Women's Health Project for Women Wanting to Lose Weight
Primary Purpose
Obesity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Diet and exercise counseling
Diet, exercise, sleep hygiene counseling
Sponsored by
About this trial
This is an interventional treatment trial for Obesity focused on measuring Obesity, weight loss, sleep hygiene, diet, exercise
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
Sites / Locations
- Texas Tech Health Sciences Center - Physicians Pavillion, Internal Medicine Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Diet, exercise, sleep hygiene counseling
Diet and exercise counseling
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT01671397
First Posted
August 20, 2012
Last Updated
April 30, 2014
Sponsor
Texas Tech University Health Sciences Center
1. Study Identification
Unique Protocol Identification Number
NCT01671397
Brief Title
Women's Health Project for Women Wanting to Lose Weight
Official Title
Intervention Study in Women Wanting to Lose Weight (Women's Health Project)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Texas Tech University Health Sciences Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Obesity, weight loss, sleep hygiene, diet, exercise
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Diet, exercise, sleep hygiene counseling
Arm Type
Experimental
Arm Description
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.
Arm Title
Diet and exercise counseling
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Diet and exercise counseling
Intervention Description
Not needed
Intervention Type
Behavioral
Intervention Name(s)
Diet, exercise, sleep hygiene counseling
Intervention Description
None needed
Primary Outcome Measure Information:
Title
Weight loss
Description
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.
Time Frame
Six months
Secondary Outcome Measure Information:
Title
Functional capacity
Description
We will measure functional capacity using gait speed, timed "Get-up and Go" test, and standing balance at baseline and at six months.
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Lipid profile
Description
We will measure cholesterol, LDL, HDL, triglycerides, and hemoglobin A 1 c at baseline and six months.
Time Frame
Six months
Title
Quality of life indices
Description
We will measure quality of life indices using questionnaires at baseline and six months.
Time Frame
Six months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenneth M Nugent, MD
Organizational Affiliation
Texas Tech University Health Sciences Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dolores M Buscemi, MD
Organizational Affiliation
Texas Tech University Health Sciences Center
Official's Role
Study Director
Facility Information:
Facility Name
Texas Tech Health Sciences Center - Physicians Pavillion, Internal Medicine Clinic
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79430
Country
United States
12. IPD Sharing Statement
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Women's Health Project for Women Wanting to Lose Weight
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