ObesityNCT05747105
A Sleep Extension Pilot Study in Adults With Obesity
A study testing Sleep Extension in people with Obesity and Sleep, run by University of Pennsylvania at 1 site in United States.
Trial summary
The pilot study will test the feasibility of a 16-week sleep extension intervention, in adults with obesity, to increase nighttime sleep duration, as well as reduce daytime sleepiness and sleep-related disturbance. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Obesity, Sleep, Weight, Body
- What is being tested?
- Sleep Extension
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Feb 2023to Jan 2024
- Phase
- Interventional
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults, aged 18-50 years old,
- All genders
- Body Mass Index within the obese weight status (BMI of ≥ 30 kg/m2)
- Short sleep duration, defined as sleeping, on average, <6.5 hours/night for at least 5 nights/week
- Sleep patterns must be stable for the past 6 months
- Weight must be stable (+/- 10 lb) for the past 6 months
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- If taking medication for medical or mental health conditions, the condition must be well-controlled with stable dosage (i.e., at least 3 months)
- Note: Individuals with and without insomnia will be eligible to participate to increase generalizability of the findings. Also, individuals with known obstructive sleep apnea that is being treated and individuals who fall below the "very high risk" category for obstructive sleep apnea (on the ARES screening questionnaire) will be included.
- Participants must provide a completed form for study participation from their primary care provider to confirm that it is safe from a medical perspective
Who cannot join
- Specific chronic sleep disorders (e.g., untreated or at very high risk for obstructive sleep apnea, restless leg syndrome, parasomnias, narcolepsy, central apnea, chronic fatigue syndrome, or fibromyalgia)
- Extreme chronotype (i.e., extreme morning or evening sleep patterns)
- Work schedule that is not compatible with sleep habit changes (e.g., night shifts, rotating shift work, or long driving)
- Chronic use of sleep aid or anticonvulsant medications
- Chronic organ disorders (e.g., untreated or uncontrolled diabetes, other endocrine disorders, COPD, chronic cardiac arrhythmia, uncontrolled hypertension or gastro-esophageal disorders)
- Current enrollment in a weight loss program or any active weight loss attempt (e.g., self-directed diet/exercise, over-the-counter supplements, weight management medication)
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- History of bariatric surgery (with the exception of an adjustable gastric band that has been removed)
- Mental health disorders judged severe (e.g., major depression, eating disorders, anxiety disorders, bipolar disorder/mania, schizophrenia, active suicidal ideation)
- Substance use (e.g., illicit drugs, marijuana dependence, excessive caffeine intake, smoking/tobacco use)
- Planned move outside of the Philadelphia area in the next 6 months
- Planned travel across time zones during the study period
- Family factors that may interfere with adherence to the study protocol (e.g., infants and young children that consistently disrupt their sleep schedule; partner, other individuals, or pets that would make compliance difficult)
- Pregnancy or lactation or plans to become pregnant during the study period
- Menopause
- Any other contraindication to participation as determined by the study team
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: A 16-Week Sleep Extension Pilot Study in Adults With Obesity
The pilot study will test the feasibility of a 16-week sleep extension intervention, in adults with obesity, to increase nighttime sleep duration, as well as reduce daytime sleepiness and sleep-related disturbance. The study will also examine changes in weight, eating behaviors, wellbeing, and blood pressure across the 16-week intervention .
Read the detailed description
Short sleep duration (<6.5 hours per night) is a risk factor for poorer health outcomes,1 including overweight and obesity,2 likely due, in part, to its impact on energy intake and eating behaviors. Previous research with experimental sleep restriction and observational studies of short sleepers has shown that short sleep duration is associated with higher calorie intake (including greater calories from fat), increased hunger ratings, a greater number of daily eating occasions, and consumption of larger food portion sizes.3 Short sleep duration is also related to cardiovascular risk factors, including hypertension.4 Sleep extension studies provide some evidence that increasing time spent asleep at night may improve weight, eating behaviors (e.g., net reduction of 270 kcal/d and 0.87 kg over 4 weeks5), and cardiovascular outcomes (e.g., blood pressure6); however, the current literature is limited by short-term intervention and study periods (e.g., 2 to 9 weeks). Therefore, it is unclear if the effects of sleep extension can be sustained over time and if a longer intervention can produce clinically meaningful weight reduction and associated health improvements in adults with obesity. This pilot study will determine the feasibility of a longer, 16-week sleep extension intervention to increase nighttime sleep duration among 10 adults, aged 18-50 years old, with obesity (BMI > 30 kg/m2). Additional secondary outcomes of changes in weight, eating behaviors, wellbeing, and blood pressure will also be assessed. If results are positive, the protocol will be used to secure external funding for a larger randomized clinical trial.
- Conditions
- Obesity, Sleep, Weight, Body, Eating Behavior, Blood Pressure, Quality of Life
- Being tested
- Sleep Extension
- Keywords
- short sleep duration, sleep extension, obesity, eating behavior, blood pressure
- Medical subject headings
- Obesity, Body Weight, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep ExtensionBehavioural
The 16-week protocol includes 11 total individual visits that integrate applicable elements of Cognitive Behavioral Therapy for Insomnia (CBT-I) and health behavior change theory. The first 6 weeks include weekly sessions (~45 minutes each) focused on psychoeducation about sleep, goal-setting and self-monitoring, stimulus control, addressing cognitive and somatic arousal, sleep hygiene, and challenging negative thoughts about sleep. Sleep restriction will also be used in specific cases where sleep efficiency is low (<85%). The remaining 10 weeks include briefer biweekly visits (5 visits, ~15-20 minutes each) to reinforce health behavior change strategies through topics such as problem-solving barriers, utilizing social support, identifying setbacks and creating an action plan, and relapse prevention. Self-reported sleep diary data and subjective sleepiness will be collected at each visit.
| Study group | Role | What they receive |
|---|---|---|
| Sleep Extension Intervention | Experimental | All participants will receive the 16-week sleep extension intervention aimed to lengthen nighttime sleep duration by at least 30-60 minutes per night. No prescription for daily calorie/dietary intake or physical activity will be provided in this study, except behaviors consistent with sleep hygiene recommendations. Receives: Behavioral: Sleep Extension |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of intervention session attendance
The percentage of sessions attended by participants across the 16-week intervention
Measured: Baseline to Week 16 of the intervention
Percentage of participants who complete the study
The percentage of participants who complete the final Week 16 visit
Measured: Baseline to Week 16 of the intervention
Secondary outcomes (2)
Change in nighttime sleep duration
Average nighttime sleep duration as measured by actigraphy during a 1-week monitoring period
Measured: Baseline to Week 16 of the intervention
Change in weight
Weight as measured in kilograms
Measured: Baseline to Week 16 of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2023
- Study start7 Feb 2023
- Primary completionJan 2024 (estimated)
- Study completionJan 2024 (estimated)
Why it stopped: Unable to move forward with the study due to personnel changes
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 University of PennsylvaniaThe 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
- Not applicable
- Intervention model
- Single group
- Model description
- This study is a single-arm pilot intervention study to assess the efficacy of a 16-week sleep extension protocol.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kelly C Allison, Ph.D., Principal investigator, University of PennsylvaniaPhilip Gehrman, Ph.D., Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05747105
- Sponsor's protocol ID
- 852866
- Status last verified
- May 2023
- First submitted
- 6 Feb 2023
- Last updated
- 19 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 16-Week Sleep Extension Pilot Study in Adults With Obesity
- ClinicalTrials.gov ID
- NCT05747105
- Acronym / sponsor ID
- 852866
- Conditions
- Obesity, Sleep, Weight, Body, Eating Behavior, Blood Pressure, Quality of Life
- Keywords
- short sleep duration, sleep extension, obesity, eating behavior, blood pressure
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to move forward with the study due to personnel changes
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 7 Feb 2023 (actual)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Jan 2024 (estimated)
- First posted
- 28 Feb 2023 (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 pilot study will test the feasibility of a 16-week sleep extension intervention, in adults with obesity, to increase nighttime sleep duration, as well as reduce daytime sleepiness and sleep-related disturbance. The study will also examine changes in weight, eating behaviors, wellbeing, and blood pressure across the 16-week intervention .
