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
  Purpose

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.


Condition Intervention
Obesity
Behavioral: Portion controlled diet
Other: Diabetes Support and Education

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effects of a Pre-packaged, Portion Controlled Meal Plan on Type 2 Diabetes and Glycemic Control: A Comparison Study

Resource links provided by NLM:


Further study details as provided by Temple University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 100
Study Start Date: March 2010
Study Completion Date: August 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: PCD

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.

  Eligibility

Ages Eligible for Study:   21 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01260337

Locations
United States, Pennsylvania
Temple University, The Center for Obesity Research and Education
Philadelphia, Pennsylvania, United States, 19140
University of Pennsylvania, Center for Weight and Eating Disorders
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Temple University
Nutrisystem, Inc.
University of Pennsylvania
Investigators
Principal Investigator: Gary D Foster, PhD Temple University, Center for Obesity Research and Education
  More Information

Additional Information:
Publications:
Responsible Party: Temple University
ClinicalTrials.gov Identifier: NCT01260337     History of Changes
Other Study ID Numbers: 12987
Study First Received: September 21, 2010
Last Updated: June 28, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Temple University:
Weight loss
Type 2 Diabetes
Behavior Modification
portion control

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Obesity
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on August 21, 2014