Research Center, Boston Medical Center Developmental and Behavioral Pediatrics Clinic, Marblehead Public Schools
- Study start
- 6 Nov 2018 (actual)
- Primary completion
- 15 Aug 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 11 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The proposed study will pilot the use of an adapted Game Squad intervention aimed at improving physical activity and other important health behaviors (nutrition, sleep hygiene, screen time habits) for children and adolescents receiving special education supports for behavioral health challenges, or who are served by the Boston Medical Center Developmental and Behavioral Pediatrics (BMC-DBP) clinic.
Detailed description
The significant health disparities that exist among people with mental health conditions (MH) and developmental disabilities (DD), including autism spectrum disorder (ASD), have been documented through research and clinical practice. The majority of studies have focused on adults with these conditions, but due to the efforts of agencies such as the Maternal Child Health Bureau, the health disparities experienced by youth with MH and DD are increasingly recognized. These youth are more likely to be overweight and obese than their typically developing (TD) counterparts, have higher cardio-metabolic risk factors, and have lower levels of health-related fitness. These conditions can be partly attributed to the low physical activity levels and poor diet quality that have been observed in these populations. Multiple barriers that operate at the individual, community, and societal levels limit opportunities for these youth to achieve good health, and thus there is an urgent need for health promotion interventions to address these disparities. One novel way to address these barriers is to explore the use of virtual methods adapted specifically for this population to reach these children and families in their homes, while also investigating viable venues through which such interventions can be delivered and supported if necessary.
This study seeks to pilot a virtual health coaching and exercise program aimed at addressing modifiable lifestyle factors that can lead to improved health and well-being for youth with MH and DD. The Game Squad Home Exergaming program, originally developed by the Pennington Biomedical Research Center, is a theoretically-guided and evidence-based intervention that has shown effectiveness at engaging parents and children with overweight/obesity in regular physical activity and virtual health counseling. Game Squad utilizes home exergaming consoles (i.e., Kinect for Xbox video games that require physical activity for gameplay) for both caregiver and child exercise sessions, as well as to deliver virtual health counseling sessions to participants. These virtual health counseling sessions were aimed at improving non-exergame related physical activity. Importantly, during a recent RCT involving a socio-economically and racially diverse population over a six-month period, the intervention yielded clinically significant reductions in BMI z-score and cardiovascular disease risk factors, as well as increased moderate to vigorous physical activity (MVPA).
The proposed project seeks to determine whether the Game Squad intervention is acceptable and engaging to children and adolescents with MH and DD, adapt the health counseling sessions to encompass additional health behaviors and meet the needs of this population, as well as to assess feasibility of implementation through both a school-based program and a specialized clinic for children with MH/DD. This is achieved through innovative partnerships with several key collaborators: Merrimack College; the Pennington Biomedical Research Center; the Therapeutic Intervention Designed for Educational Success Program (TIDES) program, a public school special education collaborative in several north shore communities in Massachusetts; and the developmental-behavioral pediatrics clinic at Boston Medical Center (BMC-DBP), a clinical site associated with the MCHB-funded Developmental Pediatrics Research Network (DBP-NET).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- The project will be carried out in three phases: 1) Formative research to implement the intervention with n=6 youth in order to make any modifications necessary before embarking on the full pilot in both sites in the next phase; 2) The pilot intervention comprised of a randomized wait-list controlled pilot intervention at two sites (school and clinic) during the school year; 3) an unsupported follow up period where participants in the school-based intervention will be offered the intervention during the summer months without school staff support. Wait-listed school site participants will also receive the unsupported intervention in this phase.
| Arm | Type | Receives |
|---|---|---|
| Formative | Other | Behavioral: NDGameSquadThis stage represents an initial formative phase to implement the NDGame Squad intervention with small samples of youth in order to make any modifications necessary before embarking on the full pilot in both sites in the next phase. Three (n=3) participants from the school site only will participate in an initial 4-week Game Squad intervention in the first formative phase. Participant feedback including barriers to engagement and suggestions for improvements will be obtained via parent/caregiver and child interviews post-intervention. |
| Pilot Intervention | Experimental | Behavioral: NDGameSquadParticipants in the pilot intervention arm will receive either 10 or 14 weeks of the NDGameSquad intervention. School site participants will receive 10 weeks during the school year, followed by another 4 weeks during summer vacation. Clinic site participants will receive 10 weeks only. |
| Pilot Waitlist Control | Other | Behavioral: NDGameSquadParticipants at both sites randomized to the waitlist control arm will be asked to maintain current physical activity levels during the first 10-week period. They will then be provided the intervention equipment and training. School site control arm participants will then participate in a 4-week, unsupported summer NDGame Squad intervention. Clinic site control arm participants will not be required to participate in the NDGameSquad intervention. |
Who may qualify
- Ages
- 11 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Receiving services either through the BMC-DBP or TIDES programs
- Wi-Fi and TV available in their home environment
Key exclusion criteria (2 listed)
- Intellectual disability
- Chronic or physically disabling conditions for which strenuous physical activity is contra-indicated or not feasible
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 |
|---|---|---|
| NDGameSquadThe intervention will be delivered within participants' homes. Participants will be provided a gaming console and exergames. Participants will be encouraged to meet a goal of 60 minutes/day of MVPA for the duration of the intervention by playing the exergames at least three times per week and engaging in non-screen based physical activity on other days. Participants will receive a booklet that includes a curriculum for playing weekly challenges. Participants will wear a FitBit during their exergaming sessions. Participants and parents meet bi-weekly with a health coach via video-chat using the exergame console. Sessions will identify and encourage specific physical activity, healthy eating, and healthy sleep habits. At the school site, participants will receive additional check-ins, engagement support, and health curricula from classroom teachers during the first 10 weeks of the intervention. | Behavioural | Formative, Pilot Intervention, Pilot Waitlist Control |
Primary outcome
Change from baseline 7-day Actigraph MVPA after 10 weeks of intervention
Time frame: Collected within 14 days of intervention start (baseline) and end (follow-up after 10 week intervention)
Change in moderate to vigorous physical activity measured via hip-worn Actigraph accelerometer
6 secondary outcomes
Change from baseline BMI after 10 weeks of intervention
Time frame: Collected within 14 days of intervention start (baseline) and end (follow-up after 10 week intervention)
Change from baseline blood pressure after 10 weeks of intervention
Time frame: Collected within 14 days of intervention start (baseline) and end (follow-up after 10 week intervention)
Change from baseline parent perceptions of child health habits after 10 weeks of intervention
Time frame: Collected within 14 days of intervention start (baseline) and end (follow-up after 10 week intervention)
Change from baseline child anxiety symptoms after 10 weeks of intervention
Time frame: Collected within 14 days of intervention start (baseline) and end (follow-up after 10 week intervention)
Change in child depression symptoms after 10 weeks of intervention
Time frame: Collected within 14 days of intervention start (baseline) and end (follow-up after 10 week intervention)
Change in child video game use habits
Time frame: Collected within 14 days of intervention start (baseline) and end (follow-up after 10 week intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2020.
- Background: PubMed 22741169Anderson SE, Must A, Curtin C, Bandini LG. Meals in Our Household: reliability and initial validation of a questionnaire to assess child mealtime behaviors and family mealtime environments. J Acad Nutr Diet. 2012 Feb;112(2):276-84. doi: 10.1016/j.jada.2011.08.035.
- Background: PubMed 27416139Baglioni C, Nanovska S, Regen W, Spiegelhalder K, Feige B, Nissen C, Reynolds CF, Riemann D. Sleep and mental disorders: A meta-analysis of polysomnographic research. Psychol Bull. 2016 Sep;142(9):969-990. doi: 10.1037/bul0000053. Epub 2016 Jul 14.
- Background: PubMed 21734319Barnett A, Cerin E, Baranowski T. Active video games for youth: a systematic review. J Phys Act Health. 2011 Jul;8(5):724-37. doi: 10.1123/jpah.8.5.724.
- Background: PubMed 20603468Biddiss E, Irwin J. Active video games to promote physical activity in children and youth: a systematic review. Arch Pediatr Adolesc Med. 2010 Jul;164(7):664-72. doi: 10.1001/archpediatrics.2010.104.
- Background: PubMed 18987092Blaine B. Does depression cause obesity?: A meta-analysis of longitudinal studies of depression and weight control. J Health Psychol. 2008 Nov;13(8):1190-7. doi: 10.1177/1359105308095977.
- Background: PubMed 28069663Bowling A, Slavet J, Miller DP, Haneuse S, Beardslee W, Davison K. Cybercycling Effects on Classroom Behavior in Children With Behavioral Health Disorders: An RCT. Pediatrics. 2017 Feb;139(2):e20161985. doi: 10.1542/peds.2016-1985. Epub 2017 Jan 9.
- Background: PubMed 24976353Broder-Fingert S, Brazauskas K, Lindgren K, Iannuzzi D, Van Cleave J. Prevalence of overweight and obesity in a large clinical sample of children with autism. Acad Pediatr. 2014 Jul-Aug;14(4):408-14. doi: 10.1016/j.acap.2014.04.004.
- Background: PubMed 15698978Brown SA. Measuring perceived benefits and perceived barriers for physical activity. Am J Health Behav. 2005 Mar-Apr;29(2):107-16. doi: 10.5993/ajhb.29.2.2.
- Background: PubMed 24449262Cook BG, Li D, Heinrich KM. Obesity, Physical Activity, and Sedentary Behavior of Youth With Learning Disabilities and ADHD. J Learn Disabil. 2015 Nov-Dec;48(6):563-76. doi: 10.1177/0022219413518582. Epub 2014 Jan 21.
- Background: PubMed 20861592Cortese S, Morcillo Penalver C. Comorbidity between ADHD and obesity: exploring shared mechanisms and clinical implications. Postgrad Med. 2010 Sep;122(5):88-96. doi: 10.3810/pgm.2010.09.2205.
- Background: PubMed 28406234TRUE Consortium. Recommended standards for assessing blood pressure in human research where blood pressure or hypertension is a major focus. J Hum Hypertens. 2017 Aug;31(8):487-490. doi: 10.1038/jhh.2017.10. Epub 2017 Apr 13. No abstract available.
- Background: PubMed 16843230Davis C, Levitan RD, Smith M, Tweed S, Curtis C. Associations among overeating, overweight, and attention deficit/hyperactivity disorder: a structural equation modelling approach. Eat Behav. 2006 Aug;7(3):266-74. doi: 10.1016/j.eatbeh.2005.09.006. Epub 2005 Oct 17.
- Individual participant dataSharing planned: No. IPD will not be shared.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NDGameSquad in people with Physical Activity and Mental Health Issue (E.G., Depression, Psychosis, Personality Disorder, Substance Abuse), run by Merrimack College at 2 sites 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 2 inclusion and 2 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 19 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change from baseline 7-day Actigraph MVPA after 10 weeks of intervention (time frame: Collected within 14 days of intervention start (baseline) and end (follow-up after 10 week intervention)). 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 NCT03665415, which also lists 33 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 19 Feb 2020.