Women's Health Project for Women Wanting to Lose Weight
|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.
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|