Sleep Initiation and Maintenance DisordersNCT01135342
Adding Sleep Intervention to Traditional Diet and Exercise Approach to Weight Loss
A study testing Diet and exercise, Cognitive Behavioral Therapy and Passion and Balance in people with Sleep Initiation and Maintenance Disorders and Obesity, run by Stanford University at 1 site in United States.
Trial summary
The goal is to determine if improved sleep will increase/enhance weight loss among overweight adults with insomnia. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sleep Initiation and Maintenance Disorders, Obesity
- What is being tested?
- Diet and exercise, Cognitive Behavioral Therapy and Passion and Balance
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to Mar 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
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- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
The goal is to determine if improved sleep will increase/enhance weight loss among overweight adults with insomnia.
Read the 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.
- Being tested
- Diet and exercise, Cognitive Behavioral Therapy, Passion and Balance
- Keywords
- Insomnia, Weight loss, Adults
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diet and exerciseBehavioural
Standardized instruction to eat less and exercise more to create an energy balance deficit to promote weight loss (16 classes)
Cognitive Behavioral TherapyBehavioural
Standardized cognitive behavioral therapy for insomnia (8 classes)
Passion and BalanceBehavioural
Attention-match sessions of general interest, but unrelated to diet, exercise, or sleep (8 sessions)
| Study group | Role | What they receive |
|---|---|---|
| Diet & Exercise plus Sleep Intervention | Experimental | Diet and exercise instruction to promote weight loss plus cognitive behavioral therapy for insomnia. Receives: 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. Receives: Behavioral: Diet and exercise; Behavioral: Passion and Balance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in weight at 8 months
Change was calculated as the value at 8 months minus the value at baseline.
Measured: Baseline and 8 months
Secondary outcomes (4)
Change from baseline in scores of Insomnia Severity Index
Change was calculated as the value at 8 months minus the value at baseline.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2010 (estimated)
- Study startJul 2009
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Initiation and Maintenance DisordersStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Christopher Gardner, Stanford University
- Investigators
- Christopher D Gardner, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01135342
- Sponsor's protocol ID
- SU-05062010-5883
- Other IDs
- 1R21HL092268-01A2
- Status last verified
- Feb 2023
- First submitted
- 1 Jun 2010
- Last updated
- 22 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adding Sleep Intervention to Traditional Diet and Exercise Approach to Weight Loss
- ClinicalTrials.gov ID
- NCT01135342
- Acronym / sponsor ID
- SU-05062010-5883
- Keywords
- Insomnia, Weight loss, Adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jul 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 2 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diet & Exercise plus Sleep Intervention | Experimental | Behavioral: Diet and exercise, Behavioral: Cognitive Behavioral TherapyDiet and exercise instruction to promote weight loss plus cognitive behavioral therapy for insomnia. |
| Diet & Exercise plus Passion and Balance | Sham comparator | Behavioral: Diet and exercise, Behavioral: Passion and BalanceDiet and exercise instruction to promote weight loss plus sessions that are of general interest, but unrelated to diet, exercise, or sleep. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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:
Key exclusion criteria (16 listed)
- 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):
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diet and exerciseStandardized instruction to eat less and exercise more to create an energy balance deficit to promote weight loss (16 classes) | Behavioural | Diet & Exercise plus Passion and Balance, Diet & Exercise plus Sleep Intervention |
| Cognitive Behavioral TherapyStandardized cognitive behavioral therapy for insomnia (8 classes) | Behavioural | Diet & Exercise plus Sleep Intervention |
| Passion and BalanceAttention-match sessions of general interest, but unrelated to diet, exercise, or sleep (8 sessions) | Behavioural | Diet & Exercise plus Passion and Balance |
Primary outcome
Change from baseline in weight at 8 months
Time frame: Baseline and 8 months
Change was calculated as the value at 8 months minus the value at baseline.
4 secondary outcomes
Change from baseline in scores of Insomnia Severity Index
Time frame: Baseline and 8 months
Change from baseline in scores of Insomnia Frequency Questionnaire
Time frame: Baseline and 8 months
Change from baseline in scores of Pittsburgh Sleep Quality Index
Time frame: Baseline and 8 months
Change from baseline in scores of Monk Social Rhythm Questionnaire
Time frame: Baseline and 8 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2023.
- Study description and summary of results.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher D Gardner principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet and exercise, Cognitive Behavioral Therapy and Passion and Balance in people with Sleep Initiation and Maintenance Disorders and Obesity, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in weight at 8 months (time frame: Baseline and 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2023.