Binge EatingNCT06349460
Trial to Optimize Just-in-Time Adaptive Intervention for Binge Eating & Weight-related Behaviors
A study testing FoodSteps behavioral intervention in people with Binge Eating and Obesity, run by Northwestern University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Binge Eating, Obesity
- What is being tested?
- FoodSteps behavioral intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Mar 2024to 16 Jun 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- Has a valid email address
- Has access to a scale
- Not pregnant
- English-speaking
Who cannot join
- Diagnosis for which the study/intervention is not clinically indicated
- Not currently receiving clinical services for weight management or binge eating
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611
About this study
Official title: A Micro-Randomized Trial to Optimize Just-in-Time Adaptive Intervention for Binge Eating & Weight-related Behaviors
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.
- Conditions
- Binge Eating, Obesity
- Being tested
- FoodSteps behavioral intervention
- Medical subject headings
- Bulimia, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FoodSteps behavioral interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| FoodSteps within-person micro-randomization | Experimental | All participants will receive access to the FoodSteps intervention. At each decision point (the start of each intervention week), participants will have two consecutive, independent randomizations to either be recommended or assigned to one of five treatment targets. Treatment targets are to increase healthy eating behaviors, increase physical activity, limit unhealthy dieting behaviors, improve self-image, and improve mood. Receives: Behavioral: FoodSteps behavioral intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weekly change in binge eating
Change in number of binge eating episodes
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2024
- Study start21 Mar 2024
- Primary completion16 Jun 2026
- Study completion16 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Binge EatingStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Graham, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06349460
- Sponsor's protocol ID
- STU00216998
- Other IDs
- R01DK133300
- Status last verified
- Oct 2026
- First submitted
- 30 Mar 2024
- Last updated
- 23 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40167045