An interventional study of Food Craving app and Sleep Coach app in Obesity, sponsored by NYU Langone Health. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2026-10-29.
Sponsored by NYU Langone Health · Not applicable, Interventional, and Treatment
The purpose of this pilot study is to examine the implementation of a combined intervention targeting food cravings and sleep for adults with obesity in clinical settings. The primary aim is implementation feasibility (i.e., recruitment rate, retention rate, adherence, acceptability ratings).
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's planned enrollment of 40 is below the median of 67 across 9,006 interventional studies indexed under Obesity.
Browse Obesity studies →NYU Langone Health is the lead sponsor of 1,430 studies on the registry; 258 are open to participants now.
Of its 235 completed or terminated interventional studies of FDA-regulated products, 197 (84%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will be encouraged to use the Food Craving app a minimum of 3 times per week and complete six weekly check-ins (15-30 min) with study staff.
Other: Food Craving app
Participants will be encouraged to use the Sleep Coach app by completing the sleep diary daily, progress through the weekly training plan, complete the app's self-assessments and use the apps tools as needed. Participants complete six weekly check-in (15-30 min) with study staff.
Other: Sleep Coach app
Participants will receive access to both the Food Craving App and Sleep Coach app simultaneously and be encouraged to use both apps accordingly. Participants complete six weekly check-in (15-30 min) with study staff
Other: Food Craving app · Other: Sleep Coach app
Waitlist participants do not receive app access during the study period. They receive brief informational instructions about the apps and are offered access to both apps after the 3-month follow-up visit is completed.
The Food Craving app uses inhibitory control training via a Go/No-Go cognitive task. Participants are presented with images of food items and trained to inhibit motor responses (press/no-press) to images of unhealthy, high-craving foods while responding to healthy food images.
The Sleep Coach app is a self-guided CBT-based intervention providing: (1) daily sleep hygiene education and tasks; (2) relaxation training exercises; and (3) individualized time-in-bed recommendations based on participant-reported sleep diary data. The app guides users through established CBT-I components (sleep restriction, stimulus control, cognitive restructuring).
Proportion of eligible/approached individuals who enroll
Time frame: End of study, up to 3 months
Proportion of participants who completed the follow-up and final assessment
Time frame: Up to 3 months
Acceptability of Intervention Measure (AIM) score
The AIM is a 4-item implementation outcome measure of acceptability used to monitor and evaluate the success of implementation efforts. Items are scored from 1 (completely disagree) to 5 (Completely agree). Scores range from 4-20, with higher scores indicating stronger acceptability of intervention measure.
Time frame: Month 3
Intervention Appropriateness Measure (IAM) score
The IAM has 4-items designed to assess the suitability and relevance of an intervention. Items are scored from 1 (completely disagree) to 5 (Completely agree). Scores range from 4-20, with higher scores indicating the intervention was appropriate.
Time frame: Month 3
Plan to share: Yes — The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: Sandra.Wittleder@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.
Supporting information: Study protocol, Statistical analysis plan
Time frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
Access criteria: The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to Sandra.Wittleder@nyulangone.org. To gain access, data requestors will need to sign a data access agreement. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's DSSB.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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