Overweight and ObesityPhase 2NCT01717352
Sleep Plus Eating Routines for Weight Loss
A Phase 2 study testing Weight Loss Education and Sleep and Eating Routine in people with Overweight and Obesity, run by The Miriam Hospital at 1 site in United States.
Trial summary
The present study will test the effectiveness of two different approaches for preparing overweight/obese individuals for weight loss: 1)providing important information about weight control, including dispelling common myths; or 2) developing a consistent sleep and eating routine to prepare for the challenges of a… Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- Weight Loss Education and Sleep and Eating Routine
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Mar 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 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age 21 to 65
- BMI 25 to 45
- sleep 7 hours or less most nights
Who cannot join
- use of medications affecting sleep
- sleep apnea
- shift work
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. Study 5-Randomized Trial of Sleep Plus Eating Routines as An Approach to Prepare Participants for Weight Loss
The present study will test the effectiveness of two different approaches for preparing overweight/obese individuals for weight loss: 1)providing important information about weight control, including dispelling common myths; or 2) developing a consistent sleep and eating routine to prepare for the challenges of a weight control intervention.
- Conditions
- Overweight and Obesity
- Being tested
- Weight Loss Education, Sleep and Eating Routine
- Keywords
- Weight loss
- 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.
Weight Loss EducationBehavioural
Sleep and Eating RoutineBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Weight Loss Education | Active comparator | Provides participants with important information about weight control and healthy eating prior to treatment to prepare participants for participation in a weight loss program and enhance outcomes. Receives: Behavioral: Weight Loss Education |
| Sleep and Eating Routine | Active comparator | Establish a consistent sleep and eating routine prior to treatment to prepare participants for participation in a weight loss program and enhance outcomes. Receives: Behavioral: Sleep and Eating Routine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight
Measured: 20 weeks
Secondary outcomes (1)
Executive Control
Executive control is measured by a variety of computer assessments. These include Go-No Go, delayed discounting, and perseverence as measured by mirror tracing and a hand grip task.
Measured: 4 and 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2012 (estimated)
- Study startSep 2012
- Primary completionMar 2016
- Study completionMar 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
- 90 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
- NCT01717352
- Sponsor's protocol ID
- U01CA150387-Study 5
- Other IDs
- U01CA150387
- Status last verified
- Jan 2017
- First submitted
- 26 Oct 2012
- Last updated
- 4 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Sleep Duration: A Novel Approach to Weight Control. Study 5-Randomized Trial of Sleep Plus Eating Routines as An Approach to Prepare Participants for Weight Loss
- ClinicalTrials.gov ID
- NCT01717352
- Acronym / sponsor ID
- U01CA150387-Study 5
- Conditions
- Overweight and Obesity
- Keywords
- Weight loss
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- The Miriam HospitalUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 30 Oct 2012 (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 present study will test the effectiveness of two different approaches for preparing overweight/obese individuals for weight loss: 1)providing important information about weight control, including dispelling common myths; or 2) developing a consistent sleep and eating routine to prepare for the challenges of a weight control intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Weight Loss Education | Active comparator | Behavioral: Weight Loss EducationProvides participants with important information about weight control and healthy eating prior to treatment to prepare participants for participation in a weight loss program and enhance outcomes. |
| Sleep and Eating Routine | Active comparator | Behavioral: Sleep and Eating RoutineEstablish a consistent sleep and eating routine prior to treatment to prepare participants for participation in a weight loss program and enhance outcomes. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age 21 to 65
- BMI 25 to 45
- sleep 7 hours or less most nights
Key exclusion criteria (3 listed)
- use of medications affecting sleep
- sleep apnea
- shift work
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 |
|---|---|---|
| Weight Loss Education | Behavioural | Weight Loss Education |
| Sleep and Eating Routine | Behavioural | Sleep and Eating Routine |
Primary outcome
Weight
Time frame: 20 weeks
1 secondary outcome
Executive Control
Time frame: 4 and 20 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 4 Jan 2017.
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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 Weight Loss Education and Sleep and Eating Routine 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 3 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 4 Jan 2017. 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?
Weight (time frame: 20 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 4 Jan 2017.