One-year Weight Losses in the Look AHEAD Study: Factors Associated With Success

This report provides a further analysis of the first year weight losses in the Look AHEAD (Action for Health in Diabetes) study and identifies factors associated with success. Participants were a total of 5,145 men and women with type 2 diabetes who were recruited at 16 sites and randomly assigned to an intensive lifestyle intervention (ILI) or a control condition, Diabetes Support and Education (DSE). During year 1, participants in ILI received comprehensive diet and physical activity counseling in a total of 42 group and individual sessions, compared with three educational sessions for DSE participants. As reported previously, at the end of the year, ILI participants lost 8.6% of initial weight, compared to 0.7% for DSE (P < 0.001). Within the ILI group, all racial/ethnic groups achieved clinically significant weight losses (>5.5%), although there were significant differences among groups. For the year, ILI participants attended an average of 35.4 treatment sessions and reported exercising a mean of 136.6 min/week and consuming a total of 360.9 meal replacement products. Greater self-reported physical activity was the strongest correlate of weight loss, followed by treatment attendance and consumption of meal replacements. The use of orlistat, during the second half of the year, increased weight loss only marginally in those ILI participants who had lost <5% of initial weight during the first 6 months and chose to take the medication thereafter as a toolbox option. The lifestyle intervention was clinically effective in all subsets of an ethnically and demographically diverse population.     

Impact of the look AHEAD intervention on NT-pro brain natriuretic peptide in overweight and obese adults with diabetes

Look AHEAD (Action for Health in Diabetes) is a randomized trial determining whether intensive lifestyle intervention (ILI) aimed at long‐term weight loss and increased physical fitness reduces cardiovascular morbidity and mortality in overweight and obese individuals with type 2 diabetes compared to control (diabetes support and education, DSE). We investigated the correlates of N‐terminal pro‐brain natriuretic peptide (NT‐proBNP), a biomarker associated with heart failure (HF) risk, in a subsample from 15 of 16 participating centers and tested the hypothesis that ILI decreased NT‐proBNP levels. Baseline and 1‐year blood samples were assayed for NT‐proBNP in a random sample of 1,500 without, and all 628 with, self‐reported baseline CVD (cardiovascular disease) (N = 2,128). Linear models were used to assess relationships that log‐transformed NT‐proBNP had with CVD risk factors at baseline and that 1‐year changes in NT‐proBNP had with intervention assignment. At baseline, the mean (s.d.) age, BMI, and hemoglobin A_1c (HbA_1c) were 59.6 (6.8) years, 36.0 kg/m² (5.8), and 7.2% (1.1), respectively. Baseline geometric mean NT‐proBNP was not different by condition (ILI 53.3 vs. DSE 51.5, P = 0.45), was not associated with BMI, and was inversely associated with HbA_1c. At 1 year, ILI participants achieved an average weight loss of 8.3% compared to 0.7% in DSE. At 1 year, NT‐proBNP levels increased to a greater extent in the intervention arm (ILI +21.3% vs. DSE +14.2%, P = 0.046). The increased NT‐proBNP associated with ILI was correlated with changes in HbA_1c, BMI, and body composition. In conclusion, among overweight and obese persons with diabetes, an ILI that reduced weight was associated with an increased NT‐proBNP.     

Four-year weight losses in the Look AHEAD study: factors associated with long-term success

This report provides a further analysis of the year 4 weight losses in the Look AHEAD (Action for Health in Diabetes) study and identifies factors associated with long-term success. A total of 5,145 overweight/obese men and women with type 2 diabetes were randomly assigned to an intensive lifestyle intervention (ILI) or a usual care group, referred to as Diabetes Support and Education (DSE). ILI participants were provided approximately weekly group or individual treatment in year 1; continued but less frequent contact was provided in years 2-4. DSE participants received three group educational sessions in all years. As reported previously, at year 4, ILI participants lost an average of 4.7% of initial weight, compared with 1.1% for DSE (P < 0.0001). More ILI than DSE participants lost ≥ 5% (46% vs. 25%, P < 0.0001) and ≥ 10% (23% vs. 10%, P < 0.0001) of initial weight. Within the ILI, achievement of both the 5% and 10% categorical weight losses at year 4 was strongly related to meeting these goals at year 1. A total of 887 participants in ILI lost ≥ 10% at year 1, of whom 374 (42.2%) achieved this loss at year 4. Participants who maintained the loss, compared with those who did not, attended more treatment sessions and reported more favorable physical activity and food intake at year 4. These results provide critical evidence that a comprehensive lifestyle intervention can induce clinically significant weight loss (i.e., ≥ 5%) in overweight/obese participants with type 2 diabetes and maintain this loss in more than 45% of patients at 4 years.     

One-year changes in symptoms of depression and weight in overweight/obese individuals with type 2 diabetes in the Look AHEAD study

Depressed individuals are frequently excluded from weight loss trials because of fears that weight reduction may precipitate mood disorders, as well as concerns that depressed participants will not lose weight satisfactorily. The present study examined participants in the Look AHEAD study to determine whether moderate weight loss would be associated with incident symptoms of depression and suicidal ideation, and whether symptoms of depression at baseline would limit weight loss at 1 year. Overweight/obese adults with type 2 diabetes (n = 5,145) were randomly assigned to an Intensive Lifestyle Intervention (ILI) or a usual care group, Diabetes Support and Education (DSE). Of these, 5,129 participants completed the Beck Depression Inventory (BDI) and had their weight measured at baseline and 1 year. Potentially significant symptoms of depression were defined by a BDI score ≥10. Participants in ILI lost 8.6 ± 6.9% of initial weight at 1 year, compared to 0.7 ± 4.8% for DSE (P < 0.001, effect size = 1.33), and had a reduction of 1.4 ± 4.7 points on the BDI, compared to 0.4 ± 4.5 for DSE (P < 0.001, effect size = 0.23). At 1 year, the incidence of potentially significant symptoms of depression was significantly lower in the ILI than DSE group (6.3% vs. 9.6%) (relative risk (RR) = 0.66, 95% confidence interval (CI) = 0.5, 0.8; P < 0.001). In the ILI group, participants with and without symptoms of depression lost 7.8 ± 6.7% and 8.7 ± 6.9%, respectively, a difference not considered clinically meaningful. Intentional weight loss was not associated with the precipitation of symptoms of depression, but instead appeared to protect against this occurrence. Mild (or greater) symptoms of depression at baseline did not prevent overweight/obese individuals with type 2 diabetes from achieving significant weight loss.     

Effects of a School‐based Weight Maintenance Program for Mexican‐American Children: Results at 2 Years

The prevalence of childhood overweight has increased significantly, with the highest rates noted among Mexican Americans. Many negative health outcomes are associated with overweight; thus, there is a need for effective weight‐loss interventions tailored to this group. This study evaluated 24‐month outcomes of a randomized, controlled trial involving an intensive lifestyle‐based weight maintenance program targeting overweight Mexican‐American children at a charter school in Houston, Texas. A total of 60 children (33 males, 55%) between the ages of 10 and 14 at or >85th percentile for BMI were recruited. Participants were randomized to an instructor‐led intervention (ILI) or a self‐help (SH) program, both aimed at modifying eating and physical activity behaviors using behavior modification strategies. Changes in participants' standardized BMI (zBMI) were assessed at baseline, 1, and 2 years. Tricep skinfold, total cholesterol, triglycerides, high‐density lipoprotein cholesterol, and calculated low‐density lipoprotein were assessed at baseline and 1 year. ILI participants showed significantly greater decreases in zBMI at 1 and 2 years (F = 26.8, P < 0.001, F = 4.1, P < 0.05, respectively) compared to SH controls. ILI participants showed greater improvements in body composition, as measured by tricep skinfold (F = 9.75, P < 0.01). Children in the ILI condition experienced benefits with respect to total cholesterol (F = 7.19, P < 0.05) and triglycerides (F = 4.35, P < 0.05) compared to children in the SH condition. Overall, the school‐based intervention resulted in improved weight and clinical outcomes in overweight Mexican‐American children, and zBMI was maintained over 2 years.     

Adiponectin and the mediation of HDL-cholesterol change with improved lifestyle: the Look AHEAD Study

Adipose tissue dysfunction plays a key role in the development of the metabolic abnormalities characteristic of type 2 diabetes (T2DM) and participates actively in lipid metabolism. Adiponectin, found abundantly in circulation and a marker of adipose health, is decreased in obese persons with T2DM. We investigated whether the changes in adiponectin with an intensive lifestyle intervention (ILI) for weight loss could potentially mediate the increase in low HDL-cholesterol (HDL-C) with ILI. Adiponectin and its fractions were determined using an ELISA with selective protease treatment in 1,397 participants from Look AHEAD, a trial examining whether ILI will reduce cardiovascular events in overweight/obese subjects with T2DM when compared with a control arm, diabetes support and education (DSE). Multivariable regression and mediational analyses were performed for adiponectin and its high-molecular-weight (HMW) and non-HMW fractions. ILI increased baseline HDL-C by 9.7% and adiponectin by 11.9%; changes with DSE were 1.3% and 0.2%, respectively (P < 0.0001). In a model including changes in weight, fitness, triglycerides, and glucose control and that adjusted for demographics and medical history, adiponectin changes remained significantly associated with HDL-C change. Data supported the contribution of changes in both HMW- and non-HMW-adiponectin to the improvement in HDL-C with ILI     

Body image changes associated with participation in an intensive lifestyle weight loss intervention

The primary aim of this study was to test for changes in body image in men and women enrolled in the Look AHEAD trial. Look AHEAD (Action for Health in Diabetes) is a multicenter, randomized controlled trial designed to test whether intentional weight loss reduces cardiovascular morbidity and mortality in overweight individuals with type 2 diabetes. Participants included 157 adults at one site (Pennington Biomedical Research Center (PBRC), Baton Rouge, LA) of the Look AHEAD study. At baseline, the mean BMI of the female participants was 36.4, and the mean BMI for males was 33.5. Following baseline assessment, participants were randomly assigned to the intensive lifestyle intervention (ILI, n = 81) or diabetes support and education (DSE, n = 76). The body morph assessment version 2.0 (BMA 2.0) was used to assess estimates of perceived current body size, ideal body size, acceptable body size, and body image dissatisfaction at baseline and 1 year. Over the 1 year, participants in the ILI group had significantly greater reductions in weight (10.1% for men and 8.9% for women) than those in the DSE group (+ 0.8% for men and -0.2%, for women). Perceived current body size was reduced significantly more in both men and women in the ILI group, relative to DSE. There were also significantly greater reductions in body image dissatisfaction in the ILI group, relative to the DSE group for men and women. The results of this study indicate that body image dissatisfaction improved following participation in an intensive behavioral weight loss program.     

Improved Psychological Well-Being,Quality of Life,and Health Practices in Moderately Overweight Women Participating in a 12-Week Structured Weight Loss Program

