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N Engl J Med ; February 26, DOI: Full of Background The diets consisted of similar foods and met guidelines for cardiovascular health. Losss participants were offered group and individual instructional sessions for 2 years. The weifht outcome was the change in body weight after 2 years in two-by-two factorial comparisons of low fat versus high fat and average protein ob protein weight loss high protein and in the ob protein weight loss of highest and lowest carbohydrate content.
Full Text of Methods Satiety, hunger, satisfaction with the diet, and attendance at group sessions were similar for all diets; attendance was strongly associated with weight loss 0. The diets improved lipid-related risk factors and fasting olss levels. Full Text of Results Reduced-calorie diets result in clinically meaningful weight loss regardless of which macronutrients they emphasize.
Full Text of Discussion There is intense debate about what types of diet are ob protein weight loss effective for treating overweight — those that emphasize protein, those that emphasize carbohydrates, or those ob protein weight loss emphasize fat. The crucial question is whether overweight people have a better response in the long term to diets that emphasize a specific macronutrient composition. Thus, we recognized the need for a large trial that would be designed to overcome the limitations of previous trials and that would compare the effects of three principal dietary macronutrients.
We studied weight change over the course of 2 years, since weight loss typically is greatest 6 to 12 months after initiation of the diet, with steady regain of weight subsequently. An expanded description of the methods is available in the Supplementary Appendixavailable with the full text of this article at NEJM. The trial was conducted at two sites: the Harvard School of Public Health and Brigham and Women's Hospital, Boston; and the Pennington Biomedical Research Center of the Louisiana State University System, Baton Rouge.
The data coordinating center was at Brigham and Women's Hospital. The project staff of the National Heart, Lung, and Blood Institute also participated in the development of the protocol, monitoring of progress, interpretation of results, and critical review of the manuscript. Participants had to be 30 to 70 years of age and have a body-mass index the weight in kilograms divided by the square of the height in meters of 25 to Major criteria for exclusion were the presence of diabetes or unstable cardiovascular disease, the use of medications that affect body weight, and insufficient motivation as assessed by interview and questionnaire.
The study was approved by the human subjects committee at each institution and by a data and safety ob protein weight loss board appointed by the National Heart, Lung, and Blood Institute. All participants gave written informed consent. They were informed that protin study would be comparing diets with different fat, protein, and carbohydrate contents and that they would be assigned a diet at random. Mass mailings were the primary means ob protein weight loss recruitment; names were identified with the use of lists of registered voters or drivers.
Random assignments to one of ob protein weight loss diet groups were generated by the data manager at the coordinating center on request of a study dietitian, after eligibility of a participant was confirmed. Thus, two diets were low-fat and two were high-fat, and two were average-protein lloss two were high-protein, constituting a two-by-two factorial design. Carbohydrate-rich foods with a low glycemic index were recommended in each diet. Each participant's caloric prescription represented a deficit of kcal per day from baseline, as calculated from the person's resting energy expenditure and activity level.
Blinding was maintained by the use of similar foods for each diet. Staff and participants were taught that each diet adhered to principles of a healthful diet deight and that each had been recommended for long-term weight loss, thereby establishing equipoise. Group sessions were held once a week, 3 of every 4 weeks during the first 6 prootein and 2 of every 4 weeks from ob protein weight loss months to 2 years; individual sessions were held every 8 weeks for the entire 2 years.
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