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

Primary Purpose

Obesity

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Weight loss counseling

Portion-Controlled Foods

About this trial

This is an interventional treatment trial for Obesity focused on measuring Obesity, Weight loss, Meal replacements, Health services research

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Center for Human Nutrition

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Full Dose

Half dose

Arm Description

Provision of 8 weight loss counseling sessions, calorie guide, pedometer, meal plan, and 2 meals per day of portion-controlled foods (shakes and entrees)

Provision of 8 weight loss counseling sessions, calorie guide, pedometer, meal plan, and 1 meal per day of portion-controlled foods (shakes and entrees)

Outcomes

Primary Outcome Measures

Weight change

Secondary Outcome Measures

Health-related quality of life

Blood pressure

Waist circumference

Body mass index

Full Information

NCT ID

NCT00907660

First Posted

May 20, 2009

Last Updated

January 28, 2020

Sponsor

Kaiser Permanente

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT00907660

Brief Title

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

Acronym

PCPCWLS

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2020

Overall Recruitment Status

Completed

Study Start Date

May 2009 (undefined)

Primary Completion Date

March 2010 (Actual)

Study Completion Date

March 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Kaiser Permanente

Collaborators

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

4. Oversight

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity

Keywords

Obesity, Weight loss, Meal replacements, Health services research

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Full Dose

Arm Type

Active Comparator

Arm Description

Provision of 8 weight loss counseling sessions, calorie guide, pedometer, meal plan, and 2 meals per day of portion-controlled foods (shakes and entrees)

Arm Title

Half dose

Arm Type

Experimental

Arm Description

Provision of 8 weight loss counseling sessions, calorie guide, pedometer, meal plan, and 1 meal per day of portion-controlled foods (shakes and entrees)

Intervention Type

Behavioral

Intervention Name(s)

Weight loss counseling

Other Intervention Name(s)

Dietary counseling, Behavior modification, Diet and exercise

Intervention Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Portion-Controlled Foods

Other Intervention Name(s)

Meal replacements

Intervention Description

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.

Primary Outcome Measure Information:

Title

Weight change

Time Frame

14 weeks

Secondary Outcome Measure Information:

Title

Health-related quality of life

Time Frame

14 weeks

Title

Blood pressure

Time Frame

14 weeks

Title

Waist circumference

Time Frame

14 weeks

Title

Body mass index

Time Frame

14 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Adam G Tsai, MD, MSCE

Organizational Affiliation

University of Colorado, Denver

Official's Role

Principal Investigator

Facility Information:

Facility Name

Center for Human Nutrition

City

Denver

State/Province

Colorado

ZIP/Postal Code

80220

Country

United States

12. IPD Sharing Statement

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

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