Clinical trial NCT00907660: A Randomized Trial Comparing Two Doses of Portion-Controlled Foods Within a Primary Care Weight Loss Program
Official title: A Randomized Trial Comparing Two Doses of Portion-Controlled Foods Within a Primary Care Weight Loss Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Obesity
Keywords: Obesity
Weight loss
Meal replacements
Health services research
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2009-05-22
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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
* 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

Primary outcomes:
measure: Weight change
timeFrame: 14 weeks
Secondary outcomes:
measure: Health-related quality of life
timeFrame: 14 weeks
measure: Blood pressure
timeFrame: 14 weeks
measure: Waist circumference
timeFrame: 14 weeks
measure: Body mass index
timeFrame: 14 weeks
Other outcomes:
Locations:
city: Denver
country: United States
facility: Center for Human Nutrition
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Adam G Tsai, MD, MSCE
role: PRINCIPAL_INVESTIGATOR
References: