Overweight and ObesityPhase 2NCT01428687
Short Term Effects of Increasing Sleep Duration
A Phase 2 study testing Sleep Duration and No change in sleep in people with Overweight and Obesity, run by The Miriam Hospital at 1 site in United States.
Trial summary
A series of studies are proposed to develop an intervention to increase sleep duration and study the effects on eating, exercise, and weight control. The hypothesis is that increasing sleep duration will help improve weight loss and maintenance. Read more about this study
- Who is it for?
- Ages 25 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- Sleep Duration and No change in sleep
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to Aug 2016
- Phase
- Phase 2
- 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 25 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- age 25 to 45;
- BMI 25 to 50;
- healthy;
- sleep 6.5 hours or less per night
Who cannot join
- use of sleep medications;
- sleep apnea;
- third shift worker
Trial locations and contacts
1 site in 1 country.
United States1 site
Weight Control & Diabetes Research Center
Providence, Rhode Island, 02903
About this study
Official title: Increasing Sleep Duration: A Novel Approach to Weight Control
A series of studies are proposed to develop an intervention to increase sleep duration and study the effects on eating, exercise, and weight control. The hypothesis is that increasing sleep duration will help improve weight loss and maintenance.
Read the detailed description
Study 1 is conducted in a sleep laboratory. Participants sleep short duration (approximately four hours per night) on one weekend and long duration (approximately nine hours per night) on another weekend.
Study 2 is examining ways to increase sleep duration in overweight individuals with short sleep and examining the effects on short term weight loss.
Study 3 is comparing a standard weight loss program with a novel Sleep+Weight Loss intervention.
- Conditions
- Overweight and Obesity
- Being tested
- Sleep Duration, No change in sleep
- Keywords
- Weight loss, Sleep duration
- Medical subject headings
- Overweight, Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep DurationBehavioural
Subjects are taught sleep hygiene strategies to increase their sleep; they record their sleep in a diary and wear an actigraph and call in their sleep to the office each day.
No change in sleepBehavioural
This group is taught to maintain their current sleep habits.
| Study group | Role | What they receive |
|---|---|---|
| Increase Sleep Gradually | Active comparator | Subjects in this condition are taught to increase their sleep by 30 minutes per night during week 1 of the intervention; 60 minutes during week 2; and 90 minutes during week 3. Following the sleep intervention, these participants receive a standard behavioral with loss intervention. Receives: Behavioral: Sleep Duration |
| Increase Sleep Immediately | Active comparator | Subjects in this condition are taught to increase their sleep by 90 minutes per night starting in week 1. Following the sleep intervention, these participants receive a standard behavioral with loss intervention. Receives: Behavioral: Sleep Duration |
| No Intervention: Control Group | Active comparator | This group is told to make no changes in their sleep habits. Following the sleep intervention, these participants receive a standard behavioral with loss intervention. Receives: Behavioral: No change in sleep |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep Duration
Participants with verified short sleep are taught to increase their sleep either gradually or immediately. These two groups are compared to a control group who makes no changes in their sleep. The primary outcome is sleep duration per night as determined by actigraphy.
Measured: 4 weeks
Secondary outcomes (2)
Eating Behavior
24-hour recalls are used to estimate dietary intake at baseline and after 4 weeks of sleep intervention.
Measured: 4 weeks
Physical Activity
Objective measures of physical activity are obtained before and after the 4-week sleep intervention.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2011 (estimated)
- Study startAug 2011
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Miriam Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rena R. Wing, The Miriam Hospital
- Investigators
- Rena R. Wing, PhD, Principal investigator, The Miriam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01428687
- Sponsor's protocol ID
- U01CA150387 - Study 2
- Other IDs
- U01CA150387
- Status last verified
- Aug 2016
- First submitted
- 1 Sep 2011
- Last updated
- 30 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Sleep Duration: A Novel Approach to Weight Control
- ClinicalTrials.gov ID
- NCT01428687
- Acronym / sponsor ID
- U01CA150387 - Study 2
- Conditions
- Overweight and Obesity
- Keywords
- Weight loss, Sleep duration
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- The Miriam HospitalUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 5 Sep 2011 (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.
A series of studies are proposed to develop an intervention to increase sleep duration and study the effects on eating, exercise, and weight control. The hypothesis is that increasing sleep duration will help improve weight loss and maintenance.
Detailed description
Study 1 is conducted in a sleep laboratory. Participants sleep short duration (approximately four hours per night) on one weekend and long duration (approximately nine hours per night) on another weekend.
Study 2 is examining ways to increase sleep duration in overweight individuals with short sleep and examining the effects on short term weight loss.
Study 3 is comparing a standard weight loss program with a novel Sleep+Weight Loss intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Increase Sleep Gradually | Active comparator | Behavioral: Sleep DurationSubjects in this condition are taught to increase their sleep by 30 minutes per night during week 1 of the intervention; 60 minutes during week 2; and 90 minutes during week 3. Following the sleep intervention, these participants receive a standard behavioral with loss intervention. |
| Increase Sleep Immediately | Active comparator | Behavioral: Sleep DurationSubjects in this condition are taught to increase their sleep by 90 minutes per night starting in week 1. Following the sleep intervention, these participants receive a standard behavioral with loss intervention. |
| No Intervention: Control Group | Active comparator | Behavioral: No change in sleepThis group is told to make no changes in their sleep habits. Following the sleep intervention, these participants receive a standard behavioral with loss intervention. |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- age 25 to 45;
- BMI 25 to 50;
- healthy;
- sleep 6.5 hours or less per night
Key exclusion criteria (3 listed)
- use of sleep medications;
- sleep apnea;
- third shift worker
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 |
|---|---|---|
| Sleep DurationSubjects are taught sleep hygiene strategies to increase their sleep; they record their sleep in a diary and wear an actigraph and call in their sleep to the office each day. | Behavioural | Increase Sleep Gradually, Increase Sleep Immediately |
| No change in sleepThis group is taught to maintain their current sleep habits. | Behavioural | No Intervention: Control Group |
Primary outcome
Sleep Duration
Time frame: 4 weeks
Participants with verified short sleep are taught to increase their sleep either gradually or immediately. These two groups are compared to a control group who makes no changes in their sleep. The primary outcome is sleep duration per night as determined by actigraphy.
2 secondary outcomes
Eating Behavior
Time frame: 4 weeks
Physical Activity
Time frame: 4 weeks
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 30 Aug 2016.
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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.
Rena R. Wing, PhD principal investigator
The Miriam Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sleep Duration and No change in sleep in people with Overweight and Obesity, run by The Miriam Hospital 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 4 inclusion and 3 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 30 Aug 2016. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Sleep Duration (time frame: 4 weeks). 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 30 Aug 2016.