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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Feasibility of ERN as measured by participation rates
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •(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.
排除标准
- •(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.
结局指标
主要结局
Feasibility of ERN as measured by participation rates
时间窗: 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)
时间窗: 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
时间窗: 2 months
The system usability scale will assess acceptability of the app and various aspects of its usability.
Feasibility of ERN as measured by retention rates at 2-months
时间窗: 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
时间窗: 4 months
We will calculate rates of retention at post-intervention and 4-months follow-up as one of the feasibility outcomes.
次要结局
- Food craving, assessed by Food Craving Questionnaire-Trait-Reduced (FCQ-Tr) at 4-months(4 months)
- Reward-based eating, assessed by the Reward-based Eating Drive (RED) scale at 2-months(2 months)
- Mindfulness, assessed by the Mindful Awareness and Attention Scale (MAAS) at 4-months(4 months)
- Depression, assessed by the Patient Health Questionnaire (PHQ-9) at 4-months(4 months)
- Food craving, assessed by Food Craving Questionnaire-Trait-Reduced (FCQ-Tr) at 2-months(2 months)
- Reward-based eating, assessed by the Reward-based Eating Drive (RED) scale at 4-months(4 months)
- Mindfulness, assessed by the Five Facet Mindfulness Questionnaire (FFMQ) at 2-months(2 months)
- Emotional regulation, assessed by the Difficulties in emotion regulation scale (DERS) at 2-months(2 & 4 months)
- Emotional regulation, assessed by the Difficulties in emotion regulation scale (DERS) at 4-months(4 months)
- Weight, measured by a standardized scale at 2-months(2 months)
- Weight, measured by a standardized scale at 3-months(3 months)
- Weight, measured by a standardized scale at 4-months(4 months)
- Mindfulness, assessed by the Mindful Awareness and Attention Scale (MAAS) at 2-months(2 months)
- Depression, assessed by the Patient Health Questionnaire (PHQ-9) at 2-months(2 months)
- Mindfulness, assessed by the Five Facet Mindfulness Questionnaire (FFMQ) at 4-months(4 months)