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Objective: A behavioral recommendation for weight loss is reduction of size of bites of food. This “proof of concept” study tested the efficacy of a new, patented, dental approach, the DDS System, for reducing food intake. This removable tool is inserted into the upper palate of the mouth, reducing the size of the oral cavity, thereby potentially reducing bite size. Research Methods and Procedures: Thirty-two adults (18 to 65 years) with BMI between 27 and 40 were randomly assigned to the control or experimental conditions. Participants ate all meals and stayed between meals at a research center. Day 1 served as baseline for both groups. On Day 2, experimental participants utilized the tool during meals. Changes in subjective ratings of hunger and satiety were measured using visual analog scales before and after each meal. Results: Food intake difference scores were calculated for each participant (Day 2 − Day 1). Analysis of covariance on difference scores, using baseline as a covariate, showed that the experimental group ate significantly less (p < 0.05) on the second day (M = −659.2 kcal/d) compared with the control group (M = −125.9 kcal/d). Analysis of covariance, with ratings on Day 1 as a covariate, revealed that the experimental and control group did not differ on visual analog scale difference scores (premeal − postmeal) from Day 1 to Day 2. Discussion: These findings suggest that use of this tool during meals significantly reduced food intake. This reduction of food intake was not associated with changes in ratings of hunger or satiety.

Objective: To compare the self-perception of overweight in the study population according to sex, race/ethnicity, and socioeconomic status and to compare the self-perception of overweight among individuals classified as normal weight, overweight, and obese. Research Methods and Procedures: Data from 5440 adults who participated in the 1994 to 1996 Continuing Survey of Food Intakes by Individuals and the Diet and Health Knowledge Survey conducted by the U.S. Department of Agriculture were analyzed. Data for analysis included self-perceived weight status, self-reported weight and height, and demographic and socioeconomic data. Underweight individuals, defined as those with a body mass index

Sibutramine is a novel new pharmacologic agent which is a specific reuptake inhibitor for norepinephrine and serotonin. Preclinical data show that sibutramine and its two metabolites reduce food intake of animals eating either high or low carbohydrate diets and of obese Zucker rats. An 8-week clinical trial showed a dose-dependent decrease on body weight. Sibutramine, 5 and 20 mg/day, produced a dose-related weight loss in obese subjects compared to placebo in an 8-week trial. In doses varying from 1 to 30 mg, sibutramine also produced a dose-dependent decrease in weight in the healthy obese population when used in 6-,8-,12-24- and 52-week trials. Although the majority of the weight loss occurred during the first 12 weeks of treatment, weight loss had not plateaued in by 24 weeks in the higher doses. Side effects were mild. This drug shows promise as an antiobesity drug.

The hypotheses that dieting and/or overeating are associated with adiposity, eating disturbances, and lowered energy expenditure were tested in this study. A sample of 44 premenopausal women scoring high and low on measures of dietary restraint and disinhibition of dietary control, as measured by the Three Factor Eating Questionnaire, was studied. A 2 x 2 factorial design was employed (High/Low restraint x High/Low Disinhibition). Dependent variables were: body composition, dietary intake, activity, resting metabolic rate, and thermic effect of food. Unrestrained overeaters (Low Restraint/High Disinhibition group) were very obese. High Dietary Restraint was associated with intent to diet and controlled eating. High scores on the Disinhibition Scale were associated with episodic overeating. Groups did not differ in resting metabolic rate (controlled for fat-free mass). Lower thermic effect of food was found to be associated with the obesity found in High Disinhibition subjects. Thus, Dietary Restraint was not associated with significant adverse effects upon physical or psychological health. High Disinhibition, however, was associated with adiposity and significant disturbances of eating.

