Child BehaviorNCT06376864
Physical Activity Intervention Effects on Executive Function, Physical Activity and Sedentary Behaviour in Children
A study testing Activity Breaks in people with Child Behavior, run by Hong Kong Baptist University at 1 site in Hong Kong.
Trial summary
The current study aims to implement the Activity Breaks intervention and evaluate its effectiveness on outcome measures of executive function (EF), physical activity (PA), and sedentary behaviour (SB) in school children. Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Child Behavior
- What is being tested?
- Activity Breaks
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jan 2023to 30 Jul 2024
- 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 8 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- School children in primary school (exclude private or special education schools), grades 4-6 (8-12 years old)
- children with parental consent.
Who cannot join
- Children with diagnosed behavioural or learning problems (e.g., attention-deficit hyperactivity disorder, ADHD)
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Department of Sport, Physical Education, and Health, Hong Kong Bapist University
Kowloon Tong
About this study
Official title: A Pilot Study Investigating the Effects of a Classroom-based Physical Activity Intervention on Executive Function, Physical Activity and Sedentary Behaviour in 8-12-year-old Children
The current study aims to implement the Activity Breaks intervention and evaluate its effectiveness on outcome measures of executive function (EF), physical activity (PA), and sedentary behaviour (SB) in school children.
Read the detailed description
In Hong Kong, as well as globally, children fail to meet the current physical activity recommendations of 60-minutes of moderate-to-vigorous physical activity (MVPA) per day. Childhood and adolescence are critical periods for developing favourable lifestyle behaviours that can continue into adulthood. Health-promoting interventions that target physical inactivity are vitally important. Researchers have repeatedly demonstrated that higher academic achievement and better attendance at school occurs among children who are more physically active, healthy and fit. To promote improvements in health and education, it is essential to recognize movement as assistive to establishing cognitive and social skills. The current study aims to implement the Activity Breaks intervention and evaluate its effectiveness on outcome measures of executive function (EF), physical activity (PA), and sedentary behaviour (SB) in school children. The Activity Breaks intervention is a 5-minute Activity Breaks programme that allows classroom teachers of all ages and ability levels to lead simple movement activities within their classrooms, negating the need for additional personnel or space. It is expected that the 5-minute Activity Breaks programme performed three times a day over 8 weeks will not only increases daily PA, but also decreases SB through interrupting prolonged sitting time. The Activity Breaks Programme also improves executive functioning among primary school-aged children.
This study will be a pilot clustered randomised controlled trial involving 8 primary schools in Hong Kong. One class from each school will be recruited from primaries 4-6 (8-11-year-old children) as our target population. Schools randomised into the intervention will receive the Activity Breaks Programme whereas schools assigned to the control group will continue to receive their normal daily instruction.
Data will be collected from all participants (intervention and control) at three time points: Time 1 (T1) (baseline), Time 2 (T2) (Post-intervention), and Time 3 (T3) (3-month follow-up). The following pupil measures will be captured at all time points: 1. EF; 2. PA levels and SB patterns using accelerometers; and 3. anthropometric measurements. Two measures will be conducted among teachers including teacher interviews and teacher fidelity checks conducted using log books. All analyses will be performed using IBM SPSS statistical programmes. Multi-level modelling regression analyses with repeated measures will be used to determine the effects of the intervention. A mixed-design ANOVA with time (pre, post and follow-up) as a within-subject variable and group (intervention and control) as a between-subjects variable will be conducted, while adjusting for age, gender and body mass index.
- Conditions
- Child Behavior
- Being tested
- Activity Breaks
- Keywords
- physical activity, sedentary behaviour, executive fundtion, health promotion, children
- Medical subject headings
- Child Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Activity BreaksBehavioural
The Activity Breaks intervention is a 5-minute Activity Breaks programme that allows classroom teachers of all ages and ability levels to lead simple movement activities within their classrooms, negating the need for additional personnel or space.
| Study group | Role | What they receive |
|---|---|---|
| Activity Breaks intervention | Experimental | The intervention arm will receive the Activity Breaks intervention. Receives: Behavioral: Activity Breaks |
| The control group | No intervention | The control arm will continue to receive their normal instruction. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Executive function
The Wisconsin Card Sorting Test (WCST): The computerized version of the WCST will be used to assess flexibility in decision making in this study. The number of total errors and perseverative errors and failure to maintain a set will be used as scores.
Measured: baseline, 8 weeks, and 20 weeks
Psychological capacities
Stroop Task. A computerized modified Stroop task will be used to reflect inhibition skills that help individuals override a prepotent response in favour of an alternative response.
Measured: baseline, 8 weeks, and 20 weeks
Working memory
Digit Span Backward: In this test, a participant will be presented with a series of digits to be repeated backwards.
Measured: baseline, 8 weeks, and 20 weeks
Attention
Measures of child attention levels will be measured using the online version of d2-R test of attention. TN-E is a total performance score which gives a measure of the relationship between performance accuracy and speed. TN-E scores are defined as 50-60% bad, 60-70% medium, 70-85% normal and over 85% is good.
Measured: baseline, 8 weeks, and 20 weeks
Secondary outcomes (4)
Physical activity (min/week)
The ActiGraph GT3X+ monitor (ActiGraph LLC, Pensacola, FL, USA) will be used to measure physical activity levels.
Measured: baseline, 8 weeks, and 20 weeks
Sedentary behavior (hour)
The ActiGraph GT3X+ monitor (ActiGraph LLC, Pensacola, FL, USA) will be used to measure sedentary behavior.
Measured: baseline, 8 weeks, and 20 weeks
Body weight (kg)
Body weight will be measured in light clothing to the nearest 0.1 kg with a calibrated electronic scale.
Measured: baseline, 8 weeks, and 20 weeks
Height (cm)
Height will be measured without shoes to the nearest 0.1 cm using a stadiometer in accordance with standard procedures.
Measured: baseline, 8 weeks, and 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2024
- Study start1 Jan 2023
- Primary completion30 Jun 2024
- Study completion30 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (38)Papers the sponsor has linked to this study.
- Other trials for Child BehaviorStudies 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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hong Kong Baptist University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gao Yang, Hong Kong Baptist University
- Investigators
- Julien S. BAKER, PhD, Study chair, HKBUWendy Yajun HUANG, PhD, Study director, Sport, Physical Education and Health/SOSC/HKBU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06376864
- Sponsor's protocol ID
- RC- FNRA-IG /20-21/SOSC/01
- Status last verified
- Oct 2024
- First submitted
- 28 Feb 2024
- Last updated
- 18 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bartholomew JB, Jowers EM. Physically active academic lessons in elementary children. Prev Med. 2011 Jun;52 Suppl 1(Suppl):S51-4. doi: 10.1016/j.ypmed.2011.01.017. Epub 2011 Jan 31.
PubMed 21281672Bates ME, Lemay EP Jr. The d2 Test of attention: construct validity and extensions in scoring techniques. J Int Neuropsychol Soc. 2004 May;10(3):392-400. doi: 10.1017/S135561770410307X.
PubMed 15147597Carlson JA, Engelberg JK, Cain KL, Conway TL, Mignano AM, Bonilla EA, Geremia C, Sallis JF. Implementing classroom physical activity breaks: Associations with student physical activity and classroom behavior. Prev Med. 2015 Dec;81:67-72. doi: 10.1016/j.ypmed.2015.08.006. Epub 2015 Aug 19.
PubMed 26297105Brooke HL, Atkin AJ, Corder K, Ekelund U, van Sluijs EM. Changes in time-segment specific physical activity between ages 10 and 14 years: A longitudinal observational study. J Sci Med Sport. 2016 Jan;19(1):29-34. doi: 10.1016/j.jsams.2014.10.003. Epub 2014 Oct 16.
PubMed 25459234Carson V, Hunter S, Kuzik N, Gray CE, Poitras VJ, Chaput JP, Saunders TJ, Katzmarzyk PT, Okely AD, Connor Gorber S, Kho ME, Sampson M, Lee H, Tremblay MS. Systematic review of sedentary behaviour and health indicators in school-aged children and youth: an update. Appl Physiol Nutr Metab. 2016 Jun;41(6 Suppl 3):S240-65. doi: 10.1139/apnm-2015-0630.
PubMed 27306432Carson V, Hunter S, Kuzik N, Wiebe SA, Spence JC, Friedman A, Tremblay MS, Slater L, Hinkley T. Systematic review of physical activity and cognitive development in early childhood. J Sci Med Sport. 2016 Jul;19(7):573-8. doi: 10.1016/j.jsams.2015.07.011. Epub 2015 Jul 10.
PubMed 26197943Chesham RA, Booth JN, Sweeney EL, Ryde GC, Gorely T, Brooks NE, Moran CN. The Daily Mile makes primary school children more active, less sedentary and improves their fitness and body composition: a quasi-experimental pilot study. BMC Med. 2018 May 10;16(1):64. doi: 10.1186/s12916-018-1049-z.
PubMed 29743076Cliff DP, Hesketh KD, Vella SA, Hinkley T, Tsiros MD, Ridgers ND, Carver A, Veitch J, Parrish AM, Hardy LL, Plotnikoff RC, Okely AD, Salmon J, Lubans DR. Objectively measured sedentary behaviour and health and development in children and adolescents: systematic review and meta-analysis. Obes Rev. 2016 Apr;17(4):330-44. doi: 10.1111/obr.12371. Epub 2016 Feb 24.
PubMed 26914664Cole TJ, Bellizzi MC, Flegal KM, Dietz WH. Establishing a standard definition for child overweight and obesity worldwide: international survey. BMJ. 2000 May 6;320(7244):1240-3. doi: 10.1136/bmj.320.7244.1240.
PubMed 10797032Drummy C, Murtagh EM, McKee DP, Breslin G, Davison GW, Murphy MH. The effect of a classroom activity break on physical activity levels and adiposity in primary school children. J Paediatr Child Health. 2016 Jul;52(7):745-9. doi: 10.1111/jpc.13182. Epub 2016 May 11.
PubMed 27168479Dumith SC, Gigante DP, Domingues MR, Kohl HW 3rd. Physical activity change during adolescence: a systematic review and a pooled analysis. Int J Epidemiol. 2011 Jun;40(3):685-98. doi: 10.1093/ije/dyq272. Epub 2011 Jan 18.
PubMed 21245072Dunn LL, Venturanza JA, Walsh RJ, Nonas CA. An observational evaluation of move-to-improve, a classroom-based physical activity program, New York City schools, 2010. Prev Chronic Dis. 2012;9:E146. doi: 10.5888/pcd9.120072.
PubMed 22974754Fairclough SJ, Hackett AF, Davies IG, Gobbi R, Mackintosh KA, Warburton GL, Stratton G, van Sluijs EM, Boddy LM. Promoting healthy weight in primary school children through physical activity and nutrition education: a pragmatic evaluation of the CHANGE! randomised intervention study. BMC Public Health. 2013 Jul 2;13:626. doi: 10.1186/1471-2458-13-626.
PubMed 23819701Huang WY, Wong SHS, Sit CHP, Wong MCS, Sum RKW, Wong SWS, Yu JJ. Results from the Hong Kong's 2018 report card on physical activity for children and youth. J Exerc Sci Fit. 2019 Jan;17(1):14-19. doi: 10.1016/j.jesf.2018.10.003. Epub 2018 Oct 8.
PubMed 30662509Kobel, S., Kettner, S., Dreyhaupt, J., & Steinacker, J. M. (2017). Objectively Determined Physical Activity Levels in German Primary School Children after a One Year School-based Health Promoting Intervention. Journal of Childhood Obesity, 2 (2).
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Investigating the Effects of a Classroom-based Physical Activity Intervention on Executive Function, Physical Activity and Sedentary Behaviour in 8-12-year-old Children
- ClinicalTrials.gov ID
- NCT06376864
- Acronym / sponsor ID
- RC- FNRA-IG /20-21/SOSC/01
- Conditions
- Child Behavior
- Keywords
- physical activity, sedentary behaviour, executive fundtion, health promotion, children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- Hong Kong Baptist UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jul 2024 (actual)
- First posted
- 19 Apr 2024 (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 current study aims to implement the Activity Breaks intervention and evaluate its effectiveness on outcome measures of executive function (EF), physical activity (PA), and sedentary behaviour (SB) in school children.
Detailed description
In Hong Kong, as well as globally, children fail to meet the current physical activity recommendations of 60-minutes of moderate-to-vigorous physical activity (MVPA) per day. Childhood and adolescence are critical periods for developing favourable lifestyle behaviours that can continue into adulthood. Health-promoting interventions that target physical inactivity are vitally important. Researchers have repeatedly demonstrated that higher academic achievement and better attendance at school occurs among children who are more physically active, healthy and fit. To promote improvements in health and education, it is essential to recognize movement as assistive to establishing cognitive and social skills. The current study aims to implement the Activity Breaks intervention and evaluate its effectiveness on outcome measures of executive function (EF), physical activity (PA), and sedentary behaviour (SB) in school children. The Activity Breaks intervention is a 5-minute Activity Breaks programme that allows classroom teachers of all ages and ability levels to lead simple movement activities within their classrooms, negating the need for additional personnel or space. It is expected that the 5-minute Activity Breaks programme performed three times a day over 8 weeks will not only increases daily PA, but also decreases SB through interrupting prolonged sitting time. The Activity Breaks Programme also improves executive functioning among primary school-aged children.
This study will be a pilot clustered randomised controlled trial involving 8 primary schools in Hong Kong. One class from each school will be recruited from primaries 4-6 (8-11-year-old children) as our target population. Schools randomised into the intervention will receive the Activity Breaks Programme whereas schools assigned to the control group will continue to receive their normal daily instruction.
Data will be collected from all participants (intervention and control) at three time points: Time 1 (T1) (baseline), Time 2 (T2) (Post-intervention), and Time 3 (T3) (3-month follow-up). The following pupil measures will be captured at all time points: 1. EF; 2. PA levels and SB patterns using accelerometers; and 3. anthropometric measurements. Two measures will be conducted among teachers including teacher interviews and teacher fidelity checks conducted using log books. All analyses will be performed using IBM SPSS statistical programmes. Multi-level modelling regression analyses with repeated measures will be used to determine the effects of the intervention. A mixed-design ANOVA with time (pre, post and follow-up) as a within-subject variable and group (intervention and control) as a between-subjects variable will be conducted, while adjusting for age, gender and body mass index.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Activity Breaks intervention | Experimental | Behavioral: Activity BreaksThe intervention arm will receive the Activity Breaks intervention. |
| The control group | No intervention | –The control arm will continue to receive their normal instruction. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- School children in primary school (exclude private or special education schools), grades 4-6 (8-12 years old)
- children with parental consent.
Key exclusion criteria (1 listed)
- Children with diagnosed behavioural or learning problems (e.g., attention-deficit hyperactivity disorder, ADHD)
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 |
|---|---|---|
| Activity BreaksThe Activity Breaks intervention is a 5-minute Activity Breaks programme that allows classroom teachers of all ages and ability levels to lead simple movement activities within their classrooms, negating the need for additional personnel or space. | Behavioural | Activity Breaks intervention |
Primary outcome
Executive function
Time frame: baseline, 8 weeks, and 20 weeks
The Wisconsin Card Sorting Test (WCST): The computerized version of the WCST will be used to assess flexibility in decision making in this study. The number of total errors and perseverative errors and failure to maintain a set will be used as scores.
Psychological capacities
Time frame: baseline, 8 weeks, and 20 weeks
Stroop Task. A computerized modified Stroop task will be used to reflect inhibition skills that help individuals override a prepotent response in favour of an alternative response.
Working memory
Time frame: baseline, 8 weeks, and 20 weeks
Digit Span Backward: In this test, a participant will be presented with a series of digits to be repeated backwards.
Attention
Time frame: baseline, 8 weeks, and 20 weeks
Measures of child attention levels will be measured using the online version of d2-R test of attention. TN-E is a total performance score which gives a measure of the relationship between performance accuracy and speed. TN-E scores are defined as 50-60% bad, 60-70% medium, 70-85% normal and over 85% is good.
4 secondary outcomes
Physical activity (min/week)
Time frame: baseline, 8 weeks, and 20 weeks
Sedentary behavior (hour)
Time frame: baseline, 8 weeks, and 20 weeks
Body weight (kg)
Time frame: baseline, 8 weeks, and 20 weeks
Height (cm)
Time frame: baseline, 8 weeks, and 20 weeks
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 18 Oct 2024.
- Background: PubMed 21281672Bartholomew JB, Jowers EM. Physically active academic lessons in elementary children. Prev Med. 2011 Jun;52 Suppl 1(Suppl):S51-4. doi: 10.1016/j.ypmed.2011.01.017. Epub 2011 Jan 31.
- Background: PubMed 15147597Bates ME, Lemay EP Jr. The d2 Test of attention: construct validity and extensions in scoring techniques. J Int Neuropsychol Soc. 2004 May;10(3):392-400. doi: 10.1017/S135561770410307X.
- Background: PubMed 26297105Carlson JA, Engelberg JK, Cain KL, Conway TL, Mignano AM, Bonilla EA, Geremia C, Sallis JF. Implementing classroom physical activity breaks: Associations with student physical activity and classroom behavior. Prev Med. 2015 Dec;81:67-72. doi: 10.1016/j.ypmed.2015.08.006. Epub 2015 Aug 19.
- Background: PubMed 25459234Brooke HL, Atkin AJ, Corder K, Ekelund U, van Sluijs EM. Changes in time-segment specific physical activity between ages 10 and 14 years: A longitudinal observational study. J Sci Med Sport. 2016 Jan;19(1):29-34. doi: 10.1016/j.jsams.2014.10.003. Epub 2014 Oct 16.
- Background: PubMed 27306432Carson V, Hunter S, Kuzik N, Gray CE, Poitras VJ, Chaput JP, Saunders TJ, Katzmarzyk PT, Okely AD, Connor Gorber S, Kho ME, Sampson M, Lee H, Tremblay MS. Systematic review of sedentary behaviour and health indicators in school-aged children and youth: an update. Appl Physiol Nutr Metab. 2016 Jun;41(6 Suppl 3):S240-65. doi: 10.1139/apnm-2015-0630.
- Background: PubMed 26197943Carson V, Hunter S, Kuzik N, Wiebe SA, Spence JC, Friedman A, Tremblay MS, Slater L, Hinkley T. Systematic review of physical activity and cognitive development in early childhood. J Sci Med Sport. 2016 Jul;19(7):573-8. doi: 10.1016/j.jsams.2015.07.011. Epub 2015 Jul 10.
- Background: PubMed 29743076Chesham RA, Booth JN, Sweeney EL, Ryde GC, Gorely T, Brooks NE, Moran CN. The Daily Mile makes primary school children more active, less sedentary and improves their fitness and body composition: a quasi-experimental pilot study. BMC Med. 2018 May 10;16(1):64. doi: 10.1186/s12916-018-1049-z.
- Background: PubMed 26914664Cliff DP, Hesketh KD, Vella SA, Hinkley T, Tsiros MD, Ridgers ND, Carver A, Veitch J, Parrish AM, Hardy LL, Plotnikoff RC, Okely AD, Salmon J, Lubans DR. Objectively measured sedentary behaviour and health and development in children and adolescents: systematic review and meta-analysis. Obes Rev. 2016 Apr;17(4):330-44. doi: 10.1111/obr.12371. Epub 2016 Feb 24.
- Background: PubMed 10797032Cole TJ, Bellizzi MC, Flegal KM, Dietz WH. Establishing a standard definition for child overweight and obesity worldwide: international survey. BMJ. 2000 May 6;320(7244):1240-3. doi: 10.1136/bmj.320.7244.1240.
- Background: PubMed 27168479Drummy C, Murtagh EM, McKee DP, Breslin G, Davison GW, Murphy MH. The effect of a classroom activity break on physical activity levels and adiposity in primary school children. J Paediatr Child Health. 2016 Jul;52(7):745-9. doi: 10.1111/jpc.13182. Epub 2016 May 11.
- Background: PubMed 21245072Dumith SC, Gigante DP, Domingues MR, Kohl HW 3rd. Physical activity change during adolescence: a systematic review and a pooled analysis. Int J Epidemiol. 2011 Jun;40(3):685-98. doi: 10.1093/ije/dyq272. Epub 2011 Jan 18.
- Background: PubMed 22974754Dunn LL, Venturanza JA, Walsh RJ, Nonas CA. An observational evaluation of move-to-improve, a classroom-based physical activity program, New York City schools, 2010. Prev Chronic Dis. 2012;9:E146. doi: 10.5888/pcd9.120072.
- 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.
Julien S. BAKER, PhD study chair
HKBU
Wendy Yajun HUANG, PhD study director
Sport, Physical Education and Health/SOSC/HKBU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Activity Breaks in people with Child Behavior, run by Hong Kong Baptist University at 1 site in Hong Kong.
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 1 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 18 Oct 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 Hong Kong. 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?
Executive function (time frame: baseline, 8 weeks, and 20 weeks). The study lists 4 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 NCT06376864, which also lists 38 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 18 Oct 2024; AzTrials last refreshed its copy on 28 Oct 2026.