A Randomized Trial Comparing Two Doses of Portion-Controlled Foods Within a Primary Care Weight Loss Program

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Randomized Trial Comparing Two Doses of Portion-Controlled Foods Within a Primary Care Weight Loss Program

Conditions
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Obesity

Intervention / Treatment
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* Behavioral: Weight loss counseling
* Dietary Supplement: Portion-Controlled Foods


Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Full Dose<br>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<br>* Monitoring of weight; review of food and physical activity records; counseling to reduce calorie intake by 500-1000 calories per day<br>* Other names: Diet and exercise;Dietary Supplement: Portion-Controlled Foods<br>* 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.<br>* Other names: Meal replacements;|
| Experimental: Half dose<br>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<br>* Monitoring of weight; review of food and physical activity records; counseling to reduce calorie intake by 500-1000 calories per day<br>* Other names: Diet and exercise;Dietary Supplement: Portion-Controlled Foods<br>* 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.<br>* Other names: Meal replacements;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight change |  | 14 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health-related quality of life |  | 14 weeks | 
| Blood pressure |  | 14 weeks | 
| Waist circumference |  | 14 weeks | 
| Body mass index |  | 14 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, Weight loss, Meal replacements, Health services research