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

This study has been completed.
Sponsor:
Collaborators:
Nutrisystem, Inc.
University of Pennsylvania
Information provided by (Responsible Party):
Temple University
ClinicalTrials.gov Identifier:
NCT01260337
First received: September 21, 2010
Last updated: June 28, 2013
Last verified: September 2010

September 21, 2010
June 28, 2013
March 2010
July 2011   (final data collection date for primary outcome measure)
Change in weight at 3 and 6 months [ Time Frame: Baseline, 3 & 6 months ] [ Designated as safety issue: Yes ]
Assess the effects of a pre-packaged, portion controlled meal plan on weight loss in overweight and obese patients with type 2 diabetes.
Same as current
Complete list of historical versions of study NCT01260337 on ClinicalTrials.gov Archive Site
Change in HbA1C at 3 and 6 months [ Time Frame: Baseline, 3 & 6 Month ] [ Designated as safety issue: Yes ]
Assess the effects of a pre-packaged, portion controlled meal plan on glycemic control in overweight and obese patients with type 2 diabetes.
Same as current
Not Provided
Not Provided
 
The Effects of a Pre-packaged, Portion Controlled Meal Plan on Type 2 Diabetes and Glycemic Control: A Comparison Study
The Effects of a Pre-packaged, Portion Controlled Meal Plan on Type 2 Diabetes and Glycemic Control: A Comparison Study

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Obesity
  • 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 Name: PCD
  • 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 Name: DSE
  • Active Comparator: Diabetes Support and Education (DSE)
    Intervention: Other: Diabetes Support and Education
  • Experimental: Portion controlled diet (PCD)
    behavior modification
    Intervention: Behavioral: Portion controlled diet
Foster GD, Borradaile KE, Vander Veur SS, Leh Shantz K, Dilks RJ, Goldbacher EM, Oliver TL, Lagrotte CA, Homko C, Satz W. The effects of a commercially available weight loss program among obese patients with type 2 diabetes: a randomized study. Postgrad Med. 2009 Sep;121(5):113-8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
August 2011
July 2011   (final data collection date for primary outcome measure)

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.
Both
21 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01260337
12987
No
Temple University
Temple University
  • Nutrisystem, Inc.
  • University of Pennsylvania
Principal Investigator: Gary D Foster, PhD Temple University, Center for Obesity Research and Education
Temple University
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP