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Women's Health Project for Women Wanting to Lose Weight

This study is currently recruiting participants.
Verified April 2013 by Texas Tech University Health Sciences Center
Sponsor:
Information provided by (Responsible Party):
Texas Tech University Health Sciences Center
ClinicalTrials.gov Identifier:
NCT01671397
First received: August 20, 2012
Last updated: April 17, 2013
Last verified: April 2013
History of Changes
  Purpose

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.


Condition Intervention
Obesity
 Behavioral: Diet and exercise counseling
Behavioral: Diet, exercise, sleep hygiene counseling

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intervention Study in Women Wanting to Lose Weight (Women's Health Project)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Texas Tech University Health Sciences Center:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Other Outcome Measures:
  • 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.


Estimated Enrollment: 50
Study Start Date: September 2012
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
None needed
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
Not needed

Detailed Description:

None needed

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01671397

Contacts
Contact: Nora Limas, BA 806-743-3150 nora.limas@ttuhsc.edu
Contact: Dolores Buscemi, MD 806-743-3150 dolores.buscemi@ttuhsc.edu

Locations
United States, Texas
Texas Tech Health Sciences Center - Physicians Pavillion, Internal Medicine Clinic Recruiting
Lubbock, Texas, United States, 79430
Contact: Nora Limas, BA     806-743-3150     nora.limas@ttuhsc.edu    
Principal Investigator: Kenneth Nugent, MD            
Sub-Investigator: Dolores Buscemi, MD            
Sponsors and Collaborators
Texas Tech University Health Sciences Center
Investigators
Principal Investigator: Kenneth M Nugent, MD Texas Tech University Health Sciences Center
Study Director: Dolores M Buscemi, MD Texas Tech University Health Sciences Center
  More Information

No publications provided

Responsible Party: Texas Tech University Health Sciences Center
ClinicalTrials.gov Identifier: NCT01671397     History of Changes
Other Study ID Numbers: 041923
Study First Received: August 20, 2012
Last Updated: April 17, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Texas Tech University Health Sciences Center:
Obesity
weight loss
sleep hygiene
diet
exercise

Additional relevant MeSH terms:
Obesity
Weight Loss
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms
Body Weight Changes

ClinicalTrials.gov processed this record on May 19, 2013