PCPCWLS: A Randomized Trial Comparing Two Doses of Portion-Controlled Foods Within a Primary Care Weight Loss Program
Study Details
Study Description
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-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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2/Phase 3 |
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 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Full Dose Provision of 8 weight loss counseling sessions, calorie guide, pedometer, meal plan, and 2 meals per day of portion-controlled foods (shakes and entrees) |
Behavioral: Weight loss counseling
Monitoring of weight; review of food and physical activity records; counseling to reduce calorie intake by 500-1000 calories per day
Other Names:
Dietary Supplement: Portion-Controlled Foods
Consumption of shakes, meal bars, and prepared entrees for 2 out of 3 meals per day during the 14 weeks of the study. "Full dose" patients are provided with both meals by the study; "half dose" patients are provided with one out of two meals by the study.
Other Names:
|
| Experimental: Half dose Provision of 8 weight loss counseling sessions, calorie guide, pedometer, meal plan, and 1 meal per day of portion-controlled foods (shakes and entrees) |
Behavioral: Weight loss counseling
Monitoring of weight; review of food and physical activity records; counseling to reduce calorie intake by 500-1000 calories per day
Other Names:
Dietary Supplement: Portion-Controlled Foods
Consumption of shakes, meal bars, and prepared entrees for 2 out of 3 meals per day during the 14 weeks of the study. "Full dose" patients are provided with both meals by the study; "half dose" patients are provided with one out of two meals by the study.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Weight change [14 weeks]
Secondary Outcome Measures
- Health-related quality of life [14 weeks]
- Blood pressure [14 weeks]
- Waist circumference [14 weeks]
- Body mass index [14 weeks]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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
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Willing to accept randomization to either treatment condition, to attend all sessions, and to complete study-related assessments
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Body mass index (BMI) ≥ 30 kg/m2 and < 50 kg/m2
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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
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Decreased high-density lipoprotein (HDL) cholesterol (< 40 for men, < 50 for women)
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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
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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
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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)
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Psychiatric diagnoses likely to affect adherence to a research study protocol (e.g., poorly controlled schizophrenia, active substance abuse)
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Prior or planned bariatric surgery
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Participation in an organized weight loss program (e.g., Weight Watchers) at the time of enrollment
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Center for Human Nutrition | Denver | Colorado | United States | 80220 |
Sponsors and Collaborators
- Kaiser Permanente
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
- Principal Investigator: Adam G Tsai, MD, MSCE, University of Colorado, Denver
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 09-0054
- K24DK065018