The Beef WISE Study: Beef's Role in Weight Improvement, Satisfaction, and Energy
Condition: Weight Loss
MeSH terms: Body Weight; Weight Loss
Study type: Interventional

Summary: 
      This is a 6 month long study to evaluate the inclusion or exclusion of beef within a weight
      loss program.
    

Detailed description: 
      This study will compare two protein sources: proteins to include beef as the sole source of
      red meat compared to proteins excluding red meat within the context of an effective
      higher-protein weight loss and maintenance program derived from the Colorado Diet.

      All subjects will participate in a group-based program consisting of 16 weekly classes in
      3-phases designed to produce weight loss and teach participants how to achieve a lifestyle to
      keep weight off permanently. All groups will be closed (same subjects, same leader) and will
      consist of 20 participants. Participants in both groups will receive instruction in cooking,
      recipes, and shopping instruction (using our grocery laboratory). This training will include
      strategies, tips and preparation techniques for preparing high protein meals according to
      their assigned groups. All subjects are given exercise plans and all subjects will receive
      memberships to the Anschutz Health and Wellness Center fitness center for the duration of the
      study.

      After completion of the 16-week program, subjects will be asked to follow the program on
      their own for an additional 2 months.

      This is a randomized study involving 120 study subjects (60 per arm). The investigators will
      compare the efficacy of inducing weight loss of two treatment arms derived from the Colorado
      Diet. Subjects will be randomly assigned to one of two study arms and instructed to follow
      the higher-protein diet by participating in weekly group classes for the first four months of
      the study. There will be 6 classes of 20 subjects each (three classes for each treatment
      group). Subjects will be followed in the study for 6 months. Subjects will be randomized into
      one of two treatment groups as follows:

        -  Group 1(SOS+B): Subjects will participate in a State of Slim group class, receive a
           State of Slim book (describing the Colorado Diet), and will receive stipends to be used
           to help purchase protein food items allowed in the Colorado Diet as modified. The
           Colorado diet is a high protein (estimated 120-160g/day), low carb and low fat diet.
           Subjects will be directed and instructed to include beef as their sole source of red
           meat as a protein source during the study. Subjects will follow the diet protein
           guidelines, but will be directed and instructed to consume 4 or more servings of beef
           per week and instructed not to consume any other red meats. Other red meats to be
           avoided include pork, veal, lamb, buffalo and venison. Subjects will be advised to use
           the monetary stipends to purchase items from the lists of acceptable foods from the SOS
           book (to include beef products). Processed beef items will be allowed as identified by a
           list provided to the subjects.

        -  Group 2 (SOS): Subjects will participate in a State of Slim class, receive the State of
           Slim book (describing the Colorado Diet), and will receive stipends to be used to help
           purchase protein food items allowed in the Colorado diet as modified. Subjects will be
           directed and instructed to exclude beef and instructed not to consume any other red
           meats. Other red meats to be avoided include pork, veal, lamb, buffalo, and venison.
    

Intervention name(s): Beef group; Non-beef group
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Subjects in the beef group will be asked to consume 4 or more servings of beef per week (and to avoid all other red meats) during the 6 month study.; Subjects in the non-beef group will be asked to avoid all red meats during the 6 month study.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: weight loss; red meats; obesity; lean body mass; body composition; dietary protein