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A Sleep Extension Pilot Study in Adults With Obesity

Primary Purpose

Obesity, Sleep, Weight, Body

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sleep Extension
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring short sleep duration, sleep extension, obesity, eating behavior, blood pressure

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 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 Exclusion Criteria: 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) 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

Sites / Locations

  • University of Pennsylvania

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Sleep Extension Intervention

Arm Description

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.

Outcomes

Primary Outcome Measures

Percentage of intervention session attendance
The percentage of sessions attended by participants across the 16-week intervention
Percentage of participants who complete the study
The percentage of participants who complete the final Week 16 visit

Secondary Outcome Measures

Change in nighttime sleep duration
Average nighttime sleep duration as measured by actigraphy during a 1-week monitoring period
Change in weight
Weight as measured in kilograms

Full Information

First Posted
February 6, 2023
Last Updated
May 17, 2023
Sponsor
University of Pennsylvania
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1. Study Identification

Unique Protocol Identification Number
NCT05747105
Brief Title
A Sleep Extension Pilot Study in Adults With Obesity
Official Title
A 16-Week Sleep Extension Pilot Study in Adults With Obesity
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Withdrawn
Why Stopped
Unable to move forward with the study due to personnel changes
Study Start Date
February 7, 2023 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Sleep, Weight, Body, Eating Behavior, Blood Pressure, Quality of Life
Keywords
short sleep duration, sleep extension, obesity, eating behavior, blood pressure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sleep Extension Intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Sleep Extension
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of intervention session attendance
Description
The percentage of sessions attended by participants across the 16-week intervention
Time Frame
Baseline to Week 16 of the intervention
Title
Percentage of participants who complete the study
Description
The percentage of participants who complete the final Week 16 visit
Time Frame
Baseline to Week 16 of the intervention
Secondary Outcome Measure Information:
Title
Change in nighttime sleep duration
Description
Average nighttime sleep duration as measured by actigraphy during a 1-week monitoring period
Time Frame
Baseline to Week 16 of the intervention
Title
Change in weight
Description
Weight as measured in kilograms
Time Frame
Baseline to Week 16 of the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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 Exclusion Criteria: 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) 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kelly C Allison, Ph.D.
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Philip Gehrman, Ph.D.
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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A Sleep Extension Pilot Study in Adults With Obesity

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