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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21HL092268-01A2 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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The goal is to determine if improved sleep will increase/enhance weight loss among overweight adults with insomnia.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diet & Exercise plus Sleep Intervention | Experimental | Diet and exercise instruction to promote weight loss plus cognitive behavioral therapy for insomnia. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diet and exercise | Behavioral | Standardized instruction to eat less and exercise more to create an energy balance deficit to promote weight loss (16 classes) |
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| 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 |
| 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 |
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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:
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):
Body Mass Index (BMI) greater than 40.
Pregnant, Lactating, or <6 months post-partum.
Inability to communicate effectively with study personnel.
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| Name | Affiliation | Role |
|---|---|---|
| Christopher D Gardner | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University School of Medicine | Stanford | California | 94305 | United States |
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| Label | URL |
|---|---|
| Study description and summary of results. | View source |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| D009765 | Obesity |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D004032 | Diet |
| D015444 | Exercise |
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D009043 | Motor Activity |
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| Cognitive Behavioral Therapy | Behavioral | Standardized cognitive behavioral therapy for insomnia (8 classes) |
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| Passion and Balance | Behavioral | Attention-match sessions of general interest, but unrelated to diet, exercise, or sleep (8 sessions) |
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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 |
| D001523 |
| Mental Disorders |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |