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 references 18

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Cardiovascular effects of intensive lifestyle intervention in type 2 diabetes.

Rena R Wing, Paula Bolin, Frederick Brancati … (2013)

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.

Thomas A. Wadden, Delia West, Linda M Delahanty … (2006)

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

Michael P Bancks:

ORCID: https://orcid.org/0000-0003-3694-6060

Scott J Pilla

Ashok Balasubramanyam:

ORCID: https://orcid.org/0000-0003-2093-5201

Hsin-Chieh Yeh:

ORCID: https://orcid.org/0000-0002-5738-0652

Karen C Johnson

Joseph Rigdon

Lynne E Wagenknecht

Mark A Espeland

Journal

Journal ID (nlm-ta): J Clin Endocrinol Metab

Journal ID (iso-abbrev): J Clin Endocrinol Metab

Journal ID (publisher-id): jcem

Title: The Journal of Clinical Endocrinology and Metabolism

Publisher: Oxford University Press (US )

ISSN (Print): 0021-972X

ISSN (Electronic): 1945-7197

Publication date Collection: March 2024

Publication date (Electronic): 18 November 2023

Publication date PMC-release: 18 November 2023

Volume: 109

Issue: 3

Pages: 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

Michael P Bancks https://orcid.org/0000-0003-3694-6060

Ashok Balasubramanyam https://orcid.org/0000-0003-2093-5201

Hsin-Chieh Yeh https://orcid.org/0000-0002-5738-0652

Article

Publisher ID: dgad674

DOI: 10.1210/clinem/dgad674

PMC ID: 10876384

PubMed ID: 37978826

SO-VID: 5d193a08-6694-4324-ae94-972143f648b3

License:

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

Date received : 07 August 2023

Date: 13 November 2023

Date: 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;

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

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Abstract

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Conclusion

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Bioscientifica Open Endocrinology

Most cited references 18

Cardiovascular effects of intensive lifestyle intervention in type 2 diabetes.

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

Eight-Year Weight Losses with an Intensive Lifestyle Intervention: The Look AHEAD Study

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