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1. Intensive Weight Loss Intervention and Cancer Risk in Adults with Type 2 Diabetes: Analysis of the Look AHEAD Randomized Clinical Trial

Author

Valerie Goldman, Christos S. Mantzoros, Nicholas M. Pajewski, Tim Byers, Thomas A. Wadden, Maria G. Montez, John M. Jakicic, Mace Coday, Steven E. Kahn, Susan Z. Yanovski, Antonio C. Wolff, William C. Knowler, Mara Z. Vitolins, Helen P. Hazuda, Edward S. Horton, Katelyn R. Garcia, Donna H. Ryan, Helmut Steinburg, Cora E. Lewis, Anne Kure, F. Xavier Pi-Sunyer, Maria Meacham, John P. Bantle, Jeanne M. Clark, Robert W. Jeffery, Monika M. Safford, Jennifer Patricio, Hsin Chieh Yeh, Henry J. Pownall, George L. Blackburn, David M. Nathan, Rebecca L. Sedjo, Rena R. Wing, Karen C. Johnson, Mark A. Espeland, John P. Foreyt, Louise Hesson, Edward W. Gregg, Caitlin Egan, James O. Hill, Lynne E. Wagenknecht, Mary T. Korytkowski, Maria Cassidy-Begay, Anne Peters, George A. Bray, and Holly R. Wyatt

Subjects
Male, medicine.medical_specialty, Endocrinology, Diabetes and Metabolism, Medicine (miscellaneous), 030209 endocrinology & metabolism, Type 2 diabetes, Overweight, Article, law.invention, 03 medical and health sciences, 0302 clinical medicine, Endocrinology, Randomized controlled trial, law, Weight loss, Neoplasms, Internal medicine, Weight Loss, medicine, Humans, Obesity, 030212 general & internal medicine, Nutrition and Dietetics, business.industry, Incidence (epidemiology), Hazard ratio, Cancer, Middle Aged, medicine.disease, Diabetes Mellitus, Type 2, Female, medicine.symptom, Skin cancer, business
Abstract

Objective This study was designed to determine whether intensive lifestyle intervention (ILI) aimed at weight loss lowers cancer incidence and mortality. Methods Data from the Look AHEAD trial were examined to investigate whether participants randomized to ILI designed for weight loss would have reduced overall cancer incidence, obesity-related cancer incidence, and cancer mortality, as compared with the diabetes support and education (DSE) comparison group. This analysis included 4,859 participants without a cancer diagnosis at baseline except for nonmelanoma skin cancer. Results After a median follow-up of 11 years, 684 participants (332 in ILI and 352 in DSE) were diagnosed with cancer. The incidence rates of obesity-related cancers were 6.1 and 7.3 per 1,000 person-years in ILI and DSE, respectively, with a hazard ratio (HR) of 0.84 (95% CI: 0.68-1.04). There was no significant difference between the two groups in total cancer incidence (HR, 0.93; 95% CI: 0.80-1.08), incidence of nonobesity-related cancers (HR, 1.02; 95% CI: 0.83-1.27), or total cancer mortality (HR, 0.92; 95% CI: 0.68-1.25). Conclusions An ILI aimed at weight loss lowered incidence of obesity-related cancers by 16% in adults with overweight or obesity and type 2 diabetes. The study sample size likely lacked power to determine effect sizes of this magnitude and smaller.

Published
2020
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2. History of Cardiovascular Disease, Intensive Lifestyle Intervention, and Cardiovascular Outcomes in the Look AHEAD Trial

Author

Lawrence J. Cheskin, John M. Jakicic, Cora E. Lewis, Helen P. Hazuda, Louise Hesson, Karen C. Johnson, Caitlin Egan, Jeffrey M. Curtis, Abbas E. Kitabchi, Edward W. Lipkin, David M. Reboussin, Thomas A. Wadden, Lynne E. Wagenknecht, John P. Bantle, George L. Blackburn, Dalane W. Kitzman, Siran Ghazarian, James O. Hill, Anne L. Peters, Edward S. Horton, David M. Nathan, Susan Z. Yanovski, Donna H. Ryan, George A. Bray, Rena R. Wing, Van S. Hubbard, Robert W. Jeffery, John P. Foreyt, Jennifer Patricio, Henry J. Pownall, Mary Evans, Sara Michaels, Maria G. Montez, Xavier Pi-Sunyer, Edward W. Gregg, Holly R. Wyatt, Bethany Barone Gibbs, Ebenezer Nyenwe, Steven E. Kahn, William C. Knowler, Frederick L. Brancati, Stephen P. Glasser, and Alain G. Bertoni

Subjects
Male, medicine.medical_specialty, Endocrinology, Diabetes and Metabolism, Physical fitness, Medicine (miscellaneous), 030209 endocrinology & metabolism, Type 2 diabetes, Overweight, Article, 03 medical and health sciences, 0302 clinical medicine, Endocrinology, Weight loss, Diabetes mellitus, Internal medicine, medicine, Humans, 030212 general & internal medicine, Myocardial infarction, Life Style, Stroke, Nutrition and Dietetics, business.industry, Hazard ratio, Middle Aged, medicine.disease, Cardiovascular Diseases, Female, medicine.symptom, business
Abstract

Objective To examine the effects of an intensive lifestyle intervention (ILI) on cardiovascular disease (CVD), the Action for Health in Diabetes (Look AHEAD) trial randomized 5,145 participants with type 2 diabetes and overweight/obesity to a ILI or diabetes support and education. Although the primary outcome did not differ between the groups, there was suggestive evidence of heterogeneity for prespecified baseline CVD history subgroups (interaction P = 0.063). Event rates were higher in the ILI group among those with a CVD history (hazard ratio 1.13 [95% CI: 0.90-1.41]) and lower among those without CVD (hazard ratio 0.86 [95% CI: 0.72-1.02]). Methods This study conducted post hoc analyses of the rates of the primary composite outcome and components, adjudicated cardiovascular death, nonfatal myocardial infarction (MI), stroke, and hospitalization for angina, as well as three secondary composite cardiovascular outcomes. Results Interaction P values for the primary and two secondary composites were similar (0.060-0.064). Of components, the interaction was significant for nonfatal MI (P = 0.035). This interaction was not due to confounding by baseline variables, different intervention responses for weight loss and physical fitness, or hypoglycemic events. In those with a CVD history, statin use was high and similar by group. In those without a CVD history, low-density lipoprotein cholesterol levels were higher (P = 0.003) and statin use was lower (P ≤ 0.001) in the ILI group. Conclusions Intervention response heterogeneity was significant for nonfatal MI. Response heterogeneity may need consideration in a CVD-outcome trial design.

Published
2020
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3. Within-Trial Cost-Effectiveness of a Structured Lifestyle Intervention in Adults With Overweight/Obesity and Type 2 Diabetes: Results From the Action for Health in Diabetes (Look AHEAD) Study

Author

Cora E. Lewis, Helen P. Hazuda, Steven E. Kahn, John M. Jakicic, Anne Peters, Mary Evans, Ping Zhang, Maria G. Montez, Gareth R. Dutton, Haiying Chen, Karen M. Atkinson, David M. Nathan, William C. Knowler, Rena R. Wing, Mace Coday, Jeanne M. Clark, Holly R. Wyatt, Julia Rushing, Tina Killean, Thomas A. Wadden, Bruce Redmon, Karen C. Johnson, Van S. Hubbard, Susan Z. Yanovski, George A. Bray, Mary T. Korytkowski, Robert W. Jeffery, John P. Foreyt, Peter J. Huckfeldt, James O. Hill, Helmut Steinburg, Henry Pownall, Caitlin Egan, Sharon D. Jackson, Jennifer Patricio, Nisa M. Maruthur, Edward S. Horton, Edward W. Gregg, Xavier Pi-Sunyer, Sara Michaels, Frank L. Greenway, and Mark A. Espeland

Subjects
Research design, Adult, Cost effectiveness, Endocrinology, Diabetes and Metabolism, Cost-Benefit Analysis, Psychological intervention, 030209 endocrinology & metabolism, Type 2 diabetes, Overweight, 03 medical and health sciences, 0302 clinical medicine, Health care, Internal Medicine, medicine, Humans, 030212 general & internal medicine, Obesity, Epidemiology/Health Services Research, Life Style, Advanced and Specialized Nursing, business.industry, medicine.disease, Diabetes Mellitus, Type 2, Quality-Adjusted Life Years, medicine.symptom, business, Health Utilities Index, Demography
Abstract

OBJECTIVE To assess the cost-effectiveness (CE) of an intensive lifestyle intervention (ILI) compared with standard diabetes support and education (DSE) in adults with overweight/obesity and type 2 diabetes, as implemented in the Action for Health in Diabetes study. RESEARCH DESIGN AND METHODS Data were from 4,827 participants during their first 9 years of study participation from 2001 to 2012. Information on Health Utilities Index Mark 2 (HUI-2) and HUI-3, Short-Form 6D (SF-6D), and Feeling Thermometer (FT), cost of delivering the interventions, and health expenditures was collected during the study. CE was measured by incremental CE ratios (ICERs) in costs per quality-adjusted life year (QALY). Future costs and QALYs were discounted at 3% annually. Costs were in 2012 U.S. dollars. RESULTS Over the 9 years studied, the mean cumulative intervention costs and mean cumulative health care expenditures were $11,275 and $64,453 per person for ILI and $887 and $68,174 for DSE. Thus, ILI cost $6,666 more per person than DSE. Additional QALYs gained by ILI were not statistically significant measured by the HUIs and were 0.07 and 0.15, respectively, measured by SF-6D and FT. The ICERs ranged from no health benefit with a higher cost based on HUIs to $96,458/QALY and $43,169/QALY, respectively, based on SF-6D and FT. CONCLUSIONS Whether ILI was cost-effective over the 9-year period is unclear because different health utility measures led to different conclusions.

Published
2020

4. The Effect of Intentional Weight Loss on Fracture Risk in Persons With Diabetes: Results From the Look AHEAD Randomized Clinical Trial

Author

Edward S. Horton, John P. Foreyt, Thomas A. Wadden, David M. Reboussin, Karen C. Johnson, Lynne E. Wagenknecht, Helmut O. Steinberg, James O. Hill, Lawrence J. Cheskin, Ping Zhang, Steven E. Kahn, Anne L. Peters, Caitlin Egan, Katelyn R. Garcia, David M. Nathan, Marsha Miller, Andrea L. Hergenroeder, Susan Z. Yanovski, Catherine Womack, William C. Knowler, Rena R. Wing, Stephen P. Glasser, George A. Bray, Cora E. Lewis, Helen P. Hazuda, Henry J. Pownall, Frank L. Greenway, Robert W. Jeffery, Jeanne M. Clark, Ann V. Schwartz, Jennifer Patricio, Edward W. Gregg, Xavier Pi-Sunyer, Maria G. Montez, J. Bruce Redmon, and John M. Jakicic

Subjects
Hip fracture, Pediatrics, medicine.medical_specialty, Bone preservation, business.industry, Endocrinology, Diabetes and Metabolism, 030209 endocrinology & metabolism, Type 2 diabetes, Overweight, medicine.disease, law.invention, Clinical trial, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, Weight loss, law, Diabetes mellitus, medicine, Physical therapy, Orthopedics and Sports Medicine, 030212 general & internal medicine, medicine.symptom, business
Abstract

Intentional weight loss is an important treatment option for overweight persons with type 2 diabetes mellitus (DM), but the effects on long term fracture risk are not known. The purpose of this Look AHEAD analysis was to evaluate whether long term intentional weight loss would increase fracture risk in overweight or obese persons with DM. Look AHEAD is a multicenter, randomized clinical trial. Recruitment began in August 2001 and follow-up continued for a median of 11.3 years at 16 academic centers. 5145 persons aged 45 – 76 with DM were randomized to either an intensive lifestyle intervention (ILI) with reduced calorie consumption and increased physical activity designed to achieve and maintain ≥7% weight loss or to diabetes support and education intervention (DSE). Incident fractures were ascertained every 6 months by self-report and confirmed with central adjudication of medical records. The baseline mean age of participants was 59 years, 60% were women, 63% were Caucasian, and the mean BMI was 36 kg/m2. Weight loss over the intervention period (median 9.6 years) was 6.0% in ILI and 3.5% in DSE. 731 participants had a confirmed incident fracture (358 in DSE v. 373 in ILI). There were no statistically significant differences in incident total or hip fracture rates between the ILI and DSE groups. However, compared to the DSE group, the ILI group had a statistically significant 39% increased risk of a frailty fracture (HR = 1.39, 95% CI 1.02, 1.89). An intensive lifestyle intervention resulting in long term weight loss in overweight/obese adults with DM was not associated with an overall increased risk of incident fracture but may be associated with an increased risk of frailty fracture. When intentional weight loss is planned, consideration of bone preservation and fracture prevention is warranted.

Published
2017
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5. Physical Function Following a Long-Term Lifestyle Intervention Among Middle Aged and Older Adults With Type 2 Diabetes: The Look AHEAD Study

Author

Ping Zhang, Rena R. Wing, John M. Jakicic, Xavier Pi-Sunyer, Maria Cassidy-Begay, W. Jack Rejeski, Sara Michaels, Mathilda Coday, Susan Z. Yanovski, Rebecca H. Neiberg, John P. Foreyt, Frank L. Greenway, John P. Bantle, Karen C. Johnson, Helmut Steinburg, Thomas A. Wadden, Stephen B. Kritchevsky, Anne Kure, Steven E. Kahn, James O. Hill, Gareth R. Dutton, Caitlin Egan, Denise K. Houston, Maria G. Montez, Jennifer Patricio, Elizabeth Beale, Andrea L. Hergenroeder, Michael E. Miller, Edward W. Gregg, William C. Knowler, Linda M. Delahanty, Henry J. Pownall, Cora E. Lewis, Helen P. Hazuda, Robert I. Berkowitz, Corby K. Martin, Robert W. Jeffery, Van S. Hubbard, Karen White, Jeanne M. Clark, Anne L. Peters, Edward S. Horton, Judith G. Regensteiner, and David M. Nathan

Subjects
Male, Aging, medicine.medical_specialty, 030209 endocrinology & metabolism, Type 2 diabetes, Overweight, law.invention, 03 medical and health sciences, Grip strength, 0302 clinical medicine, Randomized controlled trial, law, Weight loss, medicine, Humans, 030212 general & internal medicine, Obesity, Exercise, Life Style, Aged, Caloric Restriction, Hand Strength, business.industry, Middle Aged, Physical Functional Performance, medicine.disease, Walking Speed, Preferred walking speed, Weight Reduction Programs, Diabetes Mellitus, Type 2, The Journal of Gerontology: Medical Sciences, Physical therapy, Female, Geriatrics and Gerontology, medicine.symptom, business, Body mass index
Abstract

BACKGROUND: Lifestyle interventions have been shown to improve physical function over the short term; however, whether these benefits are sustainable is unknown. The long-term effects of an intensive lifestyle intervention (ILI) on physical function were assessed using a randomized post-test design in the Look AHEAD trial. METHODS: Overweight and obese (body mass index ≥ 25 kg/m(2)) middle-aged and older adults (aged 45–76 years at enrollment) with type 2 diabetes enrolled in Look AHEAD, a trial evaluating an ILI designed to achieve weight loss through caloric restriction and increased physical activity compared to diabetes support and education (DSE), underwent standardized assessments of performance-based physical function including a 4- and 400-m walk, lower extremity physical performance (expanded Short Physical Performance Battery, SPPB(exp)), and grip strength approximately 11 years postrandomization and 1.5 years after the intervention was stopped (n = 3,783). RESULTS: Individuals randomized to ILI had lower odds of slow gait speed (

Published
2017

6. Impact of an Intensive Lifestyle Intervention on Use and Cost of Medical Services Among Overweight and Obese Adults With Type 2 Diabetes: The Action for Health in Diabetes

Author

Jeffrey M. Curtis, Abbas E. Kitabchi, Frederick L. Brancati, Andrea M. Kriska, Edward S. Horton, Xavier Pi-Sunyer, Robert W. Jeffery, Monika M. Safford, David M. Nathan, Edward W. Gregg, Tina Killean, Donna H. Ryan, Don Hire, Alain G. Bertoni, Henry J. Pownall, Adam G. Tsai, Maria G. Montez, Susan Z. Yanovski, George A. Bray, John M. Jakicic, Karen C. Johnson, Siran Ghazarian, Caitlin Egan, Mary Evans, John P. Foreyt, William C. Knowler, Steven E. Kahn, Henry A. Glick, Anne L. Peters, Mark A. Espeland, Cora E. Lewis, Jeanne M. Clark, Helen P. Hazuda, Anne Murillo, J. Bruce Redmon, Van S. Hubbard, Ping Zhang, Marsha Miller, Rena R. Wing, Thomas A. Wadden, James O. Hill, Jennifer Patricio, Ebenezer Nyenwe, and Julia Rushing

Subjects
Male, Research design, Endocrinology, Diabetes and Metabolism, Type 2 diabetes, Overweight, law.invention, LOOK-AHEAD ACTION, MELLITUS, Randomized controlled trial, law, Weight loss, Health care, Single-Blind Method, 11 Medical and Health Sciences, Health Care Costs, Health Services, Middle Aged, DISEASE RISK-FACTORS, CARDIOVASCULAR-DISEASE, Cardiovascular Diseases, Female, medicine.symptom, Life Sciences & Biomedicine, Adult, medicine.medical_specialty, METFORMIN, WEIGHT-LOSS, CLINICAL-TRIAL, Endocrinology & Metabolism, Diabetes mellitus, Internal Medicine, medicine, Humans, Obesity, Epidemiology/Health Services Research, Life Style, Aged, Advanced and Specialized Nursing, Science & Technology, business.industry, Look AHEAD Research Group, medicine.disease, PREVENTION, SAVINGS, INDIVIDUALS, Diabetes Mellitus, Type 2, Emergency medicine, Physical therapy, business, Follow-Up Studies
Abstract

OBJECTIVE To assess the relative impact of an intensive lifestyle intervention (ILI) on use and costs of health care within the Look AHEAD trial. RESEARCH DESIGN AND METHODS A total of 5,121 overweight or obese adults with type 2 diabetes were randomly assigned to an ILI that promoted weight loss or to a comparison condition of diabetes support and education (DSE). Use and costs of health-care services were recorded across an average of 10 years. RESULTS ILI led to reductions in annual hospitalizations (11%, P = 0.004), hospital days (15%, P = 0.01), and number of medications (6%, P < 0.001), resulting in cost savings for hospitalization (10%, P = 0.04) and medication (7%, P < 0.001). ILI produced a mean relative per-person 10-year cost savings of $5,280 (95% CI 3,385–7,175); however, these were not evident among individuals with a history of cardiovascular disease. CONCLUSIONS Compared with DSE over 10 years, ILI participants had fewer hospitalizations, fewer medications, and lower health-care costs.

Published
2014
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7. Cardiovascular Effects of Intensive Lifestyle Intervention in Type 2 Diabetes

Author

Richard S. Crow, Siran Ghazarian, Judith G. Regensteiner, Paula Bolin, Jeffrey M. Curtis, Steven E. Kahn, Donna H. Ryan, Abbas E. Kitabchi, John M. Jakicic, Delia Smith West, Edward W. Gregg, Rena R. Wing, Anne L. Peters, John P. Foreyt, Amy D. Rickman, Robert W. Jeffery, S. Van Hubbard, Monika M. Safford, Henry J. Pownall, Susan Z. Yanovski, George A. Bray, David F. Williamson, Mary Evans, Maria G. Montez, Mark A. Espeland, Thomas A. Wadden, Anne Murillo, Karen C. Johnson, David M. Reboussin, Barbara Harrison, Barbara J. Maschak-Carey, Frederick L. Brancati, Mace Coday, Lynne E. Wagenknecht, Caitlin Egan, Jennifer Patricio, Cora E. Lewis, James O. Hill, Helen P. Hazuda, Jeanne M. Clark, Xavier Pi-Sunyer, William C. Knowler, Edward S. Horton, and David M. Nathan

Subjects
Adult, Male, medicine.medical_specialty, Diet, Reducing, Kaplan-Meier Estimate, Type 2 diabetes, Overweight, Article, law.invention, Randomized controlled trial, Risk Factors, law, Weight loss, Internal medicine, Diabetes mellitus, Weight Loss, medicine, Humans, Obesity, Treatment Failure, Myocardial infarction, Life Style, Exercise, Aged, Glycated Hemoglobin, business.industry, Hazard ratio, General Medicine, Middle Aged, medicine.disease, Diabetes Mellitus, Type 2, Cardiovascular Diseases, Physical therapy, Female, medicine.symptom, business
Abstract

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.).

Published
2013
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8. Four-Year Change in Cardiorespiratory Fitness and Influence on Glycemic Control in Adults With Type 2 Diabetes in a Randomized Trial

Author

John M. Jakicic, Judith G. Regensteiner, Sarah A. Gaussoin, Caitlin Egan, Stephen P. Glasser, Anthony N. Fabricatore, William C. Knowler, Louise Hesson, Donna H. Ryan, Paul M. Ribisl, and Wei Lang

Subjects
Blood Glucose, Male, Cardiovascular and Metabolic Risk, medicine.medical_specialty, Endocrinology, Diabetes and Metabolism, Physical fitness, 030209 endocrinology & metabolism, Type 2 diabetes, Motor Activity, Overweight, law.invention, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, law, Internal Medicine, medicine, Humans, Obesity, 030212 general & internal medicine, skin and connective tissue diseases, Life Style, Original Research, Glycemic, Advanced and Specialized Nursing, business.industry, Weight change, Cardiorespiratory fitness, Middle Aged, medicine.disease, Diabetes Mellitus, Type 2, Physical Fitness, Physical therapy, Female, sense organs, Waist Circumference, medicine.symptom, business
Abstract

OBJECTIVE To examine an intensive lifestyle intervention (ILI) compared with diabetes support and education (DSE) on 4-year change in fitness and physical activity (PA), and to examine the effect of change in fitness and PA, adjusting for potential confounders, on glycemic control in the Look AHEAD Trial. RESEARCH DESIGN AND METHODS Subjects were overweight/obese adults with type 2 diabetes mellitus (T2DM) with available fitness data at 4 years (n = 3,942).This clinical trial randomized subjects to DSE or ILI. DSE subjects received standard care plus information related to diet, PA, and social support three times per year. ILI subjects received weekly intervention contact for 6 months, which was reduced over the 4-year period, and were prescribed diet and PA. Measures included weight, fitness, PA, and HbA1c. RESULTS The difference in percent fitness change between ILI and DSE at 4 years was significant after adjustment for baseline fitness and change in weight (3.70 vs. 0.94%; P < 0.01). At 4 years, PA increased by 348 (1,562) kcal/week in ILI vs. 105 (1,309) kcal/week in DSE (P < 0.01). Fitness change at 4 years was inversely related to change in HbA1c after adjustment for clinical site, treatment, baseline HbA1c, prescribed diabetes medication, baseline fitness, and weight change (P < 0.01). Change in PA was not related to change in HbA1c. CONCLUSIONS A 4-year ILI increased fitness and PA in overweight/obese individuals with T2DM. Change in fitness was associated with improvements in glycemic control, which provides support for interventions to improve fitness in adults with T2DM.

Published
2013
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9. 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

Author

Paul Bloomquist, Anne L. Peters, Robert W. Jeffery, Monika M. Safford, Mary Evans, Dace L. Trence, Mace Coday, Henry J. Pownall, Rebecca H. Neiberg, Abbas E. Kitabchi, Susan Z. Yanovski, George A. Bray, Judith G. Regensteiner, Karen C. Johnson, Thomas A. Wadden, Edward W. Gregg, Jennifer Patricio, Gary D. Foster, Xavier Pi-Sunyer, Caitlin Egan, George L. Blackburn, James O. Hill, John M. Jakicic, Jack Rejeski, David M. Nathan, Kerry J. Stewart, Wei Lang, Maria G. Montez, Bruce Redmon, Andrea M. Kriska, Cora E. Lewis, Helen P. Hazuda, Rena R. Wing, Edward S. Horton, Jeanne M. Clark, Van S. Hubbard, Jeffrey R. Curtis, John P. Foreyt, Paul M. Ribisl, and William C. Knowler

Subjects
Male, medicine.medical_specialty, Endocrinology, Diabetes and Metabolism, Physical fitness, Population, 030209 endocrinology & metabolism, Type 2 diabetes, 030204 cardiovascular system & hematology, Lower risk, law.invention, Cohort Studies, 03 medical and health sciences, 0302 clinical medicine, Endocrinology, Randomized controlled trial, law, Weight loss, Internal medicine, Weight Loss, Internal Medicine, Medicine, Humans, Obesity, education, Health Education, Life Style, Aged, education.field_of_study, business.industry, Weight change, Disease Management, Middle Aged, medicine.disease, 3. Good health, Diabetes Mellitus, Type 2, Cardiovascular Diseases, Physical Fitness, Physical therapy, Female, medicine.symptom, business, Cohort study
Abstract

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.

Published
2016

10. Measurement characteristics of the ankle–brachial index: results from the Action for Health in Diabetes study

Author

Edward W. Lipkin, Jane Tavares, Laurie Bissett, Sarah Ledbury, Kathy Dotson, JoAnn A. Phillipp, Lynne Lichtermann, Carmen Pal, Susan Green, Ann V. Schwartz, Michael T. McDermott, Dace L. Trence, Vicki A. Maddy, Suzanne Phelan, Cara Walcheck, Jack Rejeski, Michael C. Nevitt, Paulette Cohrs, Thomas A. Wadden, Ronald J. Prineas, Kristi Rau, Magpuri Perpetua, Siran Ghazarian, Terry Barrett, Lynne E. Wagenknecht, Robert I. Berkowitz, Virginia Harlan, Jennifer Mayer, George L. Blackburn, Gary D. Miller, Jeff Honas, Sarah Michaels, Rita Donaldson, Jeanne Carls, Barbara Harrison, Barbara J. Maschak-Carey, Amy Dobelstein, Charlotte Bragg, Jackie Day, Canice E. Crerand, Debra Clark, Karen T. Vujevich, Kathy Lane, Rina R. Wing, Renee Davenport, Shandiin Begay, Alain G. Bertoni, Sharon D. Jackson, Steven E. Kahn, Richard S. Crow, Valerie Goldman, Sarah A. Jaramillo, Kristina P. Schumann, David M. Nathan, William H. Herman, James O. Hill, Kati Szamos, Steven M. Haffner, Osama Hamdy, Karen C. Johnson, Judy Bahnson, Mary Lou Klem, Denise G. Simons-Morton, David E. Kelley, Emily A. Finch, Maureen Malloy, Donna Wolf, Leeann Carmichael, Deborah Robles, Diane Hirsch, Elizabeth Bovaird, Justin Glass, Robert Kuehnel, Brenda Montgomery, Didas Fallis, Jennifer Gauvin, Kim Landry, Michaela Rahorst, Renate H. Rosenthal, William C. Knowler, Robert W. Jeffery, Monika M. Safford, John P. Foreyt, Ellen J. Anderson, Michelle Chan, Cathy Manus, Julie Currin, Elizabeth J. Mayer-Davis, Erin Patterson, Jeanne M. Clark, Mara Z. Vitolins, Nancy Scurlock, Stanley Heshka, Ken C. Chiu, Vicki DiLillo, Donna H. Ryan, Mary Evans, La Donna James, Edward W. Gregg, Gary D. Foster, Connie Mobley, Christian Speas, Eva Obarzanek, Caitlin Egan, Renee Bright, Frank L. Greenway, Robert S. Schwartz, Robert C. Kores, Ann Goebel-Fabbri, Anna Bertorelli, Ann McNamara, Patricia Lipschutz, Heather Chenot, Maria Sun, Helen Chomentowski, Carlos Lorenzo, Pamela Coward, Matthew L. Maciejewski, Donald A. Williamson, Heather Turgeon, Alan McNamara, Barbara Bancroft, Jonathan Krakoff, Debi Celnik, Erica Ferguson, Molly Gee, Lewis H. Kuller, Tatum Charron, Deborah Maier, Amelia Hodges, Linda M. Delahanty, Mary Anne Holowaty, Janet Krulia, Rebecca Danchenko, Van S. Hubbard, Rebecca S. Reeves, Lindsey Munkwitz, Linda Foss, Don Kieffer, Kara I. Gallagher, Paul M. Ribisl, Heather McCormick, David F. Williamson, Carrie Combs, Birgitta I. Rice, Edward S. Horton, Zhu Ming Zhang, Stanley Schwartz, Sharon Hall, Clara Smith, Janet Bonk, Richard Ginsburg, Cathy Roche, Mark A. Espeland, Jennifer Rush, Elizabeth Tucker, Tricia Skarpol, Maureen Daly, Susan Z. Yanovski, Nita Webb, John P. Bantle, George A. Bray, Amy A. Gorin, Theresa Michel, Lori Lambert, Lauren Lessard, Jennifer Patricio, Greg Strylewicz, Charles Campbell, Wei Lang, Cecilia Farach, Richard Carey, Vincent Pera, Carolyne Campbell, Medhat Botrous, Robert H. Knopp, William R. Hiatt, David M. Reboussin, Carolyn Thorson, Daniel Edmundowicz, Marsha Miller, Mandy Shipp, Jacqueline Wesche-Thobaben, Monica Mullen, Louise Hesson, Ruby Johnson, Henry J. Pownall, Xavier Pi-Sunyer, Natalie Robinson, Barbara Steiner, Enrico Cagliero, Sheikilya Thomas, Carol Percy, Paula Bolin, Debra Force, Lawton S. Cooper, Kathy Horak, Juliet Mancino, M. Patricia Snyder, Salma Benchekroun, Stephen P. Glasser, Douglas A. Raynor, Jeanne Charleston, Richard R. Rubin, Gracie Cunningham, Lawrence J. Cheskin, Anthony N. Fabricatore, Brandi Armand, Kimberley Chula-Maquire, Helen Lambeth, April Hamilton, Cynthia Hayashi, Straci Gilbert, Kerry J. Stewart, Cora E. Lewis, Mohammed F. Saad, Janelia Smiley, Andrea M. Kriska, Richard F. Hamman, J. P. Massaro, Barb Elnyczky, Lisa Palermo, Tammy Monk, Donna Green, Patrick Reddin, Peter H. Bennett, Kerry Ovalle, Pat Harper, Therese Ockenden, Kerin Brelje, Christos S. Mantzoros, Santica M. Marcovina, Amy Keranen, Deborah F. Tate, John M. Jakicic, Trena Johnsey, Judith G. Regensteiner, Bernadette Todacheenie, Ray Carvajal, Sarah Bain, Minnie Roanhorse, Sandra Sangster, Tina Killean, Jennifer Perault, Bruce Redmon, Jeffrey M. Curtis, Abbas E. Kitabchi, Anne E. Mathews, Shiriki K. Kumanyika, Rob Nicholson, Allison Strate, Hollie A. Raynor, L. Christie Oden, Ashok Balasubramanyam, Leigh A. Shovestull, Tina Morgan, Judith Regenseiner, Roque M. Murillo, Delia S. West, Jason Maeda, Kathryn Hayward, Patricia E. Hogan, Kristin Wallace, Maria G. Montez, John A. Shepherd, Loretta Rome, Judith E. Soberman, Peter B. Jones, Andrea Crisler, Enrique Caballero, Frederick L. Brancati, and Brent VanDorsten

Subjects
Male, medicine.medical_specialty, Brachial Artery, Blood Pressure, Type 2 diabetes, Overweight, Sensitivity and Specificity, Article, Cohort Studies, Risk Factors, Internal medicine, Diabetes mellitus, medicine, Humans, Obesity, cardiovascular diseases, Aged, Peripheral Vascular Diseases, Framingham Risk Score, business.industry, Middle Aged, medicine.disease, Surgery, body regions, medicine.anatomical_structure, Standard error, Blood pressure, Diabetes Mellitus, Type 2, Cardiology, Female, Ankle, medicine.symptom, Cardiology and Cardiovascular Medicine, business, Algorithms, Ankle Joint, Cohort study
Abstract

Abstract Many protocols have been used in clinical and research settings for collecting systolic blood pressure (SBP) measurements to calculate the ankle–brachial index (ABI); however, it is not known how useful it is to replicate measurements and which measures best reflect cardiovascular risk. Standardized measurements of ankle and arm SBP from 5140 overweight or obese individuals with type 2 diabetes were used to estimate sources of variation. Measurement characteristics of leg-specific ABI, as calculated using a standard algorithm based on the highest SBP of the dorsalis pedis or posterior tibial arteries, were projected using simulations. Coefficients of variability ranged from 2% to 3% when single SBP measurements were used and ABI was overestimated by 2–3%. Taking two SBP measurements at each site reduced standard errors and bias each by 30–40%. The sensitivity of detecting low ABI ranges exceeded 90% for ABI within 0.05 of the 0.90 clinical cut-point. The average and the minimum of the two (i.e. right and left) leg-specific ABI values had similar U-shaped relationships with Framingham risk scores; however, the average leg ABI had slightly greater precision. Replicating SBP measurements reduces the error and bias of ABI. Averaging leg-specific values may increase power for characterizing cardiovascular disease risk.

Published
2008
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11. Effect of a long-term behavioural weight loss intervention on nephropathy in overweight or obese adults with type 2 diabetes: a secondary analysis of the Look AHEAD randomised clinical trial

Author

Holly R. Wyatt, Karen C. Johnson, Rina R. Wing, Sara Michaels, Thomas A. Wadden, Jeanne M. Clark, Caitlin Egan, Frank L. Greenway, Alain G. Bertoni, John P. Bantle, W. C. Knowler, Susan Z. Yanovski, Anne L. Peters, Henry J. Pownall, Lawrence J. Cheskin, Xavier Pi-Sunyer, Ebenezer A Nyenwe, Steven E. Kahn, Don Williamson, Jonathan Krakoff, John M. Jakicic, Haiying Chen, Cora E. Lewis, Helen P. Hazuda, James O. Hill, George A. Bray, Stephen P. Glasser, Anne Kure, Marguerite Evans, Judy Bahnson, Lynne E. Wagenknecht, David M. Nathan, Robert W. Jeffery, John P. Foreyt, Barbara J. Maschak-Carey, Van S. Hubbard, Mary T. Korytkowski, Jennifer Patricio, Edward S. Horton, Maria G. Montez, Edward W. Gregg, and Abbas E. Kitabchi

Subjects
Male, medicine.medical_specialty, Pediatrics, Endocrinology, Diabetes and Metabolism, Type 2 diabetes, Overweight, Article, Nephropathy, law.invention, Endocrinology, Randomized controlled trial, law, Weight loss, Risk Factors, Diabetes mellitus, Internal Medicine, Medicine, Humans, Obesity, Renal Insufficiency, Chronic, Aged, Proportional Hazards Models, business.industry, Middle Aged, medicine.disease, Clinical trial, Weight Reduction Programs, Diabetes Mellitus, Type 2, Physical therapy, Female, medicine.symptom, business
Abstract

Long-term effects of behavioural weight loss interventions on diabetes complications are unknown. In a secondary analysis of the Look AHEAD (Action for Health in Diabetes) multicentre randomised clinical trial, we assessed whether an intensive lifestyle intervention (ILI) affects the development of nephropathy in people with type 2 diabetes.Overweight or obese people aged 45-76 years with type 2 diabetes were randomly assigned (1:1) to ILI or to a diabetes support and education (DSE) group by a central web-based data management system, stratified by clinical centre and blocked with random block sizes. The ILI was designed to achieve and maintain weight loss through reduced caloric consumption and increased physical activity. The interventions were terminated early because of absence of effect on the primary outcome of cardiovascular disease events in the main Look AHEAD trial. Albuminuria and estimated glomerular filtration rate were prespecified as two of many other outcomes and were assessed from baseline until the interventions ended. They were combined post hoc to define the main outcome for this report, very-high-risk chronic kidney disease (CKD), based on the 2013 Kidney Disease Improving Global Outcomes (KDIGO) classification. Outcomes assessors and laboratory staff were masked to treatment, but participants and interventionists were not masked. Time-to-event data were analysed by intention to treat by the Kaplan-Meier method and proportional hazards models. The Look AHEAD trial is registered with ClinicalTrials.gov, NCT00017953.Of the 5145 participants randomly assigned in the Look AHEAD trial (2570 to ILI and 2575 to DSE), analyses for very-high-risk CKD were done in 2423 (94%) of patients in the ILI group and 2408 (94%) of those in the DSE group. After a median of 8·0 years (IQR 7·9-9·9) of follow-up, the incidence of very-high-risk CKD was lower in the ILI group than in the DSE group, with incidence rates of 0·91 cases per 100 person-years in the DSE group and 0·63 per 100 person-years in the ILI group (difference 0·27 cases per 100 person-years, hazard ratio 0·69, 95% CI 0·55-0·87; p=0·0016). This effect was partly attributable to reductions in bodyweight, HbA1c, and systolic blood pressure. There were no safety concerns regarding kidney-related adverse events.Weight loss should be considered as an adjunct to medical treatments to prevent or delay progression of CKD in overweight or obese people with type 2 diabetes.National Institute of Diabetes and Digestive and Kidney Diseases.

Published
2014

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

Author

Richard R, Rubin, Thomas A, Wadden, Judy L, Bahnson, George L, Blackburn, Frederick L, Brancati, George A, Bray, Mace, Coday, Scott J, Crow, Jeffrey M, Curtis, Gareth, Dutton, Caitlin, Egan, Mary, Evans, Lin, Ewing, Lucy, Faulconbridge, John, Foreyt, Sarah A, Gaussoin, Edward W, Gregg, Helen P, Hazuda, James O, Hill, Edward S, Horton, Van S, Hubbard, John M, Jakicic, Robert W, Jeffery, Karen C, Johnson, Steven E, Kahn, William C, Knowler, Wei, Lang, Cora E, Lewis, Maria G, Montez, Anne, Murillo, David M, Nathan, Jennifer, Patricio, Anne, Peters, Xavier, Pi-Sunyer, Henry, Pownall, W Jack, Rejeski, Renate H, Rosenthal, Valerie, Ruelas, Katie, Toledo, Brent, Van Dorsten, Mara, Vitolins, Donald, Williamson, Rina R, Wing, Susan Z, Yanovski, and Ping, Zhang

Subjects
Male, medicine.medical_specialty, Endocrinology, Diabetes and Metabolism, 030209 endocrinology & metabolism, Type 2 diabetes, Overweight, law.invention, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, Quality of life, Weight loss, law, Surveys and Questionnaires, Weight Loss, Internal Medicine, Medicine, Humans, 030212 general & internal medicine, Obesity, Life Style, Depression (differential diagnoses), Advanced and Specialized Nursing, business.industry, Depression, Hazard ratio, Beck Depression Inventory, Clinical Care/Education/Nutrition/Psychosocial Research, Middle Aged, medicine.disease, humanities, Antidepressive Agents, 3. Good health, Treatment Outcome, Diabetes Mellitus, Type 2, Physical therapy, Quality of Life, Female, medicine.symptom, business
Abstract

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 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.