WHITE, MARNEY A., PAMELA DAVIS MARTIN,ROBERT L. NEWTON, HEATHER M. WALDEN,EMILY E. YORK-CROWE, STEWART T. GORDON,DONNA H. RYAN, AND DONALD A. WILLIAMSON.Mediators of weight loss in a family-based interventionpresented over the Internet. Obes Res. 2004;12:1050–1059.Objective: To assess the process variables involved in aweight loss program for African-American adolescent girls.Several process variables have been identified as affectingsuccess in in vivo weight loss programs for adults andchildren, including program adherence, self-efficacy, andsocial support. The current study sought to broaden theunderstanding of these process variables as they pertain toan intervention program that is presented using the Internet.It was hypothesized that variables such as program adher-ence, dietary self-efficacy, psychological factors, and fam-ily environment factors would mediate the effect of theexperimental condition on weight loss.Research Methods and Procedures: Participants were 57adolescent African-American girls who joined the programwith one obese parent; family pairs were randomized toeither a behavioral or control condition in an Internet-basedweight loss program. Outcome data (weight loss) are re-ported for the first 6 months of the intervention.Results: Results partially supported the hypotheses. Forweight loss among adolescents, parent variables pertainingto life and family satisfaction were the strongest mediatingvariables. For parental weight loss, changes in dietary prac-tices over the course of 6 months were the strongest medi-ators.Discussion: The identification of factors that enhance orimpede weight loss for adolescents is an important step inimproving weight loss programs for this group. The currentfindings suggest that family/parental variables exert a stronginfluence on weight loss efforts for adolescents and shouldbe considered in developing future programs.Key words: adolescents, African American, Internet,telehealth, family-based interventions

GREENWAY, FRANK L., DONNA H. RYAN, GEORGE A. BRAY, JENNIFER C. ROOD, ELIZABETH W. TUCKER, AND STEVEN R. SMITH. Pharmaceutical cost savings of treating obesity with weight loss medications. Obes Res. Objective: To evaluate, in compliant patients, the pharmaceutical costs of treating obesity with fenfluraminel/mazindol, fenfluramine/phentermine, caffeine/ephedrine, or mazindol relative to the pharmaceutical costs of treating obesity-related comorbid conditions and reducing cardiovascular risk. Methods and Procedures: Subjects were between 18 and 60 years of age with a BMI of >30 kg/m2. Pharmaceutical costs were evaluated in 73 of 220 subjects taking medications for diabetes, hyperlipidemia, or hypertension before and after treatment using fenfluramine with mazindol or phentermine. The pharmaceutical cost of weight loss, cardiac risk reduction, and low-density lipoprotein (LDL) cholesterol reduction was calculated for fenfluramine with mazindol or phentermine, caffeine with ephedrine, or mazindol alone, and compared to approved lipid-lowering medications. Results: Losses of 6% to 10% of initial body weight reduced pharmacy costs $122. 64/month for insulin treated diabetes, $42. 92/month for sulfonylurea-treated diabetes, $61. O7/month for hyperlipidemia treated with medication, and $0. 20/month for hypertension treated with medication. Blood pressure and laboratory evidence of insulin resistance improved in all medication groups. Caffeine/ephedrine was most cost-effective of the three treatments in reducing weight, cardiac risk, and LDL cholesterol. Discussion: Obesity medications produced a substantial weight loss in compliant patients and resulted in a net pharmaceutical cost savings compared to treating obesity related comorbid conditions.

BRAY, GEORGE A., GEORGE L. BLACKBURN, JAMES M. FERGUSON, FRANK L. GREENWAY, ADESH K. JAIN, CARL M. MENDEL, JOSEPH MEN-DELS, DONNA H. RYAN, SHERWYN L. SCHWARTZ, MONTE L. SCHEINBAUM, AND TIMOTHY B. SEATON. Sibutramine produces dose-related weight loss. Obes Res. Objective Sibutramine is a weight control drug that inhibits the reuptake of both serotonin and norepinephrine. In animals, it reduces food intake and increases thermogenesis and preliminary data in human beings showed weight loss. This paper reports a 24-week dose-ranging study to determine the effect of sibutramine on body weight of patients with obesity. Research Methods and Procedures Seven clinical centers screened 1463 patients with obesity and randomized 1047 to 24 weeks of treatment with 1 of 6 doses of sibutramine (1, 5, 10, 15, 20, or 30 mg) or placebo once daily. Six hundred eighty-three patients completed the study. A two-week placebo run-in period was used to initiate a standardized program of diet, physical activity, and lifestyle changes. Results Weight loss was dose-related and statistically significant vs. placebo (p

Sibutramine is a beta-phenethylamine which blocks reuptake of norepinephrine and serotonin. In this clinical study, a group of 173 patients were randomized to treatment with sibutramine at doses of 1, 5, 10, 15, 20 or 30 mg/d and were compared with placebo in a 24-week double-blind trial. There was a dose-dependent reduction in body weight, with doses of 10, 15, 20 and 30 mg being significantly greater than placebo. Weight loss was still continuing in the highest three doses at the end of the study. When drugs were discontinued patients regained weight, as expected. Side effects were generally mild and were most evident in the group treated with the highest dose. These studies suggest that sibutramine may be a valuable new drug for treatment of obesity.