Better Weight-Better Sleep (BWBS) Trial

This study has been completed.
Sponsor:
Collaborators:
Northeastern Ohio Universities College of Medicine
Ross Products
Information provided by (Responsible Party):
Everett Logue, Summa Health System
ClinicalTrials.gov Identifier:
NCT00979784
First received: September 17, 2009
Last updated: June 11, 2013
Last verified: June 2013
  Purpose

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 Intervention
Overweight
Obesity
Behavioral: Better Weight
Behavioral: Better Weight & Better Sleep

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: The Better Weight-Better Sleep Study: A Pilot Intervention in Primary Care

Resource links provided by NLM:


Further study details as provided by Summa Health System:

Primary Outcome Measures:
  • percent baseline weight lost [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • feasibility, variance-covariance estimates [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Enrollment: 49
Study Start Date: April 2009
Study Completion Date: May 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

Ages Eligible for Study:   18 Years to 84 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Everett Logue, Principal Investigator, Summa Health System
ClinicalTrials.gov Identifier: NCT00979784     History of Changes
Other Study ID Numbers: SUMMA-FMRC01
Study First Received: September 17, 2009
Last Updated: June 11, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Summa Health System:
obesity
primary care

Additional relevant MeSH terms:
Overweight
Obesity
Body Weight
Signs and Symptoms
Overnutrition
Nutrition Disorders

ClinicalTrials.gov processed this record on September 16, 2014