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

Primary Purpose

Overweight, Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Better Weight
Better Weight & Better Sleep
Sponsored by
Summa Health System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Overweight focused on measuring obesity, primary care

Eligibility Criteria

18 Years - 84 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Family Medicine Center, Summa Health System

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

percent baseline weight lost

Secondary Outcome Measures

feasibility, variance-covariance estimates

Full Information

First Posted
September 17, 2009
Last Updated
June 11, 2013
Sponsor
Summa Health System
Collaborators
Northeastern Ohio Universities College of Medicine, Ross Products
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1. Study Identification

Unique Protocol Identification Number
NCT00979784
Brief Title
Better Weight-Better Sleep (BWBS) Trial
Acronym
BWBS
Official Title
The Better Weight-Better Sleep Study: A Pilot Intervention in Primary Care
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Summa Health System
Collaborators
Northeastern Ohio Universities College of Medicine, Ross Products

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity
Keywords
obesity, primary care

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Title
2
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Better Weight
Intervention Description
Standard cognitive behavioral treatment focused on dietary & exercise behavior
Intervention Type
Behavioral
Intervention Name(s)
Better Weight & Better Sleep
Intervention Description
Standard CBT to support dietary and exercise change plus sleep hygiene and sleep focused CBT
Primary Outcome Measure Information:
Title
percent baseline weight lost
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
feasibility, variance-covariance estimates
Time Frame
16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
84 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Family Medicine Center, Summa Health System
City
Akron
State/Province
Ohio
ZIP/Postal Code
44309
Country
United States

12. IPD Sharing Statement

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Better Weight-Better Sleep (BWBS) Trial

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