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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Behavioral: Diet, exercise, sleep hygiene counseling; Behavioral: Diet and exercise counseling

Detailed Description

None needed

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Lubbock, Texas, United States, 79430
      • Texas Tech Health Sciences Center - Physicians Pavillion, Internal Medicine Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Six months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lipid profile	We will measure cholesterol, LDL, HDL, triglycerides, and hemoglobin A 1 c at baseline and six months.	Six months
Quality of life indices	We will measure quality of life indices using questionnaires at baseline and six months.	Six months

Collaborators and Investigators

• Sponsor: Texas Tech University Health Sciences Center
• Investigators: Study Director: Dolores M Buscemi, MD, Texas Tech University Health Sciences Center

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Actual): February 1, 2014
• Study Completion (Actual): February 1, 2014

Study Registration Dates

• First Submitted: August 20, 2012
• First Submitted That Met QC Criteria: August 22, 2012
• First Posted (Estimate): August 23, 2012

Study Record Updates

• Last Update Posted (Estimate): May 1, 2014
• Last Update Submitted That Met QC Criteria: April 30, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Keywords: Obesity; exercise; weight loss; diet; sleep hygiene
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Body Weight Changes; Obesity; Weight Loss
• Other Study ID Numbers: 041923