Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00072995
Status:
COMPLETED
Last Update Posted:
2013-01-30
First Post:
2003-11-13
Brief Title:
Preventing Obesity Using Novel Dietary Strategies
Sponsor:
Brigham and Womens Hospital
Organization:
Brigham and Womens Hospital
Study Overview
Official Title:
Preventing Overweight Using Novel Dietary Strategies Pounds Lost
Status:
COMPLETED
Status Verified Date:
2013-01
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 purpose of this study is to test the effectiveness for weight loss and weight maintenance of four diets differing in macronutrient composition moderate in fat 40 percent energy with two different protein levels 15 percent and 25 percent and low in fat 20 percent energy also with 15 percent and 25 percent protein levels The study is only accepting participants in the Boston Massachusetts or Baton Rouge Louisiana area For further enrollment information in Boston or Baton Rouge see Eligibility Criteria or Design Narrative
Detailed Description:
BACKGROUND
Obesity is a growing problem whose importance is reflected in the resources that are expended each year by a large section of the population on weight reduction drugs and therapies Although numerous weight loss diets are available there is little agreement in the scientific literature or the lay press as to the amount of fat protein and carbohydrates that would comprise the most efficacious diet for weight loss and long term weight loss retention Reliable information about the effectiveness of low calorie diets with differing macronutrient composition is clearly needed and of paramount importance to inform the choice of a weight reduction diet
DESIGN NARRATIVE
The study tests the effectiveness for weight loss and weight maintenance of four diets differing in macronutrient composition moderate in fat 40 energy with two different protein levels 15 and 25 and low in fat 20 energy also with 15 and 25 protein levels The moderate-fat diet will be patterned after a Mediterranean diet All four dietary approaches will be low in saturated fat and will involve reduction in total energy intake Each diet is deemed practical and suitable for public health recommendations and each would be expected to have a favorable effect on cardiovascular disease risk factors All participants will receive a state-of-the-art behavioral therapy program standardized across the two centers in Boston and Baton Rouge An estimated 800 men and women age 30-70 years body mass index BMI 25-40 kgm2 will be randomized among the 4 dietary treatments The primary outcome variable will be change in total body weight from baseline to 2 years Secondary outcomes related to obesity are body fat BMI waist circumference visceral fat and hepatic and skeletal muscle fat Other outcomes are psychological factors diet satisfaction satiety food craving dietary restraint disinhibition and hunger and quality of life major cardiovascular risk factors blood pressure low density lipoprotein LDL cholesterol high density lipoprotein HDL cholesterol and triglycerides prevalence of the metabolic syndrome blood glucose insulin and hemoglobin A1C emerging cardiovascular risk factors apolipoprotein B VLDL and LDL particles with apolipoprotein C-III lipoproteina microalbuminuria and bone mineral content The primary results will be straightforwardly applicable to public health and clinical guidelines for obesity and will increase our understanding of the biology of obesity and weight loss
The study is only accepting participants in the Boston Massachusetts or Baton Rouge Louisiana area For Boston participants contact 617-998-1047 or wwwpoundslostorg For Baton Rouge participants contact schoensjpbrcedu or 225-763-2623
Obesity is a growing problem whose importance is reflected in the resources that are expended each year by a large section of the population on weight reduction drugs and therapies Although numerous weight loss diets are available there is little agreement in the scientific literature or the lay press as to the amount of fat protein and carbohydrates that would comprise the most efficacious diet for weight loss and long term weight loss retention Reliable information about the effectiveness of low calorie diets with differing macronutrient composition is clearly needed and of paramount importance to inform the choice of a weight reduction diet
DESIGN NARRATIVE
The study tests the effectiveness for weight loss and weight maintenance of four diets differing in macronutrient composition moderate in fat 40 energy with two different protein levels 15 and 25 and low in fat 20 energy also with 15 and 25 protein levels The moderate-fat diet will be patterned after a Mediterranean diet All four dietary approaches will be low in saturated fat and will involve reduction in total energy intake Each diet is deemed practical and suitable for public health recommendations and each would be expected to have a favorable effect on cardiovascular disease risk factors All participants will receive a state-of-the-art behavioral therapy program standardized across the two centers in Boston and Baton Rouge An estimated 800 men and women age 30-70 years body mass index BMI 25-40 kgm2 will be randomized among the 4 dietary treatments The primary outcome variable will be change in total body weight from baseline to 2 years Secondary outcomes related to obesity are body fat BMI waist circumference visceral fat and hepatic and skeletal muscle fat Other outcomes are psychological factors diet satisfaction satiety food craving dietary restraint disinhibition and hunger and quality of life major cardiovascular risk factors blood pressure low density lipoprotein LDL cholesterol high density lipoprotein HDL cholesterol and triglycerides prevalence of the metabolic syndrome blood glucose insulin and hemoglobin A1C emerging cardiovascular risk factors apolipoprotein B VLDL and LDL particles with apolipoprotein C-III lipoproteina microalbuminuria and bone mineral content The primary results will be straightforwardly applicable to public health and clinical guidelines for obesity and will increase our understanding of the biology of obesity and weight loss
The study is only accepting participants in the Boston Massachusetts or Baton Rouge Louisiana area For Boston participants contact 617-998-1047 or wwwpoundslostorg For Baton Rouge participants contact schoensjpbrcedu or 225-763-2623
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U01HL073286 | NIH | None | httpsreporternihgovquickSearchU01HL073286 |