Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
Temple University Nutrisystem, Inc. |
---|---|
Information provided by: | Temple University |
ClinicalTrials.gov Identifier: | NCT00593476 |
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: | Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study |
Official Title: | A Pilot Study to Assess the Effects of a Pre-Packaged, Portion Controlled Meal Plan on Type 2 Diabetes and Glycemic Control |
Estimated Enrollment: | 120 |
Study Start Date: | March 2007 |
Estimated Study Completion Date: | March 2009 |
Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
PCD: Active Comparator
pre-packaged, portion-controlled (PCD) meal plan for 24 weeks
|
Other: PCD
pre-packaged, portion-controlled (PCD) meal plan for 24 weeks
|
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
12 weeks of diabetes support and education (DSE) (weeks 0-12) and then crosses over to 12 weeks of PCD from weeks 13-24
|
Ages Eligible for Study: | 21 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Participants must meet all of the following criteria.
Exclusion Criteria:
If participants meet one of the following criteria they will be excluded.
Any major active rheumatologic, pulmonary, hepatic, renal, dermatologic disease or inflammatory condition
Detailed Disease and Lab Value Exclusions:
Lab value exclusions are limited to all routine electrolyte values outside the normal range, except glucose. (Sodium, potassium, chloride, bicarbonate, BUN, creatinine.)
Contact: Kerri Leh, BS | 215-707-8656 | kerrileh@temple.edu |
Contact: Stephanie S Vander Veur, MPH | 215-707-8635 | vanderveur@temple.edu |
United States, Pennsylvania | |
Center for Obesity Research and Education | Recruiting |
Philadelphia, Pennsylvania, United States, 19140 | |
Contact: Kerri Leh, BS 215-707-8656 kerrileh@temple.edu | |
Principal Investigator: Gary D Foster, PhD | |
Jeanes Hospital Medical Office Building | Recruiting |
Philadelphia, Pennsylvania, United States, 19111 | |
Contact: Kerri Leh, BS 215-707-8656 kerrileh@temple.edu | |
Principal Investigator: Gary D Foster, PhD |
Principal Investigator: | Gary D Foster, PhD | Temple University - Center for Obesity Research and Education |
Responsible Party: | Temple University, Center for Obesity Research and Education ( Gary D. Foster, PhD ) |
Study ID Numbers: | Temple U - 10854, 10854 - IRB # |
Study First Received: | January 3, 2008 |
Last Updated: | January 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00593476 |
Health Authority: | USA: Institutional Review Board |
Type 2 Diabetes Glycemic Control Diabetes Support and Education Portion Control Prepackaged meals |
Body Weight Metabolic Diseases Weight Loss Diabetes Mellitus, Type 2 Diabetes Mellitus |
Endocrine System Diseases Endocrinopathy Metabolic disorder Glucose Metabolism Disorders |