ObesityNCT07904663
The Sleep and Weight Study
A study testing Food Craving app and Sleep Coach app in people with Obesity, run by NYU Langone Health at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Obesity
- What is being tested?
- Food Craving app and Sleep Coach app
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2026to 31 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-55 years
- Body Mass Index (BMI) ≥30 kg/m²
- At least sub threshold insomnia symptoms, defined as Insomnia Severity Index (ISI) score ≥8
- Fluent in English (reading and speaking) to complete app-based interventions and validated surveys. This small pilot study lacks funding for Spanish-speaking study staff, who would be required for screening, consent, weekly check-ins throughout the intervention, and the qualitative interviews and transcript translation; in addition, the Sleep Coach app (Insomnia Coach) is available only in English, so participants in arms 2 and 3 could not receive the intervention in another language. A future fully powered trial will incorporate bilingual staff and translated intervention materials.
- Owns a smartphone (iOS or Android) compatible with the Food Craving app and Sleep Coach app
- Willing and able to provide written informed consent and to participate in all study procedures (including wearing an actigraphy device for 7-day assessment periods).
Who cannot join
- Sleep disorders other than insomnia (i.e., sleep apnea, restless leg syndrome, narcolepsy); however, those reporting managed sleep apnea will be included;
- Eating disorder (anorexia nervosa, bulimia nervosa, avoidant/restrictive food intake disorder (ARFID), binge eating disorder (BED)); however, those with stable treated BED or bulimia nervosa, or in stable remission ≥6 months will be included;
- Starting or changing dosage of sleep medications or selective serotonin reuptake inhibitors (SSRIs) in the past 2 months;
- weight loss medications or medications known to significantly affect weight within the past 2 months (e.g., glucagon-like peptide-1 [GLP-1] agonist)
- A medical condition that impacts sleep, appetite, dietary intake, or weight (e.g., cancer, prostate hyperplasia; uncontrolled thyroid disease);
- Significant alcohol use issues (Alcohol Use Disorders Identification Test-Concise; Bush et al., 1998; score ≥4);
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- Current moderate or severe substance use disorder (self-reported diagnosis or current treatment), or regular (≥weekly) use of cannabis or other non-prescribed substances as a sleep aid;
- Self-reported lifetime diagnosis of bipolar disorder or a psychotic disorder;
- Current PTSD diagnosis or currently receiving treatment for PTSD;
- Severe depressive symptoms (Patient Health Questionnaire-8 [PHQ-8] ≥20);
- Currently or recently (past 6 months) receiving insomnia therapy resembling cognitive-behavioral therapy for insomnia (CBT-I);
- Shift work schedule (defined as regularly working between 10pm-6am) or highly irregular work hours that prevent a fixed sleep/wake schedule
- Being pregnant or intention to become pregnant during the study period, Pregnancy involves substantial changes in weight, appetite, energy intake, and sleep architecture that occur independently of the interventions and would confound both the mechanistic and exploratory weight outcomes. Time-in-bed restriction, a core component of the Sleep Coach app, is also not appropriate during pregnancy. Individuals intending to become pregnant are excluded because pregnancy occurring mid-study would introduce these same confounds and interrupt the intervention within the 3-month observation window.T hese criteria are applied for scientific reasons only; pregnancy status is determined by self-report and no pregnancy testing is performed.
- Caretaking for a newborn (<3 months old) or recently given birth (past 3 months);Caretaking for a newborn imposes externally driven sleep fragmentation and irregular sleep timing. The early postpartum period is likewise characterized by ongoing changes in weight, appetite, and sleep that are unrelated to the interventions and would confound the study outcomes, and time-in-bed restriction is not appropriate during this period.
- Current enrollment in another weight loss, dietary, or sleep intervention trial
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Dual-Pathway Intervention: Combining Sleep and Craving Regulation to Improve Obesity Outcomes
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).
- Conditions
- Obesity
- Being tested
- Food Craving app, Sleep Coach app
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Food Craving appOther
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.
Sleep Coach appOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Food Craving | Experimental | 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. Receives: Other: Food Craving app |
| Sleep | Experimental | 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. Receives: Other: Sleep Coach app |
| Combined | Experimental | 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 Receives: Other: Food Craving app; Other: Sleep Coach app |
| Waitlist Control | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of eligible/approached individuals who enroll
Measured: End of study, up to 3 months
Proportion of participants who completed the follow-up and final assessment
Measured: 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.
Measured: 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.
Measured: Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2026
- Study start15 Oct 2026 (estimated)
- Primary completion15 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Sponsor
- Investigators
- Sandra Wittleder, PhD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07904663
- Sponsor's protocol ID
- 26-00044
- Other IDs
- 1K12TR005770-01
- Status last verified
- Oct 2026
- First submitted
- 23 Oct 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dual-Pathway Intervention: Combining Sleep and Craving Regulation to Improve Obesity Outcomes
- ClinicalTrials.gov ID
- NCT07904663
- Acronym / sponsor ID
- 26-00044
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Study start
- 15 Oct 2026 (estimated)
- Primary completion
- 15 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 29 Oct 2026 (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 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Food Craving | Experimental | Other: Food Craving appParticipants 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. |
| Sleep | Experimental | Other: Sleep Coach appParticipants 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. |
| Combined | Experimental | Other: Food Craving app, Other: Sleep Coach appParticipants 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 |
| Waitlist Control | No intervention | –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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age 18-55 years
- Body Mass Index (BMI) ≥30 kg/m²
- At least sub threshold insomnia symptoms, defined as Insomnia Severity Index (ISI) score ≥8
- Fluent in English (reading and speaking) to complete app-based interventions and validated surveys. This small pilot study lacks funding for Spanish-speaking study staff, who would be required for screening, consent, weekly check-ins throughout the intervention, and the qualitative interviews and transcript translation; in addition, the Sleep Coach app (Insomnia Coach) is available only in English, so participants in arms 2 and 3 could not receive the intervention in another language. A future fully powered trial will incorporate bilingual staff and translated intervention materials.
- Owns a smartphone (iOS or Android) compatible with the Food Craving app and Sleep Coach app
Key exclusion criteria (15 listed)
- Sleep disorders other than insomnia (i.e., sleep apnea, restless leg syndrome, narcolepsy); however, those reporting managed sleep apnea will be included;
- Eating disorder (anorexia nervosa, bulimia nervosa, avoidant/restrictive food intake disorder (ARFID), binge eating disorder (BED)); however, those with stable treated BED or bulimia nervosa, or in stable remission ≥6 months will be included;
- Starting or changing dosage of sleep medications or selective serotonin reuptake inhibitors (SSRIs) in the past 2 months;
- weight loss medications or medications known to significantly affect weight within the past 2 months (e.g., glucagon-like peptide-1 [GLP-1] agonist)
- A medical condition that impacts sleep, appetite, dietary intake, or weight (e.g., cancer, prostate hyperplasia; uncontrolled thyroid disease);
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 |
|---|---|---|
| Food Craving appThe 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. | Other | Combined, Food Craving |
| Sleep Coach appThe 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). | Other | Combined, Sleep |
Primary outcome
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
Time frame: Month 3
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.
Intervention Appropriateness Measure (IAM) score
Time frame: Month 3
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Individual participant dataSharing planned: 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.
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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.
Sandra Wittleder, PhD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Food Craving app and Sleep Coach app in people with Obesity, run by NYU Langone Health at 1 site 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 6 inclusion and 15 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: opening soon, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laura Wong (646-987-9246, Laura.Wong@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of eligible/approached individuals who enroll (time frame: End of study, up to 3 months). The study lists 4 primary outcomes in all. 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 29 Oct 2026.