Pilot Study to Assess Pre-packaged, Portion-controlled Meal Plan on Weight Loss (NS)

This study has been completed.
Sponsor:
Collaborator:
Nutrisystem, Inc.
Information provided by (Responsible Party):
Temple University
ClinicalTrials.gov Identifier:
NCT00593476
First received: January 3, 2008
Last updated: June 28, 2013
Last verified: January 2008
  Purpose

The purpose of this trial is to study the safety and efficacy of a pre-packaged, portion controlled meal plan on weight loss and glycemic control in overweight and obese patients with type 2 diabetes.

Aim 1 - Effects on Weight Assess the effects of a pre-packaged, portion controlled meal plan on weight loss in overweight and obese patients with type 2 diabetes.

The researchers hypothesize that the pre-packaged, portion controlled diet (PCD) will produce a greater weight loss than a diabetes support and education (DSE) program at 12 weeks. The study will be powered to detect between group differences of 3% of body weight. Secondarily, the researchers will assess whether there are any differences in weight during the secondary phase from weeks 13-24 when both groups will consume a PCD diet.

Aim 2 - Effects on Glycemic Control

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

The researchers hypothesize that the PCD will show greater improvement in HbA1c levels than a DSE group at 12 weeks. The study will be powered to detect between group differences of .5% in HbA1c. Secondarily, improvements and differences in HbA1c from weeks 13-24 when both groups are consuming a PCD will be assessed.


Condition Intervention
Type 2 Diabetes
Other: PCD
Other: DSE

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

Resource links provided by NLM:


Further study details as provided by Temple University:

Primary Outcome Measures:
  • Changes in weight at 12 weeks. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Changes in HbA1c, lipids, inflammatory markers (hs-CRP), fasting glucose, blood pressure, waist circumference and survey measures at 12 weeks. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 50
Study Start Date: March 2007
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: PCD
pre-packaged, portion-controlled (PCD) meal plan for 24 weeks
Other: PCD
pre-packaged, portion-controlled (PCD) meal plan for 24 weeks
Active Comparator: DSE
12 weeks of diabetes support and education (DSE) (weeks 0-12) and then crosses over to 12 weeks of PCD from weeks 13-24
Other: DSE
12 weeks of diabetes support and education (DSE) (weeks 0-12) and then crosses over to 12 weeks of PCD from weeks 13-24

  Show Detailed Description

  Eligibility

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

Inclusion Criteria:

Participants must meet all of the following 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 ≥ 6.0

Exclusion Criteria:

If participants meet one of the following criteria they will be excluded.

  1. Use of insulin or other pharmaceutical agent for diabetic control other than thiazolidinedione (TZD), Sulfonylurea's, or Metformin or a combination of medications.
  2. BMI ≤ 24.9 or ≥ 50.1
  3. Participation in another formal weight loss program within last 6 months
  4. Participation in Diabetes Support and Education Program or other formal diabetes education program within last 6 months
  5. Uncontrolled hypertension (systolic blood pressure > 180 or diastolic blood pressure > 100 mmHg). Participants on medication treating hypertension for at least three months are allowable.
  6. Known atherosclerotic cardiovascular disease
  7. History of congestive heart failure
  8. History of a non-skin malignancy within the previous 5 years
  9. Any major active rheumatologic, pulmonary, hepatic, renal, dermatologic disease or inflammatory condition

    Detailed Disease and Lab Value Exclusions:

    • Active rheumatologic, dermatologic disease, or autoimmune/inflammatory condition will be defined as any patient who currently, or has a past medical history of chronic (> 2 weeks) immune modulating/suppressing medications.
    • Active pulmonary disease will be defined as any patient who has a history of, or currently requires, daily oral corticosteroids, leukotriene inhibitors, an oxygen requirement, or ventilation support for chronic disease management.
    • Active hepatic disease: defined as any patient who currently, or has a history of requiring immune modulating/suppressing medications, ammonia lowering medications, or hepatic disease related diet modifications.
    • Active renal disease: defined as any patient who currently, or has a history requiring potassium phosphate lowering medications, protein restriction diet, or hemo/peritoneal dialysis.

    Lab value exclusions are limited to all routine electrolyte values outside the normal range, except glucose. (Sodium, potassium, chloride, bicarbonate, BUN, creatinine.)

  10. History of testing HIV positive
  11. History of alcohol or drug abuse
  12. Weight-loss inducing medications or dietary supplements within 3 months prior to enrollment.
  13. Weight loss > 5 kg during the last 6 months
  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 with screening triglycerides above 500 mg
  17. Anyone that is physically active for ≥ 30 minutes per day as assessed in clinical interview at the screening visit
  18. Uncontrolled Dyslipidemia. Participants stable on medication treating dyslipidemia for at least 3 months or more is allowable.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00593476

Locations
United States, Pennsylvania
Center for Obesity Research and Education
Philadelphia, Pennsylvania, United States, 19140
Jeanes Hospital Medical Office Building
Philadelphia, Pennsylvania, United States, 19111
Sponsors and Collaborators
Temple University
Nutrisystem, Inc.
Investigators
Principal Investigator: Gary D Foster, PhD Temple University - Center for Obesity Research and Education
  More Information

No publications provided by Temple University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Temple University
ClinicalTrials.gov Identifier: NCT00593476     History of Changes
Other Study ID Numbers: Temple U - 10854, 10854 - IRB #
Study First Received: January 3, 2008
Last Updated: June 28, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Temple University:
Type 2 Diabetes
Glycemic Control
Diabetes Support and Education
Portion Control
Prepackaged meals

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 17, 2014