Obesity Clinical Trial
— KAMELOfficial title:
KU Alternate Meal Energy Level Study
Verified date | January 2019 |
Source | University of Kansas Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Compare intermittent versus continuous calorie restriction to learn more about these eating plans and determine whether they are useful and effective to lose weight and keep it off.
Status | Completed |
Enrollment | 35 |
Est. completion date | November 1, 2018 |
Est. primary completion date | October 4, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years to 65 Years |
Eligibility |
Inclusion Criteria: 1. Age 21-65 years. 2. BMI 25-35. Patients with a BMI less than 25 are not classified as overweight and individuals with a BMI >35 may require more aggressive weight management strategies. 3. Clearance for participation from their PCP. Exclusion Criteria: 1. Participation in a research project or formal program involving weight loss or exercise in the previous 6 mos., as these proximal experiences may impact the results of this study. 2. Participation in a regular exercise program (i.e., > 500 kcal/wk. of planned activity as estimated by questionnaire [34]. 3. Not weight stable (-/+ 5%) for 6 mos. prior to intake. This will be determined by phone screen and self-report on the health history questionnaire 4. Unwilling to be randomized to one of two diet strategies for weight loss. 5. Pregnant during the previous 6 mos., lactating, or planned pregnancy in the following 6 mos. 6. Serious medical risk (e.g. diabetes, cancer, cardiovascular disease) as determined by the individual's physician via the clearance to participate in the investigation. 7. Disordered eating as determined by the Eating Attitudes Test using a score of 20 or greater [35]. This score indicates the need for counseling outside the scope of this study. 8. Current treatment for psychological problems, or taking psychotropic medications. Addressing psychological problems is outside the scope of this study. 9. Medications known to significantly influence weight. 10. Adherence to specialized diet regimens (e.g., multiple food allergies, vegan, etc.) 11. Do not have access to or independence over grocery shopping and meal preparation (i.e. those in military, college with cafeteria plan, etc.). 12. If participants have recently undergone CT (Computed Tomography), PET, fluoroscopic, or nuclear medicine studies within the past year. |
Country | Name | City | State |
---|---|---|---|
United States | University of Kansas Medical Center | Kansas City | Kansas |
Lead Sponsor | Collaborator |
---|---|
University of Kansas Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Weight (lbs, % change from baseline) | Change in absolute (lbs) and relative (%) weight from baseline to the end of the intervention (24 weeks) | Change from baseline to 24 weeks | |
Primary | Body composition | Change in absolute (g) and relative (%) fat mass and fat-free mass from baseline to 24 weeks | Change from baseline to 24 weeks | |
Secondary | Program adherence | Compliance to intervention protocol; adherence = (# attained / # expected)*100 | weekly through study completion (24 weeks) | |
Secondary | Nutrition-related quality of life | Assessed via questionnaire; higher scores indicate greater nutrition-related quality of life. | baseline, week 12, week 24 | |
Secondary | Dietary restraint | Assessed via three-factor eating questionnaire with three component scores for cognitive restraint, disinhibition, hunger) | baseline, week 12, week 24 |
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