The Effects of a Pre-packaged, Portion Controlled Meal Plan on Type 2 Diabetes and Glycemic Control: A Comparison Study

June 28, 2013 updated by: Temple University
The purpose of this research study to find out whether a pre-packaged, portion controlled diet with a group behavior modification program or group diabetes support and education, is a safe and effective way for people with type 2 diabetes to lose weight and manage their diabetes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Eligible volunteers are randomly assigned to a treatment group consisting of a pre-packaged, portion controlled meal plan plus a group behavior modification program or to a control group that consists of a group diabetes support and education (DSE) program. Random assignment will be stratified by whether or not a subject is taking insulin at baseline, which will be included as a covariate in all subsequent analyses. Treatment assignments are unmasked. At the end of 24 weeks both groups will have completed 9 group sessions (weeks 0, 1, 2, 4, 8, 12, 16, 20 and 24). At week 16, each participant will meet individually with the study physician to review their progress to date. These meetings will take place at the week 16 group visit. The PCD program is aimed at achieving and maintaining a decrease in weight and providing a group behavior modification program from 0-24 weeks. The DSE program is aimed at providing diabetes support and education from weeks 0-24. A Certified Diabetes Educator (CDE) will review the effects of diet and weight loss, exercise, and medications on blood glucose levels among all participants at the individual session before any changes in dietary intake or exercise are prescribed. Participants will be counseled on strategies to prevent hypoglycemia and will be given a blood glucose meter and strips and instructed to measure their blood glucose at least two times per day while participating in the study. In addition, the causes, symptoms and treatment of hypoglycemia will be reviewed including when to contact their health care provider.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania, Center for Weight and Eating Disorders
      • Philadelphia, Pennsylvania, United States, 19140
        • Temple University, The Center for Obesity Research and Education

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Type 2 diabetic men and non-pregnant or non-lactating women between the ages of 21 to 75
  2. BMI ≥ 25 and ≤ 50
  3. Subjects must be willing to comply with all study-related procedures
  4. Participant with screening HbA1C ≥ 6.5 and <12.0.

Exclusion Criteria:

  1. Use of Byetta (exenatide) or Symlin (pramlintide acetate) for diabetic control< 6 months. Participants must be stable on all other medications for at least 3 months for inclusion. If a participant is on a medication for less than 3 months and the study physician determines the medications will not affect the study outcomes (weight, glycemic control, etc), they can be enrolled (excluding hypertension or cholesterol medications).
  2. BMI ≤24.9 or ≥ 50.1
  3. Participation in another formal weight loss program within last 6 months
  4. Weight loss > 5 kg during the last 6 months
  5. Participation in Diabetes Support and Education Program or other formal diabetes education program within last 6 months
  6. Uncontrolled hypertension (systolic blood pressure > 180 or diastolic blood pressure > 100 mmHg). Participants on medication treating hypertension for at least three months are allowable.
  7. Known atherosclerotic cardiovascular disease
  8. History of congestive heart failure
  9. History of a non-skin malignancy within the previous 5 years
  10. Any major active rheumatologic, pulmonary, hepatic, renal, dermatologic disease or inflammatory condition
  11. History of testing HIV positive
  12. History of alcohol or drug abuse
  13. Weight-loss inducing medications or dietary supplements within 3 months prior to enrollment.
  14. Participation in any weight loss study or investigational drug study within 6 weeks prior to the screening
  15. Serious or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study.
  16. Participants taking anti-depressants (SSRI's are allowed except for bupropion [Wellbutrin]) , mood stabilizers, anti-psychotics, and psychiatric medications treating any mood, psychological or psychiatric condition. Refer to Appendix 1 for medication exclusion list.
  17. Participants with screening triglycerides above 500 mg
  18. Uncontrolled Dyslipidemia as defined by screening LDL cholesterol of ≥ 160 mg/dL. Participants on medication treating dyslipidemia for at least 3 months are allowable.
  19. Any female who tests positive on a urine pregnancy test or who reports being pregnant at screening
  20. Gastrointestinal Disorders (gallbladder disease, Crohn's disease, Irritable bowel syndrome, and any GI disease that affects malabsorption).
  21. An allergy to certain foods that cannot be avoided due to the nature of the packaged foods such as, but not limited to nuts, dairy, gluten, etc.
  22. Non-medical related dietary restrictions, such as vegetarians
  23. Neuropathy that interferes with exercise.
  24. Smoking or tobacco use
  25. Previous weight loss surgery.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Diabetes Support and Education (DSE)
Other: Diabetes Support and Education
The DSE groups will consist of educational sessions offered for diabetes support and education which will include sessions on diet/nutrition, exercise, foot care and living with diabetes.
Other Names:
  • DSE
Experimental: Portion controlled diet (PCD)
behavior modification
Behavioral: Portion controlled diet
Participants learn skills for changing nutritional and lifestyle habits and diabetes management follow a program that includes eating a pre-packaged, portion controlled meal for weight loss in addition to attending the behavior modification groups
Other Names:
  • PCD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in weight at 3 and 6 months
Time Frame: Baseline, 3 & 6 months
Assess the effects of a pre-packaged, portion controlled meal plan on weight loss in overweight and obese patients with type 2 diabetes.
Baseline, 3 & 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in HbA1C at 3 and 6 months
Time Frame: Baseline, 3 & 6 Month
Assess the effects of a pre-packaged, portion controlled meal plan on glycemic control in overweight and obese patients with type 2 diabetes.
Baseline, 3 & 6 Month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Temple University

Collaborators

University of Pennsylvania
Nutrisystem, Inc.

Investigators

  • Principal Investigator: Gary D Foster, PhD, Temple University, Center for Obesity Research and Education

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

July 1, 2011

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

September 21, 2010

First Submitted That Met QC Criteria

December 13, 2010

First Posted (Estimate)

December 15, 2010

Study Record Updates

Last Update Posted (Estimate)

July 1, 2013

Last Update Submitted That Met QC Criteria

June 28, 2013

Last Verified

September 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12987

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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