High Intensity Interval TrainingNCT05137990
The HIIT Cognition Study
A study testing HIIT Exercise Intervention and Stretching Intervention in people with High Intensity Interval Training and Overweight and Obesity, run by University of Southern California at 1 site in United States.
Trial summary
This pilot study is a randomized control trial to test the effects of a 14-week home-based virtual, interactive high intensity interval training (HIIT) exercise intervention on cardiometabolic and cognitive outcomes in sedentary youth with overweight/obesity during adolescence. Read more about this study
- Who is it for?
- Ages 12 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- High Intensity Interval Training, Overweight and Obesity, Metabolic Disease
- What is being tested?
- HIIT Exercise Intervention and Stretching Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2021to 30 Sep 2023
- 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 12 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Typically developing youth.
- Overweight/obese (BMI >= 85th percentile)
- Does not meet current PA guidelines
- Able and willing to complete HIIT exercise intervention.
- Space for a stationary bike in the residence.
Who cannot join
- Diagnoses of neurodevelopment or psychiatric disorders.
- Diabetes, cardiovascular, pulmonary, or other significant medical problems.
- Taking medications know to alter metabolism.
- Allergy to metals.
- Inability to participate in HIIT-based exercise or active involvement in sports/exercise programs.
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Southern California
Los Angeles, California, 90032
About this study
Official title: The Effects of High Intensity Exercise in Teens on Cognition
This pilot study is a randomized control trial to test the effects of a 14-week home-based virtual, interactive high intensity interval training (HIIT) exercise intervention on cardiometabolic and cognitive outcomes in sedentary youth with overweight/obesity during adolescence. All participants (N=24) will complete screening via phone to determine eligibility. Eligible participants will be randomized to receive a) 14 weeks of a home-based HIIT intervention delivered via iPad or b) 14 weeks of a stretching intervention (control group). Each participant will undergo an in-lab pre- and post-test visit, where they will complete a fasting blood draw, a fitness test, and various cognitive and mental health measures.
Read the detailed description
Rationale: Existing literature supports the premise that physical activity (PA) has beneficial effects on cognitive function in youth, but prior studies have limitations, such as cross-sectional designs with limited insights on the intensity or duration of PA or the biological underpinnings linking physical activity and mental health and cognitive function in adolescents. A limited number of studies (and none in the U.S.) have evaluated the effects of HIIT on cognitive processes in youth, particularly in youth with overweight/obesity whose age-related declines in PA puts them at increased risk for poor outcomes. This study is particularly timely during the current COVID-19 related public health crisis because our HIIT exercise intervention is time efficient, delivered remotely, and completed using space-efficient equipment in the home.
Intervention: Participants (youth ages 12-16 years with overweight/obesity) will be randomly assigned to complete a) 14 weeks of a home-based virtual, interactive HIIT intervention or b) 14 weeks of a stretching intervention (control group).
Objectives/Purpose: The overall goal is to improve cognitive and cardiometabolic outcomes in youth with overweight/obesity by implementing an at-home HIIT intervention. The aims of this study are: 1) to determine the feasibility, acceptability, and efficacy of HIIT in adolescents with overweight/obesity, 2) to examine the effectiveness of HIIT on cognitive and mental health outcomes, and 3) to examine the effectiveness of HIIT on cardiometabolic health.
Study Population: This study will consist of youth ages 12-16 years with overweight/obesity (BMI >=85th percentile) who do not meet current PA guidelines.
Study Methodology: This pilot study is a randomized control trial to test the effects of a 14-week home-based virtual, interactive high intensity interval training (HIIT) exercise intervention on cardiometabolic and cognitive outcomes in sedentary youth with overweight/obesity during adolescence. All participants (N=24) will complete screening via phone to determine eligibility. Eligible participants will be randomized to receive a) 14 weeks of a home-based HIIT intervention delivered via iPad (HIIT group) or b) 14 weeks of a stretching intervention (control group).
Those randomized to the HIIT group will receive the intervention 3 times/week and will be given a pre-assembled stationary bicycle to use to complete each exercise session, an iPad to Zoom with the exercise trainers, and a Fitbit to assess real-time heart rate. Exercise trainers will provide encouragement and supervision for exercise prescription adherence and youth will select an age-appropriate music playlist from Spotify to enhance enjoyment throughout each session. Each exercise session consists of a 5-minute warm-up (10% HRmax), followed by a 20-minute HIIT protocol. The 20-minute HIIT protocol consists of seven bouts of 1-min high intensity exercise (90% HRmax) followed by 2-min of active recovery (10% HRmax). Participants will be encouraged to complete each exercise session with at least 24 hours of rest between each session.
Those randomized to the control group will perform a home-based program of the same stretches utilized in the exercise group. The stretching protocol consists of one set of 4 static stretching exercises held for 30 seconds and performed 3 days/week. As flexibility exercises are low-intensity, low-impact and low-volume, minimal caloric expenditure is expected to be incurred.
Study arms: Study participants will be randomly assigned to receive either the HIIT intervention (HIIT group) or receive the stretching intervention (control group).
Endpoints/Outcomes: The primary cognitive and mental health endpoints are: executive function, episodic memory, working memory, affect, mood, anxiety, stress, self-efficacy for PA, and PA enjoyment. The primary cardiometabolic endpoints are: glucose, insulin (to calculate Homeostatic Model Assessment for Insulin Resistance), IL-6, IL-1, TNF-a, and VEGF.
Statistical analyses: The populations for analyses include the full analytical dataset which consists of all randomized study participants.
- Being tested
- HIIT Exercise Intervention, Stretching Intervention
- Keywords
- High Intensity Interval Training, Physical Activity, Pediatric Obesity, Metabolic Disturbances, Mental Health
- Medical subject headings
- Overweight, Obesity, Metabolic Diseases, Motor Activity, Pediatric Obesity, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIIT Exercise InterventionBehavioural
Also called Exercise group
Exercise trainers will provide encouragement and supervision for exercise prescription adherence and youth will select an age-appropriate music playlist from Spotify to enhance enjoyment throughout each session. Each exercise session consists of a 5-minute warm-up (10% HRmax), followed by a 20-minute HIIT protocol. The 20-minute HIIT protocol consists of seven bouts of 1-min high intensity exercise (90% HRmax) followed by 2-min of active recovery (10% HRmax). Participants will be encouraged to complete each exercise session with at least 24 hours of rest between each session.
Stretching InterventionBehavioural
Also called Control group
This group will perform a home-based program of the same stretches utilized in the exercise group. The stretching protocol consists of one set of 4 static stretching exercises held for 30 seconds and performed 3 days/week. As flexibility exercises are low-intensity, low-impact and low-volume, minimal caloric expenditure is expected to be incurred. To increase compliance and aid in the standardization of the home-based stretching, participants will be provided a booklet of the flexibility exercises. Participants will be shown how to use the booklet and instructed in the stretching exercises by an exercise trainer prior to the intervention.
| Study group | Role | What they receive |
|---|---|---|
| HIIT Exercise Intervention | Experimental | At home (N=12): Participants will complete an exercise session 3 times a week for 14 weeks. Each participant will receive a pre-assembled stationary bicycle to use to complete each session, an iPad to receive the intervention virtually from exercise trainers through Zoom, and a Fitbit to assess real-time heart rate. Receives: Behavioral: HIIT Exercise Intervention |
| Stretching Intervention | Placebo comparator | At home (N=12): Participants will complete a stretching protocol 3 times a week for 14 weeks. Participants will be asked to complete weekly records of flexibility compliance. Receives: Behavioral: Stretching Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measures of intervention feasibility
percent of youth who complete an average of 70% of weekly minutes and percent of youth who attend 70% of exercise sessions
Measured: 14 weeks
Measures of intervention efficacy
percent of sessions where youth achieve their target heart rate
Measured: 14 weeks
Intervention Feasibility Measure
4-item scale with scores for each ranging from 1 to 5, higher scores indicate a better outcome for feasibility
Measured: 14 weeks
Intervention Acceptability Measure
4-item scale with scores for each ranging from 1 to 5; higher scores indicate a better outcome for acceptability
Measured: 14 weeks
Intervention Appropriateness Measure
4-item scale with scores for each ranging from 1 to 5; higher scores indicate a better outcome for appropriateness
Measured: 14 weeks
Cognitive function measures
executive function, episodic and working memory tasks from NIH Toolbox, all age-adjusted T-scores
Measured: 14 weeks
Positive and Negative Affect Scale for Children
10-item positive and negative affect scale with scores for each ranging from 0 to 5; higher scores indicate a worse outcome for negative affect and better outcome for positive affect
Measured: 14 weeks
Profile of Mood States for Adolescents
24-item scale with each ranging from 0 to 4; higher scores indicate a worse mood outcome
Measured: 14 weeks
State-Trait Anxiety Inventory for Children
20-item scale measuring acute and long-term anxiety, with a range from 20 to 80; higher scores indicate more anxiety
Measured: 14 weeks
Perceived Stress Scale
10-item scale with each ranging from 0 to 4; higher scores indicate a worse stress outcome after reverse coding applicable items
Measured: 14 weeks
Stress in Children Scale
21-item scale with each ranging from 0 to 4; higher scores indicate a worse stress outcome after reverse coding applicable items
Measured: 14 weeks
Self-Efficacy for Physical Activity Scale
5-item scale with each ranging from 1 to 5; higher scores indicating a better self-efficacy for physical activity outcome
Measured: 14 weeks
Physical Activity Enjoyment Scale
18-item scale with each ranging from 1 to 7; higher scores indicate a better physical activity enjoyment outcome after reverse coding applicable items
Measured: 14 weeks
Glucose Sensitivity
glucose, insulin (to calculate Homeostatic Model Assessment for Insulin Resistance)
Measured: 14 weeks
Markers of inflammation
interleukin-1 (IL-1), interleukin-6 (IL-6), tumor necrosis factor alpha (TNF-a), all in pg/mL
Measured: 14 weeks
Vascular Endothelial-Derived Growth
vascular endothelial growth factor (VEGF) in pg/mL
Measured: 14 weeks
Cardiorespiratory Fitness
maximal oxygen consumption (VO2max)
Measured: 14 weeks
Blood Pressure
systolic and diastolic blood pressure
Measured: 14 weeks
Body proportion
waist-to-height ratio
Measured: 14 weeks
Body composition
percent body fat
Measured: 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2021
- Study start1 Mar 2021
- Primary completion30 Sep 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Intensity Interval TrainingStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized to complete one of two conditions: 1) 14 weeks of a home-based virtual HIIT exercise intervention or 2) 14 weeks of a stretching intervention (control group).
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- Dana-Farber Cancer Institute
- Responsible party
- Principal investigator, Britni Ryan Belcher, PhD, MPH, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05137990
- Sponsor's protocol ID
- HS-21-00149
- Status last verified
- May 2024
- First submitted
- 6 Oct 2021
- Last updated
- 7 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We do not intend to share IPD with other researchers outside of our study.
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of High Intensity Exercise in Teens on Cognition
- ClinicalTrials.gov ID
- NCT05137990
- Acronym / sponsor ID
- HS-21-00149
- Keywords
- High Intensity Interval Training, Physical Activity, Pediatric Obesity, Metabolic Disturbances, Mental Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- Dana-Farber Cancer Institute
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 30 Nov 2021 (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.
This pilot study is a randomized control trial to test the effects of a 14-week home-based virtual, interactive high intensity interval training (HIIT) exercise intervention on cardiometabolic and cognitive outcomes in sedentary youth with overweight/obesity during adolescence. All participants (N=24) will complete screening via phone to determine eligibility. Eligible participants will be randomized to receive a) 14 weeks of a home-based HIIT intervention delivered via iPad or b) 14 weeks of a stretching intervention (control group). Each participant will undergo an in-lab pre- and post-test visit, where they will complete a fasting blood draw, a fitness test, and various cognitive and mental health measures.
Detailed description
Rationale: Existing literature supports the premise that physical activity (PA) has beneficial effects on cognitive function in youth, but prior studies have limitations, such as cross-sectional designs with limited insights on the intensity or duration of PA or the biological underpinnings linking physical activity and mental health and cognitive function in adolescents. A limited number of studies (and none in the U.S.) have evaluated the effects of HIIT on cognitive processes in youth, particularly in youth with overweight/obesity whose age-related declines in PA puts them at increased risk for poor outcomes. This study is particularly timely during the current COVID-19 related public health crisis because our HIIT exercise intervention is time efficient, delivered remotely, and completed using space-efficient equipment in the home.
Intervention: Participants (youth ages 12-16 years with overweight/obesity) will be randomly assigned to complete a) 14 weeks of a home-based virtual, interactive HIIT intervention or b) 14 weeks of a stretching intervention (control group).
Objectives/Purpose: The overall goal is to improve cognitive and cardiometabolic outcomes in youth with overweight/obesity by implementing an at-home HIIT intervention. The aims of this study are: 1) to determine the feasibility, acceptability, and efficacy of HIIT in adolescents with overweight/obesity, 2) to examine the effectiveness of HIIT on cognitive and mental health outcomes, and 3) to examine the effectiveness of HIIT on cardiometabolic health.
Study Population: This study will consist of youth ages 12-16 years with overweight/obesity (BMI >=85th percentile) who do not meet current PA guidelines.
Study Methodology: This pilot study is a randomized control trial to test the effects of a 14-week home-based virtual, interactive high intensity interval training (HIIT) exercise intervention on cardiometabolic and cognitive outcomes in sedentary youth with overweight/obesity during adolescence. All participants (N=24) will complete screening via phone to determine eligibility. Eligible participants will be randomized to receive a) 14 weeks of a home-based HIIT intervention delivered via iPad (HIIT group) or b) 14 weeks of a stretching intervention (control group).
Those randomized to the HIIT group will receive the intervention 3 times/week and will be given a pre-assembled stationary bicycle to use to complete each exercise session, an iPad to Zoom with the exercise trainers, and a Fitbit to assess real-time heart rate. Exercise trainers will provide encouragement and supervision for exercise prescription adherence and youth will select an age-appropriate music playlist from Spotify to enhance enjoyment throughout each session. Each exercise session consists of a 5-minute warm-up (10% HRmax), followed by a 20-minute HIIT protocol. The 20-minute HIIT protocol consists of seven bouts of 1-min high intensity exercise (90% HRmax) followed by 2-min of active recovery (10% HRmax). Participants will be encouraged to complete each exercise session with at least 24 hours of rest between each session.
Those randomized to the control group will perform a home-based program of the same stretches utilized in the exercise group. The stretching protocol consists of one set of 4 static stretching exercises held for 30 seconds and performed 3 days/week. As flexibility exercises are low-intensity, low-impact and low-volume, minimal caloric expenditure is expected to be incurred.
Study arms: Study participants will be randomly assigned to receive either the HIIT intervention (HIIT group) or receive the stretching intervention (control group).
Endpoints/Outcomes: The primary cognitive and mental health endpoints are: executive function, episodic memory, working memory, affect, mood, anxiety, stress, self-efficacy for PA, and PA enjoyment. The primary cardiometabolic endpoints are: glucose, insulin (to calculate Homeostatic Model Assessment for Insulin Resistance), IL-6, IL-1, TNF-a, and VEGF.
Statistical analyses: The populations for analyses include the full analytical dataset which consists of all randomized study participants.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomized to complete one of two conditions: 1) 14 weeks of a home-based virtual HIIT exercise intervention or 2) 14 weeks of a stretching intervention (control group).
| Arm | Type | Receives |
|---|---|---|
| HIIT Exercise Intervention | Experimental | Behavioral: HIIT Exercise InterventionAt home (N=12): Participants will complete an exercise session 3 times a week for 14 weeks. Each participant will receive a pre-assembled stationary bicycle to use to complete each session, an iPad to receive the intervention virtually from exercise trainers through Zoom, and a Fitbit to assess real-time heart rate. |
| Stretching Intervention | Placebo comparator | Behavioral: Stretching InterventionAt home (N=12): Participants will complete a stretching protocol 3 times a week for 14 weeks. Participants will be asked to complete weekly records of flexibility compliance. |
Who may qualify
- Ages
- 12 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Typically developing youth.
- Overweight/obese (BMI >= 85th percentile)
- Does not meet current PA guidelines
- Able and willing to complete HIIT exercise intervention.
- Space for a stationary bike in the residence.
Key exclusion criteria (6 listed)
- Diagnoses of neurodevelopment or psychiatric disorders.
- Diabetes, cardiovascular, pulmonary, or other significant medical problems.
- Taking medications know to alter metabolism.
- Allergy to metals.
- Inability to participate in HIIT-based exercise or active involvement in sports/exercise programs.
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 |
|---|---|---|
| HIIT Exercise InterventionAlso: Exercise groupExercise trainers will provide encouragement and supervision for exercise prescription adherence and youth will select an age-appropriate music playlist from Spotify to enhance enjoyment throughout each session. Each exercise session consists of a 5-minute warm-up (10% HRmax), followed by a 20-minute HIIT protocol. The 20-minute HIIT protocol consists of seven bouts of 1-min high intensity exercise (90% HRmax) followed by 2-min of active recovery (10% HRmax). Participants will be encouraged to complete each exercise session with at least 24 hours of rest between each session. | Behavioural | HIIT Exercise Intervention |
| Stretching InterventionAlso: Control groupThis group will perform a home-based program of the same stretches utilized in the exercise group. The stretching protocol consists of one set of 4 static stretching exercises held for 30 seconds and performed 3 days/week. As flexibility exercises are low-intensity, low-impact and low-volume, minimal caloric expenditure is expected to be incurred. To increase compliance and aid in the standardization of the home-based stretching, participants will be provided a booklet of the flexibility exercises. Participants will be shown how to use the booklet and instructed in the stretching exercises by an exercise trainer prior to the intervention. | Behavioural | Stretching Intervention |
Primary outcome
Measures of intervention feasibility
Time frame: 14 weeks
percent of youth who complete an average of 70% of weekly minutes and percent of youth who attend 70% of exercise sessions
Measures of intervention efficacy
Time frame: 14 weeks
percent of sessions where youth achieve their target heart rate
Intervention Feasibility Measure
Time frame: 14 weeks
4-item scale with scores for each ranging from 1 to 5, higher scores indicate a better outcome for feasibility
Intervention Acceptability Measure
Time frame: 14 weeks
4-item scale with scores for each ranging from 1 to 5; higher scores indicate a better outcome for acceptability
Intervention Appropriateness Measure
Time frame: 14 weeks
4-item scale with scores for each ranging from 1 to 5; higher scores indicate a better outcome for appropriateness
Cognitive function measures
Time frame: 14 weeks
executive function, episodic and working memory tasks from NIH Toolbox, all age-adjusted T-scores
Positive and Negative Affect Scale for Children
Time frame: 14 weeks
10-item positive and negative affect scale with scores for each ranging from 0 to 5; higher scores indicate a worse outcome for negative affect and better outcome for positive affect
Profile of Mood States for Adolescents
Time frame: 14 weeks
24-item scale with each ranging from 0 to 4; higher scores indicate a worse mood outcome
State-Trait Anxiety Inventory for Children
Time frame: 14 weeks
20-item scale measuring acute and long-term anxiety, with a range from 20 to 80; higher scores indicate more anxiety
Perceived Stress Scale
Time frame: 14 weeks
10-item scale with each ranging from 0 to 4; higher scores indicate a worse stress outcome after reverse coding applicable items
Stress in Children Scale
Time frame: 14 weeks
21-item scale with each ranging from 0 to 4; higher scores indicate a worse stress outcome after reverse coding applicable items
Self-Efficacy for Physical Activity Scale
Time frame: 14 weeks
5-item scale with each ranging from 1 to 5; higher scores indicating a better self-efficacy for physical activity outcome
Physical Activity Enjoyment Scale
Time frame: 14 weeks
18-item scale with each ranging from 1 to 7; higher scores indicate a better physical activity enjoyment outcome after reverse coding applicable items
Glucose Sensitivity
Time frame: 14 weeks
glucose, insulin (to calculate Homeostatic Model Assessment for Insulin Resistance)
Markers of inflammation
Time frame: 14 weeks
interleukin-1 (IL-1), interleukin-6 (IL-6), tumor necrosis factor alpha (TNF-a), all in pg/mL
Vascular Endothelial-Derived Growth
Time frame: 14 weeks
vascular endothelial growth factor (VEGF) in pg/mL
Cardiorespiratory Fitness
Time frame: 14 weeks
maximal oxygen consumption (VO2max)
Blood Pressure
Time frame: 14 weeks
systolic and diastolic blood pressure
Body proportion
Time frame: 14 weeks
waist-to-height ratio
Body composition
Time frame: 14 weeks
percent body fat
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 7 May 2024.
- Individual participant dataSharing planned: No. We do not intend to share IPD with other researchers outside of our study.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HIIT Exercise Intervention and Stretching Intervention in people with High Intensity Interval Training and Overweight and Obesity, run by University of Southern California 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 5 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 7 May 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. Some participants in this study may receive a placebo. 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?
Measures of intervention feasibility (time frame: 14 weeks). The study lists 20 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 May 2024.