Detailed description
Short sleep duration (<6.5 hours per night) is a risk factor for poorer health outcomes,1 including overweight and obesity,2 likely due, in part, to its impact on energy intake and eating behaviors. Previous research with experimental sleep restriction and observational studies of short sleepers has shown that short sleep duration is associated with higher calorie intake (including greater calories from fat), increased hunger ratings, a greater number of daily eating occasions, and consumption of larger food portion sizes.3 Short sleep duration is also related to cardiovascular risk factors, including hypertension.4 Sleep extension studies provide some evidence that increasing time spent asleep at night may improve weight, eating behaviors (e.g., net reduction of 270 kcal/d and 0.87 kg over 4 weeks5), and cardiovascular outcomes (e.g., blood pressure6); however, the current literature is limited by short-term intervention and study periods (e.g., 2 to 9 weeks). Therefore, it is unclear if the effects of sleep extension can be sustained over time and if a longer intervention can produce clinically meaningful weight reduction and associated health improvements in adults with obesity. This pilot study will determine the feasibility of a longer, 16-week sleep extension intervention to increase nighttime sleep duration among 10 adults, aged 18-50 years old, with obesity (BMI > 30 kg/m2). Additional secondary outcomes of changes in weight, eating behaviors, wellbeing, and blood pressure will also be assessed. If results are positive, the protocol will be used to secure external funding for a larger randomized clinical trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study is a single-arm pilot intervention study to assess the efficacy of a 16-week sleep extension protocol.
| Arm | Type | Receives |
|---|---|---|
| Sleep Extension Intervention | Experimental | Behavioral: Sleep ExtensionAll participants will receive the 16-week sleep extension intervention aimed to lengthen nighttime sleep duration by at least 30-60 minutes per night. No prescription for daily calorie/dietary intake or physical activity will be provided in this study, except behaviors consistent with sleep hygiene recommendations. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Adults, aged 18-50 years old,
- All genders
- Body Mass Index within the obese weight status (BMI of ≥ 30 kg/m2)
- Short sleep duration, defined as sleeping, on average, <6.5 hours/night for at least 5 nights/week
- Sleep patterns must be stable for the past 6 months
Key exclusion criteria (15 listed)
- Specific chronic sleep disorders (e.g., untreated or at very high risk for obstructive sleep apnea, restless leg syndrome, parasomnias, narcolepsy, central apnea, chronic fatigue syndrome, or fibromyalgia)
- Extreme chronotype (i.e., extreme morning or evening sleep patterns)
- Work schedule that is not compatible with sleep habit changes (e.g., night shifts, rotating shift work, or long driving)
- Chronic use of sleep aid or anticonvulsant medications
- Chronic organ disorders (e.g., untreated or uncontrolled diabetes, other endocrine disorders, COPD, chronic cardiac arrhythmia, uncontrolled hypertension or gastro-esophageal disorders)
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 |
|---|---|---|
| Sleep ExtensionThe 16-week protocol includes 11 total individual visits that integrate applicable elements of Cognitive Behavioral Therapy for Insomnia (CBT-I) and health behavior change theory. The first 6 weeks include weekly sessions (~45 minutes each) focused on psychoeducation about sleep, goal-setting and self-monitoring, stimulus control, addressing cognitive and somatic arousal, sleep hygiene, and challenging negative thoughts about sleep. Sleep restriction will also be used in specific cases where sleep efficiency is low (<85%). The remaining 10 weeks include briefer biweekly visits (5 visits, ~15-20 minutes each) to reinforce health behavior change strategies through topics such as problem-solving barriers, utilizing social support, identifying setbacks and creating an action plan, and relapse prevention. Self-reported sleep diary data and subjective sleepiness will be collected at each visit. | Behavioural | Sleep Extension Intervention |
Primary outcome
Percentage of intervention session attendance
Time frame: Baseline to Week 16 of the intervention
The percentage of sessions attended by participants across the 16-week intervention
Percentage of participants who complete the study
Time frame: Baseline to Week 16 of the intervention
The percentage of participants who complete the final Week 16 visit
2 secondary outcomes
Change in nighttime sleep duration
Time frame: Baseline to Week 16 of the intervention
Change in weight
Time frame: Baseline to Week 16 of the intervention
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2023.
- Individual participant dataSharing planned: No
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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.
Kelly C Allison, Ph.D. principal investigator
University of Pennsylvania
Philip Gehrman, Ph.D. principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep Extension in people with Obesity and Sleep, run by University of Pennsylvania 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 9 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: withdrawn, as of the sponsor's last update on 19 May 2023. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Percentage of intervention session attendance (time frame: Baseline to Week 16 of the intervention). The study lists 2 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 19 May 2023.