NCT05201391

An App-based Mindfulness Intervention for Sexual Minority Women With a History of Early Life Adversities (ELA)

Completed NA Last updated 8 July 2022

What this trial tests

NA trial testing "Eat Right Now" (ERN) mobile application in Overweight and Obesity in 30 participants. Completed in 30 April 2022.

Timeline

2 November 2021

Primary endpoint
30 April 2022

30 April 2022

Quick facts

Lead sponsor	Brown University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	30
Start date	2 November 2021
Primary completion	30 April 2022
Estimated completion	30 April 2022
Sites	1 location across United States

Drugs / interventions tested

• "Eat Right Now" (ERN) mobile application

Conditions studied

• Overweight and Obesity — all drugs for Overweight and Obesity →

Sponsor

Brown University

Who can join

Adults 30 to 55, female only, with Overweight and Obesity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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. 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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Mindfulness-Based Mobile Health to Address Unhealthy Eating Among Middle-Aged Sexual Minority Women With Early Life Adversity: Mixed Methods Feasibility Trial.
   Sun S, Nardi W, Murphy M, Scott T, et al · · 2023 · cited 4× · PMID 37751273 · DOI 10.2196/46310