Women's Health Project for Women Wanting to Lose Weight

NCT ID: NCT01671397

Last Updated: 2014-05-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2014-02-28

Brief Summary

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.

Detailed Description

None needed

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Diet, exercise, sleep hygiene counseling

Intervention Type: BEHAVIORAL

None needed

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.

Group Type: ACTIVE_COMPARATOR

Diet and exercise counseling

Intervention Type: BEHAVIORAL

Not needed

Interventions

Diet and exercise counseling

Not needed

Intervention Type: BEHAVIORAL

Diet, exercise, sleep hygiene counseling

None needed

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Texas Tech University Health Sciences Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kenneth M Nugent, MD

Role: PRINCIPAL_INVESTIGATOR

Texas Tech University Health Sciences Center

Dolores M Buscemi, MD

Role: STUDY_DIRECTOR

Texas Tech University Health Sciences Center

Locations

Texas Tech Health Sciences Center - Physicians Pavillion, Internal Medicine Clinic

Lubbock, Texas, United States

Countries

United States

Other Identifiers

041923

Identifier Type: -

Identifier Source: org_study_id