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Clinical Trials/NCT01671397
NCT01671397
Completed
Not Applicable

Intervention Study in Women Wanting to Lose Weight (Women's Health Project)

Texas Tech University Health Sciences Center1 site in 1 country40 target enrollmentSeptember 2012
ConditionsObesity

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obesity
Sponsor
Texas Tech University Health Sciences Center
Enrollment
40
Locations
1
Primary Endpoint
Weight loss
Status
Completed
Last Updated
12 years ago

Overview

Brief Summary

The prevalence of obesity has steadily increased in the United States. This can lead to the worsening of type 2 diabetes mellitus, hypertension, sleep apnea, coronary artery disease and osteoarthritis. The medical management of obesity involves dietary counseling and education, behavioral counseling with goal setting, and exercise. Patients with short sleep periods in the range of 5 to 7 hours per night are often heavier than normal sleepers even after controlling for other factors. We hypothesize that the addition of focused counseling on healthy sleeping to counseling on healthy eating (dieting) and healthy exercise can help women lose weight.

Detailed Description

None needed

Registry
clinicaltrials.gov
Start Date
September 2012
End Date
February 2014
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Any woman between the ages of 18 and 70 who is interested in counseling for weight loss
  • The body mass index (BMI) must be over 25 (overweight category) and below 40 (morbidly obese)

Exclusion Criteria

  • Women who cannot reasonably expect to commit the time needed for 6 visits, two lab draws, and completion of three one week sleep logs
  • Women who have had recent hospitalization or major surgery and cannot participate in a self directed exercise program
  • Women with significant cardiac or respiratory disease and cannot participate in a self directed exercise program

Outcomes

Primary Outcomes

Weight loss

Time Frame: Six months

Patients will be monitored for weight loss over a six month study period. We estimate that the sleep hygiene intervention group will lose 10 pounds more than the control group.

Secondary Outcomes

  • Functional capacity(6 months)

Study Sites (1)

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