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NCT06348251 Clinical Trial

FoodSteps for Binge Eating & Food Insecurity

Type 2 Diabetes Clinical Trial

Official title:
Evaluating a Digital Intervention for Binge Eating and Weight Management Among Adults With Food Insecurity

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06348251
Other study ID # STU00219612
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 26, 2024
Est. completion date November 30, 2024

Study information
Verified date March 2024
Source Northwestern University
Contact Andrea K Graham, PhD
Phone 312-503-5266
Email andrea.graham@northwestern.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to conduct a pilot trial of a mobile intervention that targets binge eating and weight-related behaviors, to determine the feasibility, acceptability, and preliminary efficacy of the intervention among adults with recurrent binge eating, diabetes, and food insecurity.

Recruitment information / eligibility
Status Recruiting
Enrollment 30
Est. completion date November 30, 2024
Est. primary completion date November 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Adults age 18 years or older - Recurrent binge eating (=12 episodes in the past 3 months) - Type 2 diabetes mellitus - Food insecure status (e.g. difficulty accessing food) - Interested in losing weight and reducing binge eating - Willing to use a mobile application - Has a smartphone with Internet access and capacity for calls and text messaging - Has a valid email address - Not pregnant - English-speaking Exclusion Criteria: - Diagnosis for which the study/intervention is not clinically indicated - Currently receiving clinical services for weight management or binge eating - Started or recently (within the past month) changed dosage of a medication for binge eating, weight management, or diabetes

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• FoodSteps
Participants will get access to the FoodSteps digital intervention with coaching for 16 weeks and receive a weekly stipend benefit to aid with implementing health behavior changes

Locations
Country Name City State
United States Northwestern University Feinberg School of Medicine Chicago Illinois

Sponsors (1)
Lead Sponsor Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Recruitment and retention rates Feasibility assessed by study recruitment and retention rates 16 weeks
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