Preventing Obesity Using Novel Dietary Strategies
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00072995|
Recruitment Status : Completed
First Posted : November 17, 2003
Last Update Posted : January 30, 2013
|Condition or disease||Intervention/treatment||Phase|
|Cardiovascular Diseases Heart Diseases Obesity||Behavioral: Four Diets Differing in Macronutrient Composition Behavioral: Diets Low in Saturated Fat||Not Applicable|
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.
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 kg/m2, 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, lipoprotein[a]); 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 www.poundslost.org. For Baton Rouge participants, contact: email@example.com or 225-763-2623.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||811 participants|
|Official Title:||Preventing Overweight Using Novel Dietary Strategies (Pounds Lost)|
|Study Start Date :||September 2003|
|Actual Primary Completion Date :||December 2007|
|Actual Study Completion Date :||December 2007|
- Change in body weight (measured at Year 2)
- Body fat
- Waist circumference
- Visceral fat
- Hepatic and skeletal muscle
- Psychological factors from diet
- Major cardiovascular risk factors
- Prevalence of the metabolic syndrome (measured at Year 2)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00072995
|United States, Louisiana|
|Pennington Biomedical Reseach Center, Louisiana State University|
|Baton Rouge, Louisiana, United States, 70808|
|United States, Massachusetts|
|Harvard University School of Public Health|
|Boston, Massachusetts, United States, 02115|