CClinicalTrials.gg
CompletedNCT01260337Updated Jul 1, 2013

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

An interventional study of Portion controlled diet and Diabetes Support and Education in Obesity, sponsored by Temple University. Completed at 2 sites in United States. Open to participants aged 21 Years to 75 Years. Per ClinicalTrials.gov, last updated 2013-07-01.

Sponsored by Temple University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
21 Years to 75 Years
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Obesity

Keywords

  • Weight loss
  • Type 2 Diabetes
  • Behavior Modification
  • portion control
03

In context

Diabetes Mellitus, Type 2

9,357 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.

This study's enrollment of 100 is above the median of 80 across 7,523 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

Temple University is the lead sponsor of 219 studies on the registry; 30 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 7 (58%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (actual)

Study arms

  • Active comparator
    Diabetes Support and Education (DSE)

    Other: Diabetes Support and Education

  • Experimental
    Portion controlled diet (PCD)

    behavior modification

    Behavioral: Portion controlled diet

Interventions

  • BehavioralPortion 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

    Also known as: PCD

  • OtherDiabetes 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.

    Also known as: DSE

06

What researchers measure

Primary outcomes

  1. Change in weight at 3 and 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.

    Time frame: Baseline, 3 & 6 months

Secondary outcomes

  1. Change in HbA1C at 3 and 6 months

    Assess the effects of a pre-packaged, portion controlled meal plan on glycemic control in overweight and obese patients with type 2 diabetes.

    Time frame: Baseline, 3 & 6 Month

07

Study locations

2 sites
  • University of Pennsylvania, Center for Weight and Eating Disorders
    Philadelphia, Pennsylvania 19104, United States
  • Temple University, The Center for Obesity Research and Education
    Philadelphia, Pennsylvania 19140, United States
08

References and documents

Publications

  • 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. doi: 10.3810/pgm.2009.09.2046. PubMed 19820280 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 1, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01260337
Lead sponsor
Temple University
Collaborators
Nutrisystem, Inc., University of Pennsylvania
Responsible party
Sponsor
First posted
Dec 15, 2010
Start date
Mar 2010
Primary completion
Jul 2011
Completion
Aug 2011
Last update
Jul 1, 2013

Study contacts

Gary D Foster, PhD
principal investigator · Temple University, Center for Obesity Research and Education

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2010. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion