Physical ActivityFACEiTNCT07862062
Fathers and Children Exercising Together
A study testing Standard Intervention, Community-enhanced intervention and Dietary modification in people with Physical Activity, run by Pennington Biomedical Research Center at 1 site in United States.
Trial summary
Children engage in low amounts of activity, which predisposes them to develop health disparities as they age. Fathers may be instrumental in helping to promote physical activity in their children. Read more about this study
- Who is it for?
- Ages 6 years and olderHealthy volunteers can take part
- Conditions the study is for
- Physical Activity
- What is being tested?
- Standard Intervention, Community-enhanced intervention and Dietary modification
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2025to 31 Mar 2026
- 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 6 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
"Fathers" Inclusion criteria
- self-identified male
- at least 18 years of age
- self-classify as a father/father figure of a 6-10 year old child
- willing to attend group sessions (virtual and in person)
- physically capable of exercise Exclusion criteria
- cognitive or physical impairment that would interfere with participating in a group discussion or activity
- unwilling to be audio recorded
- unwilling to give written informed consent
Children Inclusion criteria
- 6-10 years of age
- willing to attend group sessions (in person)
- average steps per day of less than the 50th percentile for age and gender
- physically capable of exercise Exclusion criteria
- cognitive or physical impairment that would interfere with participating in a group discussion or activity
- unwilling to be audio recorded
- unwilling to give written informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808-4124
About this study
Children engage in low amounts of activity, which predisposes them to develop health disparities as they age. Fathers may be instrumental in helping to promote physical activity in their children. The current proposal is designed to use community-engaged research methods to develop a physical activity intervention for children in which their fathers are the agents of change, and to determine the feasibility of implementing this intervention.
Read the detailed description
The high prevalence of chronic disease in adults places African American children at increased risk of developing these conditions. Adults experience several chronic diseases that are modifiable via behavior change, including coronary heart disease, hypertension, stroke, diabetes, and obesity. One of the major modifiable risk factors for these chronic diseases is a lack of regular physical activity (PA). Neither adults nor children are engaging in PA at nationally recommended levels. Parents play an important role in shaping their children's PA. Cross-sectional research has shown that mothers and fathers exert unique influences on their child's PA. The role of mothers has been clearly explicated, and the research field is saturated with studies where mothers are the participating parent in an intervention. However, the unique contributions of fathers, especially African American fathers, and the benefits that they bring to a family-based intervention, are just beginning to be studied. To address this research gap, the investigators propose to assess the feasibility of a family-based PA promotion intervention in families that utilizes the father as the participating parent and to obtain preliminary evidence of efficacy. Phase I of the study involves conducted focus groups with fathers to determine key intervention components. Phase II will involve iterative refinement of the intervention materials through a series of focus groups. Phase III involves a randomized clinical trial to determine feasibility and preliminary evidence of efficacy. Father-child dyads will be randomly assigned into a standard intervention, a community-enhanced intervention, or an attention matched active control group. "Fathers" are defined as the resident or non-resident biological father, step-father, or male role model. Children must be insufficiently active and 6 - 10 years of age. Father-child dyads randomized into the standard intervention will receive the FACEiT family-based PA promotion intervention for 12 weeks. Father-child dyads randomized into the community-enhanced intervention will receive the standard intervention in addition to community supports. For this group, the investigators will work with Fathers On A Mission (F.O.A.M.) to provide community-based PA opportunities specifically for this group. This intervention is theoretically based. Father-child dyads randomized into the attention-matched active control group will receive the family-based healthy eating intervention for 8-weeks. This will be a standard behavioral program targeting improved nutrition. All study groups will have 8 group meetings. Dyads will be recruited through a variety of methods the investigators have utilized previously to recruit men and children into research studies including outreach, paid media, earned media, and school-based efforts. Dyads will complete a number of assessments including accelerometry, feasibility, satisfaction, anthropometry, activity readiness, sociodemographics, dietary intake, and questionnaires that tap into the theoretical underpinnings of the study. It is hypothesized that the FACEiT physical activity promotion intervention will be feasible to deliver and that participants will be highly satisfied with the program. Feasibility will be determined based on current recommendations utilizing clear thresholds and benchmarks. It is also hypothesized that the study will show preliminary evidence of efficacy, i.e. the physical activity intervention will result in a significantly greater increased daily step counts compared to the attention matched active control group. Finally, the investigators expect a greater change in secondary outcomes. It is expected that the feasibility data and estimated intervention effect sizes outcomes from this R21 proposal will be used to determine the requisite sample size for a larger R01 randomized trial. The overall goal of FACEiT is to refine the intervention to be an effective tool to promote physical activity in fathers and their children. In addition, not only will the investigators' community-based partner, F.O.A.M., work to ensure that the PA intervention is appropriate for fathers, but F.O.A.M. will also help to disseminate the intervention if it is shown to be effective.
- Conditions
- Physical Activity
- Being tested
- Standard Intervention, Community-enhanced intervention, Dietary modification
- Keywords
- father, child, home environment, exercise
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard InterventionBehavioural
This is an 8-week intervention. Each session is 60 minutes. Each PA group session will end with group exercise (gradually progressing from 15 to 30 min) that is fun and engaging for the children. These activities will include rough-and-tumble play, collaborative dyad activities (e.g. sack races), and rewards for children for engaging in PA. Elements include behavioral strategies to increase children's PA, emotional regulation, monitoring, adaptive step goals, and competition.
Community-enhanced interventionBehavioural
This is the standard intervention plus a community element. The local non-profit organization will build upon their existing infrastructure to host regularly planned activities in the community and events at their facility. This will serve to alter the current community social environment and overcome barriers in the built environment to create an environment conducive to fathers exercising with their children.
Dietary modificationBehavioural
This is an 8-week behavioral intervention. Sessions are planned to take place within the institution's dietary kitchen as well as remotely. The importance of the father/male role model to their child's dietary intake will be emphasized. Topics will be adapted from the Traffic Light Diet. Fathers will not receive any behavioral strategies for increasing PA.
| Study group | Role | What they receive |
|---|---|---|
| Physical activity | Experimental | Designed to increase physical activity Receives: Behavioral: Standard Intervention; Behavioral: Community-enhanced intervention |
| Control | Experimental | This is a control arm Receives: Behavioral: Dietary modification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attendance: The percent of the total number of participants who attend each group session.
Attendance is defined as the number of participants who attend each group session. The outcome will be reported as a percentage calculated as follows: the number who attend each group divided by the number of participants enrolled in the group across all group sessions. This pertains to all study groups.
Measured: 8 weeks
The percent of participants who are enrolled at study completion
Retention is defined as the number of participants who complete the study. Retention will be defined as the number of participants who formally drop out of the study or do not complete any end of study assessments. Retention will be calculated as the number of participants who formally drop out of the study or do not complete any end of study assessments divided by the number of participants who enrolled in the study.
Measured: Through study completion, an average of 8 weeks
Satisfaction with the program as measured by the Program Satisfaction scale
The questionnaire will assess overall satisfaction with the program. Specific areas of assessment include helpfulness of the content, enjoyment of the group sessions, and relevance of the information received.
Measured: 8 weeks
Secondary outcomes (9)
Moderate intensity physical activity as measured by the ActiGraph WGT3X+BT device.
The ActiGraph WGT3X+BT accelerometer (ActiGraph LLC, Pensacola, FL) will be used to report the number of daily steps taken.
Measured: 8 weeks
The number of steps participants take daily as measured by the Fitbit Charge device.
The Fitbit Charge will be used to measure the child's daily step count. Children will wear the Fitbit daily on their wrist.
Measured: Through study completion, an average of 8 weeks
Children's perceived support for activity as measured by the Activity Support Scale for Multiple Groups (ACTS-MG).
Children will complete the Activity Support Scale for Multiple Groups (ACTS-MG). Scores range from 9-36, with higher scores indicating more support for physical activity.
Measured: 8 weeks
Chilren's sedentary behavior as measured by the sedentary behavior questionnaire (SBQ).
Father's sedentary behavior will be assessed using the sedentary behavior questionnaire (SBQ)
Measured: 8 weeks
Strategies parents use to promote dietary intake and physical activity as measured by the Parenting Strategies for Eating and Activity Scale.
The Parenting Strategies for Eating and Activity Scale which is a 33-item measure of parenting strategies for PA and eating habits. Higher scores indicating more frequent use of perceived paternal control, limit setting, monitoring, reinforcement, permission, and discipline.
