Overweight and ObesityNCT05201391
An App-based Mindfulness Intervention for Sexual Minority Women With a History of Early Life Adversities (ELA)
A study testing "Eat Right Now" (ERN) mobile application in people with Overweight and Obesity, run by Brown University at 1 site in United States.
Trial summary
Sexual minority women (SMW) in mid-age are at significantly higher risk for obesity, which is associated with greater vulnerability to cardiovascular disease, diabetes, cancer, and mortality. Further, this group also has elevated risk of early life adversities (ELA), such as childhood trauma and abuse. Read more about this study
- Who is it for?
- Ages 30 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- "Eat Right Now" (ERN) mobile application
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Nov 2021to 30 Apr 2022
- 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 30 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Inclusion Criteria: (a) 30-55 years of age; (b) BMI ≥ 25; (c) fluent in English; (d) have a smartphone; (e) reside in the U.S.; (f) experience food (salty or sweet) cravings and endorsed overeating of these foods (i.e. responded 'yes' to 'do you find yourself eating more than you'd like of a particular food or category of foods?') at least 4 times per week; (g) self-identify as a sexual minority woman (e.g., lesbian, bisexual, queer, or other sexual minority women); and (h) experienced early life adversity, screened via an adapted measure of childhood abuse.
Exclusion Criteria: (a) current eating disorder; (b) current strict diet (e.g. paleo, keto, vegan, calorie restriction); (c) current insulin use; (d) pregnant or trying to become pregnant; (e) previous use of the "Eat Right Now" application; and (f) history of serious mental illness, such as bipolar or psychotic disorders or self-injurious behaviors.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Examining the Feasibility and Acceptability of an App-based Mindfulness Intervention for Sexual Minority Women With a History of Early Life Adversities (ELA): A Single Arm Trial
Sexual minority women (SMW) in mid-age are at significantly higher risk for obesity, which is associated with greater vulnerability to cardiovascular disease, diabetes, cancer, and mortality. Further, this group also has elevated risk of early life adversities (ELA), such as childhood trauma and abuse. ELA has been linked to increased risks of midlife obesity and food addiction. However, interventions addressing this public health issue among SMW is scarce. Mindfulness-based interventions (MBI), delivered via smartphone, could be an effective approach to reduce the dual burden of obesity among ELA-affected SMW in their midlife. The study investigators developed an app-based MBI (28 daily modules, self-paced), "Eat Right Now" (ERN), which uses mindfulness to target craving-based eating.
The current single-arm, exploratory clinical trial evaluates the utility of ERN among mid-aged sexual minority women who are overweight (BMI larger or equal to 25) and have a history of early life adversities. Specifically, two aims guide the study: (1) Investigators will examine the feasibility and acceptability of ERN among mid-aged sexual minority women who are overweight and have a history of early life adversities. Exit-interviews will be conducted to understand women's experience and inform future adaptation of the intervention. (2) Preliminary, pre-post trial efficacy will be evaluated.
Participants will be screened using a two-part process taking place online, via an online screener and a Zoom-based screening. Research assessments will take place at baseline, post-intervention, and 4-month follow-up, digitally using using Qualtrics, LLC (Provo, UT, USA) survey management tool. Exit-interviews at post-intervention will be conducted via Zoom.
Read the detailed description
Sexual minority women (SMW) in mid-age are at significantly higher risk for obesity, which is associated with greater vulnerability to cardiovascular disease, diabetes, cancer, and mortality. Further, this group also has elevated risk of early life adversities (ELA), such as childhood trauma and abuse. ELA has been linked to increased risks of midlife obesity and food addiction. However, interventions addressing this public health issue among SMW is scarce.
Mindfulness-based interventions (MBI), delivered via smartphone, could be an effective approach to reduce the dual burden of obesity among ELA-affected SMW in their midlife. Our team has developed an app-based MBI (28 daily modules, self-paced), known as "Eat Right Now" (ERN), which uses mindfulness to target craving-based eating. Results from a pilot study where ERN was administered to a general population of 64 adults showed promising results. However, despite these promising outcomes, no MBI, including ERN, has been tested specifically in ELA-affected adults including SMW. The potential effect of ERN as an MBI to enhance emotion regulation and mental health is also unknown.
Our team's overarching goal is to address the behavioral health burden of ELAs among SMW in midlife through mindfulness-based intervention and evaluate the biopsychosocial mechanisms of MBI for this population. The two (abbreviated) aims of this research study are: Aim 1. Examine the acceptability and preliminary efficacy of ERN as an internet-delivered MBI for distressed, overweight (BMI greater or equal to 25) ELA-affected SMW in midlife (age 30-54; n = 30). Aim 2. Investigate the mechanisms of ERN for ELA-affected SMW.
This is a stage 1 single arm trial where investigators hope to enroll 30 sexual minority women (SMW) aged 30-55, who meet all inclusion and exclusion criteria, including having a BMI>25, who are experiencing food cravings and endorsed overeating of these foods and who have experienced early life adversity (ELA).
Screening for eligibility will take place in a two-step process: (1) completion of a 5-10-minute online survey and (2) a face-to-face 15-25-minute zoom interview with a trained staff member. Given the online, remote nature of the study, a waiver of documentation of informed consent has been granted. Participants will be given a copy of the ICF at both screening steps. A trained research staff member will review all components of the ICF with the participant during the zoom interview.
Eligible participants will then be invited to complete an online baseline assessment designed to take up to one hour. Once complete, participants will be given access to the mobile-based mindfulness eating app and will be asked to complete it over the course of six to eight weeks.
Self-reported weight measurements will be taken periodically throughout the study using a standardized weight scale mailed to participants prior to the start of the intervention.
Participants that complete the self-paced intervention will then be invited to complete a 60-90-minute exit interview conducted via zoom with trained research staff. Online follow up assessments will also be conducted at 2-month and 4-month post-intervention.
- Conditions
- Overweight and Obesity
- Being tested
- "Eat Right Now" (ERN) mobile application
- Keywords
- mindfulness-based intervention, weight management, sexual and gender minorities, adverse childhood experiences, mobile application
- Medical subject headings
- Overweight, Obesity, Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"Eat Right Now" (ERN) mobile applicationBehavioural
"Eat Right Now" (ERN) is an app-based (28 daily modules, self-paced) Mindfulness-Based Intervention (MBI), which uses mindfulness to target craving-based eating. The program is designed to take 6-8 weeks to complete.
| Study group | Role | What they receive |
|---|---|---|
| "Eat Right Now" (ERN) mobile application | Experimental | Participants in this single-arm trial will receive the ERN app as the intervention. Receives: Behavioral: "Eat Right Now" (ERN) mobile application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of ERN as measured by retention rates at 2-months
We will calculate rates of retention at post-intervention and 2-months follow-up as one of the feasibility outcomes.
Measured: 2 months
Feasibility of ERN as measured by retention rates at 4-months
We will calculate rates of retention at post-intervention and 4-months follow-up as one of the feasibility outcomes.
Measured: 4 months
Feasibility of ERN as measured by participation rates
We will calculate the rates of module completion by enrolled participants as an indicator of the feasibility of the program.
Measured: 2 months
Acceptability of ERN as measured by the Client Satisfaction Questionnaire (CSQ)
The Client Satisfaction Questionnaire (CSQ) will assess participants' satisfaction with recruitment, retention, and intervention procedures. An overall score is produced by summing all item responses. For the CSQ-8 version, scores range from 8 to 32, with higher values indicating higher satisfaction.
Measured: 2 months
Acceptability of ERN as measured by the adapted system usability scale
The system usability scale will assess acceptability of the app and various aspects of its usability.
Measured: 2 months
Secondary outcomes (15)
Food craving, assessed by Food Craving Questionnaire-Trait-Reduced (FCQ-Tr) at 2-months
The Food Craving Questionnaire-Trait-Reduced (FCQ-Tr) will assess participants' experience of food craving. Scores range from 15 to 75 with higher scores indicating higher levels of craving.
Measured: 2 months
Food craving, assessed by Food Craving Questionnaire-Trait-Reduced (FCQ-Tr) at 4-months
The Food Craving Questionnaire-Trait-Reduced (FCQ-Tr) will assess participants' experience of food craving. Scores range from 15 to 75 with higher scores indicating higher levels of craving.
Measured: 4 months
Reward-based eating, assessed by the Reward-based Eating Drive (RED) scale at 2-months
The Reward-based Eating Drive (RED) scale will assess participants' experience of reward-based eating. Overall scores range from 0 to 52 with higher scores indicating more engagement with reward-based eating.
