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Sleep your way slim? new study tests weight loss + sleep program

NCT ID NCT07255287

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 04, 2026 · Updated 2 times

Summary

This study tests whether adding a sleep health program to a standard weight loss plan helps overweight adults lose more weight and sleep better. Researchers will enroll 25 people to see if the program is practical and liked by participants. The goal is to gather feedback and early results to improve future programs.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 25 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

Jul 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 60 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Body Mass Index 25-40 kg/m2 * Suboptimal sleep defined as: 1) short sleep duration (actigraphy total sleep time \<6.5 hrs/night), 2) sleep irregularity (actigraphy standard deviation, SD of wake time, bed time or sleep duration \>60 min), 3) poor sleep satisfaction/quality (Pittsburgh Sleep Quality Index, PSQI single item sleep quality question response of "fairly bad" or "very bad"), 4) suboptimal sleep timing (actigraphy sleep midpoint before 2 AM or after 4 AM), 5) daytime sleepiness (Epworth Sleepiness Scale, ESS \>10) and/or 6) suboptimal sleep efficiency (actigraphy sleep efficiency \<85%). * Physically Inactive: defined as \<150 minutes per week of exercise at moderate intensity or greater and \<60 min per day of total habitual physical activity (i.e., work related, transportation related) at moderate intensity or greater, over the past 3 months. * No self-report of acute or chronic disease (cardiovascular disease (CVD), diabetes, pulmonary, gastrointestinal disorders, and orthopedic problems in particular). * No plans to relocate within the next 12 months. * No plans for extended travel (\>2 weeks) within the next 12 months. * Live or work within 30 minutes of the AHWC (exceptions may be made at the discretion of the Study PI). * Capable and willing to give informed consent, understand exclusion criteria, and accept the randomized group assignment. * Own or willing to purchase a smartphone, willing to download and use the Oura Ring and/or Headspace App if randomized to these components. (Data from the Pew Research Center 2024 Mobile Fact Sheet suggests \>95% of adults in our target age range own a smartphone) * Have a primary care physician (or are willing to establish care prior to study enrollment) to address any medical issues which may arise during screening procedures or study interventions. * No contraindications to exercise or limitations on ability to be physically active. * Agree to refrain from use of anti-obesity medications (AOMs) agents during the 6-month pilot study. * For Females: * Not currently pregnant or lactating, * Not pregnant within the past 6 months, * Not planning to become pregnant in the next 12 months. Sexually active women of childbearing potential may be enrolled if they have had a tubal ligation or use a reliable means of contraception. Exclusion Criteria: * Diastolic blood pressure \>100 mmHG, systolic blood pressure \>160 mmHG, or resting heart rate \>100 bpm as measured in duplicate on the screening visit after 5 minutes of rest in a seated position. * Diabetes (fasting glucose greater than or equal to 126 mg/dL or Hemoglobin A1C greater than or equal to 6.5%) as measured during the screening visit. * Undiagnosed hypo- or hyper-thyroid (TSH outside of the normal range as measured during the screening visit) or history of uncontrolled thyroid disorder. History of thyroid disease or current thyroid disease treated with a stable medication regimen for at least 6 months is acceptable. * Hematocrit, white blood cell count or platelets significantly outside the normal reference range as measured on the screening visit. * Triglycerides \>400 mg/dL as measured on the screening visit. * LDL cholesterol \>200 mg/dL as measured on the screening visit. * Abnormal resting electrocardiogram (ECG) as measured on the screening visit: serious arrhythmias, including multifocal PVC's, frequent PVC's (defined as 10 or more per min), ventricular tachycardia (defined as runs of 3 or more successive PVC's), or sustained atrial tachyarrhythmia; 2nd or 3rd degree A-V block, QTc interval \> 480 msec or other significant conduction defects. * Presence or history of any metabolic or chronic health problems which would affect appetite, food intake, energy metabolism, or ability to participate in physical activity: cardiovascular disease (CVD), peripheral vascular disease, cerebrovascular disease, significant cardiac arrhythmias or cardiac valve disease, diabetes, uncontrolled hyper- or hypothyroidism, uncontrolled hypertension, cancer (within the last 5 years, except skin cancer or other cancers considered cured with excellent prognosis), HIV infection (unless treated with undetectable viral load), significant gastrointestinal disorders (described below), significant pulmonary disorders (described below), significant renal, musculoskeletal, neurologic, hematologic, or psychiatric disease. * Significant gastrointestinal disorders including chronic malabsorptive conditions, active peptic ulcer disease, Crohn's disease, Ulcerative Colitis, chronic diarrhea, or active gallbladder disease. * Significant pulmonary disorders including chronic obstructive pulmonary disease (COPD), interstitial lung disease, cystic fibrosis, or uncontrolled asthma. * Symptoms suggestive of CVD: chest pain, shortness of breath at rest or with mild exertion, syncope. * Primary sleep disorders including but not limited to chronic insomnia \>= 3 months, untreated moderate-to-severe sleep apnea (apnea hypopnea index, AHI greater than or equal to 15), narcolepsy periodic limb movements in sleep, parasomnias including sleepwalking or night terrors, Insomnia Severity Index (ISI) Score greater than or equal to 15. * \*Note: If we find that too many screened participants are ineligible based on AHI greater than or equal to 15, we will consider increasing AHI threshold to greater than or equal to 30 in order to improve generalizability results. * \*Note: If we find that too many screened participants are ineligible based on ISI greater than or equal to 15, we will consider increasing ISI threshold to greater than or equal to 22 in order to improve generalizability results. o * Night-time shiftwork, rotating work, or other circadian disruptions and disorders (e.g., diagnosed delayed sleep-wake phase disorder). * Regular use (greater than or equal to 2 days/wk) of prescription sleep medications (e.g., benzodiazepines, doxepin, zolpidem, trazodone, etc.). * Regular use of other prescription or over-the-counter medications known to affect appetite, weight, sleep, or energy metabolism (e.g., lithium, stimulants, anti-psychotics, tricyclic antidepressants). * Regular use of systemic glucocorticoids (except physiological doses for replacement therapy in adrenal insufficiency). * Regular use of anti-obesity medications (AOMs) within the last 6 months, plans to begin AOMs in the next year. * Previous obesity treatment with surgery or weight loss device, except: (1) liposuction and/or abdominoplasty if performed \> 1 year before screening, (2) lap banding if the band has been removed \> 1 year before screening, (3) intragastric balloon if the balloon has been removed \> 1 year before screening (4) duodenal-jejunal bypass sleeve, if the sleeve has been removed \> 1 year before screening or 5) AspireAssist or other endoscopically placed weight loss device if the device has been removed \> 1 year before screening. * Current alcohol or substance abuse. * Nicotine use (current or quit in the past 6 months). * History of clinically diagnosed eating disorders including anorexia nervosa, bulimia, binge eating disorder. Score \>20 on the Eating Attitudes Test (EATS-26) or pattern of response on the Questionnaire of Eating and Weight Patterns (QEWP-5) suggestive of possible binge eating disorder or bulimia will require further assessment by the Study MD to determine if it is appropriate for the subject to participate in the study. * Current severe depression or history of severe depression within the previous year, based on DSM-IV-TR criteria for Major Depressive Episode. Score \> 16 on the Center for Epidemiologic Studies Depression Scale (CES-D) will require further assessment by the Study MD to determine if it is appropriate for the subject to participate in the study. * History of other significant psychiatric illness (e.g., psychosis, schizophrenia, mania, bipolar disorder) which significantly impacts sleep or which in the opinion of the Study MD would interfere with ability to adhere to the interventions. * Currently participating in or planning to participate in any formal weight loss programs, physical activity programs, sleep health programs, or clinical trials. * Weight change of +/- 5 kg in past 3 months.

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Conditions

The condition(s) this trial relates to.

Obesity Overweight Weight Loss

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • University of Colorado Anschutz Medical Campus, Aurora, Colorado 80045

    Aurora, Colorado, 80045, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.