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A Sleep Extension Pilot Study in Adults With Obesity

NCT05747105 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2023-05-19

No results posted yet for this study

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

Interventions

BEHAVIORAL

Sleep Extension

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.

Sponsors & Collaborators

Principal Investigators

  • Kelly C Allison, Ph.D. · University of Pennsylvania

  • Philip Gehrman, Ph.D. · University of Pennsylvania

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-07
Primary Completion
2024-01-31
Completion
2024-01-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05747105 on ClinicalTrials.gov