OverweightBWBSNCT00979784
Better Weight-Better Sleep (BWBS) Trial
A study testing Better Weight and Better Weight & Better Sleep in people with Overweight and Obesity, run by Summa Health System at 1 site in United States.
Trial summary
The hypothesis of this study is that overweight and obese patients exposed to sleep focused counseling and standard dietary and exercise counseling will have better outcomes than similar patients exposed to standard dietary and exercise counseling only. Read more about this study
- Who is it for?
- Ages 18 to 84 years
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- Better Weight and Better Weight & Better Sleep
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2009to May 2012
- 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 to 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMI 25 to 39.9
- ages 18 to 84
- PCP permission
- patient in Family Medicine Center with an encounter in the last six months
Who cannot join
- various obesity and sleep related disorders
Trial locations and contacts
1 site in 1 country.
United States1 site
Family Medicine Center, Summa Health System
Akron, Ohio, 44309
About this study
Official title: The Better Weight-Better Sleep Study: A Pilot Intervention in Primary Care
The hypothesis of this study is that overweight and obese patients exposed to sleep focused counseling and standard dietary and exercise counseling will have better outcomes than similar patients exposed to standard dietary and exercise counseling only.
Read the detailed description
Objective: To explore the feasibility of integrating sleep management interventions with dietary and exercise interventions for obesity in a 12-week randomized trial. Methods: We randomized 49 overweight or obese adult patients either to a better weight (BW) cognitive behavioral intervention, or to a combination of the BW intervention and a better sleep intervention, better weight-better sleep (BWBS). Results: The BWBS group lost weight faster (P=.04), and coping self-efficacy accelerated (P=.01). Conclusions: These preliminary results merit replication in a larger primary care-based trial with a longer continuous intervention and followup period. Key words: obesity, sleep, weight loss, primary care, health behavior E Logue et al. Am J Health Behav. 2012;36(3):319-334 DOI: http://dx.doi.org/10.5993/AJHB.36.3.4
- Conditions
- Overweight, Obesity
- Being tested
- Better Weight, Better Weight & Better Sleep
- Keywords
- obesity, primary care
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Better WeightBehavioural
Standard cognitive behavioral treatment focused on dietary \& exercise behavior
Better Weight & Better SleepBehavioural
Standard CBT to support dietary and exercise change plus sleep hygiene and sleep focused CBT
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Behavioral: Better Weight |
| 2 | Experimental | Not described Receives: Behavioral: Better Weight & Better Sleep |
What is being measured
The primary outcome is the main question the study is designed to answer.
percent baseline weight lost
Measured: 16 weeks
Secondary outcomes (1)
feasibility, variance-covariance estimates
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2009 (estimated)
- Study startApr 2009
- Primary completionDec 2011
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies 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 N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Summa Health System
- Sponsor type
- University, hospital or other
- Collaborators
- Northeastern Ohio Universities College of Medicine, Ross Products
- Responsible party
- Principal investigator, Everett Logue, Summa Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00979784
- Sponsor's protocol ID
- SUMMA-FMRC01
- Acronym
- BWBS
- Status last verified
- Jun 2013
- First submitted
- 17 Sep 2009
- Last updated
- 12 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Better Weight-Better Sleep Study: A Pilot Intervention in Primary Care
- ClinicalTrials.gov ID
- NCT00979784
- Acronym / sponsor ID
- BWBS / SUMMA-FMRC01
- Conditions
- Overweight, Obesity
- Keywords
- obesity, primary care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Summa Health SystemUniversity, hospital or other
- Collaborators
- Northeastern Ohio Universities College of Medicine, Ross Products
- Study start
- Apr 2009
- Primary completion
- Dec 2011 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 18 Sep 2009 (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 hypothesis of this study is that overweight and obese patients exposed to sleep focused counseling and standard dietary and exercise counseling will have better outcomes than similar patients exposed to standard dietary and exercise counseling only.
Detailed description
Objective: To explore the feasibility of integrating sleep management interventions with dietary and exercise interventions for obesity in a 12-week randomized trial. Methods: We randomized 49 overweight or obese adult patients either to a better weight (BW) cognitive behavioral intervention, or to a combination of the BW intervention and a better sleep intervention, better weight-better sleep (BWBS). Results: The BWBS group lost weight faster (P=.04), and coping self-efficacy accelerated (P=.01). Conclusions: These preliminary results merit replication in a larger primary care-based trial with a longer continuous intervention and followup period. Key words: obesity, sleep, weight loss, primary care, health behavior E Logue et al. Am J Health Behav. 2012;36(3):319-334 DOI: http://dx.doi.org/10.5993/AJHB.36.3.4
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Behavioral: Better Weight |
| 2 | Experimental | Behavioral: Better Weight & Better Sleep |
Who may qualify
- Ages
- 18 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- BMI 25 to 39.9
- ages 18 to 84
- PCP permission
- patient in Family Medicine Center with an encounter in the last six months
Key exclusion criteria (1 listed)
- various obesity and sleep related disorders
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 |
|---|---|---|
| Better WeightStandard cognitive behavioral treatment focused on dietary \& exercise behavior | Behavioural | 1 |
| Better Weight & Better SleepStandard CBT to support dietary and exercise change plus sleep hygiene and sleep focused CBT | Behavioural | 2 |
Primary outcome
percent baseline weight lost
Time frame: 16 weeks
1 secondary outcome
feasibility, variance-covariance estimates
Time frame: 16 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 12 Jun 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Better Weight and Better Weight & Better Sleep in people with Overweight and Obesity, run by Summa Health System 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 1 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 12 Jun 2013. 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.
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?
percent baseline weight lost (time frame: 16 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 12 Jun 2013.