A Sleep Extension Pilot Study in Adults With Obesity

NCT05747105 | Withdrawn

• 1 other identifier: 852866
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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 .

Conditions

Obesity; Sleep; Weight, Body; Eating Behavior; Blood Pressure; Quality of Life

Keywords

short sleep duration; sleep extension; obesity; eating behavior; blood pressure

Outcome Measures

Primary Outcomes (2)

• Percentage of intervention session attendance

  The percentage of sessions attended by participants across the 16-week intervention

  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

  Baseline to Week 16 of the intervention

Secondary Outcomes (2)

• Change in nighttime sleep duration

  Baseline to Week 16 of the intervention

• Change in weight

  Baseline to Week 16 of the intervention

Study Arms (1)

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.

Behavioral: Sleep Extension

Interventions

Sleep Extension BEHAVIORAL

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.

Sleep Extension Intervention

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Obesity; Body Weight; Feeding Behavior

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior, Animal; Behavior

Study Officials

• Kelly C Allison, Ph.D.

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

• Philip Gehrman, Ph.D.

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study is a single-arm pilot intervention study to assess the efficacy of a 16-week sleep extension protocol.

Study Record Dates

• First Submitted: February 6, 2023
• First Posted: February 28, 2023
• Study Start: February 7, 2023
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2024
• Last Updated: May 19, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)