NCT06348251

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 26, 2024

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

March 30, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 4, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2024

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

January 28, 2026

Completed
Last Updated

January 28, 2026

Status Verified

January 1, 2026

Enrollment Period

8 months

First QC Date

March 30, 2024

Results QC Date

December 11, 2025

Last Update Submit

January 27, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Recruitment Rate

    Feasibility assessed by study recruitment and retention rates

    16 weeks

  • Study Retention Rate

    Feasibility assessed by study recruitment and retention rates

    16 weeks

Study Arms (1)

Behavioral intervention

OTHER
Behavioral: FoodSteps

Interventions

FoodStepsBEHAVIORAL

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

Behavioral intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern University Feinberg School of Medicine

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

BulimiaDiabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

HyperphagiaSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Results Point of Contact

Title
Andrea Graham
Organization
Northwestern University Feinberg School of Medicine

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 30, 2024

First Posted

April 4, 2024

Study Start

March 26, 2024

Primary Completion

November 20, 2024

Study Completion

November 20, 2024

Last Updated

January 28, 2026

Results First Posted

January 28, 2026

Record last verified: 2026-01

Locations