- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00979784
Better Weight-Better Sleep (BWBS) Trial (BWBS)
June 11, 2013 updated by: Everett Logue, Summa Health System
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
49
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ohio
-
Akron, Ohio, United States, 44309
- Family Medicine Center, Summa Health System
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 84 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- BMI 25 to 39.9
- ages 18 to 84
- PCP permission
- patient in Family Medicine Center with an encounter in the last six months
Exclusion Criteria:
- various obesity and sleep related disorders
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 2
|
Standard CBT to support dietary and exercise change plus sleep hygiene and sleep focused CBT
|
Active Comparator: 1
|
Standard cognitive behavioral treatment focused on dietary & exercise behavior
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
percent baseline weight lost
Time Frame: 16 weeks
|
16 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
feasibility, variance-covariance estimates
Time Frame: 16 weeks
|
16 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2009
Primary Completion (Actual)
December 1, 2011
Study Completion (Actual)
May 1, 2012
Study Registration Dates
First Submitted
September 17, 2009
First Submitted That Met QC Criteria
September 17, 2009
First Posted (Estimate)
September 18, 2009
Study Record Updates
Last Update Posted (Estimate)
June 12, 2013
Last Update Submitted That Met QC Criteria
June 11, 2013
Last Verified
June 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SUMMA-FMRC01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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