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

NCT ID: NCT01135342

Last Updated: 2023-02-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-07-31
• Study Completion Date: 2010-03-31

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.

Conditions

Sleep Initiation and Maintenance Disorders; Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Diet & Exercise plus Sleep Intervention

Diet and exercise instruction to promote weight loss plus cognitive behavioral therapy for insomnia.

Group Type: EXPERIMENTAL

Diet and exercise

Intervention Type: BEHAVIORAL

Standardized instruction to eat less and exercise more to create an energy balance deficit to promote weight loss (16 classes)

Cognitive Behavioral Therapy

Intervention Type: BEHAVIORAL

Standardized cognitive behavioral therapy for insomnia (8 classes)

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.

Group Type: SHAM_COMPARATOR

Diet and exercise

Intervention Type: BEHAVIORAL

Standardized instruction to eat less and exercise more to create an energy balance deficit to promote weight loss (16 classes)

Passion and Balance

Intervention Type: BEHAVIORAL

Attention-match sessions of general interest, but unrelated to diet, exercise, or sleep (8 sessions)

Interventions

Diet and exercise

Standardized instruction to eat less and exercise more to create an energy balance deficit to promote weight loss (16 classes)

Intervention Type: BEHAVIORAL

Cognitive Behavioral Therapy

Standardized cognitive behavioral therapy for insomnia (8 classes)

Intervention Type: BEHAVIORAL

Passion and Balance

Attention-match sessions of general interest, but unrelated to diet, exercise, or sleep (8 sessions)

Intervention Type: BEHAVIORAL

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

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Christopher Gardner

Professor of Medicine (Research)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christopher D Gardner

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University School of Medicine

Stanford, California, United States

Countries

United States

Related Links

https://med.stanford.edu/nutrition/research/completed-studies/sleep-and-weight-loss.html

Study description and summary of results.

Other Identifiers

1R21HL092268-01A2

Identifier Type: NIH

Identifier Source: secondary_id

View Link

SU-05062010-5883

Identifier Type: -

Identifier Source: org_study_id