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View Clinical Trial (Medical Research Study)
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A Randomized Trial Comparing Two Doses of Portion-Controlled Foods Within a Primary Care Weight Loss Program - NCT00907660-80220 (Clinical Trial 293864)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy293864.aspx
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| City: |
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Denver |
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State:
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CO |
| Zip Code: |
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80220 |
| Conditions: |
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Obesity |
| Purpose: |
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We hypothesize that individuals provided with 1 meal per day of portion-controlled foods
(shakes and prepared entrees) will lose as much weight as individuals provided with 2 meals
per day of portion-controlled foods. The study is designed to assess whether equal weight
loss can be achieved at a lower cost to the health care system (or health care payer), with
patients contributing some of the cost of their own treatment.
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| Study summary: |
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The study has two goals. First, it will assess the efficacy of a weight loss program, using
a combination of counseling by peer weight coaches and portion-controlled foods. Second, the
study will test the effect of varying the "dose" of portion-controlled foods provided to
patients by randomly assigning individuals to receive half or all of the food required to
follow a meal replacement regimen. The primary endpoint of the study will be weight change.
Secondary endpoints will include adherence to the recommended eating plan, health-related
quality of life, as well as changes in waist circumference and blood pressure. The provision
of "half-dose" portion-controlled foods (1 meal per day) is hypothesized to be non-inferior
to provision of "full-dose" (2 meals per day). The goal of non-inferiority is important
because it can demonstrate that health care payers wishing to support weight loss programs
can achieve equivalent results at a lower cost. All patients have the choice regarding
their use of portion-controlled foods in the study, and no patients will be asked to leave
the study because of non-adherence. |
| Criteria: |
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Inclusion Criteria:
- Patients from the University Medicine Denver, University Medicine Anschutz, and AF
Williams clinics meeting the following criteria
- Age 18 or older
- Able to keep a food record for 3 days prior to study entry
- Able to give informed consent
- Willing to accept randomization to either treatment condition, to attend all
sessions, and to complete study-related assessments
- Body mass index (BMI) ≥ 30 kg/m2 and < 50 kg/m2
- Elevated waist circumference (≥ 88 cm for women, ≥ 102 cm for men) + any one of the
following:
- Glucose intolerance (fasting glucose ≥ 100 or non-fasting glucose ≥ 140, including
type 2 diabetes); individuals taking medications for diabetes qualify automatically
- Elevated blood pressure (≥130/85), including hypertension (≥140/90); individuals
taking anti-hypertensive medication qualify automatically
- Hypertriglyceridemia (TG ≥ 150); individuals taking lipid-lowering medications
qualify automatically
- Decreased high-density lipoprotein (HDL) cholesterol (< 40 for men, < 50 for women)
- Obstructive sleep apnea
Exclusion Criteria:
- Medical conditions in which significant weight loss is normally contraindicated (e.g.
pregnancy, congestive heart failure requiring diuretics, poorly controlled diabetes,
Stage 4 or 5 chronic kidney disease, clinically evident cirrhosis, other severe
internal organ disease); exceptions may be made if a referring physician documents
that it is safe and appropriate for the individual to lose weight
- Treated for cancer within the past 5 years, except for basal cell or squamous cell
skin cancer; exceptions may be made with written permission from a physician
- Weight gain or loss of ≥5% of weight in the past 6 months; patients who have not been
weight stable may be re-screened in 3 months
- Concurrent use of corticosteroids or second-generation antipsychotic medications
(exceptions may be made for individuals using these medications who have been weight
stable for 6 months)
- Psychiatric diagnoses likely to affect adherence to a research study protocol (e.g.,
poorly controlled schizophrenia, active substance abuse)
- Prior or planned bariatric surgery
- Participation in an organized weight loss program (e.g., Weight Watchers) at the time
of enrollment |
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| Study is available at: |
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Center for Human Nutrition
Denver, CO 80220
United States
Primary Contact:
Tim Goss
Email: tim.goss@ucdenver.edu
Secondary Contact:
Sue Felton, MA
Email: sue.felton@ucdenver.edu
Phone: 303-724-2253 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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November 16, 2009 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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