Obesity
Conditions
Keywords
Obesity, weight loss, sleep hygiene, diet, exercise
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
Interventions
BEHAVIORALDiet and exercise counseling
Not needed
BEHAVIORALDiet, exercise, sleep hygiene counseling
None needed
Sponsors
Texas Tech University Health Sciences Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight loss | 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
| Measure | Time frame | Description |
|---|---|---|
| Functional capacity | 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
| Measure | Time frame | Description |
|---|---|---|
| Lipid profile | Six months | We will measure cholesterol, LDL, HDL, triglycerides, and hemoglobin A 1 c at baseline and six months. |
| Quality of life indices | Six months | We will measure quality of life indices using questionnaires at baseline and six months. |
Countries
United States
Outcome results
None listed