NCT00593476

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable type-2-diabetes

Timeline
Completed

Started Mar 2007

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 3, 2008

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 15, 2008

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

July 1, 2013

Status Verified

January 1, 2008

Enrollment Period

2 years

First QC Date

January 3, 2008

Last Update Submit

June 28, 2013

Conditions

Type 2 Diabetes

Keywords

Type 2 DiabetesGlycemic ControlDiabetes Support and EducationPortion ControlPrepackaged meals

Outcome Measures

Primary Outcomes (1)

  • Changes in weight at 12 weeks.

    12 weeks

Secondary Outcomes (1)

  • Changes in HbA1c, lipids, inflammatory markers (hs-CRP), fasting glucose, blood pressure, waist circumference and survey measures at 12 weeks.

    12 weeks

Study Arms (2)

PCD

ACTIVE COMPARATOR

pre-packaged, portion-controlled (PCD) meal plan for 24 weeks

Other: PCD

DSE

ACTIVE COMPARATOR

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

Interventions

PCDOTHER

pre-packaged, portion-controlled (PCD) meal plan for 24 weeks

PCD
DSEOTHER

12 weeks of diabetes support and education (DSE) (weeks 0-12) and then crosses over to 12 weeks of PCD from weeks 13-24

DSE

Eligibility Criteria

Age21 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants must meet all of the following criteria.
  • Type 2 diabetic men and non-pregnant or non-lactating women between the ages of 21 to 75
  • BMI ≥ 25 and ≤ 50
  • Subjects must be willing to comply with all study-related procedures
  • Participant with screening HbA1C ≥ 6.0

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Jeanes Hospital Medical Office Building

Philadelphia, Pennsylvania, 19111, United States

Location

Center for Obesity Research and Education

Philadelphia, Pennsylvania, 19140, United States

Location

Related Publications (2)

  • McAndrew LM, Napolitano MA, Pogach LM, Quigley KS, Shantz KL, Vander Veur SS, Foster GD. The impact of self-monitoring of blood glucose on a behavioral weight loss intervention for patients with type 2 diabetes. Diabetes Educ. 2013 May-Jun;39(3):397-405. doi: 10.1177/0145721712449434. Epub 2012 Jun 26.

    PMID: 22735195DERIVED

  • 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.

    PMID: 19820280DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Gary D Foster, PhD

    Temple University - Center for Obesity Research and Education

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 3, 2008

First Posted

January 15, 2008

Study Start

March 1, 2007

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

July 1, 2013

Record last verified: 2008-01

Locations

US(2)