Women's Health Project for Women Wanting to Lose Weight

Texas Tech University Health Sciences Center

Status: Completed

Conditions: Obesity

Treatments: Behavioral: Diet and exercise counseling; Behavioral: Diet, exercise, sleep hygiene counseling

Study type: Interventional

Funder types: Other

Identifiers

NCT01671397

041923

Details and patient eligibility

About

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.

Full description

None needed

Enrollment: 40 patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups

Diet, exercise, sleep hygiene counseling

Experimental group

Description:

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.

Treatment:

Behavioral: Diet, exercise, sleep hygiene counseling

Diet and exercise counseling

Active Comparator group

Description:

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.

Treatment:

Behavioral: Diet and exercise counseling