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NCT07904663Not yet recruiting

The Sleep and Weight Study

Dual-Pathway Intervention: Combining Sleep and Craving Regulation to Improve Obesity Outcomes

Source: ClinicalTrials.gov · Last updated 29 Oct 2026

Brief summary (registry, in English)

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).

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
40 (estimated)
First submitted
23 Oct 2026
Start date
15 Oct 2026
Primary completion date
15 Jul 2027
Lead sponsor
NYU Langone Health
Diseases
Obesity
NCT number
NCT07904663

What you commit to

  • Study type: Interventional
  • Planned participants: 40
  • From 15 Oct 2026 to the primary completion date, 15 Jul 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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)
  • Current PTSD diagnosis or currently receiving treatment for PTSD;
  • Currently or recently (past 6 months) receiving insomnia therapy resembling cognitive-behavioral therapy for insomnia (CBT-I);

Other illness

  • 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;
  • 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);
  • 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;

Other

  • Severe depressive symptoms (Patient Health Questionnaire-8 \[PHQ-8\] ≥20);
  • 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

Who the study is looking for

  • 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).

Age in the registry: 18 years to 55 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
NYU Langone Health
Coordinator of this site? Confirm its status
New YorkUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.