Intensive Lifestyle Intervention For Weight Loss Research Articles

O5-5 Neighbourhood Walkability and Physical Activity: Moderating Role of a Physical Activity Interventions in Overweight and Obese Older Adults with Metabolic Syndrome

BackgroundWhile urban built environments might promote active ageing, an infrequently studied question is how the neighbourhood walkability modulates physical activity changes during a physical activity intervention program in older adults. We assessed the influence of objectively assessed neighbourhood walkability on the change in physical activity during the intervention program used in the ongoing PREvención con DIeta MEDiterránea (PREDIMED)-Plus trial. PREDIMED-Plus is a parallel-group, randomized trial which tested the effect of an intensive lifestyle intervention on cardiovascular disease prevention, in overweight and obese participants with the metabolic syndrome.MethodThe present study involved 228 PREDIMED-Plus senior participants aged between 55 to 75, recruited in Palma de Mallorca (Spain). Overweight/obese older adults with metabolic syndrome were randomized to an intensive weight-loss lifestyle intervention or a control group (106 intervention group and 122 control group). A home neighborhood environment walkability index (residential density, land use mix, intersections density) was calculated using geographic information systems (1km sausage-network buffer). Physical activity was assessed using accelerometer for seven days, and a REGICOR validated physical activity questionnaire, at baseline and 2 follow-up visits (six-months and one-year later). Generalized Additive Mixed Models (GAMMs) were fitted to estimate the association between the neighbourhood walkability index and changes in physical activity during follow-up.ResultsHigher neighbourhood walkability (1 z-score increment) was associated with moderate-to-vigorous accelerometer assessed physical activity duration, (ß = 3,44; 95% CI = 0.52;6.36 minutes per day). When analyses were stratified by intervention arm, the association was only observed in the intervention group (ß = 6.357; 95% CI = 2.07;10.64 minutes per day) (p for interaction = 0.055). There were no statistically significant associations between neighbourhood walkability and self-reported physical activity nor brisk walking duration.ConclusionsThe results indicate that the walkability of the neighbourhood could support a physical activity intervention, helping to maintain or increase older adults' objectively measured physical activity. This research may modify evidence on whether environmental factors modify habits acquisition during physical activity intervention programs.

Effect on gut microbiota of a 1-y lifestyle intervention with Mediterranean diet compared with energy-reduced Mediterranean diet and physical activity promotion: PREDIMED-Plus Study

ABSTRACTBackgroundThe Mediterranean diet is a well-recognized healthy diet that has shown to induce positive changes in gut microbiota. Lifestyle changes such as diet along with physical activity could aid in weight loss and improve cardiovascular risk factors.ObjectivesTo investigate the effect of an intensive lifestyle weight loss intervention on gut microbiota.MethodsThis is a substudy of the PREDIMED-Plus (Prevención con Dieta Mediterránea-Plus), a randomized controlled trial conducted in overweight/obese men and women (aged 55–75 y) with metabolic syndrome. The intervention group (IG) underwent an intensive weight loss lifestyle intervention based on an energy-restricted Mediterranean diet (MedDiet) and physical activity promotion, and the control group (CG) underwent a non-energy-restricted MedDiet for 1 y. Anthropometric, biochemical, and gut microbial 16S rRNA sequencing data were analyzed at baseline (n = 362) and 1-y follow-up (n = 343).ResultsIG participants had a weight loss of 4.2 (IQR, –6.8, –2.5) kg compared with 0.2 (IQR, –2.1, 1.4) kg in the CG (P < 0.001). Reductions in BMI, fasting glucose, glycated hemoglobin, and triglycerides and an increase in HDL cholesterol were greater in IG than in CG participants (P < 0.05). We observed a decrease in Butyricicoccus, Haemophilus, Ruminiclostridium 5, and Eubacterium hallii in the IG compared with the CG. Many genera shifted in the same direction within both intervention groups, indicating an overall effect of the MedDiet. Decreases in Haemophilus, Coprococcus 3, and few other genera were associated with a decrease in adiposity parameters in both intervention groups. Changes in Lachnospiraceae NK4A136 were positively associated with changes in MedDiet adherence.ConclusionsWeight loss induced by an energy-restricted MedDiet and physical activity induce changes in gut microbiota. The role of MedDiet-induced changes on the host might be via short-chain fatty acid producing bacteria, whereas with energy restriction, these changes might be modulated with other mechanisms, which need to be explored in future studies. This trial was registered at http://www.isrctn.com/ISRCTN89898870 as ISRCT 89898870.

Halo effect of a Mediterranean-lifestyle weight-loss intervention on untreated family members' weight and physical activity: a prospective study.

Obesity is subject to strong family clustering. The relatives of participants in weight-loss interventions may also modify their lifestyle and lose weight. The aim of this study was to examine the presence and magnitude of a halo effect in untreated family members of participants enrolled in a randomized, multi-component, lifestyle intervention. A total of 148 untreated adult family members of participants in an intensive weight-loss lifestyle intervention (the PREDIMED-Plus study) were included. Changes at 1 and 2 years in body weight, physical activity, and adherence to a traditional Mediterranean diet (MedDiet) were measured. Generalized linear mixed models were used to assess whether the change differed between family members of the intervention group compared to the control. Untreated family members from the intervention group displayed a greater weight loss than those from the control after 1 and 2 years: adjusted 2-year weight change difference between groups was -3.98 (SE 1.10) kg (p < 0.001). There was a halo effect with regard to adherence to the MedDiet at one year which was sustained at two years: 2-year adjusted difference in MedDiet score change +3.25 (SE 0.46) (p < 0.001). In contrast, no halo effect was observed with regard to physical activity, as the untreated family members did not substantially modify their physical activity levels in either group, and the adjusted difference at two years between the 2 groups was -272 (SE 624) METs.min/week (p = 0.665). In the first prospective study to assess the influence on untreated family members of a diet and physical activity weight-loss intervention, we found evidence of a halo effect in relatives on weight loss and improvement in adherence to a MedDiet, but not on physical activity. The expansion of MedDiet changes from individuals involved in a weight-loss intervention to their family members can be a facilitator for obesity prevention.

Effect of an Intensive Weight-Loss Lifestyle Intervention on Kidney Function: A Randomized Controlled Trial

Introduction: Large randomized trials testing the effect of a multifactorial weight-loss lifestyle intervention including Mediterranean diet (MedDiet) on renal function are lacking. Here, we evaluated the 1-year efficacy of an intensive weight-loss intervention with an energy-reduced MedDiet (erMedDiet) plus increased physical activity (PA) on renal function. Methods: Randomized controlled “PREvención con DIeta MEDiterránea-Plus” (PREDIMED-Plus) trial is conducted in 23 Spanish centers comprising 208 primary care clinics. Overweight/obese (n = 6,719) adults aged 55–75 years with metabolic syndrome were randomly assigned (1:1) to an intensive weight-loss lifestyle intervention with an erMedDiet, PA promotion, and behavioral support (intervention) or usual-care advice to adhere to an energy-unrestricted MedDiet (control) between September 2013 and December 2016. The primary outcome was 1-year change in estimated glomerular filtration rate (eGFR). Secondary outcomes were changes in urine albumin-to-creatinine ratio (UACR), incidence of moderately/severely impaired eGFR (<60 mL/min/1.73 m²) and micro- to macroalbuminuria (UACR ≥30 mg/g), and reversion of moderately (45 to <60 mL/min/1.73 m²) to mildly impaired GFR (60 to <90 mL/min/1.73 m²) or micro- to macroalbuminuria. Results: After 1 year, eGFR declined by 0.66 and 1.25 mL/min/1.73 m² in the intervention and control groups, respectively (mean difference, 0.58 mL/min/1.73 m²; 95% CI: 0.15–1.02). There were no between-group differences in mean UACR or micro- to macroalbuminuria changes. Moderately/severely impaired eGFR incidence and reversion of moderately to mildly impaired GFR were 40% lower (HR 0.60; 0.44–0.82) and 92% higher (HR 1.92; 1.35–2.73), respectively, in the intervention group. Conclusions: The PREDIMED-Plus lifestyle intervention approach may preserve renal function and delay CKD progression in overweight/obese adults.

Neighbourhood walkability and physical activity: moderating role of a physical activity intervention in overweight and obese older adults with metabolic syndrome.

BackgroundWhile urban built environments might promote active ageing, an infrequently studied question is how the neighbourhood walkability modulates physical activity changes during a physical activity intervention programme in older adults. We assessed the influence of objectively assessed neighbourhood walkability on the change in physical activity during the intervention programme used in the ongoing PREvención con DIeta MEDiterránea (PREDIMED)-Plus trial.MethodThe present study involved 228 PREDIMED-Plus senior participants aged between 55 and 75, recruited in Palma de Mallorca (Spain). Overweight/obese older adults with metabolic syndrome were randomised to an intensive weight-loss lifestyle intervention or a control group. A walkability index (residential density, land use mix, intersections density) was calculated using geographic information systems (1 km sausage-network buffer). Physical activity was assessed using accelerometer and a validated questionnaire, at baseline and two follow-up visits (6-months and 1-year later). Generalised additive mixed models were fitted to estimate the association between the neighbourhood walkability index and changes in physical activity during follow-up.ResultsHigher neighbourhood walkability (1 z-score increment) was associated with moderate-to-vigorous accelerometer assessed physical activity duration, (β = 3.44; 95% CI = 0.52; 6.36 min/day). When analyses were stratified by intervention arm, the association was only observed in the intervention group (β = 6.357; 95% CI = 2.07;10.64 min/day) (P for interaction = 0.055).ConclusionsThe results indicate that the walkability of the neighbourhood could support a physical activity intervention, helping to maintain or increase older adults’ physical activity.

Effect of a lifestyle intervention program with energy-restricted Mediterranean diet and exercise on the serum polyamine metabolome in individuals at high cardiovascular disease risk: a randomized clinical trial

Many food items included in the Mediterranean diet (MedDiet) are rich in polyamines, small aliphatic amines with potential cardioprotective effects. The consumption of a MedDiet could increase polyamine concentrations. Based on experimental models, polyamine concentrations may be also influenced by physical activity (PA). We aimed to evaluate whether an intervention based on an energy-restricted MedDiet (er-MedDiet) and PA promotion, in comparison with an energy-unrestricted MedDiet and traditional health care, influences the serum pattern of polyamines and related metabolites in subjects at high risk of cardiovascular disease (CVD). This was a substudy from the PREDIMED-Plus trial, an ongoing randomized clinical trial including 6874 participants allocated either to an intensive weight-loss lifestyle intervention based on er-MedDiet, PA promotion, and behavioral support (er-MedDiet+PA group), or to an energy-unrestricted MedDiet and traditional health care group (MedDiet group). A total of 75 patients (n=38, er-MedDiet+PA group; n=37, MedDiet group) were included in this study. Serum concentrations of arginine, ornithine, polyamines, and acetyl polyamines at baseline and 26 wk of intervention were measured by an ultra-high-performance LC-tandem MS platform. At week 26, study groups had similar adherence to the MedDiet but patients randomly assigned to the er-MedDiet+PA group showed significantly lower mean energy intake (-340.3 kcal/d; 95% CI: -567.3, -113.4 kcal/d; P=0.004), higher mean PA (1290.6; 95% CI: 39.9, 2541.3 metabolic equivalent tasks · min/d; P=0.043), and higher mean decrease in BMI (in kg/m2) (-1.3; 95% CI: -1.8, -0.6; P<0.001) than the MedDiet group. However, no significant differences in serum polyamines or related metabolites were found between study groups after 26 wk of intervention and no significant between-group differences were found in glycated hemoglobin, HDL-cholesterol, or triglyceride concentrations. In individuals at high CVD risk, an er-MedDiet with increased PA did not result in significant changes of serum concentrations of polyamines or related metabolites in comparison with an energy-unrestricted MedDiet and no increase in PA. This trial was registered at isrctn.com as ISRCTN89898870.

Carbohydrate quality changes and concurrent changes in cardiovascular risk factors: a longitudinal analysis in the PREDIMED-Plus randomized trial

Overall quality of dietary carbohydrate intake rather than total carbohydrate intake may determine the risk of cardiovascular disease (CVD). We examined 6- and 12-mo changes in carbohydrate quality index (CQI) and concurrent changes in several CVD risk factors in a multicenter, randomized, primary-prevention trial (PREDIMED-Plus) based on an intensive weight-loss lifestyle intervention program. Prospective analysis of 5373 overweight/obese Spanish adults (aged 55-75 y) with metabolic syndrome (MetS). Dietary intake information obtained from a validated 143-item semiquantitative food-frequency questionnaire was used to calculate 6- and 12-mo changes in CQI (categorized in quintiles), based on 4 criteria (total dietary fiber intake, glycemic index, whole grain/total grain ratio, and solid carbohydrate/total carbohydrate ratio). The outcomes were changes in intermediate markers of CVD. During the 12-mo follow-up, the majority of participants improved their CQI by increasing their consumption of fruits, vegetables, legumes, fish, and nuts and decreasing their consumption of refined cereals, added sugars, and sugar-sweetened beverages. After 6 mo, body weight, waist circumference (WC), systolic and diastolic blood pressure (BP), fasting blood glucose, glycated hemoglobin (HbA1c), triglyceride levels, triglycerides and glucose (TyG) index, and TyG-WC decreased across successive quintiles of improvement in the CQI. After 12 mo, improvements were additionally observed for HDL cholesterol and for the ratio of total to HDL cholesterol. Favorable improvements (expressed in common units of SD and 95% CI) for quintile 5 compared with quintile 1 of CQI change were observed for most risk factors, including TyG-WC (SD -0.20; 95% CI -0.26, -0.15), HbA1c (SD -0.16; 95% CI -0.23, -0.10), weight (SD -0.12; 95% CI -0.14, -0.09), systolic BP (SD -0.11; 95% CI -0.19, -0.02) and diastolic BP (SD -0.11; 95% CI -0.19, -0.04). Improvements in CQI were strongly associated with concurrent favorable CVD risk factor changes maintained over time in overweight/obese adults with MetS. This trial was registered as ISRCTN 89898870.

P4990Heterogeneity of treatment effects from an intensive lifestyle weight loss intervention on cardiovascular events in patients with type 2 diabetes: data from the Look AHEAD trial

Abstract Background The Action for Health in Diabetes trial (Look AHEAD) randomized overweight and obese patients with type 2 diabetes to either an intensive lifestyle intervention (ILI) or diabetes support and education (DSE). The trial was stopped early for futility after a median follow-up of 9.6 years due to a lack of effect on cardiovascular disease outcomes, despite beneficial effects on metabolic control and cardiovascular risk factors. Subgroup analyses identified no subgroups based on baseline characteristics with a significant treatment effect. However, traditional simple subgroup analyses have several disadvantages compared to a multivariable risk-based approach to identify heterogeneity of treatment effects (HTE). Purpose To explore the possible presence of HTE of an ILI on the occurrence of major cardiovascular events (4-point MACE: nonfatal myocardial infarction, nonfatal stroke, hospitalization for angina, and death from cardiovascular causes) in overweight or obese patients with type 2 diabetes mellitus, and to identify patient characteristics associated with treatment. Methods In 4,901 patients from Look AHEAD, a ridge penalized Cox regression model to predict treatment effect of ILI versus DSE on the risk of MACE was derived including all possible treatment-by-covariate interaction terms. Next, the ability of the model to predict HTE was confirmed by calculating hazard ratios (HR) and absolute risk change in quartiles of predicted treatment effect, thereby leaving randomization intact. Finally, baseline patient characteristics were compared between quartiles of predicted treatment effect. Results During a median follow-up of 9.4 years, 799 events occurred (Fig. 1A). The derived risk model showed good internal calibration, with a C-statistic for discrimination of 0.73 (95% confidence interval [95% CI] 0.71–0.73). The median estimated absolute treatment effect on 10 year risk for MACE with ILI was −1.3% and varied substantially, ranging from −39% to +43% (Fig. 1B). In quartile 1, the quartile with the highest benefit, there was a significant treatment benefit of ILI versus DSE (HR 0.64; 95% CI 0.49–0.83), while there was no effect from treatment in quartiles 2 and 3 (HR 0.81, 95% CI 0.58–1.14, and 1.13, 95% CI 0.80–1.60, respectively), and a detrimental effect in quartile 4 (HR 1.37, 95% CI 1.09–1.73) (Fig. 1C). Patient characteristics most notably associated with higher benefit of ILI were higher age, male sex, higher socio-economic status, no history of cardiovascular disease, no use of insulin, higher blood pressure, lower HbA1c, and the presence of micro-albuminuria but absence of macro-albuminuria. Figure 1 Conclusion This post-hoc analysis of the Look AHEAD trial shows evidence of considerable HTE of an intensive lifestyle intervention aimed at weight loss for reducing MACE. Future research into ILI for MACE risk reduction should be specifically aimed at subgroups of patients with a high likelihood of treatment benefit. Acknowledgement/Funding None

Heterogeneity of Treatment Effects From an Intensive Lifestyle Weight Loss Intervention on Cardiovascular Events in Patients With Type 2 Diabetes: Data From the Look AHEAD Trial.

To explore the presence of heterogeneity of treatment effect (HTE) of an intensive lifestyle intervention on the occurrence of major cardiovascular events (MACE) in overweight or obese patients with type 2 diabetes, and to identify patient characteristics associated with individual treatment effect. In 4,901 participants from the Action for Health in Diabetes (Look AHEAD) trial, a penalized Cox regression model to predict treatment effect of intensive lifestyle intervention for the risk of MACE was derived, including all possible treatment-by-covariate interaction terms. The ability of the model to predict HTE was confirmed by calculating hazard ratios (HRs) and absolute risk change in quartiles of predicted treatment effect, and baseline patient characteristics were compared between quartiles. In quartile 1 of predicted treatment effect, with the highest predicted risk reduction, there was a significant treatment benefit of intensive lifestyle intervention (HR 0.64 [95% CI 0.49-0.83]), whereas there was no effect from treatment in quartiles 2 and 3 (HR 0.81 [95% CI 0.58-1.14] and 1.13 [95% CI 0.80-1.60], respectively) and a detrimental effect in quartile 4 (HR 1.37 [95% CI 1.09-1.73]). Several patient characteristics in demographics, medical history, physical examination, and laboratory values were associated with the level of treatment effect. This post hoc analysis of the Look AHEAD trial showed that an intensive lifestyle intervention aimed at weight loss may reduce cardiovascular events in selected patients but may have a detrimental treatment effect in others.

Effectiveness of the physical activity intervention program in the PREDIMED-Plus study: a randomized controlled trial

BackgroundThe development and implementation of effective physical activity (PA) intervention programs is challenging, particularly in older adults. After the first year of the intervention program used in the ongoing PREvención con DIeta MEDiterránea (PREDIMED)-Plus trial, we assessed the initial effectiveness of the PA component.MethodsPREDIMED-Plus is an ongoing randomized clinical trial including 6874 participants randomized to an intensive weight-loss lifestyle intervention based on an energy-restricted Mediterranean diet (MedDiet), physical activity promotion and behavioral support and to a control group using MedDiet recommendations but without calorie restriction or PA advice. Body mass index (BMI) and waist circumference (WC) are measured by standard clinical protocols. Duration and intensity of PA is self-reported using the validated REGICOR Short Physical Activity Questionnaire. The primary endpoint of the PREDIMED-Plus trial is a combined cardiovascular outcome: myocardial infarction (acute coronary syndromes with positive troponin test), stroke, or cardiovascular mortality. The present study involved secondary analysis of PA data (n = 6059; mean age 65 ± 4.9 years) with one-year changes in total, light, and moderate-to-vigorous PA within and between intervention groups as the outcome. Generalized estimating equation models were fitted to evaluate time trends of PA, BMI, and WC within groups and differences between intervention and control groups.ResultsAfter 12 months, average daily MVPA increased by 27.2 (95%CI 5.7;48.7) METs-min/day and 123.1 (95%CI 109.7–136.6) METs-min/day in the control and intervention groups, respectively. Total-PA, light-PA, and MVPA increased significantly (p < 0.01) in both groups. A significant (p < 0.001) time*intervention group interaction was found for Total-PA and MVPA, meaning the PA trajectory over time differed between the intervention and control groups. Age, sex, education level, and BMI did not moderate the effectiveness of the PA intervention. BMI and WC decreased significantly with increasing MVPA, compared with participants who reported no changes in MVPA.ConclusionAfter one year of follow-up, the PREDIMED-Plus PA intervention has been effective in increasing daily PA in older adults.Trial registrationRetrospectively registered at the International Standard Randomized Controlled Trial (http://www.isrctn.com/ISRCTN89898870), registration date: 24 July 2014.

Effect of a Lifestyle Intervention Program With Energy-Restricted Mediterranean Diet and Exercise on Weight Loss and Cardiovascular Risk Factors: One-Year Results of the PREDIMED-Plus Trial.

The long-term impact of intentional weight loss on cardiovascular events remains unknown. We describe 12-month changes in body weight and cardiovascular risk factors in PREvención con DIeta MEDiterránea (PREDIMED)-Plus, a trial designed to evaluate the long-term effectiveness of an intensive weight loss lifestyle intervention on primary cardiovascular prevention. Overweight/obese adults with metabolic syndrome aged 55-75 years (n = 626) were randomized to an intensive weight loss lifestyle intervention based on an energy-restricted Mediterranean diet, physical activity promotion, and behavioral support (IG) or a control group (CG). The primary and secondary outcomes were changes in weight and cardiovascular risk markers, respectively. Diet and physical activity changes were in the expected direction, with significant improvements in IG versus CG. After 12 months, IG participants lost an average of 3.2 kg vs. 0.7 kg in the CG (P < 0.001), a mean difference of -2.5 kg (95% CI -3.1 to -1.9). Weight loss ≥5% occurred in 33.7% of IG participants compared with 11.9% in the CG (P < 0.001). Compared with the CG, cardiovascular risk factors, including waist circumference, fasting glucose, triglycerides, and HDL cholesterol, significantly improved in IG participants (P < 0.002). Reductions in insulin resistance, HbA1c, and circulating levels of leptin, interleukin-18, and MCP-1 were greater in IG than CG participants (P < 0.05). IG participants with prediabetes/diabetes significantly improved glycemic control and insulin sensitivity, along with triglycerides and HDL cholesterol levels compared with their CG counterparts. PREDIMED-Plus intensive lifestyle intervention for 12 months was effective in decreasing adiposity and improving cardiovascular risk factors in overweight/obese older adults with metabolic syndrome, as well as in individuals with or at risk for diabetes.

Diabetes in remission

Diabetes in remission

Surgical vs medical treatments for type 2 diabetes mellitus: a randomized clinical trial.

Many questions remain unanswered about the role of bariatric surgery for people with type 2 diabetes mellitus (T2DM). To determine feasibility of a randomized clinical trial (RCT) and compare initial outcomes of bariatric surgery and a structured weight loss program for treating T2DM in participants with grades I and II obesity. A 12-month, 3-arm RCT at a single center including 69 participants aged 25 to 55 years with a body mass index (calculated as weight in kilograms divided by height in meters squared) of 30 to 40 and T2DM. Roux-en-Y gastric bypass (RYGB), laparoscopic adjustable gastric banding (LAGB), and an intensive lifestyle weight loss intervention (LWLI). Primary outcomes in the intention-to-treat cohort were feasibility and effectiveness measured by weight loss and improvements in glycemic control. Of 667 potential participants who underwent screening, 69 (10.3%) were randomized. Among the randomized participants, 30 (43%) had grade I obesity, and 56 (81%) were women. Mean (SD) age was 47.3 (6.4) years and hemoglobin A1c level, 7.9% (2.0%). After randomization, 7 participants (10%) refused to undergo their allocated intervention (3 RYGB, 1 LAGB, and 3 LWLI), and 1 RYGB participant was excluded for current smoking. Twenty participants underwent RYGB; 21, LAGB; and 20, LWLI, with 12-month retention rates of 90%, 86%, and 70%, respectively. In the intention-to-treat cohort with multiple imputation for missing data, RYGB participants had the greatest mean weight loss from baseline (27.0%; 95% CI, 30.8-23.3) compared with LAGB (17.3%; 95% CI, 21.1-13.5) and LWLI (10.2%; 95% CI, 14.8-5.61) (P < .001). Partial and complete remission of T2DM were 50% and 17%, respectively, in the RYGB group and 27% and 23%, respectively, in the LAGB group (P < .001 and P = .047 between groups for partial and complete remission), with no remission in the LWLI group. Significant reductions in use of antidiabetics occurred in both surgical groups. No deaths were noted. The 3 serious adverse events included 1 ulcer treated medically in the RYGB group and 2 rehospitalizations for dehydration in the LAGB group. This study highlights several potential challenges to successful completion of a larger RCT for treatment of T2DM and obesity in patients with a body mass index of 30 to 40, including the difficulties associated with recruiting and randomizing patients to surgical vs nonsurgical interventions. Preliminary results show that RYGB was the most effective treatment, followed by LAGB for weight loss and T2DM outcomes at 1 year. clinicaltrials.gov Identifier: NCT01047735.

Weight Loss Prevents Urinary Incontinence in Women With Type 2 Diabetes: Results From the Look AHEAD Trial

We determined the effect of weight loss on the prevalence, incidence and resolution of weekly or more frequent urinary incontinence in overweight/obese women with type 2 diabetes after 1 year of intervention in the Look AHEAD (Action for Health in Diabetes) trial. Women in this substudy (2,739, mean ± SD age 57.9 ± 6.8 years, body mass index 36.5 ± 6.1 kg/m(2)) were randomized into an intensive lifestyle weight loss intervention or a diabetes support and education control condition. At baseline 27% of participants reported urinary incontinence on a validated questionnaire (no significant difference by intensive lifestyle intervention vs diabetes support and education). After 1 year of intervention the intensive lifestyle intervention group in this substudy lost 7.7 ± 7.0 vs 0.7 ± 5.0 kg in the diabetes support and education group. At 1 year fewer women in the intensive lifestyle intervention group reported urinary incontinence (25.3% vs 28.6% in the diabetes support and education group, p = 0.05). Among participants without urinary incontinence at baseline 10.5% of intensive lifestyle intervention and 14.0% of diabetes support and education participants experienced urinary incontinence after 1 year (p = 0.02). There were no significant group differences in the resolution of urinary incontinence (p >0.17). Each kg of weight lost was associated with a 3% reduction in the odds of urinary incontinence developing (p = 0.01), and weight losses of 5% to 10% reduced these odds by 47% (p = 0.002). Moderate weight loss reduced the incidence but did not improve the resolution rates of urinary incontinence at 1 year among overweight/obese women with type 2 diabetes. Weight loss interventions should be considered for the prevention of urinary incontinence in overweight/obese women with diabetes.

Effect of 1 year of an intentional weight loss intervention on bone mineral density in type 2 diabetes: Results from the look AHEAD randomized trial

Intentional weight loss is an important component of treatment for overweight patients with type 2 diabetes, but the effects on bone density are not known. We used data from the Look AHEAD trial to determine the impact of an intensive lifestyle weight loss intervention (ILI) compared with diabetes support and education (DSE) on changes in bone mineral density (BMD) over 12 months. Overweight and obese adults with type 2 diabetes were randomly assigned to ILI or DSE. In a substudy of BMD conducted at 5 of 16 clinical centers, hip, spine, and whole body dual X-ray absorptiometry scans were obtained at baseline and 1-year later on 642 of 739 ILI and 632 of 740 DSE participants. At baseline, mean age was 58.4 years, and average body mass index was 35.2 kg/m(2). Total hip BMD T-score was <-2.5 in 1% and <-1.0 in 8%. At 1 year, weight loss was greater in ILI than DSE (-8.6% versus -0.7%), and glycemic control and fitness were also improved. Bone loss over 1 year was greater in ILI at the total hip (-1.4% versus -0.4%; p < 0.001) and femoral neck (-1.5% versus -0.8%; p = 0.009), but change in BMD for the lumbar spine and whole body did not differ between groups. In ILI, bone loss at the total hip was independently associated with weight loss in men and women and with poorer glycemic control in men, but was not associated with changes in fitness. One year of an intensive lifestyle intervention in adults with type 2 diabetes, resulting in weight loss, was associated with a modest increase in hip bone loss despite improved fitness and glycemic control.

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.

Effect of a lifestyle intervention on change in cardiorespiratory fitness in adults with type 2 diabetes: results from the Look AHEAD Study

ObjectiveTo examine the effect of an intensive lifestyle weight loss intervention (ILI) compared to diabetes support and education (DSE) on changes in fitness and physical activity in the Look AHEAD trial.DesignRandomized clinical trial to compare a lifestyle intervention for weight loss with a diabetes support and education condition in individuals with type 2 diabetes.SubjectsData from 4,376 overweight or obese adults with type 2 diabetes (age = 58.7±6.8 years, BMI = 35.8±5.8 kg/m2) who completed one-year of the Look AHEAD trial and had available fitness data were analyzed.InterventionSubjects were randomly assigned to DSE or ILI. DSE received standard-care plus 3 education sessions over the one-year period. ILI included individual and group contact throughout the year, restriction in energy intake, and 175 min/wk of prescribed physical activity.MeasurementsFitness was assessed using a submaximal graded exercise test. Physical activity was assessed via questionnaire in a subset of 2,221 subjects.ResultsChange in fitness was statistically greater in ILI vs. DSE after adjustment for baseline fitness (20.9% vs. 5.7%) (p<0.0001). Multivariate analysis showed that change in fitness was greater in overweight vs. obese Class II and III (p<0.05). Physical activity increased by 892±1694 kcal/wk in ILI vs. 108±1254 kcal/wk in DSE (p<0.01). Changes in fitness (r=0.41) and physical activity (r=0.42) were significantly correlated with weight loss (p<0.0001).ConclusionsThe ILI was effective in increasing physical activity and improving cardiorespiratory fitness in overweight and obese individuals with type 2 diabetes. This effect may add to weight loss in improving metabolic control in patients in lifestyle intervention programs.