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Better Weight-Better Sleep (BWBS) Trial (BWBS)

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ClinicalTrials.gov Identifier: NCT00979784
Recruitment Status : Completed
First Posted : September 18, 2009
Last Update Posted : June 12, 2013
Sponsor:
Collaborators:
Northeastern Ohio Universities College of Medicine
Ross Products
Information provided by (Responsible Party):
Everett Logue, Summa Health System

Brief 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.

Condition or disease Intervention/treatment Phase
Overweight Obesity Behavioral: Better Weight Behavioral: Better Weight & Better Sleep Not Applicable

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  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: The Better Weight-Better Sleep Study: A Pilot Intervention in Primary Care
Study Start Date : April 2009
Actual Primary Completion Date : December 2011
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1 Behavioral: Better Weight
Standard cognitive behavioral treatment focused on dietary & exercise behavior
Experimental: 2 Behavioral: Better Weight & Better Sleep
Standard CBT to support dietary and exercise change plus sleep hygiene and sleep focused CBT



Primary Outcome Measures :
  1. percent baseline weight lost [ Time Frame: 16 weeks ]

Secondary Outcome Measures :
  1. feasibility, variance-covariance estimates [ Time Frame: 16 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 84 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00979784


Locations
United States, Ohio
Family Medicine Center, Summa Health System
Akron, Ohio, United States, 44309
Sponsors and Collaborators
Summa Health System
Northeastern Ohio Universities College of Medicine
Ross Products

Responsible Party: Everett Logue, Principal Investigator, Summa Health System
ClinicalTrials.gov Identifier: NCT00979784     History of Changes
Other Study ID Numbers: SUMMA-FMRC01
First Posted: September 18, 2009    Key Record Dates
Last Update Posted: June 12, 2013
Last Verified: June 2013

Keywords provided by Everett Logue, Summa Health System:
obesity
primary care

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms