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NCT05201391 · ClinicalTrials.gov registry record · NA
An App-based Mindfulness Intervention for Sexual Minority Women With a History of Early Life Adversities (ELA)
A NA study, sponsored by Brown University.
- Completed
- Registry status
- NA
- Development phase
- 30
- Enrollment target
NCT05201391: Completed NA study, sponsored by Brown University.
NCT05201391 is a NA study that has completed, run by Brown University. The registered enrollment target is 30 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05201391, a NA study, has completed, sponsored by Brown University.
- COMPLETED
- Registry status
- NA
- Development phase
- 30 participants
- Enrollment target
Study 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. 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.
Primary Outcome
We will calculate rates of retention at post-intervention and 2-months follow-up as one of the feasibility outcomes.
Interventions
- BEHAVIORAL "Eat Right Now" (ERN) mobile application
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2021-11-02 |
| Est. Completion | 2022-04-30 |
| Phase | NA |
What the finished NCT05201391 record still lists
NCT05201391 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which "Eat Right Now" (ERN) mobile application is the first listed.
NCT05201391 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05201391 about?
NCT05201391 is a clinical study titled "An App-based Mindfulness Intervention for Sexual Minority Women With a History of Early Life Adversities (ELA)". 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 abu...
What is the current status of trial NCT05201391?
This trial is currently completed. It is a NA study. The enrollment target is 30 participants. The study started on 2021-11-02. Estimated completion is 2022-04-30.
What interventions are being tested in trial NCT05201391?
The interventions under investigation include: "Eat Right Now" (ERN) mobile application (BEHAVIORAL).
Who is sponsoring clinical trial NCT05201391?
This trial is sponsored by Brown University, which has 231 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05201391's enrollment target sits among peer trials
30 1593rd of 2000 higher than 299 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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