Overweight and ObesityPhase 2NCT06547320
Sensor-based Just-in Time Adaptive Interventions (JITAIs) Targeting Eating Behavior
A Phase 2 study testing Eat Less Intervention and Eat Slower Intervention in people with Overweight and Obesity, run by The Miriam Hospital at 2 sites in United States.
Trial summary
The purpose of this study is to determine whether a sensor device called an Automatic Ingestion Monitor (AIM) that is worn on eyeglasses can be used with a smartphone to change eating behavior. Participants will wear the device for one week of no-intervention observation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- Eat Less Intervention and Eat Slower Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jan 2025to 30 May 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Body mass index (BMI) between 27 and 45 kg/m-squared
- Weight stable within 5% in the past 6 months
- Self-reports basic familiarity with use of a smartphone
Who cannot join
- Diagnosed diabetes (type 1 and 2)
- Any poorly controlled medical condition that could affect weight and/or eating behavior (e.g., hypothyroidism)
- Medical conditions or use of medications or diets/supplements known to affect energy regulation or appetite
- Difficulty chewing or swallowing
- Diagnosed eating disorder
- Night or shift work
Show all 13Show fewer
- Current participation in a weight loss program
- History of bariatric surgery
- Current pregnancy or lactation within the past 1 year, or planning a pregnancy during the study participation period
- Consuming a medically-prescribed or unusual diet (e.g., macrobiotic)
- Food allergies or sensitivities, or other conditions which result in avoidance of a wide range of foods (e.g. celiac disease, tree nut allergy)
- Reported recreational drug use
- Report of conditions that would significantly interfere with an ability to follow the protocol including terminal illness, substance abuse, or other significant uncontrolled psychiatric problem
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Boston University
Boston, Massachusetts, 02215
The Miriam Hospital Weight Control and Diabetes Resarch Center
Providence, Rhode Island, 02903
About this study
The purpose of this study is to determine whether a sensor device called an Automatic Ingestion Monitor (AIM) that is worn on eyeglasses can be used with a smartphone to change eating behavior. Participants will wear the device for one week of no-intervention observation. They will then test behavioral interventions focused on eating for two weeks. The researchers hypothesize that messages sent to a smartphone that are based on information from the AIM can reduce the amount of food that is eaten and slow eating.
- Conditions
- Overweight and Obesity
- Being tested
- Eat Less Intervention, Eat Slower Intervention
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eat Less InterventionBehavioural
A sensor worn on eyeglasses monitors eating and provides messages to a smartphone when eating occurs to prompt small reductions in the amount of food eaten.
Eat Slower InterventionBehavioural
A sensor worn on eyeglasses monitors eating and provides messages to a smartphone when eating occurs to prompt small reductions in the rate of eating.
| Study group | Role | What they receive |
|---|---|---|
| Just-in-time Adaptive Intervention | Experimental | A sensor device called an Automatic Ingestion Monitor (AIM) will be worn on eyeglasses to monitor eating. Information from the device will be used to send messages to a smartphone to change eating behavior. Receives: Behavioral: Eat Less Intervention; Behavioral: Eat Slower Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total energy intake
Total amount of energy consumed from foods and beverages
Measured: Daily average computed for the 7-day observation period and each 7-day intervention period
Secondary outcomes (2)
Energy intake per eating occasion
Amount of energy consumed from foods and beverages during each eating occasion
Measured: Average intake per eating occasion computed for the 7-day observation period and each 7-day intervention period
Rate of eating per eating occasion
Chews per minute during each eating occasion.
Measured: Average intake per eating occasion computed for the 7-day observation period and each 7-day intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start1 Jan 2025
- Primary completion30 May 2025
- Study completion30 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Miriam Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06547320
- Sponsor's protocol ID
- R01DK122473
- Status last verified
- Oct 2025
- First submitted
- 30 Jul 2024
- Last updated
- 20 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will make data and documentation available under a data-sharing agreement that provides for (1) a commitment to use the data for research purposes only; (2) a commitment to securing the data using appropriate computer technology; (3) a commitment to destroying or returning the data after analyses are completed and (4) a commitment not to attempt to identify participants individually. Information shared with outside collaborators will link personal health information to a unique study ID in order to maintain participant anonymity.
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensor-based Just-in Time Adaptive Interventions (JITAIs) Targeting Eating Behavior
- ClinicalTrials.gov ID
- NCT06547320
- Acronym / sponsor ID
- R01DK122473
- Conditions
- Overweight and Obesity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- The Miriam HospitalUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 30 May 2025 (actual)
- Study completion
- 30 May 2025 (actual)
- First posted
- 9 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether a sensor device called an Automatic Ingestion Monitor (AIM) that is worn on eyeglasses can be used with a smartphone to change eating behavior. Participants will wear the device for one week of no-intervention observation. They will then test behavioral interventions focused on eating for two weeks. The researchers hypothesize that messages sent to a smartphone that are based on information from the AIM can reduce the amount of food that is eaten and slow eating.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Just-in-time Adaptive Intervention | Experimental | Behavioral: Eat Less Intervention, Behavioral: Eat Slower InterventionA sensor device called an Automatic Ingestion Monitor (AIM) will be worn on eyeglasses to monitor eating. Information from the device will be used to send messages to a smartphone to change eating behavior. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Body mass index (BMI) between 27 and 45 kg/m-squared
- Weight stable within 5% in the past 6 months
- Self-reports basic familiarity with use of a smartphone
Key exclusion criteria (13 listed)
- Diagnosed diabetes (type 1 and 2)
- Any poorly controlled medical condition that could affect weight and/or eating behavior (e.g., hypothyroidism)
- Medical conditions or use of medications or diets/supplements known to affect energy regulation or appetite
- Difficulty chewing or swallowing
- Diagnosed eating disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eat Less InterventionA sensor worn on eyeglasses monitors eating and provides messages to a smartphone when eating occurs to prompt small reductions in the amount of food eaten. | Behavioural | Just-in-time Adaptive Intervention |
| Eat Slower InterventionA sensor worn on eyeglasses monitors eating and provides messages to a smartphone when eating occurs to prompt small reductions in the rate of eating. | Behavioural | Just-in-time Adaptive Intervention |
Primary outcome
Total energy intake
Time frame: Daily average computed for the 7-day observation period and each 7-day intervention period
Total amount of energy consumed from foods and beverages
2 secondary outcomes
Energy intake per eating occasion
Time frame: Average intake per eating occasion computed for the 7-day observation period and each 7-day intervention period
Rate of eating per eating occasion
Time frame: Average intake per eating occasion computed for the 7-day observation period and each 7-day intervention period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2025.
- Individual participant dataSharing planned: Yes. We will make data and documentation available under a data-sharing agreement that provides for (1) a commitment to use the data for research purposes only; (2) a commitment to securing the data using appropriate computer technology; (3) a commitment to destroying or returning the data after analyses are completed and (4) a commitment not to attempt to identify participants individually. Information shared with outside collaborators will link personal health information to a unique study ID in order to maintain participant anonymity.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Eat Less Intervention and Eat Slower Intervention in people with Overweight and Obesity, run by The Miriam Hospital at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total energy intake (time frame: Daily average computed for the 7-day observation period and each 7-day intervention period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2025.