Outcomes from a medical weight loss program: primary care clinics versus weight loss clinics

BackgroundFew studies have focused on weight loss programs implemented in community-based primary care settings. The objective of this analysis was to evaluate the effectiveness of a weight loss program and determine whether physicians in primary care practices could achieve reductions in body weight and body fat similar to those obtained in weight loss clinics.MethodsAnalyses were performed on chart review data from 413 obese participants who underwent weight loss at a primary care (n = 234) or weight loss (n = 179) clinic. Participants received physician-guided behavioral modification sessions and self-selected a diet plan partially or fully supplemented by meal replacements. A repeated-measures analysis of covariance was conducted with age and sex serving as covariates; significance was set at P ≤ .05.ResultsIn 178 subjects (43%) completing 12 weeks of the program, primary care clinics were as effective as weight loss clinics at achieving reductions in body weight (12.4 vs 12.1 kg) but better with regard to reduction in body fat percentage (3.8% vs 2.7%; P ≤ .05). Regardless of location, participants completing 12 weeks lost an average of 11.1% of their body weight. Participants selecting full meal replacement had greater reductions in weight and body fat percentage (12.7 kg, 3.5%) compared with participants selecting a partial meal replacement plan (8.3 kg, 2.3%).ConclusionPrimary care physicians can successfully manage and treat obese patients using behavioral modification techniques coupled with meal replacement diets.     

A randomized comparison of a commercially available portion-controlled weight-loss intervention with a diabetes self-management education program

Objective:

This study examined the efficacy of a commercially available, portion-controlled diet (PCD) on body weight and HbA_1c over 6 months in obese patients with type 2 diabetes.

Research Design and Methods:

One-hundred participants with a mean±s.d. age of 55.6±10.6 year, body weight of 102.9±18.4 kg and HbA_1c of 7.7±1.3% were randomly assigned to a 9-session group lifestyle intervention that included a PCD or to a 9-session group program of diabetes self-management education (DSME). Participants in the two groups were prescribed the same goals for energy intake (1250–1550 kcal per day) and physical activity (200 min per week).

Results:

While both groups produced significant improvements in weight and HbA_1c after 6 months of treatment, PCD participants lost 7.3 kg [95% confidence interval (CI): −5.8 to −8.8 kg], compared with 2.2 kg (95% CI: −0.7 to −3.7 kg) in the DSME group (P<0.0001). Significantly more PCD than DSME participants lost ⩾5% of initial weight (54.0% vs 14.0%, P<0.0001) and ⩾10% (26.0% vs 6.0%, P<0.0001). HbA_1c declined by 0.7% (95% CI: −0.4 to −1.0%) in the PCD group, compared with 0.4% (95% CI: −0.1 to −0.7%) in DSME (P<0.026). Across both groups, larger weight losses were associated with greater reductions in HbA_1c (r=0.52, P<0.0001).

Conclusions:

These findings demonstrate that a commercially available portion-controlled meal plan can induce clinically meaningful improvements in weight and glycemic control in obese individuals with type 2 diabetes. These data have implications for the management of obesity in primary care, as now provided by the Centers for Medicare and Medicaid Services.     

Lifestyle modification for the management of obesity

Several expert panels have recommended that obese individuals attempt to lose 10% of their initial body weight through a combination of diet, physical activity, and behavior therapy (frequently referred to as lifestyle modification). This article reviews the short-and long-term results of lifestyle modification and methods to improve them. Randomized controlled trials were examined that compared different diet and activity interventions for inducing and maintaining weight loss. Studies that compared different methods of providing lifestyle modification, including on-site vs. Internet-based delivery, also were examined. A comprehensive lifestyle modification program was found to induce a loss of approximately 10% of initial weight in 16 to 26 weeks of group or individual treatment, delivered on-site. Comprehensive Internet-based programs induced a loss of approximately half this size. Patients' consumption of portion-controlled diets, including liquid meal replacements, was associated with significantly greater short-term weight loss than was the consumption of isocaloric diets comprised of conventional foods. Factors associated with long-term weight control included continued patient-practitioner contact (whether on-site or by e-mail), high levels of physical activity, and the long-term use of pharmacotherapy combined with lifestyle modification. In summary, lifestyle modification induces clinically significant weight loss that is associated with the prevention or amelioration of cardiovascular risk factors.     

A randomized trial of improved weight loss with a prepared meal plan in overweight and obese patients: impact on cardiovascular risk reduction

OBJECTIVE: To assess the long-term effects of a prepackaged, nutritionally complete, prepared meal plan compared with a usual-care diet (UCD) on weight loss and cardiovascular risk factors in overweight and obese persons. DESIGN: In this randomized multicenter study, 302 persons with hypertension and dyslipidemia (n = 183) or with type 2 diabetes mellitus (n = 119) were randomized to the nutrient-fortified prepared meal plan (approximately 22% energy from fat, 58% from carbohydrate, and 20% from protein) or to a macronutrient-equivalent UCD. MAIN OUTCOME MEASURES: The primary outcome measure was weight change. Secondary measures were changes in blood pressure or plasma lipid, lipoprotein, glucose, or glycosylated hemoglobin levels; quality of life; nutrient intake; and dietary compliance. RESULTS: After 1 year, weight change in the hypertension/dyslipidemia group was -5.8+/-6.8 kg with the prepared meal plan vs -1.7+/-6.5 kg with the UCD plan (P<.001); for the type 2 diabetes mellitus group, the change was -3.0+/-5.4 kg with the prepared meal plan vs -1.0+/-3.8 kg with the UCD plan (P<.001) (data given as mean +/- SD). In both groups, both interventions improved blood pressure, total and low-density lipoprotein cholesterol levels, glycosylated hemoglobin level, and quality of life (P<.02); in the diabetic group, the glucose level was reduced (P<.001). Compared with those in the UCD group, participants with hypertension/dyslipidemia in the prepared meal plan group showed greater improvements in total (P<.01) and high-density lipoprotein (P<.03) cholesterol levels, systolic blood pressure (P<.03), and glucose level (P<.03); in participants with type 2 diabetes mellitus, there were greater improvements in glucose (P =.046) and glycosylated hemoglobin (P<.02) levels. The prepared meal plan group also showed greater improvements in quality of life (P<.05) and compliance (P<.001) than the UCD group. CONCLUSIONS: Long-term dietary interventions induced significant weight loss and improved cardiovascular risk in high-risk patients. The prepared meal plan simultaneously provided the simplicity and nutrient composition necessary to maintain long-term compliance and to reduce cardiovascular risk.     

Effect of a high-protein, energy-restricted diet on weight loss and energy expenditure after weight stabilization in hyperinsulinemic subjects

OBJECTIVE: To determine the effect of replacing some dietary carbohydrate with protein, during energy restriction, on weight loss, total energy expenditure (TEE), resting energy expenditure (REE), respiratory quotient (RQ), and the thermic effect of feeding (TEF) in subjects with hyperinsulinemia. DESIGN: Parallel, clinical intervention study of 12 weeks energy restriction (6.5 MJ/day) and 4 weeks energy balance (8.2 MJ/day) in two groups of subjects randomly assigned to either a high-protein (HP) diet (27% of energy (%E) as protein, 45%E as carbohydrate) or a lower-protein (LP) diet (16%E as protein, 57%E as carbohydrate). SUBJECTS: A total of 36 obese nondiabetic volunteers with hyperinsulinemia (10 males/26 females, aged 34-65 y, BMI 28-43 kg/m(2), fasting insulin 12-45 mU/l). MEASUREMENTS: Body weight and composition, TEE, REE, and RQ were measured at baseline and at week 16. In addition, the TEF to an HP or LP meal was determined for 3 h, at baseline and at week 16. RESULTS: After 16 weeks, weight loss was similar in response to each diet; the overall decrease was 7.9+/-0.6 kg (P<0.001), of which 6.8+/-0.5 kg was fat (P<0.001). REE fell similarly with each diet; the overall decrease was 719+/-106 kJ/day (P<0.001). The TEF was 2% greater after the HP than after the LP meal at baseline (P<0.01) and 0.8% greater at week 16 (P=0.35). After 16 weeks, the TEF was not reduced in either dietary group. There was no change in TEE after 16 weeks. CONCLUSION: In subjects with hyperinsulinemia an energy-restrictive diet containing an increased protein-to-carbohydrate ratio does not enhance weight loss or significantly affect energy expenditure. Caloric restriction, rather than the macronutrient composition of the diet, is the most important determinant of weight loss.     

Predictors of programme adherence and weight loss in women in an obesity programme using meal replacements

OBJECTIVE: To explore predictors of programme adherence and weight loss in patients participating in a weight management programme using meal replacements (MR). DESIGN: One hundred and fifty healthy obese women, age 48.5 years (s.d. = 8.3); weight, 97.6 kg (13.4); body mass index (BMI) 36.5 (3.7), participated in a longitudinal study with a 16-week acute weight loss phase (Phase 1) followed by 1 year of a trial of weight-loss maintenance (Phase 2). Energy intake during Phase 1 totaled 900 kcal (3.7 MJ) a day from a diet including two MR. Energy intake during Phase 2 consisted of either MR or a low-fat diet with a calculated energy deficit of 600 kcal/day (2.5 MJ). METHODS: Weight, height and waist circumference were measured and body composition assessed by air plethysmography (Bodpod). Glucose and insulin were measured by standard immunoassays and insulin sensitivity assessed by homeostatic model assessment. RESULTS: At the end of 16 weeks, 114 subjects (76%) completed Phase 1 and achieved a mean weight loss of 8.95 kg (3.38). Adherence to Phase 1 was predicted by weight loss over the first 2 weeks (p < 0.001). Weight loss during Phase 1 was predicted by initial weight and initial systolic blood pressure. Adherence to Phase 2 was not predicted by physiological measures. Weight loss maintenance in Phase 2 (not gaining more than 3% of the weight at start of phase 2) was predicted by cholesterol and triglyceride measured at the start of Phase 2 but otherwise was not predicted by the physiological measures. Initial insulin sensitivity did not predict weight loss in either phase. CONCLUSION: Participants whose weight loss over the first 2 weeks falls in the bottom third may need additional intervention if they are to continue in this type of programme. A battery of physiological measures at entry to a MR weight loss and maintenance programme explains only a very small proportion of the variation in weight loss.     

Ghrelin secretion in severely obese subjects before and after a 3-week integrated body mass reduction program

Ghrelin, the endogenous ligand of GH-secretagogue receptors, has been implicated in the regulation of feeding behavior and energy balance. Aim of the study was to investigate ghrelin levels in fasting conditions and after a standard meal test in obese subjects before and after a 3-week integrated body weight reduction (BWR) program (consisting of energy-restricted diet, exercise training, psychological counselling and nutritional education). Weight, height, fat mass, fat free mass (by impedentiometry), circulating ghrelin, insulin and leptin levels were evaluated in 10 obese subjects (3 male, 7 female; mean age: 35 +/- 9.3 yr; body mass index BMI: 45.2 +/- 10.6 kg/m2) before and after weight reduction. At baseline, obese subjects showed significantly lower ghrelin levels than controls, which were negatively correlated with BMI, weight, insulin and leptin levels. Fasting ghrelin levels were not modified by standard meal test in obese subjects (from 110.8 +/- 69.7 to 91.8 +/- 70.2 pmol/l p=ns), while a significant reduction was observed in controls (from 352.4 +/- 176.7 to 199.0 +/- 105.2 pmol/l; p<0.01). After a 3-week integrated BWR program obese subjects significantly reduced weight, BMI and leptin levels, while no significant changes were found both in fasting ghrelin and in ghrelin response after the meal. In conclusion, 5% weight loss obtained after a short-term period of integrated BWR program is not sufficient to normalize fasting ghrelin levels nor to restore the normal ghrelin suppression after a meal in severely obese subjects.     

Comparison of a phone vs clinic approach to achieve 10% weight loss

OBJECTIVE: To compare the efficacy of a phone vs a traditional face-to-face clinic approach to achieve 10% weight loss and weight maintenance. DESIGN: Twenty-six week, randomized, controlled trial. SUBJECTS: Twenty-four men and 72 women, ages 25-68 years, with a body mass index (BMI) of 33.2+/-3.8. MEASUREMENTS: Weight loss at 12 weeks and weight maintenance at 26 weeks were the primary outcomes. Attendance, meal replacements (MRs), fruits/vegetables (F/V), and physical activity (PA) were measured weekly for process evaluation. RESULTS: Median weight loss (range) from baseline at 12 weeks was significantly different for phone at 10.6 kg (16.6) or 10.4% and clinic at 12.7 kg (19.9) or 13.7%, and both were significantly different when compared with the control group with a weight loss of 0.25 kg (5.6) or 0.24%. Median weight loss at 26 weeks was 12.8 kg (23.4) or 13.0% from baseline for the phone group and 12.5 kg (35.2) or 12.6% from baseline for the clinic group (P>0.05). CONCLUSION: The median weight loss for both phone and clinic groups at 12 and 26 weeks exceeded the NHLBI guideline of 10% weight loss from baseline. The phone approach may be a viable option to the traditional weight management clinic for both service providers and participants.     

Weight loss and long-term follow-up of severely obese individuals treated with an intense behavioral program

OBJECTIVE: To review weight loss and maintenance for severely obese individuals enrolled in intensive behavioral weight loss program using very-low or low-energy diets. DESIGN: Chart review of consecutively treated patients between 1995 and 2002 seen at three weight loss centers. SUBJECTS: One thousand five hundred and thirty one patients with severe obesity (>or=40 kg/m(2)) treated in three cities ('Study Group'). Of these, 1100 completed the 12-week core curriculum ('Completer Group'). Weight loss >or=100 lbs (>45 kg) was seen in 268 patients ('100-Pound Group'). MEASUREMENTS: Charts were reviewed for baseline characteristics, weekly weights, follow-up weights and side effects. RESULTS: In the Study Group, average weight loss+/-s.e. for 998 women was 23.9+/-0.6 kg (18.5% of initial body weight (IBW)) and for 533 men was 36.0+/-1.0 kg (22.5%) over 30 weeks. For Completers, average weight loss for women was 30.8+/-0.6 kg (23.9%) and for men was 42.6+/-1.1 kg (26.7%) over 39 weeks. In the 100-Pound Group, average weight loss for women was 58.2+/-1.2 kg (41.5%) in 65 weeks and for men was 65.7+/-1.5 kg (37.5%) in 51 weeks. Side effects, assessed in 100 patients losing >45 kg, were mild to moderate in severity. Severe adverse events unrelated to the diet were noted in 5% of patients and during weight loss 1% had elective cholecystectomies. Follow-up weights were available for 86% of Completers at an average of 72 weeks with average maintenance of 23 kg or 59% of weight loss; follow-up weights were available for 94% of the 100-Pound Group at an average of 95 weeks with average maintenance of 41 kg or 65% of weight loss maintained. CONCLUSIONS: Intensive behavioral treatment with meal replacements is a safe and effective weight-loss strategy for selected severely obese individuals.     

Influence of weight loss on plasma ghrelin responses to high-fat and high-carbohydrate test meals in obese women

BACKGROUND: Diet-induced weight loss is associated with an increase in fasting ghrelin. The influence of weight loss on postprandial ghrelin response remains discussed, but the specific response to macronutrients is not known. OBJECTIVE: The objective of the study was to assess the influence of weight loss in obese women on the plasma ghrelin response to a fat- or carbohydrate-rich meal. DESIGN: Seventeen obese women (mean body mass index 37.6 +/- 5 kg/m2) were given an energy-restricted diet (800 kcal/d) for 7 wk, followed by a maintenance diet for 1 wk. Before and after the weight reduction diet, each woman was given (in random order) two isoenergetic test meals, corresponding to 40% of daily energy needs. The test meals contained either 80% fat and 20% protein or 80% carbohydrate and 20% protein. Blood samples were collected over a 10-h period. Two-way ANOVA with repeated measures was used to assess the effect of the test meal on variables. RESULTS: Weight loss (-11.2 +/- 1.4 kg) was associated with a significant decrease in baseline plasma insulin (9.7 +/- 4.1 to 7.9 +/- 2.4 mU/ml; P < 0.0001) and leptin (25.9 +/- 8.3 to 17.2 +/- 7.8 ng/ml; P < 0.0001) and an increase in plasma ghrelin (1.86 +/- 1.05 to 2.28 +/- 1.48 ng/ml; P < 0.05). Before weight loss, there was no significant difference in postprandial ghrelin response between the test meals. After weight reduction, the ghrelin response was more pronounced after the carbohydrate test meal than after the fat test meal (P < 0.02). CONCLUSION: Weight loss is associated with an improved postprandial plasma ghrelin response to a carbohydrate meal, whereas the response to a fat meal is not modified.     

Benefits of lifestyle modification in the pharmacologic treatment of obesity: a randomized trial

BACKGROUND: Weight loss medications are recommended as an adjunct to diet and exercise modification but seem to be prescribed as a monotherapy by many physicians. This practice is likely to be associated with suboptimal weight loss. METHODS: This 1-year, randomized trial compared the effects of sibutramine hydrochloride used alone (ie, the drug-alone group) to sibutramine plus group lifestyle modification, prescribed with either a 5021- to 6276-kJ/d diet (1200-1500-kcal/d diet) (ie, the drug-plus-lifestyle group) or, for the first 4 months, a 4184-kJ/d diet (1000-kcal/d diet (ie, drug-plus-lifestyle with a portion-controlled diet [the combined treatment] group). Participants were 53 women with a mean (+/-SD) age of 47.2 +/- 9.8 years and weight of 101.3 +/- 9.7 kg. At baseline, they reported the number of pounds they expected to lose at the end of treatment. RESULTS: At month 12, patients treated with the drug alone lost (mean +/- SD) 4.1% +/- 6.3% of their initial body weight compared with significantly (P<.05) larger losses in the drug-plus-lifestyle group of 10.8% +/- 10.3% and the combined treatment group of 16.5% +/- 8.0%. Women in the 2 lifestyle groups achieved a significantly (P<.05) greater percentage of their expected weight loss than those in the drug-alone group and were significantly more satisfied with the medication and with changes in weight, health, appearance, and self-esteem (P<.05 for all). Significant reductions were observed at 12 months in triglyceride and low-density lipoprotein cholesterol levels but systolic and diastolic blood pressure both increased significantly (P<.05 for all). CONCLUSION: The addition of group lifestyle modification to the pharmacologic management of obesity significantly improved weight loss and patients' satisfaction with treatment outcome.     

Use of packaged entrees as part of a weight-loss diet in overweight men: an 8-week randomized clinical trial

AIM: This study assessed the efficacy of a weight-loss diet by using packaged portion-controlled entrees vs. a self-selected diet based on the United States Department of Agriculture Food Guide Pyramid (FGP). METHODS: Sixty healthy overweight men (body mass index (BMI) 26-42 kg/m2; aged 24-60 years) were randomized into two groups for an 8-week intervention. Group E consumed two portion-controlled entrees daily, plus recommended servings from the FGP. Group P consumed a self-selected diet consisting of a recommended number of servings from the FGP. Diets were designed to be isocaloric (1700 kcal) and identical in macronutrient composition (55% carbohydrate, 25% protein and 20% fat). Participants were instructed to make no changes in physical activity levels. Each group was blinded to the protocol of the other group, and received separate diet instructions, but no behavioural or diet counselling. Outcomes included weight, BMI, body composition by dual energy X-ray absorptiometry, waist and hip circumference, blood pressure (BP), fasting blood lipids, glucose, insulin and C-reactive protein. RESULTS: Fifty-one men completed the study. The portion-control group E (n = 25) experienced greater decreases in weight (-7.4 +/- 3.1 vs. -5.1 +/- 4.0 kg), BMI (-2.4 +/- 1.0 vs. -1.6 +/- 1.3 kg/m2), fat mass (-3.6 +/- 1.8 vs. -2.5 +/- 1.8 kg), waist circumference (-6.6 +/- 3.3 vs. -4.3 +/- 2.9 cm) and diastolic BP (-6.0 +/- 7.2 vs. + 0.2 +/- 10.1 mmHg) than group P (n = 26) (p < 0.05). Consumption of a packaged entree diet resulted in greater losses of weight and fat mass, and reduced BP. CONCLUSIONS: Use of packaged entrees as part of a weight-loss diet is an effective means of achieving portion control and enhancing losses of weight and fat mass in overweight men.     

Obesity, macrophage migration inhibitory factor, and weight loss

OBJECTIVE: Elevated macrophage migration inhibitory factor (MIF) has been implicated as a causal mechanism in a number of disease conditions including cardiovascular disease (CVD), diabetes, and cancer. Excess body fat is associated with an increased risk of numerous health conditions including CVD, diabetes, and cancer. To our knowledge, the association between MIF and obesity status and the effect of weight loss on serum MIF concentrations have not been reported. In this study, we examined the effects of participation in a behavior-based weight loss program on MIF concentrations in obese individuals. SUBJECTS: Study participants were 71 men and women enrolled in The Cooper Institute Weight Management Program. Participants were predominantly female (68%, n=48), middle-aged (46.5+/-9.8 y), and severely obese (BMI=43.0+/-8.6). METHOD: Plasma MIF concentrations and other standard risk factors were measured before and after participation in a diet and physical activity based weight management program. RESULTS: The mean follow-up was 8.5+/-3.0 months with an average weight loss of 14.4 kg (P<0.001). The majority of clinical risk factors significantly improved at follow-up. Median levels of plasma MIF concentration were significantly lower at follow-up (median [IQR]; 5.1[3.6-10.3]) compared to baseline (8.4 [4.3-48.8]; P=0.0005). The percentage of participants with plasma MIF concentration > or =19.5 mg/nl (highest tertile at baseline) decreased from 33.8 to 5.6% (P<0.001). Further, elevated baseline plasma MIF concentration was associated with markers of beta-cell dysfunction and reductions in MIF were associated with improvements in beta-cell function. CONCLUSIONS: Circulating MIF concentrations are elevated in obese but otherwise healthy individuals; however, this elevation in MIF is not uniform across individuals. In obese individuals with elevated circulating MIF concentrations, participation in physical activity and a dietary-focused weight management program resulted in substantial reduction in MIF.     

Orlistat in the treatment of overweight or obese Chinese patients with newly diagnosed Type 2 diabetes.

AIMS: Orlistat promotes weight loss in overweight and obese patients with Type 2 diabetes receiving hypoglycaemic treatment, but has not been investigated in patients with newly diagnosed and previously untreated Type 2 diabetes. We evaluated the efficacy of 24 weeks' treatment with orlistat, combined with a mildly reduced-calorie diet, on weight loss and glycaemic control in overweight and obese patients with newly diagnosed and previously untreated Type 2 diabetes. METHODS: A total of 249 Chinese patients (body mass index 25-40 kg/m2) with recently diagnosed Type 2 diabetes were randomized to placebo (n=124) or orlistat 120 mg (n=125) three times daily; all patients followed a mildly reduced-calorie diet. Patients had HbA1c 6.5-8.5% (mean 7.3%) and had never received any glucose-lowering medication. RESULTS: Orlistat-treated patients achieved significantly greater weight loss at the study end than placebo-treated patients (-5.4 vs. -2.4 kg; P<0.0001). More orlistat than placebo patients lost>or=5% (60.5 vs. 26.8%; P<0.0001) and >or=10% of their body weight (20.2 vs. 4.9%; P=0.0002). A significantly greater decrease in HbA(1c) from baseline was obtained with orlistat than placebo (-1.0 vs. -0.6%; P=0.0008). Orlistat-treated patients achieved a significantly greater decrease in fasting plasma glucose (-1.3 vs. -0.5 mmol/l; P=0.0003) and in the 2-h oral glucose tolerance test (-4.1 vs. -1.4 mmol/l; P<0.0001) than placebo recipients. Also, more orlistat- than placebo-treated patients improved from diabetic status to normal or impaired glucose tolerance (44.3 vs. 32.5%; P=0.0763) after 24 weeks. Orlistat also produced improvements in lipid profiles and waist circumference. CONCLUSIONS: In combination with a mildly reduced-calorie diet, orlistat significantly reduces body weight, and improves glycaemic control and several cardiovascular risk factors in overweight and obese Chinese patients with newly diagnosed Type 2 diabetes.     

Weight Management Using a Meal Replacement Strategy in Type 2 Diabetes

The growing prevalence of diabetes parallels the increased prevalence of obesity. Overweight and obese individuals with diabetes who attempt weight reduction face considerable challenges. However, several recent studies showed that weight reduction in patients with diabetes is feasible using a multidisciplinary approach that incorporates structured dietary intervention and meal replacements (MRs). Nutritionally complete MRs are shown to be useful at the start of weight reduction programs and for weight maintenance because of their nutrition adequacy. However, patients using this approach need to monitor their blood glucose levels closely and may need to adjust their diabetes medications. Most commercial MRs are currently fortified with vitamins and minerals to prevent long-term deficiency in essential micronutrients that are commonly seen in low-calorie diet plans. They also come in different flavors and formats that improve their general acceptability. To successfully initiate weight loss, MRs are generally used as absolute replacement of an agreed upon number of meals/snacks. This article covers the use of MRs for patients with diabetes for short-term and long-term weight reduction in clinical trials and real-world clinical practice.     

Weight loss with meal replacement and meal replacement plus snacks: a randomized trial

OBJECTIVE: To evaluate whether snacking would improve weight loss and weight maintenance in overweight individuals within the context of a structured meal replacement (MR) weight loss program. DESIGN: A prospective 24 week, 2 (snacking vs nonsnacking) x 2 (MR vs meal replacement augmented with snacks (MRPS)) randomized trial. Participants were instructed to limit their total daily intake to 1200 (women) or 1500 (men) kcals. Those receiving the MR program were instructed not to snack while those in the MRPS program were told to snack three times per day. SUBJECTS: A total of 100 participants were block-randomized, based on prestudy snacking status (high vs low), to receive a standard meal replacement program (MR) or MRPS. MEASUREMENTS: Weight, height, blood pressure, lipid fractions, glucose, and insulin were assessed at the baseline, 12-, and 24 weeks. RESULTS: Completers analysis at 24 weeks demonstrated a significant time effect (F(1,46)=44.6, P<0.001), indicating that all participants lost significant amounts of weight regardless of group assignment. An intention-to-treat model resulted in similar results. By week 24, the average weight loss across groups was 4.6 kg. There also were significant improvements across all groups among completers for systolic blood pressure (P=0.047), cholesterol (P=0.001), LDL (P=0.001), glucose (P=0.004), and insulin (P=0.001) at week 12, and glucose (P=0.001) and insulin at week 24 (P=0.003). CONCLUSIONS: Our results suggest that a participant's preferences for snacking did not affect their response to treatment. Snackers and nonsnackers responded equally well whether they received a standard meal replacement program or one augmented with snacks.     

Dietary thermogenesis in obesity. Response to carbohydrate and protein meals: the effect of beta-adrenergic blockade and semistarvation

Four obese and four lean women were studied for 4 or 5 weeks in a metabolic unit to assess their short-term responses to carbohydrate- and protein-containing meals and the effects of beta-adrenergic blockade during both weight maintenance and semistarvation. The study was divided into four periods: a period of weight maintenance; a maintenance diet with propranolol; semistarvation; semistarvation plus propranolol. The low-energy diets contained half the amount of carbohydrate and fat but the protein intake was maintained. The metabolic rate was measured in the fasting state by indirect calorimetry prior to a test meal and then for prolonged periods up to 5.5 h after carbohydrate and 7.5 h after protein test meals. Three lean subjects also spent 23 h in a whole-body calorimeter in each period, when BMR and metabolic rate at different activity levels were measured. Propranolol causes a fall in BMR in both groups on a maintenance diet, but had little further effect on the lower BMR during semistarvation. The protein meal caused a peak increase of 30 percent in oxygen consumption (321 kJ in obese, 257 kJ in lean), two to three times that of the carbohydrate meal (91 kJ) despite the energy intake being 25 percent less in the protein meal. There was no consistent difference in postprandial thermogenesis in obese and lean subjects and the effect was not modified by propranolol or semistarvation. Propranolol caused reduced thermogenesis after a mixed meal in lean subjects.     

Weight maintenance after a very low calorie diet (VLCD) weight reduction period and the effects of VLCD supplementation: A prospective,randomized, comparative,controlled long-term trial

Abstract. Objectives . To evaluate the efficacy of a structured very low calorie diet (VLCD) weight reduction/weight maintenance behaviour programme on weight maintenance in obese patients (BMI ≥ 30 kg/m²). Design . Prospective, randomized, controlled intervention trial. Setting . University out-patient obesity clinic. Subjects . A total of 114 obese patients from the waiting list were invited to participate in the structured weight reduction/weight maintenance programme lasting for 64 weeks. Sixty patients agreed to participate. Intervention . All 60 patients were placed on a Cambridge 330 kcal day^-1diet during the first 12 weeks. Fifty-two were subsequently randomized to either a well balanced hypocaloric diet (1600 kcal day^-1), of which 220 kcal were provided by two sachets of Cambridge diet (group 1), or the same energy provided by the same principal diet (group 2) during the following 52-week weight maintenance period. Main outcome measures . During the VLCD period, the mean body weight decreased significantly from 112.4 ± 19.8 to 91.6 ± 17.7 kg (P < 0.0001). Seventy-one per cent of the weight loss was fat. During the weight maintenance period the average body weight increased significantly in group 1: 8.0 ± 8.2 vs. 12.3 ± 9.7 kg in group 2 (P < 0.0001). After the 64-week treatment period the mean body weight in group 1 was 93.7 ± 18.1 kg and significantly lower compared to 109.9 ± 23.8 kg in group 2 (P = 0.008). Compliance was high: 87% completed the VLCD period and 75% completed the whole 64-week treatment programme. Conclusion . Very low calorie diet as part of the dietary allowance during the weight maintenance programme partly prevents weight regain. This finding can be translated into practical treatment recommendations.     

Effects of orlistat on obesity-related diseases - a six-month randomized trial

AIM: To assess the effect of orlistat on body weight and concomitant diseases in patients with body mass index (BMI) of > 28 kg/m2 and poorly controlled type 2 diabetes, hypertension or hypercholesterolaemia. METHODS: This trial was a six-month, randomized, double-blind, placebo-controlled study of orlistat 120 mg three times daily plus a mildly reduced-calorie diet. 1004 obese patients (BMI 28-40 kg/m2) were included by 253 private endocrinologists and received orlistat (n = 499) or placebo (n = 505). Patients were stratified by concomitant disorder (type 2 diabetes, n = 193; hypertension, n = 614; hypercholesterolaemia, n = 197). Body weight, anthropometry, lipid and glycaemic control parameters and blood pressure. RESULTS: After six months, orlistat produced a significantly greater weight loss than placebo in type 2 diabetes (-4.2% vs. -1.4%), hypertension (-6.2% vs. -1.9%) and hypercholesterolaemia (-5.5% vs. -2.3%) groups (p < 0.0001 for all). There was a greater decrease in HbA(1c) in the type 2 diabetes group (-0.54 vs. -0.18%; p = 0.002) and low-density lipoprotein (LDL)-cholesterol in the hypercholesterolaemia group (-11.7% vs. -4.5%; p = 0.004) with orlistat vs. placebo. Early weight loss (> or = 5% at 12 weeks) was associated with the highest weight loss in each group, and the highest decreases in HbA1c, LDL-cholesterol and diastolic blood pressure in patients with type 2 diabetes, hypercholesterolaemia and hypertension, respectively, at six months. The incidence of adverse events was similar for orlistat and placebo, except for certain generally well-tolerated gastrointestinal events that were more common with orlistat. CONCLUSION: Orlistat plus a mildly reduced-calorie diet produced clinically meaningful weight loss and improvements in risk factors in overweight and obese patients with poorly controlled type 2 diabetes, hypertension or hypercholesterolaemia.