Pilot Study to Assess Pre-packaged, Portion-controlled Meal Plan on Weight Loss (NS)
|First Received Date ICMJE||January 3, 2008|
|Last Updated Date||June 28, 2013|
|Start Date ICMJE||March 2007|
|Primary Completion Date||March 2009 (final data collection date for primary outcome measure)|
|Current Primary Outcome Measures ICMJE
||Changes in weight at 12 weeks. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]|
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT00593476 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
||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 ]|
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Pilot Study to Assess Pre-packaged, Portion-controlled Meal Plan on Weight Loss|
|Official Title ICMJE||A Pilot Study to Assess the Effects of a Pre-packaged, Portion Controlled Meal Plan on Type 2 Diabetes and Glycemic Control|
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.
Randomized, non-blinded, controlled clinical trial using a parallel and cross-over design of either the treatment group which receives a pre-packaged, portion-controlled (PCD) meal plan for 24 weeks (weeks 0-24) or to the control group which receives 12 weeks of diabetes support and education (DSE) (weeks 0-12) and then crosses over to 12 weeks of PCD from weeks 13-24.
Up to 120 volunteers with type 2 diabetes who are 21-75 years of age and overweight or obese (body mass index ≥ 25 and ≤ 50 kg/m2) with a fasting HbA1c level of 6.0 or greater.
Participants must meet all of the following criteria
If participants meet one of the following criteria they will be excluded
Diabetes control: Measures of HbA1c and fasting glucose will be takes at visits 1-4 to assess diabetes and glycemic control. In addition, we will track use of medications used to control diabetes.
Dyslipidemia: Lipid/lipoprotein concentrations (total cholesterol, HDL-cholesterol, LDL-cholesterol, and triglycerides) will be measured at visits 1-4. Current medication use will be collected at each clinic visit. We will use these data to track the incidence and prevalence of dyslipidemia.
Inflammatory Markers: Inflammation will be measured using high sensitivity C reactive protein (hs- CRP) at visits 2-4.
Electrocardiograms: Electrocardiograms will be obtained at visit 1 according to a standard protocol.
Hypertension and blood pressure measures: Through blood pressure measurements at visits 1-4, and self-reported current medication use, we will track the incidence and prevalence of hypertension as a measure of periphery artery disease.
Weight, height, and waist circumference: Body weight will be measured at each PCD visit, using calibrated scales. Participants will be weighed in light indoor clothing. Waist circumference will be measured at visits 1-4. Height will be measured at visit 1.
Serum and DNA samples: Samples of serum will be frozen and stored for future testing of new and emerging cardiovascular risk factors. DNA samples will be frozen and stored to identify genetic markers of diet response. We will use these samples to determine the possibility that the common genetic variant ENPP1 K121Q could predispose diabetic and metabolic syndrome subjects to respond better to weight loss intervention than those who have the common variant K121K. Similarly, other genetic variants that associate with obesity and insulin resistance may change susceptibility to weight loss in different directions. If at any time during the study a participant decides they do not want their serum samples to be stored they may have them destroyed
Psychosocial measures: A battery of psychosocial measures will be assessed including standardized assessments such as the Beck Depression Inventory8 and an eating disorders questionnaire.9 These surveys will be measured will be assessed at visits 1-4.
Quality of life: The Short Form 36 (SF-36) version will be used to measure general health related quality of life at visits 1-4.10 It can be used to calculate domain scores plus two summary scores: physical summary (four domains, 21 items), and mental health summary (four domains, 14 items).
7-day Food Records: A 7 day food record will be recorded at visits 2-4 to assess compliance with the PCD in phases 1 and 2.
Acceptability: Acceptability of each program (PCD and DSE) will be measured at visits 2-4 to determine tolerability and ease of each program.
Socio-demographics: Information on employment, household composition, and education is collected at visit 1.
Weight history, personal medical history, family medical history: At visit one only. Participants report their weights at various ages, history of weight cycling, and family and personal history of disease. Participants will be referred to appropriate treatment for any eating disorders, depression or other complications discovered as a result of the standard of care weight and lifestyle inventory and beck depression inventory administered at the screening visit. This treatment will be offered at CORE, or if participants prefer, with a provider at another location relevant to their complication.
Concomitant medications and adverse events: At visits 1-4 concomitant medications and adverse events will be recorded. Additional changes to these will be assessed as needed throughout the study.
Eligible volunteers are randomly assigned to a treatment group consisting of a pre-packaged, portion controlled meal plan (PCD) or to a control group that consists of a combination diabetes support and education (DSE) program/pre-packaged, portion controlled meal plan (PCD) cross-over group. Treatment assignments are unmasked. At the end of 24 weeks the treatment group will have completed 18 group sessions and the control group will have completed 15 group sessions. The PCD program is aimed at achieving and maintaining a decrease in weight from 1-24 weeks. Combination DSE/PCD program is aimed at achieving and maintaining a decrease in weight from weeks 13-24. A Certified Diabetes Educator will review the effects of diet and weight loss, exercise, and medications on blood glucose levels among all participants at the first group meeting before any changes in dietary intake or exercise are prescribed. Participants will be counseled on strategies to prevent hypoglycemia. In addition the causes, symptoms and treatment of hypoglycemia will be reviewed including when to contact their health care provider.
|Study Type ICMJE||Interventional|
|Study Phase||Not Provided|
|Study Design ICMJE||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
|Condition ICMJE||Type 2 Diabetes|
|Study Arm (s)||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Completion Date||March 2009|
|Primary Completion Date||March 2009 (final data collection date for primary outcome measure)|
|Eligibility Criteria ICMJE||
Participants must meet all of the following criteria.
If participants meet one of the following criteria they will be excluded.
|Ages||21 Years to 75 Years (Adult, Senior)|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT00593476|
|Other Study ID Numbers ICMJE||Temple U - 10854, 10854 - IRB #|
|Has Data Monitoring Committee||No|
|Plan to Share Data||Not Provided|
|IPD Description||Not Provided|
|Responsible Party||Temple University|
|Study Sponsor ICMJE||Temple University|
|Collaborators ICMJE||Nutrisystem, Inc.|
|Information Provided By||Temple University|
|Verification Date||January 2008|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP