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      Association of Lifestyle Intervention With Risk for Cardiovascular Events Differs by Level of Glycated Hemoglobin

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          Abstract

          Purpose

          We reevaluated the Action for Health in Diabetes (Look AHEAD) intensive lifestyle intervention (ILI) to assess whether the effect of ILI on cardiovascular disease (CVD) prevention differed by baseline glycated hemoglobin (HbA1c).

          Methods

          Look AHEAD randomized 5145 adults, aged 45 to 76 years with type 2 diabetes and overweight/obesity to ILI or a diabetes support and education (DSE) control group for a median of 9.6 years. ILI focused on achieving weight loss through decreased caloric intake and increased physical activity. We assessed the parent trial's primary composite CVD outcome. We evaluated additive and multiplicative heterogeneity of the intervention on CVD risk by baseline HbA1c.

          Results

          Mean baseline HbA1c was 7.3% (SD 1.2) and ranged from 4.4% (quintile 1) to 14.5% (quintile 5). We observed additive and multiplicative heterogeneity of the association between ILI and CVD (all P < .001) by baseline HbA1c. Randomization to ILI was associated with lower CVD risk for HbA1c quintiles 1 [hazard ratio (HR): 0.68, 95% confidence interval (CI): 0.53, 0.88] and 2 (HR: 0.80, 95% CI: 0.66, 0.96) and associated with higher CVD risk for HbA1c quintile 5 (HR: 1.27, 95% CI: 1.02, 1.58), compared to DSE.

          Conclusion

          Among adults with type 2 diabetes and overweight/obesity, randomization to a lifestyle intervention was differentially associated with CVD risk by baseline HbA1c such that it was associated with lower risk at lower HbA1c levels and higher risk at higher HbA1c levels. There is a critical need to develop and tailor lifestyle interventions to be successful for individuals with type 2 diabetes and high HbA1c.

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          Most cited references18

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          Cardiovascular effects of intensive lifestyle intervention in type 2 diabetes.

          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. 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. 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). 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.).
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            The Look AHEAD study: a description of the lifestyle intervention and the evidence supporting it.

            The Look AHEAD (Action for Health in Diabetes) study is a multicenter, randomized controlled trial designed to determine whether intentional weight loss reduces cardiovascular morbidity and mortality in overweight individuals with type 2 diabetes. The study began in 2001 and is scheduled to conclude in 2012. A total of 5145 participants have been randomly assigned to a lifestyle intervention or to an enhanced usual care condition (i.e., diabetes support and education). This article describes the lifestyle intervention and the empirical evidence to support it. The two principal intervention goals are to induce a mean loss >or = 7% of initial weight and to increase participants' moderately intense physical activity to > or =175 min/wk. For the first 6 months, participants attend one individual and three group sessions per month and are encouraged to replace two meals and one snack a day with liquid shakes and meal bars. From months 7 to 12, they attend one individual and two group meetings per month and continue to replace one meal per day (which is recommended for the study's duration). Starting at month 7, more intensive behavioral interventions and weight loss medication are available from a toolbox, designed to help participants with limited weight loss. In Years 2 to 4, treatment is provided mainly on an individual basis and includes at least one on-site visit per month and a second contact by telephone, mail, or e-mail. After Year 4, participants are offered monthly individual visits. The intervention is delivered by a multidisciplinary team that includes medical staff who monitor participants at risk of hypoglycemic episodes.
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              Eight-Year Weight Losses with an Intensive Lifestyle Intervention: The Look AHEAD Study

              (2014)
              Objective To evaluate 8-year weight losses achieved with intensive lifestyle intervention (ILI) in the Look AHEAD (Action for Health in Diabetes) study. Design and Methods Look AHEAD assessed the effects of intentional weight loss on cardiovascular morbidity and mortality in 5,145 overweight/obese adults with type 2 diabetes, randomly assigned to ILI or usual care (i.e., diabetes support and education [DSE]). The ILI provided comprehensive behavioral weight loss counseling over 8 years; DSE participants received periodic group education only. Results All participants had the opportunity to complete 8 years of intervention before Look AHEAD was halted in September 2012; ≥88% of both groups completed the 8-year outcomes assessment. ILI and DSE participants lost (mean±SE) 4.7±0.2% and 2.1±0.2% of initial weight, respectively (p<0.001) at year 8; 50.3% and 35.7%, respectively, lost ≥5% (p<0.001), and 26.9% and 17.2%, respectively, lost ≥10% (p<0.001). Across the 8 years ILI participants, compared with DSE, reported greater practice of several key weight-control behaviors. These behaviors also distinguished ILI participants who lost ≥10% and kept it off from those who lost but regained. Conclusions Look AHEAD’s ILI produced clinically meaningful weight loss (≥5%) at year 8 in 50% of patients with type 2 diabetes and can be used to manage other obesity-related co-morbid conditions. Trial Registration clinicaltrials.gov Identifier: NCT00017953
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                Author and article information

                Contributors
                Journal
                J Clin Endocrinol Metab
                J Clin Endocrinol Metab
                jcem
                The Journal of Clinical Endocrinology and Metabolism
                Oxford University Press (US )
                0021-972X
                1945-7197
                March 2024
                18 November 2023
                18 November 2023
                : 109
                : 3
                : e1012-e1019
                Affiliations
                Department of Epidemiology and Prevention, Wake Forest University School of Medicine , Winston-Salem, NC 27157, USA
                Department of Medicine, Johns Hopkins School of Medicine , Baltimore, MD 21205, USA
                Department of Medicine, Baylor College of Medicine , Houston, TX 77030, USA
                Department of Medicine, Johns Hopkins School of Medicine , Baltimore, MD 21205, USA
                Department of Preventive Medicine, University of Tennessee Health Science Center , Memphis, TN 38163, USA
                Department of Biostatistics and Data Science, Wake Forest University School of Medicine , Winston-Salem, NC 27157, USA
                Department of Epidemiology and Prevention, Wake Forest University School of Medicine , Winston-Salem, NC 27157, USA
                Department of Biostatistics and Data Science, Wake Forest University School of Medicine , Winston-Salem, NC 27157, USA
                Department of Internal Medicine, Wake Forest University School of Medicine , Winston-Salem, NC 27157, USA
                Author notes
                Correspondence: Mike Bancks, PhD, MPH, Division of Public Health Sciences, Department of Epidemiology & Prevention, 1 Medical Center Boulevard, Wake Forest University School of Medicine, Winston-Salem, NC 27157, USA. Email: mbancks@ 123456wakehealth.edu .
                Author information
                https://orcid.org/0000-0003-3694-6060
                https://orcid.org/0000-0003-2093-5201
                https://orcid.org/0000-0002-5738-0652
                Article
                dgad674
                10.1210/clinem/dgad674
                10876384
                37978826
                5d193a08-6694-4324-ae94-972143f648b3
                © The Author(s) 2023. Published by Oxford University Press on behalf of the Endocrine Society.

                This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( https://creativecommons.org/licenses/by/4.0/), which permits unrestricted reuse, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                : 07 August 2023
                : 13 November 2023
                : 28 November 2023
                Page count
                Pages: 8
                Funding
                Funded by: National Institute of Diabetes and Digestive and Kidney Diseases, DOI 10.13039/100000062;
                Award ID: K23DK128572
                Award ID: DK57136
                Award ID: DK57149
                Award ID: DK56990
                Award ID: DK57177
                Award ID: DK57171
                Award ID: DK57151
                Award ID: DK57182
                Award ID: DK57131
                Award ID: DK57002
                Award ID: DK57078
                Award ID: DK57154
                Award ID: DK57178
                Award ID: DK57219
                Award ID: DK57008
                Award ID: DK57135
                Award ID: DK56992
                Funded by: National Heart, Lung, and Blood Institute, DOI 10.13039/100000050;
                Funded by: National Institute of Nursing Research, DOI 10.13039/100000056;
                Funded by: National Center on Minority Health and Health Disparities, DOI 10.13039/100000096;
                Funded by: National Institutes of Health Office of Research on Women’s Health, DOI 10.13039/100000124;
                Funded by: Centers for Disease Control and Prevention, DOI 10.13039/100000030;
                Funded by: The Johns Hopkins Medical Institutions Bayview General Clinical Research Center;
                Award ID: M01RR02719
                Funded by: Massachusetts General Hospital Mallinckrodt General Clinical Research Center, DOI 10.13039/100005294;
                Funded by: Massachusetts Institute of Technology General Clinical Research Center;
                Award ID: M01RR01066
                Funded by: Harvard Clinical and Translational Science Center, DOI 10.13039/100007299;
                Award ID: RR025758-04
                Funded by: University of Colorado Health Sciences Center General Clinical Research Center;
                Award ID: M01RR00051
                Funded by: Clinical Nutrition Research Unit;
                Award ID: P30 DK48520
                Funded by: University of Tennessee, DOI 10.13039/100007135;
                Funded by: Memphis General Clinical Research Center;
                Award ID: M01RR0021140
                Funded by: General Clinical Research Center;
                Award ID: M01RR000056
                Funded by: Clinical & Translational Science Award;
                Award ID: UL1 RR 024153
                Funded by: National, DOI 10.13039/100000002;
                Funded by: Institutes of Health;
                Award ID: DK 046204
                Funded by: VA Puget Sound Health Care System Medical Research Service;
                Funded by: Department of Veterans Affairs, DOI 10.13039/100000738;
                Funded by: Frederic C. Bartter General Clinical Research Center;
                Award ID: M01RR01346
                Funded by: FedEx Corporation, DOI 10.13039/100004756;
                Funded by: Health Management Resources;
                Funded by: LifeScan, Inc, DOI 10.13039/100004719;
                Funded by: Johnson & Johnson Company;
                Funded by: Nestle HealthCare Nutrition, Inc;
                Funded by: Hoffmann-La Roche Inc;
                Funded by: Abbott Nutrition, DOI 10.13039/100011947;
                Funded by: Slim-Fast Brand of Unilever North America;
                Categories
                Clinical Research Article
                AcademicSubjects/MED00250

                Endocrinology & Diabetes
                cardiovascular disease,hba1c,intensive lifestyle intervention,overweight/obesity,type 2 diabetes mellitus

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