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Women's Health Project for Women Wanting to Lose Weight

Primary Purpose

Obesity

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Diet and exercise counseling

Diet, exercise, sleep hygiene counseling

About this trial

This is an interventional treatment trial for Obesity focused on measuring Obesity, weight loss, sleep hygiene, diet, exercise

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Diet, exercise, sleep hygiene counseling

Diet and exercise counseling

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT01671397

First Posted

August 20, 2012

Last Updated

April 30, 2014

Sponsor

Texas Tech University Health Sciences Center

1. Study Identification

Unique Protocol Identification Number

NCT01671397

Brief Title

Women's Health Project for Women Wanting to Lose Weight

Official Title

Intervention Study in Women Wanting to Lose Weight (Women's Health Project)

Study Type

Interventional

2. Study Status

Record Verification Date

April 2014

Overall Recruitment Status

Completed

Study Start Date

September 2012 (undefined)

Primary Completion Date

February 2014 (Actual)

Study Completion Date

February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Texas Tech University Health Sciences Center

4. Oversight

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity

Keywords

Obesity, weight loss, sleep hygiene, diet, exercise

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Diet, exercise, sleep hygiene counseling

Arm Type

Experimental

Arm Description

Arm Title

Diet and exercise counseling

Arm Type

Active Comparator

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Diet and exercise counseling

Intervention Description

Not needed

Intervention Type

Behavioral

Intervention Name(s)

Diet, exercise, sleep hygiene counseling

Intervention Description

None needed

Primary Outcome Measure Information:

Title

Weight loss

Description

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.

Time Frame

Six months

Secondary Outcome Measure Information:

Title

Functional capacity

Description

We will measure functional capacity using gait speed, timed "Get-up and Go" test, and standing balance at baseline and at six months.

Time Frame

6 months

Other Pre-specified Outcome Measures:

Title

Lipid profile

Description

We will measure cholesterol, LDL, HDL, triglycerides, and hemoglobin A 1 c at baseline and six months.

Time Frame

Six months

Title

Quality of life indices

Description

We will measure quality of life indices using questionnaires at baseline and six months.

Time Frame

Six months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kenneth M Nugent, MD

Organizational Affiliation

Texas Tech University Health Sciences Center

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Dolores M Buscemi, MD

Organizational Affiliation

Texas Tech University Health Sciences Center

Official's Role

Study Director

Facility Information:

Facility Name

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

City

Lubbock

State/Province

Texas

ZIP/Postal Code

79430

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Women's Health Project for Women Wanting to Lose Weight

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