NCT00979784

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 17, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 18, 2009

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

June 12, 2013

Status Verified

June 1, 2013

Enrollment Period

2.7 years

First QC Date

September 17, 2009

Last Update Submit

June 11, 2013

Conditions

OverweightObesity

Keywords

obesityprimary care

Outcome Measures

Primary Outcomes (1)

  • percent baseline weight lost

    16 weeks

Secondary Outcomes (1)

  • feasibility, variance-covariance estimates

    16 weeks

Study Arms (2)

1

ACTIVE COMPARATOR
Behavioral: Better Weight

2

EXPERIMENTAL
Behavioral: Better Weight & Better Sleep

Interventions

Better WeightBEHAVIORAL

Standard cognitive behavioral treatment focused on dietary \& exercise behavior

1
Better Weight & Better SleepBEHAVIORAL

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

2

Eligibility Criteria

Age18 Years - 84 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI 25 to 39.9
  • ages 18 to 84
  • PCP permission
  • patient in Family Medicine Center with an encounter in the last six months

You may not qualify if:

  • various obesity and sleep related disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Family Medicine Center, Summa Health System

Akron, Ohio, 44309, United States

Location

MeSH Terms

Conditions

OverweightObesity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 17, 2009

First Posted

September 18, 2009

Study Start

April 1, 2009

Primary Completion

December 1, 2011

Study Completion

May 1, 2012

Last Updated

June 12, 2013

Record last verified: 2013-06

Locations

US(1)