NCT06349460

Brief Summary

The purpose of this study is to conduct a micro-randomized trial to learn which evidence-based targets within a mobile intervention for binge eating and weight-related behaviors are most impactful for which people and in what sequence.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
2mo left

Started Mar 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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 Progress94%
Mar 2024Jun 2026

Study Start

First participant enrolled

March 21, 2024

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

March 30, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 5, 2024

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Last Updated

December 17, 2025

Status Verified

December 1, 2025

Enrollment Period

2.3 years

First QC Date

March 30, 2024

Last Update Submit

December 11, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Weekly change in binge eating

    Change in number of binge eating episodes

    1 week

Study Arms (10)

Increase healthy eating behaviors - Assigned

EXPERIMENTAL

Individuals will be assigned to increase healthy eating behaviors that week.

Behavioral: FoodSteps behavioral intervention

Increase healthy eating behaviors - Recommended

EXPERIMENTAL

Individuals will be recommend to increase healthy eating behaviors that week.

Behavioral: FoodSteps behavioral intervention

Increase physical activity - Assigned

EXPERIMENTAL

Individuals will be assigned to increase physical activity that week.

Behavioral: FoodSteps behavioral intervention

Increase physical activity - Recommended

EXPERIMENTAL

Individuals will be recommended to increase physical activity that week.

Behavioral: FoodSteps behavioral intervention

Limit unhealthy dieting behaviors - Assigned

EXPERIMENTAL

Individuals will be assigned to limit unhealthy dieting behaviors that week.

Behavioral: FoodSteps behavioral intervention

Limit unhealthy dieting behaviors - Recommended

EXPERIMENTAL

Individuals will be recommended to limit unhealthy dieting behaviors that week.

Behavioral: FoodSteps behavioral intervention

Improve self-image - Assigned

EXPERIMENTAL

Individuals will be assigned to improve self-image that week.

Behavioral: FoodSteps behavioral intervention

Improve self-image - Recommended

EXPERIMENTAL

Individuals will be recommended to improve self-image that week.

Behavioral: FoodSteps behavioral intervention

Improve mood - Assigned

EXPERIMENTAL

Individuals will be assigned to improve mood that week.

Behavioral: FoodSteps behavioral intervention

Improve mood - Recommended

EXPERIMENTAL

Individuals will be recommended to improve mood that week.

Behavioral: FoodSteps behavioral intervention

Interventions

Behavioral intervention that targets binge eating and weight-related behaviors. Each week, users are recommended or assigned one of five targets, set a relevant goal, and track their progress. If a target is recommended, the user can choose to select that target or a different target.

Improve mood - AssignedImprove mood - RecommendedImprove self-image - AssignedImprove self-image - RecommendedIncrease healthy eating behaviors - AssignedIncrease healthy eating behaviors - RecommendedIncrease physical activity - AssignedIncrease physical activity - RecommendedLimit unhealthy dieting behaviors - AssignedLimit unhealthy dieting behaviors - Recommended

Eligibility Criteria

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

You may qualify if:

  • Adults age 18 years or older
  • Obesity (BMI ≥30)
  • Recurrent binge eating (≥12 episodes in the past 3 months)
  • 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
  • Has access to a scale
  • Not pregnant
  • English-speaking

You may not qualify if:

  • Diagnosis for which the study/intervention is not clinically indicated
  • Not currently receiving clinical services for weight management or binge eating

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern University Feinberg School of Medicine

Chicago, Illinois, 60611, United States

Location

Related Publications (1)

  • Ortega A, Rooper IR, Massion T, Azubuike C, Lipman LD, Lakhtakia T, Camino MK, Parsons LM, Tack E, Alshurafa N, Kay M, Graham AK. Co-designing prediction data visualizations for a digital binge eating intervention. Transl Behav Med. 2025 Jan 16;15(1):ibaf009. doi: 10.1093/tbm/ibaf009.

MeSH Terms

Conditions

BulimiaObesity

Condition Hierarchy (Ancestors)

HyperphagiaSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody Weight

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: In this micro-randomized trial, participants will have 2 consecutive, independent micro-randomizations at the time of target selection each week for 16 weeks: namely, 1 of 5 treatment targets will be randomly delivered, either as a recommended or assigned target, to each user, of equal probability per randomization.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 30, 2024

First Posted

April 5, 2024

Study Start

March 21, 2024

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

December 17, 2025

Record last verified: 2025-12

Locations