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Behavioral Intervention

"Eat Right Now" (ERN) mobile application for Obesity

N/A
Waitlist Available
Led By Shufang Sun, PhD
Research Sponsored by Brown University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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.
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 & 4 months
Awards & highlights

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.

Eligible Conditions
  • Obesity

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 & 4 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 & 4 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Acceptability of ERN as measured by the Client Satisfaction Questionnaire (CSQ)
Acceptability of ERN as measured by the adapted system usability scale
Feasibility of ERN as measured by participation rates
+2 more
Secondary outcome measures
Depression, assessed by the Patient Health Questionnaire (PHQ-9) at 2-months
Depression, assessed by the Patient Health Questionnaire (PHQ-9) at 4-months
Emotional regulation, assessed by the Difficulties in emotion regulation scale (DERS) at 2-months
+12 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: "Eat Right Now" (ERN) mobile applicationExperimental Treatment1 Intervention
Participants in this single-arm trial will receive the ERN app as the intervention.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
"Eat Right Now" (ERN) mobile application
2021
N/A
~30

Find a Location

Who is running the clinical trial?

Brown UniversityLead Sponsor
459 Previous Clinical Trials
559,327 Total Patients Enrolled
20 Trials studying Obesity
9,985 Patients Enrolled for Obesity
National Institute on Aging (NIA)NIH
1,704 Previous Clinical Trials
28,033,227 Total Patients Enrolled
45 Trials studying Obesity
12,958 Patients Enrolled for Obesity
Shufang Sun, PhDPrincipal InvestigatorBrown University
2 Previous Clinical Trials
58 Total Patients Enrolled
~8 spots leftby Jul 2025