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Sleep and Obesity Management in Primary Care

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Northeastern Ohio Universities College of Medicine
Ross Products
Information provided by:
Summa Health System
ClinicalTrials.gov Identifier:
NCT00979784
First received: September 17, 2009
Last updated: January 6, 2012
Last verified: January 2012
History of Changes
  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: Sleep & Obesity Management in Primary Care--Pilot Study2

Resource links provided by NLM:

U.S. FDA Resources

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 ]

Estimated Enrollment: 80
Study Start Date: April 2009
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (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

  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
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, PhD / Director, Family Medicine Research Center, Summa Health System
ClinicalTrials.gov Identifier: NCT00979784     History of Changes
Other Study ID Numbers: SUMMA-FMRC01
Study First Received: September 17, 2009
Last Updated: January 6, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Summa Health System:
obesity
primary care

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

ClinicalTrials.gov processed this record on May 19, 2013