Measured: 2 months
Reward-based eating, assessed by the Reward-based Eating Drive (RED) scale at 4-months
The Reward-based Eating Drive (RED) scale will assess participants' experience of reward-based eating. Overall scores range from 0 to 52 with higher scores indicating more engagement with reward-based eating.
Measured: 4 months
Mindfulness, assessed by the Five Facet Mindfulness Questionnaire (FFMQ) at 2-months
The Five Facet Mindfulness Questionnaire (FFMQ) will assess participants' self-reported mindfulness level. Total scores range from 39 to 195 with higher scores indicating greater levels of mindfulness. Sub-scale scores as well as mean scoring are also able to be obtained.
Measured: 2 months
Mindfulness, assessed by the Five Facet Mindfulness Questionnaire (FFMQ) at 4-months
The Five Facet Mindfulness Questionnaire (FFMQ) will assess participants' self-reported mindfulness level. Total scores range from 39 to 195 with higher scores indicating greater levels of mindfulness. Sub-scale scores as well as mean scoring are also able to be obtained.
Measured: 4 months
Mindfulness, assessed by the Mindful Awareness and Attention Scale (MAAS) at 2-months
The Mindful Awareness and Attention Scale (MAAS) will assess participants' self-reported mindfulness level. Scoring is obtained by computing a mean score for the 15-items. Scores range from 1 to 6 with higher scores reflecting greater levels of dispositional mindfulness.
Measured: 2 months
Mindfulness, assessed by the Mindful Awareness and Attention Scale (MAAS) at 4-months
The Mindful Awareness and Attention Scale (MAAS) will assess participants' self-reported mindfulness level. Scoring is obtained by computing a mean score for the 15-items. Scores range from 1 to 6 with higher scores reflecting greater levels of dispositional mindfulness.
Measured: 4 months
Depression, assessed by the Patient Health Questionnaire (PHQ-9) at 2-months
The Patient Health Questionnaire (PHQ-9) will assess participants' depressive symptoms. Scores range from 0 to 27, with higher scores indicating greater severity of depression. Scale is self-report; responses should be verified by a clinician for true diagnosis of depression.
Measured: 2 months
Depression, assessed by the Patient Health Questionnaire (PHQ-9) at 4-months
The Patient Health Questionnaire (PHQ-9) will assess participants' depressive symptoms. Scores range from 0 to 27, with higher scores indicating greater severity of depression. Scale is self-report; responses should be verified by a clinician for true diagnosis of depression.
Measured: 4 months
Emotional regulation, assessed by the Difficulties in emotion regulation scale (DERS) at 2-months
The Difficulties in emotion regulation scale (DERS) short form is an 18-item scale that will assess participants' emotional regulation skills. Scores can be summed or averaged for interpretation. Total scores range from 18 to 90 with higher scores indicating greater emotion regulation.
Measured: 2 & 4 months
Emotional regulation, assessed by the Difficulties in emotion regulation scale (DERS) at 4-months
The Difficulties in emotion regulation scale (DERS) short form is an 18-item scale that will assess participants' emotional regulation skills. Scores can be summed or averaged for interpretation. Total scores range from 18 to 90 with higher scores indicating greater emotion regulation.
Measured: 4 months
Weight, measured by a standardized scale at 2-months
Change in weight and BMI will be assessed using a standardized scale provided to participants at baseline.
Measured: 2 months
Weight, measured by a standardized scale at 3-months
Change in weight and BMI will be assessed using a standardized scale provided to participants at baseline.
Measured: 3 months
Weight, measured by a standardized scale at 4-months
Change in weight and BMI will be assessed using a standardized scale provided to participants at baseline.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2022
- Study start2 Nov 2021
- Primary completion30 Apr 2022
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- More trials run by Brown UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- "Eat Right Now" (ERN) is an app-based (28 daily modules, self-paced) Mindfulness-Based Intervention (MBI), which uses mindfulness to target craving-based eating. The program is designed to take 6-8 weeks to complete.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Shufang Sun, PhD, Principal investigator, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05201391
- Sponsor's protocol ID
- #2106003013
- Other IDs
- R24AG065174
- Status last verified
- Jul 2022
- First submitted
- 24 Nov 2021
- Last updated
- 8 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: External researchers interested in utilizing these data will be encouraged to do so provided they adhere to participant confidentiality requirements stipulated by the research study protection of human subjects protocol and the Brown University IRB.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Feasibility and Acceptability of an App-based Mindfulness Intervention for Sexual Minority Women With a History of Early Life Adversities (ELA): A Single Arm Trial
- ClinicalTrials.gov ID
- NCT05201391
- Acronym / sponsor ID
- #2106003013
- Conditions
- Overweight and Obesity
- Keywords
- mindfulness-based intervention, weight management, sexual and gender minorities, adverse childhood experiences, mobile application
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 2 Nov 2021 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 21 Jan 2022 (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.
Sexual minority women (SMW) in mid-age are at significantly higher risk for obesity, which is associated with greater vulnerability to cardiovascular disease, diabetes, cancer, and mortality. Further, this group also has elevated risk of early life adversities (ELA), such as childhood trauma and abuse. ELA has been linked to increased risks of midlife obesity and food addiction. However, interventions addressing this public health issue among SMW is scarce. Mindfulness-based interventions (MBI), delivered via smartphone, could be an effective approach to reduce the dual burden of obesity among ELA-affected SMW in their midlife. The study investigators developed an app-based MBI (28 daily modules, self-paced), "Eat Right Now" (ERN), which uses mindfulness to target craving-based eating.
The current single-arm, exploratory clinical trial evaluates the utility of ERN among mid-aged sexual minority women who are overweight (BMI larger or equal to 25) and have a history of early life adversities. Specifically, two aims guide the study: (1) Investigators will examine the feasibility and acceptability of ERN among mid-aged sexual minority women who are overweight and have a history of early life adversities. Exit-interviews will be conducted to understand women's experience and inform future adaptation of the intervention. (2) Preliminary, pre-post trial efficacy will be evaluated.
Participants will be screened using a two-part process taking place online, via an online screener and a Zoom-based screening. Research assessments will take place at baseline, post-intervention, and 4-month follow-up, digitally using using Qualtrics, LLC (Provo, UT, USA) survey management tool. Exit-interviews at post-intervention will be conducted via Zoom.
Detailed description
Sexual minority women (SMW) in mid-age are at significantly higher risk for obesity, which is associated with greater vulnerability to cardiovascular disease, diabetes, cancer, and mortality. Further, this group also has elevated risk of early life adversities (ELA), such as childhood trauma and abuse. ELA has been linked to increased risks of midlife obesity and food addiction. However, interventions addressing this public health issue among SMW is scarce.
Mindfulness-based interventions (MBI), delivered via smartphone, could be an effective approach to reduce the dual burden of obesity among ELA-affected SMW in their midlife. Our team has developed an app-based MBI (28 daily modules, self-paced), known as "Eat Right Now" (ERN), which uses mindfulness to target craving-based eating. Results from a pilot study where ERN was administered to a general population of 64 adults showed promising results. However, despite these promising outcomes, no MBI, including ERN, has been tested specifically in ELA-affected adults including SMW. The potential effect of ERN as an MBI to enhance emotion regulation and mental health is also unknown.
Our team's overarching goal is to address the behavioral health burden of ELAs among SMW in midlife through mindfulness-based intervention and evaluate the biopsychosocial mechanisms of MBI for this population. The two (abbreviated) aims of this research study are: Aim 1. Examine the acceptability and preliminary efficacy of ERN as an internet-delivered MBI for distressed, overweight (BMI greater or equal to 25) ELA-affected SMW in midlife (age 30-54; n = 30). Aim 2. Investigate the mechanisms of ERN for ELA-affected SMW.
This is a stage 1 single arm trial where investigators hope to enroll 30 sexual minority women (SMW) aged 30-55, who meet all inclusion and exclusion criteria, including having a BMI>25, who are experiencing food cravings and endorsed overeating of these foods and who have experienced early life adversity (ELA).
Screening for eligibility will take place in a two-step process: (1) completion of a 5-10-minute online survey and (2) a face-to-face 15-25-minute zoom interview with a trained staff member. Given the online, remote nature of the study, a waiver of documentation of informed consent has been granted. Participants will be given a copy of the ICF at both screening steps. A trained research staff member will review all components of the ICF with the participant during the zoom interview.
Eligible participants will then be invited to complete an online baseline assessment designed to take up to one hour. Once complete, participants will be given access to the mobile-based mindfulness eating app and will be asked to complete it over the course of six to eight weeks.
Self-reported weight measurements will be taken periodically throughout the study using a standardized weight scale mailed to participants prior to the start of the intervention.
Participants that complete the self-paced intervention will then be invited to complete a 60-90-minute exit interview conducted via zoom with trained research staff. Online follow up assessments will also be conducted at 2-month and 4-month post-intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- "Eat Right Now" (ERN) is an app-based (28 daily modules, self-paced) Mindfulness-Based Intervention (MBI), which uses mindfulness to target craving-based eating. The program is designed to take 6-8 weeks to complete.
| Arm | Type | Receives |
|---|---|---|
| "Eat Right Now" (ERN) mobile application | Experimental | Behavioral: "Eat Right Now" (ERN) mobile applicationParticipants in this single-arm trial will receive the ERN app as the intervention. |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- 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 |
|---|---|---|
| "Eat Right Now" (ERN) mobile application"Eat Right Now" (ERN) is an app-based (28 daily modules, self-paced) Mindfulness-Based Intervention (MBI), which uses mindfulness to target craving-based eating. The program is designed to take 6-8 weeks to complete. | Behavioural | "Eat Right Now" (ERN) mobile application |
Primary outcome
Feasibility of ERN as measured by retention rates at 2-months
Time frame: 2 months
We will calculate rates of retention at post-intervention and 2-months follow-up as one of the feasibility outcomes.
Feasibility of ERN as measured by retention rates at 4-months
Time frame: 4 months
We will calculate rates of retention at post-intervention and 4-months follow-up as one of the feasibility outcomes.
Feasibility of ERN as measured by participation rates
Time frame: 2 months
We will calculate the rates of module completion by enrolled participants as an indicator of the feasibility of the program.
Acceptability of ERN as measured by the Client Satisfaction Questionnaire (CSQ)
Time frame: 2 months
The Client Satisfaction Questionnaire (CSQ) will assess participants' satisfaction with recruitment, retention, and intervention procedures. An overall score is produced by summing all item responses. For the CSQ-8 version, scores range from 8 to 32, with higher values indicating higher satisfaction.
Acceptability of ERN as measured by the adapted system usability scale
Time frame: 2 months
The system usability scale will assess acceptability of the app and various aspects of its usability.
15 secondary outcomes
Food craving, assessed by Food Craving Questionnaire-Trait-Reduced (FCQ-Tr) at 2-months
Time frame: 2 months
Food craving, assessed by Food Craving Questionnaire-Trait-Reduced (FCQ-Tr) at 4-months
Time frame: 4 months
Reward-based eating, assessed by the Reward-based Eating Drive (RED) scale at 2-months
Time frame: 2 months
Reward-based eating, assessed by the Reward-based Eating Drive (RED) scale at 4-months
Time frame: 4 months
Mindfulness, assessed by the Five Facet Mindfulness Questionnaire (FFMQ) at 2-months
Time frame: 2 months
Mindfulness, assessed by the Five Facet Mindfulness Questionnaire (FFMQ) at 4-months
Time frame: 4 months
Mindfulness, assessed by the Mindful Awareness and Attention Scale (MAAS) at 2-months
Time frame: 2 months
Mindfulness, assessed by the Mindful Awareness and Attention Scale (MAAS) at 4-months
Time frame: 4 months
Depression, assessed by the Patient Health Questionnaire (PHQ-9) at 2-months
Time frame: 2 months
Depression, assessed by the Patient Health Questionnaire (PHQ-9) at 4-months
Time frame: 4 months
Emotional regulation, assessed by the Difficulties in emotion regulation scale (DERS) at 2-months
Time frame: 2 & 4 months
Emotional regulation, assessed by the Difficulties in emotion regulation scale (DERS) at 4-months
Time frame: 4 months
Weight, measured by a standardized scale at 2-months
Time frame: 2 months
Weight, measured by a standardized scale at 3-months
Time frame: 3 months
Weight, measured by a standardized scale at 4-months
Time frame: 4 months
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 8 Jul 2022.
- Individual participant dataSharing planned: Yes. External researchers interested in utilizing these data will be encouraged to do so provided they adhere to participant confidentiality requirements stipulated by the research study protection of human subjects protocol and the Brown University IRB.
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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.
Shufang Sun, PhD principal investigator
Brown University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "Eat Right Now" (ERN) mobile application in people with Overweight and Obesity, run by Brown University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 8 Jul 2022. 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?
Feasibility of ERN as measured by retention rates at 2-months (time frame: 2 months). The study lists 5 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 8 Jul 2022.