Women's Health Project for Women Wanting to Lose Weight

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Texas Tech University Health Sciences Center
ClinicalTrials.gov Identifier:
NCT01671397
First received: August 20, 2012
Last updated: April 30, 2014
Last verified: April 2014

August 20, 2012
April 30, 2014
September 2012
February 2014   (final data collection date for primary outcome measure)
Weight loss [ Time Frame: Six months ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01671397 on ClinicalTrials.gov Archive Site
Functional capacity [ Time Frame: 6 months ] [ Designated as safety issue: No ]
We will measure functional capacity using gait speed, timed "Get-up and Go" test, and standing balance at baseline and at six months.
Same as current
  • Lipid profile [ Time Frame: Six months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    We will measure quality of life indices using questionnaires at baseline and six months.
Same as current
 
Women's Health Project for Women Wanting to Lose Weight
Intervention Study in Women Wanting to Lose Weight (Women's Health Project)

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.

None needed

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Obesity
  • Behavioral: Diet and exercise counseling
    Not needed
  • Behavioral: Diet, exercise, sleep hygiene counseling
    None needed
  • 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.
    Intervention: 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.
    Intervention: Behavioral: Diet and exercise counseling
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
February 2014
February 2014   (final data collection date for primary outcome measure)

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
Female
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01671397
041923
No
Texas Tech University Health Sciences Center
Texas Tech University Health Sciences Center
Not Provided
Principal Investigator: Kenneth M Nugent, MD Texas Tech University Health Sciences Center
Study Director: Dolores M Buscemi, MD Texas Tech University Health Sciences Center
Texas Tech University Health Sciences Center
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP