Women's Health Project for Women Wanting to Lose Weight

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Behavioral: Diet, exercise, sleep hygiene counseling; Behavioral: Diet and exercise counseling

• Registration Number: NCT01671397
• Lead Sponsor: Texas Tech University Health Sciences Center

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

Study Timeline

• Study First Submitted: 2012-08-20
• Study First Submitted QC: 2012-08-22
• Study First Posted: 2012-08-23
• Study Start: 2012-09
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-30
• Last Update Posted: 2014-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Diet, exercise, sleep hygiene counseling	Diet, exercise, sleep hygiene counseling	Subjects will meet with a dietitian and a physician and receive counseling on diet restriction, exercise goals, and good sleep hygiene. Subjects will identify goals in each domain and keep a calendar of the success with achieving these goals.
Diet and exercise counseling	Diet and exercise counseling	Subjects will meet with a dietitian and a physician and receive counseling on calorie restriction and exercise. They will identify goals in each domain and keep a calendar to determine their success with achieving these goals.

Primary Outcome Measures

Name	Time	Method
Weight loss	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 Outcome Measures

Name	Time	Method
Functional capacity	6 months	We will measure functional capacity using gait speed, timed "Get-up and Go" test, and standing balance at baseline and at six months.

Trial Locations

Locations (1)

Texas Tech Health Sciences Center - Physicians Pavillion, Internal Medicine Clinic; 🇺🇸 Lubbock, Texas, United States