Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00198757
Status:
COMPLETED
Last Update Posted:
2005-09-20
First Post:
2005-09-13
Brief Title:
Efficacy of 2 Diet Plans Designed for People With Type II Diabetes on Weight and Health Measures
Sponsor:
Johns Hopkins Bloomberg School of Public Health
Organization:
Johns Hopkins Bloomberg School of Public Health
Study Overview
Official Title:
Efficacy of 2 Diet Plans Designed for People With Type II Diabetes on Weight and Health Measures
Status:
COMPLETED
Status Verified Date:
2005-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of this study is to evaluate the efficacy of Medifast Plus for Diabetics compared to a standard weight loss treatment program in terms of changes in weight loss in overweight men and women over an 86 week active weight loss and weight maintenance program There will be up to 34 weeks active weight loss and 52 weeks weight maintenance The planned sample size is 80 overweight BMI 25-40 males and females aged 18-65 with type 2 diabetes It is anticipated that pre-packaged meal replacements will provide an advantage to those desiring weight loss
Detailed Description:
This study will test the efficacy of Medifast Plus for Diabetics compared to a standard American Diabetes Association ADA weight loss treatment program using whole foods in 80 participants randomized into 2 groups of 40 during an active weight loss and weight maintenance program lasting 68-86 weeks The study data collection will occur in two phases active weight loss phase 1 and weight maintenance phase 2 Transition into phase 2 will be individually timed by participant attainment of a goal healthy weight following a minimum of 16 weeks or week 34 whichever comes first A dietitian will prescribe an individualized weight loss and weight maintenance calorie levels for participants based on the Harris Benedict equation RMR x AF x Deficit RMRresting metabolic rate AFactivity factor All participants will have a goal healthy weight determined at baseline by a combination of personal participant goals Harris Benedict equation predictions body composition goals and BMI range but in no case will participants be prescribed a goal weight that would result in an BMI of less than 24 For the weight loss phase participants will be randomly assigned to one of 2 groups Medifast Plus for Diabetics or standard ADA weight loss treatment program Both groups will attend educational lessons every other week during weight loss and once every four weeks during the maintenance phase Data collection visits will occur when goal weight is reached at week 26 of maintenance and week 52 of maintenance During the weight loss phase group 1 will receive 5 Medifast Plus for Diabetics supplements and one small meal to consume every day As participants reach their goal weights they will be re-randomize according to weight loss success and gender categories into two different maintenance plans One maintenance group will first receive 26 weeks of Medifast Plus for Diabetics maintenance diet still receiving 5 supplementsday but with a larger portion of calories coming from whole foods followed by 26 weeks of a purely food-based maintenance diet the same as the control group where participants will choose all foods and receive no supplements The second group will be a reversal of the order of maintenance diets first the food-based maintenance for 26 weeks and then the Medifast Plus for Diabetics maintenance for 26 weeks The control group will remain on a food-based no supplement maintenance diet for the entire 52-week maintenance period Participants will be encouraged to report any adverse events or changes in medications at any time during the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None