Status:
COMPLETED
A Randomized Trial Comparing Two Doses of Portion-Controlled Foods Within a Primary Care Weight Loss Program
Lead Sponsor:
Kaiser Permanente
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Obesity
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
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-...
Detailed Description
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...
Eligibility Criteria
Inclusion
- Patients from the University Medicine Denver, University Medicine Anschutz, and A.F. 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
- 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
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00907660
Start Date
May 1 2009
End Date
March 1 2010
Last Update
January 30 2020
Active Locations (1)
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1
Center for Human Nutrition
Denver, Colorado, United States, 80220