Better Weight-Better Sleep (BWBS) Trial | NCT00979784

Studies
Better Weight-Better Sleep (BWBS) Trial

NCT00979784

Sponsor

Summa Health System

Status

Completed

Last Update Posted

Jun 12, 2013Estimated

Enrollment

49Actual

Phase

Not Applicable

Conditions

Overweight
Obesity

Interventions

Better Weight
Better Weight & Better Sleep

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2009

Primary Completion Date

Dec 2011Actual

Completion Date

May 2012Actual

First Submitted Date

Sep 17, 2009

First Submission Date that Met QC Criteria

Sep 17, 2009

First Posted Date

Sep 18, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 11, 2013

Last Update Posted Date

Jun 12, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Everett Logue, Principal Investigator, Summa Health SystemPrincipal Investigator

Lead Sponsor

Summa Health SystemOTHER

Collaborators

Name	Class
Northeastern Ohio Universities College of Medicine	OTHER
Ross Products	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

49Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator		Behavioral: Better Weight
2	Experimental		Behavioral: Better Weight & Better Sleep

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Better Weight	Behavioral	Standard cognitive behavioral treatment focused on dietary & exercise behavior	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
percent baseline weight lost		16 weeks

Secondary Outcomes

Measure	Description	Time Frame
feasibility, variance-covariance estimates		16 weeks

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

84 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Family Medicine Center, Summa Health System		Akron	Ohio	44309	United States

Condition Browse Module

MeSH Terms

ID	Term
D050177	Overweight
D009765	Obesity

Ancestor Terms

ID	Term
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases
D001835	Body Weight

Browse Leaves

Not provided

Browse Branches

Not provided