Women's Health Project for Women Wanting to Lose Weight
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|ClinicalTrials.gov Identifier: NCT01671397|
Recruitment Status : Completed
First Posted : August 23, 2012
Last Update Posted : May 1, 2014
|Condition or disease||Intervention/treatment||Phase|
|Obesity||Behavioral: Diet and exercise counseling Behavioral: Diet, exercise, sleep hygiene counseling||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Intervention Study in Women Wanting to Lose Weight (Women's Health Project)|
|Study Start Date :||September 2012|
|Actual Primary Completion Date :||February 2014|
|Actual Study Completion Date :||February 2014|
Experimental: 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.
Behavioral: Diet, exercise, sleep hygiene counseling
Active Comparator: 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.
Behavioral: Diet and exercise counseling
- 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.
- Functional capacity [ Time Frame: 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.
- Lipid profile [ Time Frame: Six months ]We will measure cholesterol, LDL, HDL, triglycerides, and hemoglobin A 1 c at baseline and six months.
- Quality of life indices [ Time Frame: Six months ]We will measure quality of life indices using questionnaires at baseline and six months.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01671397
|United States, Texas|
|Texas Tech Health Sciences Center - Physicians Pavillion, Internal Medicine Clinic|
|Lubbock, Texas, United States, 79430|
|Principal Investigator:||Kenneth M Nugent, MD||Texas Tech University Health Sciences Center|
|Study Director:||Dolores M Buscemi, MD||Texas Tech University Health Sciences Center|