Mace Coday

Cardiovascular effects of intensive lifestyle intervention in type 2 diabetes

BACKGROUND Weight loss is recommended for overweight or obese patients with type 2 diabetes on the basis of short-term studies, but long-term effects on cardiovascular disease remain unknown. We examined whether an intensive lifestyle intervention for weight loss would decrease cardiovascular morbidity and mortality among such patients. METHODS In 16 study centers in the United States, we randomly assigned 5145 overweight or obese patients with type 2 diabetes to participate in an intensive lifestyle intervention that promoted weight loss through decreased caloric intake and increased physical activity (intervention group) or to receive diabetes support and education (control group). The primary outcome was a composite of death from cardiovascular causes, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for angina during a maximum follow-up of 13.5 years. RESULTS The trial was stopped early on the basis of a futility analysis when the median follow-up was 9.6 years. Weight loss was greater in the intervention group than in the control group throughout the study (8.6% vs. 0.7% at 1 year; 6.0% vs. 3.5% at study end). The intensive lifestyle intervention also produced greater reductions in glycated hemoglobin and greater initial improvements in fitness and all cardiovascular risk factors, except for low-density-lipoprotein cholesterol levels. The primary outcome occurred in 403 patients in the intervention group and in 418 in the control group (1.83 and 1.92 events per 100 person-years, respectively; hazard ratio in the intervention group, 0.95; 95% confidence interval, 0.83 to 1.09; P=0.51). CONCLUSIONS An intensive lifestyle intervention focusing on weight loss did not reduce the rate of cardiovascular events in overweight or obese adults with type 2 diabetes. (Funded by the National Institutes of Health and others; Look AHEAD ClinicalTrials.gov number, NCT00017953.).

Long-term effects of a lifestyle intervention on weight and cardiovascular risk factors in individuals with type 2 diabetes mellitus: Four-year results of the look AHEAD trial

BACKGROUND Lifestyle interventions produce short-term improvements in glycemia and cardiovascular disease (CVD) risk factors in individuals with type 2 diabetes mellitus, but no long-term data are available. We examined the effects of lifestyle intervention on changes in weight, fitness, and CVD risk factors during a 4-year study. METHODS The Look AHEAD (Action for Health in Diabetes) trial is a multicenter randomized clinical trial comparing the effects of an intensive lifestyle intervention (ILI) and diabetes support and education (DSE; the control group) on the incidence of major CVD events in 5145 overweight or obese individuals (59.5% female; mean age, 58.7 years) with type 2 diabetes mellitus. More than 93% of participants provided outcomes data at each annual assessment. RESULTS Averaged across 4 years, ILI participants had a greater percentage of weight loss than DSE participants (-6.15% vs -0.88%; P < .001) and greater improvements in treadmill fitness (12.74% vs 1.96%; P < .001), hemoglobin A(1c) level (-0.36% vs -0.09%; P < .001), systolic (-5.33 vs -2.97 mm Hg; P < .001) and diastolic (-2.92 vs -2.48 mm Hg; P = .01) blood pressure, and levels of high-density lipoprotein cholesterol (3.67 vs 1.97 mg/dL; P < .001) and triglycerides (-25.56 vs -19.75 mg/dL; P < .001). Reductions in low-density lipoprotein cholesterol levels were greater in DSE than ILI participants (-11.27 vs -12.84 mg/dL; P = .009) owing to greater use of medications to lower lipid levels in the DSE group. At 4 years, ILI participants maintained greater improvements than DSE participants in weight, fitness, hemoglobin A(1c) levels, systolic blood pressure, and high-density lipoprotein cholesterol levels. CONCLUSIONS Intensive lifestyle intervention can produce sustained weight loss and improvements in fitness, glycemic control, and CVD risk factors in individuals with type 2 diabetes. Whether these differences in risk factors translate to reduction in CVD events will ultimately be addressed by the Look AHEAD trial. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00017953.

Overview of the Activity Counseling Trial (ACT) intervention for promoting physical activity in primary health care settings

Counseling by health care providers has the potential to increase physical activity in sedentary patients, yet few studies have tested interventions for physical activity counseling delivered in health care settings. The Activity Counseling Trial (ACT) is a 5-yr randomized clinical trial to evaluate the efficacy of two primary care, practice-based physical activity behavioral interventions relative to a standard care control condition. A total of 874 sedentary men and women, 35-75 yr of age, have been recruited from primary care physician offices at three clinical centers for 2 yr of participation. They were randomly assigned to one of three experimental conditions that vary, in a hierarchical fashion, by level of counseling intensity and resource requirements. The interventions, which are based on social cognitive theory and the transtheoretical model, are designed to alter empirically based psychosocial mediators that are known to be associated with physical activity. The present paper describes the theoretical background of the intervention, the intervention methods, and intervention training and quality control procedures.

Impact of intensive lifestyle intervention on depression and health-related quality of life in type 2 diabetes: the Look AHEAD Trial.

OBJECTIVE We examined the effects of an intensive lifestyle intervention (ILI), compared with a diabetes support and education (DSE) control intervention, on long-term changes in depression symptoms, antidepressant medication (ADM) use, and health-related quality of life (HRQoL) in overweight/obese individuals with type 2 diabetes. RESEARCH DESIGN AND METHODS Look AHEAD was a multisite randomized controlled trial of 5,145 overweight/obese participants assigned to ILI (designed to produce weight loss) or DSE and followed for a median of 9.6 years. The Beck Depression Inventory (BDI) was administered at baseline, annually at years 1–4, and again at year 8. Mean BDI scores and incidence of BDI scores ≥10, indicative of likely mild or greater depression, were examined. Annually through year 10, participants reported their ADM use and completed the Medical Outcomes Study Short Form 36 (SF-36) questionnaire, which yields physical component summary (PCS) and mental component summary (MCS) scores. RESULTS ILI significantly reduced the incidence of mild or greater depression symptoms (BDI scores ≥10) compared with DSE (hazard ratio [HR] = 0.85; 95% CI 0.75–0.97; P = 0.0145). Although SF-36 PCS scores worsened over time in both groups, ILI participants reported better physical function than DSE throughout the first 8 years (all P values <0.01). There were no significant differences between treatment arms in the proportion of participants who used ADMs or in SF-36 MCS scores. CONCLUSIONS ILI for overweight/obese patients with type 2 diabetes may reduce the risk of developing clinically significant symptoms of depression and preserve physical HRQoL. These findings should be considered when evaluating the potential benefits of ILIs.

Perceived Environments As Physical Activity Correlates and Moderators of Intervention in Five Studies

PURPOSE Few studies have explored how relationships of perceived environment and physical activity vary across different activity domains and populations. This question was explored in five physical activity intervention trials funded by the National Institutes of Health Behavior Change Consortium. DESIGN Observational. SETTINGS San Francisco peninsula, California (N = 94); Eugene, Oregon (N = 122); Atlanta, Georgia (N = 256); Kingston, Rhode Island (N = 109); Memphis, Tennessee (N = 64). SUBJECTS Ethnically diverse community adults ages 18 to 85 years. MEASURES The Neighborhood Environment Walkability Scale and CHAMPS physical activity questionnaire. Response rate among those invited to complete these measures was 90%. RESULTS Cross-sectional pooled signal detection analysis indicated that people who reported living in neighborhoods with more attractive scenery and ease of walking were more likely to meet national physical activity recommendations (67%) compared with those without these neighborhood attributes (36%; chi2 = 13.04, p = .0003). Within-site multiple regression identified two additional variables--seeing others when walking and encountering loose dogs that make it difficult to walk--as correlates across multiple sites and activity domains (i.e., minutes of weekly moderate or more vigorous activity, walking for errands, walking leisurely) (incremental R2 = 2.0-7.5; p < .05). Analyses of covariance suggested that traffic safety might be particularly important in facilitating or impeding physical activity in response to a formal intervention (for traffic-arm assignment interactions, F = 3.8-7.0, p < or = .05). CONCLUSIONS Relationships between perceived environments and physical activity may differ depending upon population groups and activity domains and merit investigation by using stronger prospective designs.

Support Group Meeting Attendance is Associated with Better Weight Loss

BackgroundSupport group meetings (SGM) are assumed to be an integral part of success after bariatric surgery. This investigation studies the effect of SGM on weight loss as well as factors associated with attendance of SGM. It is our hypothesis that patients who attend SGM (ASGM) lose more weight than those patients who do not attend SGM (NASGM).MethodsPostoperative bariatric patients completed a questionnaire regarding their opinions of SGM. Change in body mass index (BMI) was computed for each patient. The patients were then divided into two groups: ASGM and NASGM for data comparison.ResultsThere were 46 patients in the investigation. Patients in the NASGM group tended to feel that SGM are not needed after bariatric surgery compared to the ASGM group (5.29 vs. 7.06; p = 0.07). Patients in the NASGM group tended to feel that they would lose the same amount of weight with or without attending SGM compared to the ASGM group (5.67 vs. 7.38; p = 0.07). There were no differences in distance to clinic nor in time to clinic between both groups. Gastric bypass patients in the ASGM group had a statistically significantly higher percent decrease in BMI than the patients in the NASGM group (42% vs. 32%; p < 0.03).ConclusionPatients in the ASGM group lose more weight than patients in the NASGM group. The importance of attending SGM should be incorporated in preoperative patient counseling and encouraged during postoperative follow-up visits.

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.

Association of the magnitude of weight loss and changes in physical fitness with long-term cardiovascular disease outcomes in overweight or obese people with type 2 diabetes: a post-hoc analysis of the Look AHEAD randomised clinical trial

BACKGROUND Findings from the Look AHEAD trial showed no significant reductions in the primary outcome of cardiovascular disease incidence in adults with type 2 diabetes randomly assigned to an intensive lifestyle intervention for weight loss compared with those randomly assigned to diabetes support and education (control). We examined whether the incidence of cardiovascular disease in Look AHEAD varied by changes in weight or fitness. METHODS Look AHEAD was a randomised clinical trial done at 16 clinical sites in the USA, recruiting patients from Aug 22, 2001, to April 30, 2004. In the trial, 5145 overweight or obese adults aged 45-76 years with type 2 diabetes were assigned (1:1) to an intensive lifestyle intervention or diabetes support and education. In this observational, post-hoc analysis, we examined the association of magnitude of weight loss and fitness change over the first year with incidence of cardiovascular disease. The primary outcome of the trial and of this analysis was a composite of death from cardiovascular causes, non-fatal acute myocardial infarction, non-fatal stroke, or admission to hospital for angina. The secondary outcome included the same indices plus coronary artery bypass grafting, carotid endartectomy, percutaneous coronary intervention, hospitalisation for congestive heart failure, peripheral vascular disease, or total mortality. We adjusted analyses for baseline differences in weight or fitness, demographic characteristics, and risk factors for cardiovascular disease. The Look AHEAD trial is registered with ClinicalTrials.gov, number NCT00017953. FINDINGS For the analyses related to weight change, we excluded 311 ineligible participants, leaving a population of 4834; for the analyses related to fitness change, we excluded 739 participants, leaving a population of 4406. In analyses of the full cohort (ie, combining both study groups), over a median 10·2 years of follow-up (IQR 9·5-10·7), individuals who lost at least 10% of their bodyweight in the first year of the study had a 21% lower risk of the primary outcome (adjusted hazard ratio [HR] 0·79, 95% CI 0·64-0·98; p=0·034) and a 24% reduced risk of the secondary outcome (adjusted HR 0·76, 95% CI 0·63-0·91; p=0·003) compared with individuals with stable weight or weight gain. Achieving an increase of at least 2 metabolic equivalents in fitness change was associated with a significant reduction in the secondary outcome (adjusted HR 0·77, 95% CI 0·61-0·96; p=0·023) but not the primary outcome (adjusted HR 0·78, 0·60-1·03; p=0·079). In analyses treating the control group as the reference group, participants in the intensive lifestyle intervention group who lost at least 10% of their bodyweight had a 20% lower risk of the primary outcome (adjusted HR 0·80, 95% CI 0·65-0·99; p=0·039), and a 21% lower risk of the secondary outcome (adjusted HR 0·79, 95% CI 0·66-0·95; p=0·011); however, change in fitness was not significantly associated with a change in the primary outcome. INTERPRETATION The results of this post-hoc analysis of Look AHEAD suggest an association between the magnitude of weight loss and incidence of cardiovascular disease in people with type 2 diabetes. These findings suggest a need to continue to refine approaches to identify individuals who are most likely to benefit from lifestyle interventions and to develop strategies to improve the magnitude of sustained weight loss with lifestyle interventions. FUNDING US National Institute of Diabetes and Digestive and Kidney Diseases.Background The Look AHEAD Study found no significant reduction in cardiovascular disease (CVD) incidence among adults with diabetes enrolled in an intensive weight loss intervention (ILI) compared to those randomized to diabetes support and education (DSE). We examined whether CVD incidence in Look AHEAD varied by weight or fitness change. Methods Among overweight or obese adults people aged 45–76 with type 2 diabetes in the Look AHEAD study, this observational analysis examined the association of magnitude of weight loss (N=4834) and fitness change (N=4406) over the first year with CVD incidence over a median 10.2 years of follow-up. The primary outcome was a composite of CVD death, myocardial infarction, stroke, or angina hospitalization; the secondary outcome included the same indices plus coronary–artery bypass grafting, carotid endartectomy, percutaneous coronary intervention, hospitalization for congestive heart failure, peripheral vascular disease, or total mortality. Analyses adjusted for baseline differences in weight or fitness, demographics and CVD risk factors. Findings In analyses of the full cohort combining ILI and DSE, persons who lost > 10% body weight in the first year had 21% lower risk of the primary outcome (HR=0.79, 95% CI, 0.64 to 0.98) and a 24% reduced risk of the secondary outcome (HR=0.76, 95% CI, 0.63 to 0.91) relative to those with stable weight/weight gain. Achieving a > 2 MET fitness change was associated with a significant reduction in the secondary outcome (HR=0.77, 95% CI, 0.61 – 0.96) but not the primary outcome (HR=0.78, 0.60 – 1.03). In analyses treating the DSE as the referent group, ILI participants with > 10% weight losses had a 20% lower risk of the primary outcome (HR=0.80 (95% CI, 0.65 – 0.99) and a 21% reduced risk of the secondary outcome (0.79 (95% CI, 0.66 – 0.95); fitness change was not significantly associated with either outcome. Interpretation This secondary analysis of Look AHEAD suggests an association between the magnitude of intentional weight loss and CVD incidence.

Binge eating and weight loss outcomes in overweight and obese individuals with type 2 diabetes: results from the Look AHEAD trial.

CONTEXT Binge eating (BE) is common in overweight and obese individuals with type 2 diabetes mellitus, but little is known about how BE affects weight loss in this population. OBJECTIVE To determine whether BE was related to 1-year weight losses in overweight and obese individuals with type 2 diabetes participating in an ongoing clinical trial. DESIGN, SETTING, AND PARTICIPANTS The Look AHEAD (Action for Health in Diabetes) trial is a randomized controlled trial examining the long-term effect of intentional weight loss on cardiovascular disease in overweight and obese adults with type 2 diabetes. A total of 5145 overweight and obese individuals aged 45 to 76 years with type 2 diabetes participated in this study. INTERVENTIONS Participants were randomly assigned to an intensive lifestyle intervention or to enhanced usual care (a diabetes support and education control condition). MAIN OUTCOME MEASURES At baseline and 1 year, participants had their weight measured and completed a fitness test and self-report measures of BE and dietary intake. Four groups were created based on BE status at baseline and 1 year (yes/yes, no/no, yes/no, and no/yes). Analyses controlled for baseline differences between binge eaters and non-binge eaters. RESULTS Most individuals (85.4%) did not report BE at baseline or 1 year (no/no), 7.5% reported BE only at baseline (yes/no), 3.7% reported BE at both times (yes/yes), and 3.4% reported BE only at 1 year (no/yes), with no differences between intensive lifestyle intervention and diabetes support and education conditions (P = .14). Across intensive lifestyle intervention and diabetes support and education, greater weight losses were observed in participants who stopped BE at 1 year (mean [SE] weight loss, 5.3 [0.4] kg) and those who reported no BE at either time (mean [SE] weight loss, 4.8 [0.1] kg) than in those who continued BE (mean [SE] weight loss, 3.1 [0.6] kg) and those who began BE at 1 year (mean [SE] weight loss, 3.0 [0.6] kg) (P < .001). Post hoc analyses suggested that these differences were due to changes in caloric intake. CONCLUSION Overweight and obese individuals with type 2 diabetes who stop BE appear to be just as successful at weight loss as non-binge eaters after 1 year of treatment. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00017953.

Identifying subgroups that succeed or fail with three levels of physical activity intervention: the Activity Counseling Trial.

The authors used recursive partitioning methods to identify combinations of baseline characteristics that predict 2-year physical activity success in each of 3 physical activity interventions delivered in the multisite Activity Counseling Trial. The sample consisted of 874 initially sedentary primary care patients, ages 35-75 years, who were at risk for cardiovascular disease. Predictors of 2-year success were specific to each intervention and represented a range of domains, including physiological, demographic, psychosocial, health-related, and environmental variables. The results indicate how specific patient subgroups (e.g., obese, unfit individuals; high-income individuals in stable health) may respond differently to varying levels and amounts of professional assistance and support. The methods used provide a practical first step toward identifying clinically meaningful patient subgroups for further systematic investigation.