Clinical trial NCT05201391: An App-based Mindfulness Intervention for Sexual Minority Women With a History of Early Life Adversities (ELA)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obesity
Keywords: mindfulness-based intervention
weight management
sexual and gender minorities
adverse childhood experiences
mobile application
Lead sponsor: Brown University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2022-01-21
Enrollment: 30
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Feasibility of ERN as measured by retention rates at 2-months
timeFrame: 2 months
measure: Feasibility of ERN as measured by retention rates at 4-months
timeFrame: 4 months
measure: Feasibility of ERN as measured by participation rates
timeFrame: 2 months
measure: Acceptability of ERN as measured by the Client Satisfaction Questionnaire (CSQ)
timeFrame: 2 months
measure: Acceptability of ERN as measured by the adapted system usability scale
timeFrame: 2 months
Secondary outcomes:
measure: Food craving, assessed by Food Craving Questionnaire-Trait-Reduced (FCQ-Tr) at 2-months
timeFrame: 2 months
measure: Food craving, assessed by Food Craving Questionnaire-Trait-Reduced (FCQ-Tr) at 4-months
timeFrame: 4 months
measure: Reward-based eating, assessed by the Reward-based Eating Drive (RED) scale at 2-months
timeFrame: 2 months
measure: Reward-based eating, assessed by the Reward-based Eating Drive (RED) scale at 4-months
timeFrame: 4 months
measure: Mindfulness, assessed by the Five Facet Mindfulness Questionnaire (FFMQ) at 2-months
timeFrame: 2 months
measure: Mindfulness, assessed by the Five Facet Mindfulness Questionnaire (FFMQ) at 4-months
timeFrame: 4 months
measure: Mindfulness, assessed by the Mindful Awareness and Attention Scale (MAAS) at 2-months
timeFrame: 2 months
measure: Mindfulness, assessed by the Mindful Awareness and Attention Scale (MAAS) at 4-months
timeFrame: 4 months
measure: Depression, assessed by the Patient Health Questionnaire (PHQ-9) at 2-months
timeFrame: 2 months
measure: Depression, assessed by the Patient Health Questionnaire (PHQ-9) at 4-months
timeFrame: 4 months
measure: Emotional regulation, assessed by the Difficulties in emotion regulation scale (DERS) at 2-months
timeFrame: 2 & 4 months
measure: Emotional regulation, assessed by the Difficulties in emotion regulation scale (DERS) at 4-months
timeFrame: 4 months
measure: Weight, measured by a standardized scale at 2-months
timeFrame: 2 months
measure: Weight, measured by a standardized scale at 3-months
timeFrame: 3 months
measure: Weight, measured by a standardized scale at 4-months
timeFrame: 4 months
Other outcomes:
Locations:
city: Providence
country: United States
facility: Brown University
state: Rhode Island
Study officials:
affiliation: Brown University
name: Shufang Sun, PhD
role: PRINCIPAL_INVESTIGATOR
References: