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

Sponsor:	University of Colorado, Denver
Information provided by:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:	NCT00907660

Purpose

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	Intervention	Phase
Obesity	Behavioral: Weight loss counseling Dietary Supplement: Portion-Controlled Foods	Phase II Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Randomized Trial Comparing Two Doses of Portion-Controlled Foods Within a Primary Care Weight Loss Program

Resource links provided by NLM:

MedlinePlus related topics: Obesity Tremor Weight Control

U.S. FDA Resources

Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Primary Outcome Measures:

Weight change [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Health-related quality of life [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
Blood pressure [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
Waist circumference [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
Body mass index [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	50
Study Start Date:	May 2009
Study Completion Date:	March 2010
Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 counseling Behavior modification Diet and exercise 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 Name: Meal replacements
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 counseling Behavior modification Diet and exercise 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 Name: Meal replacements

Arms

Assigned Interventions

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 counseling
Behavior modification
Diet and exercise

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 Name: Meal replacements

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 counseling
Behavior modification
Diet and exercise

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 Name: Meal replacements

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00907660

Locations

United States, Colorado
Center for Human Nutrition
Denver, Colorado, United States, 80220

Sponsors and Collaborators

University of Colorado, Denver

Investigators

Principal Investigator:

Adam G Tsai, MD, MSCE

University of Colorado, Denver

More Information

No publications provided

Responsible Party:	Adam Gilden Tsai, MD, University of Colorado Denver
ClinicalTrials.gov Identifier:	NCT00907660 History of Changes
Other Study ID Numbers:	COMIRB 09-0054 (completed)
Study First Received:	May 20, 2009
Last Updated:	August 10, 2010
Health Authority:	United States: Institutional Review Board

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Obesity
Weight loss
Meal replacements
Health services research

Additional relevant MeSH terms:

Obesity
Weight Loss
Overnutrition
Nutrition Disorders

Overweight
Body Weight
Signs and Symptoms
Body Weight Changes

ClinicalTrials.gov processed this record on February 09, 2012