Women's Health Project for Women Wanting to Lose Weight

Study Overview
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Brief Summary
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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
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None needed

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

Conditions
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Obesity

Intervention / Treatment
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* Behavioral: Diet and exercise counseling
* Behavioral: Diet, exercise, sleep hygiene counseling


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diet, exercise, sleep hygiene counseling<br>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. | Behavioral: Diet, exercise, sleep hygiene counseling<br>* None needed<br>|
| Active Comparator: Diet and exercise counseling<br>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. | Behavioral: Diet and exercise counseling<br>* Not needed<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight loss | 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. | Six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional capacity | We will measure functional capacity using gait speed, timed Get-up and Go test, and standing balance at baseline and at six months. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, weight loss, sleep hygiene, diet, exercise