Measured: 8 weeks
Father/father figure involvement in their child's lives as measured by the Index of Paternal Involvement scale.
Fathers will complete the Index of Paternal Involvement. This 19-item measure assesses fathers' involvement with their children in a variety of ways, such as spending time with the child, being a part of special celebrations and rituals, providing financial, support, and providing discipline). Total scale scores range from 0 to 76 with higher scores indicating higher paternal involvement.
Measured: 8 weeks
The availability of media devices in the home as measured by the Physical Activity and Media Inventory (PAMI).
The Physical Activity and Media Inventory (PAMI) is designed to be a self-report inventory of both the availability and accessibility of equipment to support PA and sedentary behavior.
Measured: 8 weeks
Neighborhood disorder as measured by the Neighborhood Psychosocial Hazards (NPH) scale.
Physical disorder will be measured via the physical disorder construct of the Neighborhood Psychosocial Hazards (NPH) scale. The NPH is a 12-item scale with higher values indicate more neighborhood psychosocial hazards.
Measured: 8 weeks
Food consumed by children as measured by the NCI's Automated Self-Administered 24-hour Recall (ASA24).
The NCI's Automated Self-Administered 24-hour Recall (ASA24) will be used to estimate daily intake of nutrients and macronutrients, food group servings, and alcohol.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2026
- Study start1 Sep 2025
- Primary completion31 Mar 2026
- Study completion31 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor
- Investigators
- Robert L Newton, PhD, Principal investigator, Pennington Biomedical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07862062
- Sponsor's protocol ID
- PBRC 2020-060
- Other IDs
- R21MD019097
- Acronym
- FACEiT
- Status last verified
- Jun 2026
- First submitted
- 21 Aug 2025
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified data can be shared via request to the study PI.
Publications
Maitland C, Stratton G, Foster S, Braham R, Rosenberg M. A place for play? The influence of the home physical environment on children's physical activity and sedentary behaviour. Int J Behav Nutr Phys Act. 2013 Aug 17;10:99. doi: 10.1186/1479-5868-10-99.
PubMed 23958282Troiano RP, Berrigan D, Dodd KW, Masse LC, Tilert T, McDowell M. Physical activity in the United States measured by accelerometer. Med Sci Sports Exerc. 2008 Jan;40(1):181-8. doi: 10.1249/mss.0b013e31815a51b3.
PubMed 18091006Newton RL Jr, Marker AM, Allen HR, Machtmes R, Han H, Johnson WD, Schuna JM Jr, Broyles ST, Tudor-Locke C, Church TS. Parent-targeted mobile phone intervention to increase physical activity in sedentary children: randomized pilot trial. JMIR Mhealth Uhealth. 2014 Nov 10;2(4):e48. doi: 10.2196/mhealth.3420.
PubMed 25386899
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fathers and Children Exercising Together
- ClinicalTrials.gov ID
- NCT07862062
- Acronym / sponsor ID
- FACEiT / PBRC 2020-060
- Conditions
- Physical Activity
- Keywords
- father, child, home environment, exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 31 Mar 2026 (actual)
- Study completion
- 31 Mar 2026 (actual)
- First posted
- 7 Oct 2026 (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.
Children engage in low amounts of activity, which predisposes them to develop health disparities as they age. Fathers may be instrumental in helping to promote physical activity in their children. The current proposal is designed to use community-engaged research methods to develop a physical activity intervention for children in which their fathers are the agents of change, and to determine the feasibility of implementing this intervention.
Detailed description
The high prevalence of chronic disease in adults places African American children at increased risk of developing these conditions. Adults experience several chronic diseases that are modifiable via behavior change, including coronary heart disease, hypertension, stroke, diabetes, and obesity. One of the major modifiable risk factors for these chronic diseases is a lack of regular physical activity (PA). Neither adults nor children are engaging in PA at nationally recommended levels. Parents play an important role in shaping their children's PA. Cross-sectional research has shown that mothers and fathers exert unique influences on their child's PA. The role of mothers has been clearly explicated, and the research field is saturated with studies where mothers are the participating parent in an intervention. However, the unique contributions of fathers, especially African American fathers, and the benefits that they bring to a family-based intervention, are just beginning to be studied. To address this research gap, the investigators propose to assess the feasibility of a family-based PA promotion intervention in families that utilizes the father as the participating parent and to obtain preliminary evidence of efficacy. Phase I of the study involves conducted focus groups with fathers to determine key intervention components. Phase II will involve iterative refinement of the intervention materials through a series of focus groups. Phase III involves a randomized clinical trial to determine feasibility and preliminary evidence of efficacy. Father-child dyads will be randomly assigned into a standard intervention, a community-enhanced intervention, or an attention matched active control group. "Fathers" are defined as the resident or non-resident biological father, step-father, or male role model. Children must be insufficiently active and 6 - 10 years of age. Father-child dyads randomized into the standard intervention will receive the FACEiT family-based PA promotion intervention for 12 weeks. Father-child dyads randomized into the community-enhanced intervention will receive the standard intervention in addition to community supports. For this group, the investigators will work with Fathers On A Mission (F.O.A.M.) to provide community-based PA opportunities specifically for this group. This intervention is theoretically based. Father-child dyads randomized into the attention-matched active control group will receive the family-based healthy eating intervention for 8-weeks. This will be a standard behavioral program targeting improved nutrition. All study groups will have 8 group meetings. Dyads will be recruited through a variety of methods the investigators have utilized previously to recruit men and children into research studies including outreach, paid media, earned media, and school-based efforts. Dyads will complete a number of assessments including accelerometry, feasibility, satisfaction, anthropometry, activity readiness, sociodemographics, dietary intake, and questionnaires that tap into the theoretical underpinnings of the study. It is hypothesized that the FACEiT physical activity promotion intervention will be feasible to deliver and that participants will be highly satisfied with the program. Feasibility will be determined based on current recommendations utilizing clear thresholds and benchmarks. It is also hypothesized that the study will show preliminary evidence of efficacy, i.e. the physical activity intervention will result in a significantly greater increased daily step counts compared to the attention matched active control group. Finally, the investigators expect a greater change in secondary outcomes. It is expected that the feasibility data and estimated intervention effect sizes outcomes from this R21 proposal will be used to determine the requisite sample size for a larger R01 randomized trial. The overall goal of FACEiT is to refine the intervention to be an effective tool to promote physical activity in fathers and their children. In addition, not only will the investigators' community-based partner, F.O.A.M., work to ensure that the PA intervention is appropriate for fathers, but F.O.A.M. will also help to disseminate the intervention if it is shown to be effective.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical activity | Experimental | Behavioral: Standard Intervention, Behavioral: Community-enhanced interventionDesigned to increase physical activity |
| Control | Experimental | Behavioral: Dietary modificationThis is a control arm |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| Standard InterventionThis is an 8-week intervention. Each session is 60 minutes. Each PA group session will end with group exercise (gradually progressing from 15 to 30 min) that is fun and engaging for the children. These activities will include rough-and-tumble play, collaborative dyad activities (e.g. sack races), and rewards for children for engaging in PA. Elements include behavioral strategies to increase children's PA, emotional regulation, monitoring, adaptive step goals, and competition. | Behavioural | Physical activity |
| Community-enhanced interventionThis is the standard intervention plus a community element. The local non-profit organization will build upon their existing infrastructure to host regularly planned activities in the community and events at their facility. This will serve to alter the current community social environment and overcome barriers in the built environment to create an environment conducive to fathers exercising with their children. | Behavioural | Physical activity |
| Dietary modificationThis is an 8-week behavioral intervention. Sessions are planned to take place within the institution's dietary kitchen as well as remotely. The importance of the father/male role model to their child's dietary intake will be emphasized. Topics will be adapted from the Traffic Light Diet. Fathers will not receive any behavioral strategies for increasing PA. | Behavioural | Control |
Primary outcome
Attendance: The percent of the total number of participants who attend each group session.
Time frame: 8 weeks
Attendance is defined as the number of participants who attend each group session. The outcome will be reported as a percentage calculated as follows: the number who attend each group divided by the number of participants enrolled in the group across all group sessions. This pertains to all study groups.
The percent of participants who are enrolled at study completion
Time frame: Through study completion, an average of 8 weeks
Retention is defined as the number of participants who complete the study. Retention will be defined as the number of participants who formally drop out of the study or do not complete any end of study assessments. Retention will be calculated as the number of participants who formally drop out of the study or do not complete any end of study assessments divided by the number of participants who enrolled in the study.
Satisfaction with the program as measured by the Program Satisfaction scale
Time frame: 8 weeks
The questionnaire will assess overall satisfaction with the program. Specific areas of assessment include helpfulness of the content, enjoyment of the group sessions, and relevance of the information received.
9 secondary outcomes
Moderate intensity physical activity as measured by the ActiGraph WGT3X+BT device.
Time frame: 8 weeks
The number of steps participants take daily as measured by the Fitbit Charge device.
Time frame: Through study completion, an average of 8 weeks
Children's perceived support for activity as measured by the Activity Support Scale for Multiple Groups (ACTS-MG).
Time frame: 8 weeks
Chilren's sedentary behavior as measured by the sedentary behavior questionnaire (SBQ).
Time frame: 8 weeks
Strategies parents use to promote dietary intake and physical activity as measured by the Parenting Strategies for Eating and Activity Scale.
Time frame: 8 weeks
Father/father figure involvement in their child's lives as measured by the Index of Paternal Involvement scale.
Time frame: 8 weeks
The availability of media devices in the home as measured by the Physical Activity and Media Inventory (PAMI).
Time frame: 8 weeks
Neighborhood disorder as measured by the Neighborhood Psychosocial Hazards (NPH) scale.
Time frame: 8 weeks
Food consumed by children as measured by the NCI's Automated Self-Administered 24-hour Recall (ASA24).
Time frame: 8 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 7 Oct 2026.
- Background: PubMed 23958282Maitland C, Stratton G, Foster S, Braham R, Rosenberg M. A place for play? The influence of the home physical environment on children's physical activity and sedentary behaviour. Int J Behav Nutr Phys Act. 2013 Aug 17;10:99. doi: 10.1186/1479-5868-10-99.
- Background: PubMed 18091006Troiano RP, Berrigan D, Dodd KW, Masse LC, Tilert T, McDowell M. Physical activity in the United States measured by accelerometer. Med Sci Sports Exerc. 2008 Jan;40(1):181-8. doi: 10.1249/mss.0b013e31815a51b3.
- Background: PubMed 25386899Newton RL Jr, Marker AM, Allen HR, Machtmes R, Han H, Johnson WD, Schuna JM Jr, Broyles ST, Tudor-Locke C, Church TS. Parent-targeted mobile phone intervention to increase physical activity in sedentary children: randomized pilot trial. JMIR Mhealth Uhealth. 2014 Nov 10;2(4):e48. doi: 10.2196/mhealth.3420.
- Individual participant dataSharing planned: Yes. Deidentified data can be shared via request to the study PI.
Related trials for Physical Activity
RecruitingPhase 1
Imatinib to Increase RUNX1 Activity in Participants With Germline RUNX1 Deficiency
Inherited Bone Marrow Failure Syndrome, Familial Platelet Disorder With Predisposition to Myeloid Malignancies
Active, not recruitingObservational study
A Study to Learn About the Effectiveness of Etrasimod in People With Ulcerative Colitis
Colitis, Ulcerative
RecruitingPhase 2
Neurovascular Regulation During Exercise in Humans With Chronic Kidney Disease: Sympatholysis in CKD
Chronic Kidney Disease
Not yet recruiting
Combined Versus Multicomponent Training in People With Chronic Kidney Disease Stages 3a and 3b
Chronic Kidney Disease Stage 3A, Chronic Kidney Disease Stage 3B
Not yet recruitingObservational study
A Study of Fatigue, Itching and Daily Activities in People With Primary Biliary Cholangitis Starting Elafibranor
Primary Biliary Cholangitis (PBC)
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.
Robert L Newton, PhD principal investigator
Pennington Biomedical
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Intervention, Community-enhanced intervention and Dietary modification in people with Physical Activity, run by Pennington Biomedical Research Center 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?
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 Oct 2026. 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?
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?
Attendance: The percent of the total number of participants who attend each group session. (time frame: 8 weeks). The study lists 3 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 NCT07862062, which also lists 3 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 7 Oct 2026.