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

NCT ID: NCT00907660

Last Updated: 2020-01-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2010-03-31

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.

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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)

Group Type: ACTIVE_COMPARATOR

Weight loss counseling

Intervention Type: BEHAVIORAL

Monitoring of weight; review of food and physical activity records; counseling to reduce calorie intake by 500-1000 calories per day

Portion-Controlled Foods

Intervention Type: DIETARY_SUPPLEMENT

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.

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)

Group Type: EXPERIMENTAL

Weight loss counseling

Intervention Type: BEHAVIORAL

Monitoring of weight; review of food and physical activity records; counseling to reduce calorie intake by 500-1000 calories per day

Portion-Controlled Foods

Intervention Type: DIETARY_SUPPLEMENT

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.

Interventions

Weight loss counseling

Monitoring of weight; review of food and physical activity records; counseling to reduce calorie intake by 500-1000 calories per day

Intervention Type: BEHAVIORAL

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.

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Dietary counseling; Behavior modification; Diet and exercise; Meal replacements

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

Kaiser Permanente

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Adam G Tsai, MD, MSCE

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

Center for Human Nutrition

Denver, Colorado, United States

Countries

United States

Other Identifiers

K24DK065018

Identifier Type: NIH

Identifier Source: secondary_id

View Link

09-0054

Identifier Type: -

Identifier Source: org_study_id