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

NCT05201391 | Completed

• 2 other identifiers: #2106003013R24AG065174
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight and Obesity

Keywords

mindfulness-based intervention; weight management; sexual and gender minorities; adverse childhood experiences; mobile application

Outcome Measures

Primary Outcomes (5)

• Feasibility of ERN as measured by retention rates at 2-months

  We will calculate rates of retention at post-intervention and 2-months follow-up as one of the feasibility outcomes.

  2 months

• Feasibility of ERN as measured by retention rates at 4-months

  We will calculate rates of retention at post-intervention and 4-months follow-up as one of the feasibility outcomes.

  4 months

• Feasibility of ERN as measured by participation rates

  We will calculate the rates of module completion by enrolled participants as an indicator of the feasibility of the program.

  2 months

• Acceptability of ERN as measured by the Client Satisfaction Questionnaire (CSQ)

  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.

  2 months

• Acceptability of ERN as measured by the adapted system usability scale

  The system usability scale will assess acceptability of the app and various aspects of its usability.

  2 months

Secondary Outcomes (15)

• Food craving, assessed by Food Craving Questionnaire-Trait-Reduced (FCQ-Tr) at 2-months

  2 months

• 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

• 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

Study Arms (1)

"Eat Right Now" (ERN) mobile application

EXPERIMENTAL

Participants in this single-arm trial will receive the ERN app as the intervention.

Behavioral: "Eat Right Now" (ERN) mobile application

Interventions

"Eat Right Now" (ERN) mobile application BEHAVIORAL

"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.

"Eat Right Now" (ERN) mobile application

Eligibility Criteria

• Age: 30 Years - 55 Years
• Gender Eligibility Details: Female sex at birth
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

Sponsors & Collaborators

• Brown University: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Brown University

Providence, Rhode Island, 02912, United States

Location

MeSH Terms

Conditions

Overweight; Obesity; Coitus

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sexual Behavior; Behavior

Study Officials

• Shufang Sun, PhD

  Brown University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: "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.

Study Record Dates

• First Submitted: November 24, 2021
• First Posted: January 21, 2022
• Study Start: November 2, 2021
• Primary Completion: April 30, 2022
• Study Completion: April 30, 2022
• Last Updated: July 8, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Within 1.5 years of study completion.
• Access Criteria: Please contact the principal investigator, Shufang Sun, PhD, at shufang\ sun@brown.edu

Locations

US (1)