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Completed

NCT Number: NCT01671397

Women's Health Project for Women Wanting to Lose Weight

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.

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Key information

Conditions

Obesity Behavior Body Weight Body Weight Changes Health Behavior Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Hygiene Weight Loss

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

Lubbock, Texas, 79430, United States

About this study

None needed

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diet and exercise counseling

Behavioral

Not needed

Diet, exercise, sleep hygiene counseling

Behavioral

None needed

Primary outcomes

  1. Weight loss

    Time frame: Six months

    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 outcomes

  1. Functional capacity

    Time frame: 6 months

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

Other outcomes

  1. Lipid profile

    Time frame: Six months

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

  2. Quality of life indices

    Time frame: Six months

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

Sponsors and collaborators

Lead sponsor

Texas Tech University Health Sciences Center

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Aug 23, 2012
Registry last updated
May 1, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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