Adding Sleep Intervention to Traditional Diet and Exercise Approach to Weight Loss

Not Applicable

Completed

• Conditions: Obesity; Sleep Initiation and Maintenance Disorders
• Interventions: Behavioral: Diet and exercise; Behavioral: Passion and Balance; Behavioral: Cognitive Behavioral Therapy

• Registration Number: NCT01135342
• Lead Sponsor: Stanford University

Brief Summary

The goal is to determine if improved sleep will increase/enhance weight loss among overweight adults with insomnia.

Detailed Description

The major purpose of this study is to examine the effect of sleep quality and quantity on weight loss. The outcomes being studied are weight loss and improved sleep. The subjects being studied are those with body mass index 28-40kg/m2 who report sleeping less than 6.5 hours per day for 4 day per week or more for the past 6 months or longer and would likely benefit the most from the sleep intervention should it prove to be effective. We hope to learn if improved sleep habits among overweight adults with insomnia will help them to adhere to a diet and exercise program and increase their success with weight loss. Given the current world-wide obesity epidemic and the established difficulties many people have with weight control, any approaches that can be demonstrated to contribute to successful weight loss have direct public health significance.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2009-07
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Study First Submitted: 2010-06-01
• Study First Submitted QC: 2010-06-01
• Study First Posted: 2010-06-02
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-18
• Last Update Posted: 2023-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

• Gender: Both women and men

• Age: > or = 18 years

• Ethnicity and race: All ethnic and racial backgrounds welcome

• The following, which will be measured at the screening clinic visit:

  • Body Mass Index: 28-40 (kg/m-squared)
  • Chronic Short Sleep: total sleep time < 6.5 hours, greater than or equal to 4 days per week (determined by 1-week sleep log) for the past 6 months or longer (based on self-report).
  • Insomnia: sleep latency and/or wake after sleep onset > 30 minutes, greater than or equal to 4 days per week, insomnia severity index > 10, and complaint of at least one negative effect during waking hours (such as fatigue, sleepiness, impaired functioning, mood disturbance) attributed to sleep (as determined by self report).
  • Eligible sleep disorder: sleep apnea or upper airway resistance syndrome treated by positive airway therapy for > or = 3 months resulting in improved sleep.
  • Psychiatric disorders that are stable on SSRI, SNRI, or bupropion antidepressant for greater than or equal to 3 months if no anticipated changes in medications to occur during the trial if they are weight stable.
  • Planning to be available for clinic visits and for the 8 weeks of study participation
  • Ability and willingness to give written informed consent.

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Exclusion Criteria

At screening:

• Sleep apnea (apnea-hypopnea index > 15/hr) determined by portable sleep diagnostic system Periodic limb movements during sleep (PLM with arousal index > 15/hr) determined by polysomnography.

• Any suspected sleep disorders identified by the Global Sleep Assessment Questionnaire, including circadian rhythm disorders (including shift work), parasomnias, narcolepsy, and restless leg.

• Self reported personal history of:

• DSM-IV Axis-I and Axis-II diagnoses (i.e. eating disorders, bi-polar disorder, schizophrenia and other psychotic disorders, substance-related disorders, personality disorders, poorly controlled major depression and anxiety disorders determined by SCID) except those allowed under Inclusions.

• Subjects currently receiving the following medications known to affect sleep(self report):

  • sedative hypnotics
  • sedative antidepressants
  • systemic steroids
  • anticonvulsants
  • histamine-1
  • receptor antagonists
  • narcotic analgesics
  • CNS stimulants

• Body Mass Index (BMI) greater than 40.

• Pregnant, Lactating, or <6 months post-partum.

• Inability to communicate effectively with study personnel.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Diet & Exercise plus Passion and Balance	Passion and Balance	Diet and exercise instruction to promote weight loss plus sessions that are of general interest, but unrelated to diet, exercise, or sleep.
Diet & Exercise plus Sleep Intervention	Diet and exercise	Diet and exercise instruction to promote weight loss plus cognitive behavioral therapy for insomnia.
Diet & Exercise plus Sleep Intervention	Cognitive Behavioral Therapy	Diet and exercise instruction to promote weight loss plus cognitive behavioral therapy for insomnia.
Diet & Exercise plus Passion and Balance	Diet and exercise	Diet and exercise instruction to promote weight loss plus sessions that are of general interest, but unrelated to diet, exercise, or sleep.

Primary Outcome Measures

Name	Time	Method
Change from baseline in weight at 8 months	Baseline and 8 months	Change was calculated as the value at 8 months minus the value at baseline.

Secondary Outcome Measures

Name	Time	Method
Change from baseline in scores of Pittsburgh Sleep Quality Index	Baseline and 8 months	Change was calculated as the value at 8 months minus the value at baseline.
Change from baseline in scores of Insomnia Severity Index	Baseline and 8 months	Change was calculated as the value at 8 months minus the value at baseline.
Change from baseline in scores of Insomnia Frequency Questionnaire	Baseline and 8 months	Change was calculated as the value at 8 months minus the value at baseline.
Change from baseline in scores of Monk Social Rhythm Questionnaire	Baseline and 8 months	Change was calculated as the value at 8 months minus the value at baseline.

Trial Locations

Locations (1)

Stanford University School of Medicine; 🇺🇸 Stanford, California, United States