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

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

Study Overview

• Status: Completed
• Conditions: Obesity; Sleep Initiation and Maintenance Disorders
• Intervention / Treatment: Behavioral: Diet and exercise; Behavioral: Cognitive Behavioral Therapy; Behavioral: Passion and Balance

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.

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Diet & Exercise plus Sleep Intervention; Diet and exercise instruction to promote weight loss plus cognitive behavioral therapy for insomnia.	Behavioral: Diet and exercise; Standardized instruction to eat less and exercise more to create an energy balance deficit to promote weight loss (16 classes); Behavioral: Cognitive Behavioral Therapy; Standardized cognitive behavioral therapy for insomnia (8 classes)
Sham Comparator: Diet & Exercise plus 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.	Behavioral: Diet and exercise; Standardized instruction to eat less and exercise more to create an energy balance deficit to promote weight loss (16 classes); Behavioral: Passion and Balance; Attention-match sessions of general interest, but unrelated to diet, exercise, or sleep (8 sessions)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in weight at 8 months	Change was calculated as the value at 8 months minus the value at baseline.	Baseline and 8 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)

Publications and helpful links

Helpful Links

• Study description and summary of results.

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (Actual): March 1, 2010
• Study Completion (Actual): March 1, 2010

Study Registration Dates

• First Submitted: June 1, 2010
• First Submitted That Met QC Criteria: June 1, 2010
• First Posted (Estimate): June 2, 2010

Study Record Updates

• Last Update Posted (Estimate): February 22, 2023
• Last Update Submitted That Met QC Criteria: February 18, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Adults; Weight loss; Insomnia
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Body Weight; Body Weight Changes; Sleep Initiation and Maintenance Disorders; Weight Loss
• Other Study ID Numbers: SU-05062010-5883; 1R21HL092268-01A2 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No