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

This study has been completed.
Sponsor:
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT01135342
First received: June 1, 2010
Last updated: NA
Last verified: June 2010
History: No changes posted
  Purpose

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


Condition Intervention Phase
Sleep Initiation and Maintenance Disorders
Obesity
Behavioral: Weight Loss Regimen and Sleep Cognitive Behavioral Therapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Adding Sleep Intervention to Traditional Diet and Exercise Approach to Weight Loss

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Weight Loss [ Time Frame: 8 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Improvement in quality and quantity of sleep [ Time Frame: 8 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: July 2009
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01135342

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Christopher D Gardner Stanford University
  More Information

Additional Information:
No publications provided

Responsible Party: Christopher D Gardner, Stanford University School of Medicine
ClinicalTrials.gov Identifier: NCT01135342     History of Changes
Other Study ID Numbers: SU-05062010-5883, 15051
Study First Received: June 1, 2010
Last Updated: June 1, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Obesity
Weight Loss
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Mental Disorders
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Body Weight Changes

ClinicalTrials.gov processed this record on July 31, 2014