Objective : To study the effects of a 12-week weight loss strategy involving increased physical activity, self-selected hypocaloric diet, and group support on psychological well-being, quality of life, and health practices in moderately obese women. Methods; Eighty women aged 20–49 years weighing between 20–50% above 1983 Metropolitan Life Insurance Tables were randomly assigned to a weight loss intervention (6279 kJ/week of physical activity, 33,258-41,462 kJ/week diet and weekly meetings) or served as controls. Subjects were tested pre and post 12-weeks. Results : The intervention group lost significant (p<0.001) body weight (kg) and body fat (%) compared to controls (-6.07 ± 4.01 kg vs. 1.31 ± 1.28 kg; 36.8%-32.5% vs. 36.2%-36.0%). Intervention subjects vs. controls achieved significant improvements (p<0.001) in body cathexis (X Change 18.6 ± 16.7 vs. 0.7 ± 8.6) and estimation of ability to achieve physical fitness (X Change 8.1 ± 7.1 vs. 0.9 ± 5.9). Various quality of life indices also improved (p<0.01) in the intervention group compared to controls (physical function: X Change 13.5.2 ± 16.7 vs. 1.4 ± 9.5; vitality: X change 21.7 ± 17.9 vs. 2.9 20.8; mental health: X change 10.4 ± 16.0 vs. 2.3 ± 10.1). Similarly, physical activity levels also improved significantly (p<0.0001) in the intervention group (4.4 ± 2.3 vs. 0.6 ± 1.3; on NASA 0–7 scale). Conclusions : Practical weight loss practices such as increased activity, self-selected hypocaloric diet, and group support are effective for weight loss and yield significant health and psychological benefits in moderately obese females.     

Disparities in counseling for lifestyle modification among obese adults: insights from the Dallas Heart Study

Clinician counseling is a catalyst for lifestyle modification in obesity. Unfortunately, clinicians do not appropriately counsel all obese patients about lifestyle modification. The extent of disparities in clinician counseling is not well understood. Obese participants (BMI ≥30 kg/m², N = 2097) in the Dallas Heart Study (DHS), a probability‐based sample of Dallas County residents ages 18–65, were surveyed regarding health‐care utilization and lifestyle counseling over the year prior to DHS enrollment. Health‐care utilization and counseling were compared between obese participants across three categories based on the presence of 0, 1, or 2+ of the following cardiovascular (CV) risk factors: hypertension, hypercholesterolemia, or diabetes. Logistic regression modeling was used to determine likelihood of counseling in those with 0 vs. 1+ CV risk factors, stratified by race, adjusting for age, sex, insurance status, and education. Among obese subjects who sought medical care, those with 0 CV risk factors, compared to those with 1 or 2+ CV risk factors, were less likely to report counseling about losing weight (41% vs. 67% vs. 87%, P trend <0.001), dietary changes (44% vs. 71% vs. 85%, P trend <0.001), and physical activity (46% vs. 71% vs. 86%, P trend <0.001). Blacks and Hispanics without CV risk factors had a lower odds of receiving counseling than whites without risk factors on weight loss (adjusted odds ratio (OR), 95% confidence interval (CI) for nonwhites 0.19, [0.13–0.28], whites 0.48, [0.26–0.87]); dietary changes (nonwhites 0.19, [0.13–0.27], whites 0.37, [0.21–0.64]); and physical activity (nonwhites 0.22, [0.16–0.32], whites 0.32, [0.18–0.57]). Lifestyle counseling rates by clinicians are suboptimal among obese patients without CV risk factors, especially blacks and Hispanics. Systematic education about and application of lifestyle interventions could capitalize on opportunities for primary CV risk prevention.     

Quality of life in Mexican-American children following a weight management program

Objective: The objective was to evaluate quality of life (QOL) in at‐risk‐for‐overweight and overweight Mexican‐American children after participating in 6 months of intensive weight management or self‐help. Research Methods and Procedures: Eighty sixth‐ and seventh‐grade at‐risk‐for‐overweight (BMI ≥85th to <95th percentile) and overweight (BMI ≥95th percentile) Mexican‐American children were randomly assigned to either intensive instructor‐led intervention (ILI) or self‐help (SH). The ILI condition included daily participation for 12 weeks in a school‐based program comprised of nutrition education, physical activity, and behavior modification, followed by ongoing monthly maintenance. QOL was assessed at baseline and 6 months via child self‐report PedsQL. QOL outcomes were compared across treatment groups, and the impact of change in zBMI on change in QOL was evaluated. Results: Children in the ILI condition not only achieved significantly greater weight loss (zBMI, ?0.13 ± 0.14; p < 0.001) but also significantly greater physical QOL improvements than those in the SH condition at 6 months (p < 0.05). Furthermore, physical QOL increases were associated with zBMI reduction (p < 0.05). However, neither psychosocial nor total QOL was significantly impacted by intervention or zBMI change. Discussion: These findings show that even modest decreases in zBMI after weight management result in improved physical QOL in Mexican‐American children. These results illustrate the clear need to include evaluation of QOL in the process of identifying effective weight management programs.     

The Women on the Move Through Activity and Nutrition (WOMAN) study: final 48-month results

The Women on the Move through Activity and Nutrition (WOMAN) study was designed to test whether a nonpharmacological intervention including qualitative and quantitative dietary changes to induce weight loss and increased physical activity levels would reduce blood triglyceride levels and number of low‐density lipoprotein particles (LDL‐P). Such decreases in lipoproteins and other risk factors could reduce or slow progression of subclinical cardiovascular disease (CVD). Study participants were randomized to either the intervention (Lifestyle Change) or assessment (Health Education) group. Most of the intervention ended at the 30‐month visit. The last 48‐month examination was completed in 9/2008. There was very substantial weight loss and increased exercise during the first 30 months of the trial resulting in significant decreases in CV risk factors. Most of the intervention effect was lost through 48 months. Weight loss was 3.4 kg in Lifestyle Intervention and 0.2 kg in the Health Education at 48 months (P = 0.000). There were no significant changes at 48 months in lipid levels, blood pressure (BP), glucose, insulin, or in the subclinical measures of coronary calcium, carotid intima media thickness, or plaque. There was a significant decrease in long‐distance corridor walk time in the Lifestyle vs. Health Education groups. Significant lifestyle changes can be achieved that result in decreases in CV risk factors. Whether such changes reduce CV outcomes is still untested in clinical trials of weight loss or exercise. Long‐term maintenance of successful lifestyle changes, weight loss and reduced risk factors is the hurdle for lifestyle interventions attempting to prevent CV and other chronic diseases.     

FTO Genotype and the Weight Loss Benefits of Moderate Intensity Exercise

The fat mass and obesity‐associated (FTO) gene was genotyped for the participants in the Dose‐Response to Exercise in postmenopausal Women (DREW) trial and analyses were performed to determine whether an FTO variant was associated with adiposity and cardiorespiratory fitness (CRF) before and after 6 months of moderate intensity exercise in white women (n = 234). The A/A homozygotes for rs8050136 had a higher BMI (kg/m²) compared to C/C homozygotes at baseline (32.8 (0.6) vs. 31.0 (0.4), respectively; P < 0.05) and at follow‐up (31.9 (0.6) vs. 30.4 (0.5), respectively; P < 0.05). Weight loss occurred after exercise, but there was no significant genotype by exercise interaction over time. Exploratory analyses among women exposed to moderate intensity exercise meeting, or exceeding, the physical activity recommendation found that those homozygous A/A lost significantly more weight than the C allele carriers (?3.3 (0.7) kg vs. ?1.4 (0.4) kg and ?1.5 (0.5) kg, respectively; P < 0.05). CRF, defined as VO_2peak (oxygen consumption), increased after exercise and the magnitude of the increase was similar for each genotype. In conclusion, women genetically predisposed to being obese experienced weight loss and CRF benefits with moderate intensity exercise, with additional weight loss observed when the women met or exceeded the physical activity recommendations.     

Differences in motivations and weight loss behaviors in young adults and older adults in the national weight control registry

Objective:

The goal of this study was to compare young adults (YA) and older adults (OA) in the National Weight Control Registry on motivations for weight loss and weight‐loss behaviors.

Design and Methods:

Participants (n = 2,964, 82% female, 94% White, BMI = 24.8 ± 4.4) were divided into two age groups (18‐35 vs. 36‐50) and compared on motivations, strategies for weight loss, diet, physical activity (PA), and the three‐factor eating questionnaire.

Results:

YA were 28.6% of the sample (n = 848). YA and OA achieved similar weight losses (P = 0.38), but duration of maintenance was less in YA (43 vs. 58 months, P < 0.001). YA were more likely to cite appearance and social motivations for weight loss, were less motivated by health, and were less likely to report a medical trigger for weight loss (P's < 0.001). YA were more likely to use exercise classes and to lose weight on their own, and less likely to use a commercial program (P's < 0.001). YA reported engaging in more high‐intensity PA (P = 0.001). There were no group differences in total calories consumed (P = 0.47), or percent calories from fat (P = 0.97), alcohol (P = 0.52), or sugar‐sweetened beverages (P = 0.26).

Conclusions:

YA successful weight losers (SWL) are motivated more by appearance and social influences than OA, and physical activity appears to play an important role in their weight‐loss efforts. The differences reported by YA and OA SWL should be considered when developing weight‐loss programs for YA.     

Arterial stiffness,lifestyle intervention and a low‐calorie diet in morbidly obese patients—A nonrandomized clinical trial

Objective:

Arterial stiffness is an independent predictor of cardiovascular morbidity and mortality. This study aimed to compare the 7‐week effect of a low‐calorie diet (LCD) and an intensive lifestyle intervention program (ILI) on arterial stiffness in morbidly obese individuals.

Design and Methods:

Nonrandomized clinical trial. The LCD provided 900 kcal/day, and participants in the LCD group were instructed to maintain their habitual physical activity level. The ILI included two 90‐min supervised training sessions 3 days a week at moderate to high intensity (4‐8 METs) and a caloric restriction of 1000 kcal/day.

Results:

A total of 179 individuals completed the study, 88 (56 women) in the ILI group and 91 (57 women) in the LCD group. High‐fidelity applanation tonometry (Millar^®, Sphygmocor^®) was used to measure carotid‐femoral pulse wave velocity (PWV). After adjustment for relevant confounders, the ILI group had a significantly greater reduction in PWV than the LCD group; ?0.4 (?0.6, ?0.1) m/s, P = 0.004. When compared to the LCD group, the ILI group showed a larger reduction in systolic and diastolic blood pressure ?5 (?9, ?1) and ?5 (?7, ?2) mmHg, P = 0.038 and P ≤ 0.001 respectively, whereas no difference was observed regarding pulse pressure, P = 0.661. No significant differences between groups were found regarding the loss of fat mass, P = 0.259, but the loss of muscle mass was larger in the LCD group, 0.8 (0.5, 1.1) kg, P ≤ 0.001.

Conclusion:

Despite the limitations of a nonrandomized design, our findings indicate that for morbidly obese individuals a moderate caloric restriction combined with aerobic physical exercise is associated with a greater decline in PWV than a LCD alone.

     

Influence of knee osteoarthritis on exercise capacity and quality of life in obese adults

Objective: The objective was to determine whether knee osteoarthritis (OA) reduces exercise ambulatory capacity and impairs quality of life (QOL) in obese individuals. Research Methods and Procedures: There were 56 subjects, with and without knee OA, who were obese. The subjects were evaluated with anthropometric measurements, a body composition assessment, maximal cardiopulmonary exercise test, 6‐minute walk test (6‐MWT), perceived exertion (RPE), self‐reported disability [Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)], and the Medical Outcomes Study Short Form 36 (SF‐36). Results: VO_2peak was significantly higher in the controls when compared with the patients (mean ± standard deviation, 1.584 ± 0.23 L/kg per min vs. 0.986 ± 0.20 L/kg per min; p < 0.001). Obese subjects without knee OA walked a significantly longer distance in the 6‐MWT than obese patients with knee OA (p < 0.001). We also observed significant negative correlation between Vo ₂max and RPE, WOMAC pain and physical limitation, and bodily pain and general health domains of short‐form 36. Discussion: Knee OA reduces exercise and ambulatory capacity and impairs QOL in obese individuals. RPE, WOMAC pain, and SF‐36 items might provide information about exercise capacity in the obese subjects with knee OA. Our study confirms that exercise capacity and QOL might be improved by energetic and intensive treatment of pain resulting from knee OA.     

Exercise Improves Body Fat,Lean Mass,and Bone Mass in Breast Cancer Survivors

Given the negative effects of a breast cancer diagnosis and its treatments on body weight and bone mass, we investigated the effects of a 6‐month randomized controlled aerobic exercise intervention vs. usual care on body composition in breast cancer survivors. Secondary aims were to examine the effects stratified by important prognostic and physiologic variables. Seventy‐five physically inactive postmenopausal breast cancer survivors were recruited through the Yale–New Haven Hospital Tumor Registry and randomly assigned to an exercise (n = 37) or usual care (n = 38) group. The exercise group participated in 150 min/week of supervised gym‐ and home‐based moderate‐intensity aerobic exercise. The usual care group was instructed to maintain their current physical activity level. Body composition was assessed at baseline and 6‐months through dual‐energy X‐ray absorptiometry (DXA) by one radiologist blinded to the intervention group of the participants. On an average, exercisers increased moderate‐intensity aerobic exercise by 129 min/week over and above baseline levels compared with 45 min/week among usual care participants (P < 0.001). Exercisers experienced decreases in percent body fat (P = 0.0022) and increases in lean mass (P = 0.047) compared with increases in body fat and decreases in lean mass in usual care participants. Bone mineral density (BMD) was also maintained among exercisers compared with a loss among usual care participants (P = 0.043). In summary, moderate‐intensity aerobic exercise, such as brisk walking, produces favorable changes in body composition that may improve breast cancer prognosis.     

The effect of pioglitazone and resistance training on body composition in older men and women undergoing hypocaloric weight loss

Age‐related increases in ectopic fat accumulation are associated with greater risk for metabolic and cardiovascular diseases, and physical disability. Reducing skeletal muscle fat and preserving lean tissue are associated with improved physical function in older adults. PPARγ‐agonist treatment decreases abdominal visceral adipose tissue (VAT) and resistance training preserves lean tissue, but their effect on ectopic fat depots in nondiabetic overweight adults is unclear. We examined the influence of pioglitazone and resistance training on body composition in older (65–79 years) nondiabetic overweight/obese men (n = 48, BMI = 32.3 ± 3.8 kg/m²) and women (n = 40, BMI = 33.3 ± 4.9 kg/m²) during weight loss. All participants underwent a 16‐week hypocaloric weight‐loss program and were randomized to receive pioglitazone (30 mg/day) or no pioglitazone with or without resistance training, following a 2 × 2 factorial design. Regional body composition was measured at baseline and follow‐up using computed tomography (CT). Lean mass was measured using dual X‐ray absorptiometry. Men lost 6.6% and women lost 6.5% of initial body mass. The percent of fat loss varied across individual compartments. Men who were given pioglitazone lost more visceral abdominal fat than men who were not given pioglitazone (?1,160 vs. ?647 cm³, P = 0.007). Women who were given pioglitazone lost less thigh subcutaneous fat (?104 vs. ?298 cm³, P = 0.002). Pioglitazone did not affect any other outcomes. Resistance training diminished thigh muscle loss in men and women (resistance training vs. no resistance training men: ?43 vs. ?88 cm³, P = 0.005; women: ?34 vs. ?59 cm³, P = 0.04). In overweight/obese older men undergoing weight loss, pioglitazone increased visceral fat loss and resistance training reduced skeletal muscle loss. Additional studies are needed to clarify the observed gender differences and evaluate how these changes in body composition influence functional status.     

Changes in Health State Utilities With Changes in Body Mass in the Diabetes Prevention Program

Health utilities are measures of health‐related quality of life (HRQL) used in cost‐effectiveness research. We evaluated whether changes in body weight were associated with changes in health utilities in the Diabetes Prevention Program (DPP) and whether associations differed by treatment assignment (lifestyle intervention, metformin, placebo) or baseline obesity severity. We constructed physical (PCS‐36) and mental component summary (MCS‐36) subscales and short‐form‐6D (SF‐6D) health utility index for all DPP participants completing a baseline 36‐item short form (SF‐36) HRQL assessment (N = 3,064). We used linear regression to test associations between changes in body weight and changes in HRQL indicators, while adjusting for other demographic and behavioral variables. Overall differences in HRQL between treatment groups were highly statistically significant but clinically small after 1 year. In multivariable models, weight change was independently associated with change in SF‐6D score (increase of 0.007 for every 5 kg weight loss; P < 0.001), but treatment effects independent of weight loss were not. We found no significant interaction between baseline obesity severity and changes in SF‐6D with changes in body weight. However, increases in physical function (PCS‐36) with weight loss were greater in persons with higher baseline obesity severity. In summary, improvements in HRQL are associated with weight loss but not with other effects of obesity treatments that are unrelated to weight loss. Although improvements in the SF‐6D did not exceed commonly reported thresholds for a minimally important difference (0.04), these changes, if causal, could still have a significant impact on clinical cost‐effectiveness estimates if sustained over multiple years.     

Obesity Reduction Black Intervention Trial (ORBIT): 18‐Month Results

Obesity is a chronic condition that is prevalent in black women. The Obesity Reduction Black Intervention Trial (ORBIT) was a randomized controlled weight loss and weight‐loss maintenance (WLM) trial. Participants (N = 213) were randomized to the intervention or control groups in August 2005 and September 2006. Follow‐up data were collected 6 and 18 months after randomization. The main outcome was change in weight and BMI from baseline to 18 months. The mean weight at baseline was 104.9 kg, and the mean weight loss in the intervention group at 6 months was 3.0 kg and a gain of 0.2 kg in the control group (mean difference between groups in weight change at 6 months, adjusting for baseline weight and cohort, ?3.27 kg; 95% confidence interval (CI), ?4.50 to ?2.05 kg; P < 0.001). Both groups gained weight between 6 and 18 months (mean 1.0 kg in the intervention group and 0.1 kg in the control group). However, intervention participants lost significantly more weight than control participants during the 18‐month intervention (adjusted mean difference between groups at 18 months, ?2.83 kg; 95% CI, ?4.71 to ?0.95; P = 0.003). At 18 months, intervention participants were more likely than control participants to have lost at least 5% of baseline weight (24% vs. 12%, P < 0.04). Our results indicate that the ORBIT program did promote weight loss and weight‐loss maintenance. However, the results also clearly illustrate there is more to learn about what will contribute to meaningful weight loss and maintenance in this population.     

Lifestyle intervention and/or statins for the reduction of C‐reactive protein in type 2 diabetes: From the look AHEAD study

Objective:

Cardiovascular risk remains high despite statin use. Overweight/obese diabetic persons usually have normal/low LDL‐cholesterol but high C‐reactive protein (CRP) levels. We aimed to examine the effects of intensive lifestyle intervention for weight loss (ILI) on CRP levels in overweight/obese diabetic individuals by statin use.

Design and Methods:

Look AHEAD was a randomized trial in overweight/obese type 2 diabetic individuals testing whether ILI would reduce cardiovascular mortality, when compared to usual care. CRP changes in 1,431 participants with biomarker levels, who remained on or off statin treatment for 1 year, were evaluated.

Results:

The reduction in CRP levels with ILI at 1 year in men and women on statins was ?44.9 and ?42.3%, respectively, compared to ?13.7 and ?21.0% for those on statins and usual care (P < 0.0001). At 1 year, median CRP levels were: 1.8 mg L^?1 in participants randomized to ILI on statin therapy; 2.6 mg L^?1 for those on statins randomized to usual care and 2.9 mg L^?1 for participants not on statins but randomized to ILI. Weight loss was associated with 1‐year CRP reduction (P < 0.0001) in statin and nonstatin users.

Conclusions:

Our findings suggest that in overweight/obese diabetic persons, ILI and statin therapy may have substantial additive anti‐inflammatory benefits.