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NCT00593476 · ClinicalTrials.gov registry record · NA
Pilot Study to Assess Pre-packaged, Portion-controlled Meal Plan on Weight Loss
A NA study, sponsored by Temple University.
- Completed
- Registry status
- NA
- Development phase
- 50
- Enrollment target
NCT00593476 is a NA study that has completed, run by Temple University. The registered enrollment target is 50 participants.
The verdict
NCT00593476, a NA study, has completed, sponsored by Temple University.
- COMPLETED
- Registry status
- NA
- Development phase
- 50 participants
- Enrollment target
Study 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.
Interventions
- OTHER PCD
- OTHER DSE
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2007-03 |
| Est. Completion | 2009-03 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00593476
The ClinicalTrials.gov registry entry for NCT00593476 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Temple University, which has 163 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which PCD is the first listed.
NCT00593476 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00593476 about?
NCT00593476 is a clinical study titled "Pilot Study to Assess Pre-packaged, Portion-controlled Meal Plan on Weight Loss". 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 we...
What is the current status of trial NCT00593476?
This trial is currently completed. It is a NA study. The enrollment target is 50 participants. The study started on 2007-03. Estimated completion is 2009-03.
What interventions are being tested in trial NCT00593476?
The interventions under investigation include: PCD (OTHER), DSE (OTHER).
Who is sponsoring clinical trial NCT00593476?
This trial is sponsored by Temple University, which has 163 total clinical trials registered on ClinicalTrials.gov.
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