An App-based Mindfulness Intervention for Sexual Minority Women With a History of Early Life Adversities (ELA)
Condition: Overweight and Obesity
MeSH terms: Overweight
Study type: Interventional

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.
    

Intervention name(s): "Eat Right Now" (ERN) mobile application
Intervention type(s): Behavioral
Intervention description(s): "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.
Intervention model: Single Group Assignment
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.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: mindfulness-based intervention; weight management; sexual and gender minorities; adverse childhood experiences; mobile application