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

NCT01135342 | Completed

• 2 other identifiers: SU-05062010-58831R21HL092268-01A2
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Sleep Initiation and Maintenance Disorders; Obesity

Keywords

Insomnia; Weight loss; Adults

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change from baseline in scores of Insomnia Severity Index

  Baseline and 8 months

• Change from baseline in scores of Insomnia Frequency Questionnaire

  Baseline and 8 months

• Change from baseline in scores of Pittsburgh Sleep Quality Index

  Baseline and 8 months

• Change from baseline in scores of Monk Social Rhythm Questionnaire

  Baseline and 8 months

Study Arms (2)

Diet & Exercise plus Sleep Intervention

EXPERIMENTAL

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

Behavioral: Diet and exercise; Behavioral: Cognitive Behavioral Therapy

Diet & Exercise plus Passion and Balance

SHAM COMPARATOR

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; Behavioral: Passion and Balance

Interventions

Diet and exercise BEHAVIORAL

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

Diet & Exercise plus Passion and Balance; Diet & Exercise plus Sleep Intervention

Cognitive Behavioral Therapy BEHAVIORAL

Standardized cognitive behavioral therapy for insomnia (8 classes)

Diet & Exercise plus Sleep Intervention

Passion and Balance BEHAVIORAL

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

Diet & Exercise plus Passion and Balance

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• 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.

Sponsors & Collaborators

• Stanford University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Related Links

• Study description and summary of results.

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Obesity; Weight Loss

Interventions

Diet; Exercise; Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Christopher D Gardner

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine (Research)

Study Record Dates

• First Submitted: June 1, 2010
• First Posted: June 2, 2010
• Study Start: July 1, 2009
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: February 22, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)