Better Weight-Better Sleep (BWBS) Trial

NCT ID: NCT00979784

Last Updated: 2013-06-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2012-05-31

Brief Summary

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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

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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

Conditions

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Overweight Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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1

Group Type ACTIVE_COMPARATOR

Better Weight

Intervention Type BEHAVIORAL

Standard cognitive behavioral treatment focused on dietary \& exercise behavior

2

Group Type EXPERIMENTAL

Better Weight & Better Sleep

Intervention Type BEHAVIORAL

Standard CBT to support dietary and exercise change plus sleep hygiene and sleep focused CBT

Interventions

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Better Weight

Standard cognitive behavioral treatment focused on dietary \& exercise behavior

Intervention Type BEHAVIORAL

Better Weight & Better Sleep

Standard CBT to support dietary and exercise change plus sleep hygiene and sleep focused CBT

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

84 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Northeastern Ohio Universities College of Medicine

OTHER

Sponsor Role collaborator

Ross Products

INDUSTRY

Sponsor Role collaborator

Summa Health System

OTHER

Sponsor Role lead

Responsible Party

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Everett Logue

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Family Medicine Center, Summa Health System

Akron, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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SUMMA-FMRC01

Identifier Type: -

Identifier Source: org_study_id

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