Published
2014

13. Partial Meal Replacement Plan and Quality of the Diet at 1 Year: Action for Health in Diabetes (Look AHEAD) Trial

Author

Hollie A. Raynor, Andrea M. Anderson, Gary D. Miller, Rebecca Reeves, Linda M. Delahanty, Mara Z. Vitolins, Patricia Harper, Connie Mobley, Kati Konersman, Elizabeth Mayer-Davis, Frederick L. Brancati, Jeff Honas, Lawrence Cheskin, Jeanne M. Clark, Kerry Stewart, Richard Rubin, Jeanne Charleston, Kathy Horak, George A. Bray, Kristi Rau, Allison Strate, Brandi Armand, Frank L. Greenway, Donna H. Ryan, Donald Williamson, Amy Bachand, Michelle Begnaud, Betsy Berhard, Elizabeth Caderette, Barbara Cerniauskas, David Creel, Diane Crow, Helen Guay, Nancy Kora, Kelly LaFleur, Kim Landry, Missy Lingle, Jennifer Perault, Mandy Shipp, Marisa Smith, Elizabeth Tucker, Cora E. Lewis, Sheikilya Thomas, Monika Safford, Vicki DiLillo, Charlotte Bragg, Amy Dobelstein, Stacey Gilbert, Stephen Glasser, Sara Hannum, Anne Hubbell, Jennifer Jones, DeLavallade Lee, Ruth Luketic, Karen Marshall, L. Christie Oden, Janet Raines, Cathy Roche, Janet Truman, Nita Webb, Audrey Wrenn, David M. Nathan, Heather Turgeon, Kristina Schumann, Enrico Cagliero, Linda Delahanty, Kathryn Hayward, Ellen Anderson, Laurie Bissett, Richard Ginsburg, Valerie Goldman, Virginia Harlan, Charles McKitrick, Alan McNamara, Theresa Michel, Alexi Poulos, Barbara Steiner, Joclyn Tosch, Edward S. Horton, Sharon D. Jackson, Osama Hamdy, A. Enrique Caballero, Sarah Bain, Elizabeth Bovaird, Ann Goebel-Fabbri, Lori Lambert, Sarah Ledbury, Maureen Malloy, Kerry Ovalle, George Blackburn, Christos Mantzoros, Kristinia Day, Ann McNamara, James O. Hill, Marsha Miller, JoAnn Phillipp, Robert Schwartz, Brent Van Dorsten, Judith Regensteiner, Salma Benchekroun, Ligia Coelho, Paulette Cohrs, Elizabeth Daeninck, Amy Fields, Susan Green, April Hamilton, Jere Hamilton, Eugene Leshchinskiy, Michael McDermott, Lindsey Munkwitz, Loretta Rome, Kristin Wallace, Terra Worley, John P. Foreyt, Rebecca S. Reeves, Henry Pownall, Ashok Balasubramanyam, Peter Jones, Michele Burrington, Chu-Huang Chen, Allyson Clark, Molly Gee, Sharon Griggs, Michelle Hamilton, Veronica Holley, Jayne Joseph, Patricia Pace, Julieta Palencia, Olga Satterwhite, Jennifer Schmidt, Devin Volding, Carolyn White, Mohammed F. Saad, Siran Ghazarian, Ken C. Chiu, Medhat Botrous, Michelle Chan, Magpuri Perpetua, Karen C. Johnson, Carolyn Gresham, Stephanie Connelly, Amy Brewer, Mace Coday, Lisa Jones, Lynne Lichtermann, Shirley Vosburg, J. Lee Taylor, Abbas E. Kitabchi, Helen Lambeth, Debra Clark, Andrea Crisler, Gracie Cunningham, Donna Green, Debra Force, Robert Kores, Renate Rosenthal, Elizabeth Smith, Maria Sun, Judith Soberman, Robert W. Jeffery, Carolyn Thorson, John P. Bantle, J. Bruce Redmon, Richard S. Crow, Scott Crow, Susan K. Raatz, Kerrin Brelje, Carolyne Campbell, Jeanne Carls, Tara Carmean-Mihm, Emily Finch, Anna Fox, Elizabeth Hoelscher, La Donna James, Vicki A. Maddy, Therese Ockenden, Birgitta I. Rice, Tricia Skarphol, Ann D. Tucker, Mary Susan Voeller, Cara Walcheck, Xavier Pi-Sunyer, Jennifer Patricio, Stanley Heshka, Carmen Pal, Lynn Allen, Diane Hirsch, Mary Anne Holowaty, Thomas A. Wadden, Barbara J. Maschak-Carey, Stanley Schwartz, Gary D. Foster, Robert I. Berkowitz, Henry Glick, Shiriki K. Kumanyika, Johanna Brock, Helen Chomentowski, Vicki Clark, Canice Crerand, Renee Davenport, Andrea Diamond, Anthony Fabricatore, Louise Hesson, Stephanie Krauthamer-Ewing, Robert Kuehnel, Patricia Lipschutz, Monica Mullen, Leslie Womble, Nayyar Iqbal, David E. Kelley, Jacqueline Wesche-Thobaben, Lewis Kuller, Andrea Kriska, Janet Bonk, Rebecca Danchenko, Daniel Edmundowicz, Mary L. Klem, Monica E. Yamamoto, