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Measures Self-report measures Block 100-Item Food Frequency Questionnaire (FFQ) The Block FFQ is designed to assess nutrient intake levels as well as specific foods and food groups (e.g., fruits, vegetables, meats) over extended periods. Dietary data from the National Health and Nutrition Examination Survey was used to construct the food list, portion sizes, and corresponding nutrient values for foods on the questionnaire. The full-length version of the Block measures the frequency of consumption for 100 foods. The Block provides estimates of overall calorie intake and macronutrient composition of the diet. Randomly scheduled 24-hour food recalls Dietary recalls will be collected and analyzed by the staff at the Diet Assessment Center (DAC) at Pennsylvania State University, with whom the present investigators have established a sub-contract. Participants will be called on three randomly-scheduled days during each assessment period. Of particular importance for the current application are procedures that Diane Mitchell, M.S, R.D., is currently developing with Barbara Rolls, Ph.D. for recording and analyzing the energy density of the diet. Ms. Mitchell and Dr. Rolls are conducting a validation study that will compare various methods of dietary data collection and the calculation of energy density from dietary recalls and food records. For the proposed project, dietary interviewers will be trained to inquire about and record all fluid intake, including water (which often is not done when energy density is not of interest). This includes recording all liquids used in food preparation (e.g. oatmeal). In the instructions participants are given for food recalls, they will told that they will be asked about all fluid intake when called by the DAC. Having this information available will be important when calculating the ED from the food recalls. Dr. Rolls is about to begin a study aimed at reducing the energy density of the diet among overweight individuals. These energy density assessment procedures will be applied to the data from this study. The energy density procedures applied to the data to be collected in the proposed studies would be those recommended by Ms. Mitchell and Dr. Rolls based on their experiences. The five methods that we are currently using to assess energy density are listed below. The calculation of alternative ways of assessing energy density may provide new insights into the role of solid and liquid foods in facilitating or undermining weight control. Table 1: Methods for Energy Density calculation Method Beverages Included 1. Food Only No beverages 2. Food & Milk Milk 3. Food, Milk & Juice Milk and 100% juice 4. Food & Caloric Beverages Soda, all juices, milk, cocoa, ready-to drink sweetened iced teas, alcohol, etc. 5. Food & All Beverages All energy and non-energy beverages (except water)

Eating Inventory: This 65-item measure assesses cognitive restraint, disinhibition, and hunger. Binge Eating Scale (BES): The BES is a 16-item scale designed to determine the severity of binge eating. Items describe both behavioral manifestations (e.g., eating large amounts of food) and feelings/cognitions surrounding a binge episode (e.g., guilt, fear of being unable to stop eating. Physical Activity Measures Paffenbarger Physical Activity Recall: This is a 15-item, interview-based measure for assessing physical activity during the prior month. By converting these activities into metabolic equivalents based on body mass, total expenditure from physical activity will be calculated. Pedometer Measure of Physical Activity: A Yamax DIGI-WALKER SW-200 pedometer will be used to measure activity, specifically steps taken and distance traveled. Meal Replacement Adherence Measure: A series of questions answered on Likert-type scales that were designed for this project to assess level of adherence to the MRs during weight loss and maintenance (e.g., "During the past week, on how many days did you replace two meals per day with meal replacements?"). Weight Efficacy Life-Style Questionnaire (WEL): The WEL is a 20-item scale that measures perceived self-efficacy in being able to control eating in five types of situations: negative emotions, food availability, social pressure, physical discomfort, and positive activities. Impact of Weight on Quality of Life- Lite (IWQOL-Lite): The IWQOL-Lite is a 31-item self-report instrument that measures the perceived impact of obesity and weight reduction on quality of life. The five sub-scales are: physical function, self-esteem, sexual life, public distress, and work. Participant and physician satisfaction with the interventions : Participants will be asked about their satisfaction regarding treatment for both the weight loss and weight maintenance phases of the study. Physicians will be asked to evaluate the different components of the intervention (use of meal replacements, the REDE intervention, their perception of the patients' satisfaction with their program, their satisfaction with their own role in the intervention). The self-report questionnaires will follow the same format as The Health Care Questionnaire developed by Wadden et al., which examined the degree of satisfaction of obese women with their physicians' weight management attitudes and practices using a 7 point scale (ranging from 1 (very dissatisfied) to 7 (very satisfied). At 12, 24, and 36 months participants will rate the perceived effectiveness of their program for weight loss maintenance, how easy (or difficult) it was to incorporate the program into their everyday lives, the perceived likelihood of being able to continue

following their program in the future, the perceived impact of the program on general health, and their likelihood of recommending the program to others. Physicians will be asked about the perceived effectiveness of the maintenance program as well as the feasibility and desirability of incorporating the different features of the maintenance interventions into their routine primary care practice. Measures of weight-related health risk factors: Blood lipids and blood pressure: Total cholesterol, triglycerides, and HDL- and LDLcholesterol will be assessed at each assessment point. Blood draws will be conducted following an overnight fast of 12 hours in the same primary care practices where the study will be implemented. Lipid levels will be analyzed in conjunction with plasma carotenoids. Blood pressure will also be measured in all subjects by qualified nursing staff using a tabletop sphygmomanometer with an appropriate-size arm cuff. Three readings will be taken using the right arm at 1-minute intervals after subjects have rested for at least 5 minutes; systolic and diastolic blood pressure will be calculated as the average of the second and third readings. Also analyzed will be plasma biomarkers of fruit and vegetable consumption by measuring carotenoid levels. Hemoglobin A1c Measurement of Hemoglobin A1c is the standard method for assessing long-term glycemic control. This measure reflects the glycemic history over the previous 2 to 3 months and is positively impacted by weight loss, physical activity, and improvements in the nutritional composition of the diet. Height: A stadiometer will be used to measure height. Weight: Weight will be determined in street clothes using a standardized Secca® scale accurate to .1 kg. We are also proposing to purchase digital scales (accurate to the nearest .1 kg) for home weighing by all participants. Waist circumference: Circumference will be assessed using a measuring tape placed at the midpoint between the bottom of the rib and the tip of the iliac crest. The circumference will be measured during minimum respiration. Analysis of Body Composition: Percent body fat and fat free mass (FFM) will be assessed using Bioelectrical Impedance (BIA), RJL Quantum II model. This model is highly reliable and detects very small changes in body composition. BIA relies on the concept of electrical conductivity of different body parts and is reproducible, inexpensive and easy to perform. Participants will be tested in the morning after an overnight fast.

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