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

Not Recruiting

Trial ID: NCT01135342


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

Official Title

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

Stanford Investigator(s)


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.

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.


behavioral: Diet and exercise

behavioral: Cognitive Behavioral Therapy

behavioral: Passion and Balance

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Antonella Dewell