Better Weight-Better Sleep (BWBS) Trial

Obesity Clinical Trial

— BWBS  

Official title:

The Better Weight-Better Sleep Study: A Pilot Intervention in Primary Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00979784
• Other study ID #: SUMMA-FMRC01
• Status: Completed
• Phase: N/A
• First received: September 17, 2009
• Last updated: June 11, 2013
• Start date: April 2009
• Est. completion date: May 2012

Study information

• Verified date: June 2013
• Source: Summa Health System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: May 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 84 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Behavioral:
• Better Weight
Standard cognitive behavioral treatment focused on dietary & exercise behavior
• Better Weight & Better Sleep
Standard CBT to support dietary and exercise change plus sleep hygiene and sleep focused CBT

Locations

Country	Name	City	State
United States	Family Medicine Center, Summa Health System	Akron	Ohio

Sponsors (3)

Lead Sponsor	Collaborator
Summa Health System	Northeastern Ohio Universities College of Medicine, Ross Products

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	percent baseline weight lost		16 weeks	No
Secondary	feasibility, variance-covariance estimates		16 weeks	No