Clinical trial NCT01135342: Adding Sleep Intervention to Traditional Diet and Exercise Approach to Weight Loss
Official title: Adding Sleep Intervention to Traditional Diet and Exercise Approach to Weight Loss
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Initiation and Maintenance Disorders
Obesity
Keywords: Insomnia
Weight loss
Adults
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2010-06-02
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline in weight at 8 months
timeFrame: Baseline and 8 months
Secondary outcomes:
measure: Change from baseline in scores of Insomnia Severity Index
timeFrame: Baseline and 8 months
measure: Change from baseline in scores of Insomnia Frequency Questionnaire
timeFrame: Baseline and 8 months
measure: Change from baseline in scores of Pittsburgh Sleep Quality Index
timeFrame: Baseline and 8 months
measure: Change from baseline in scores of Monk Social Rhythm Questionnaire
timeFrame: Baseline and 8 months
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Christopher D Gardner
role: PRINCIPAL_INVESTIGATOR
References: