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

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.

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.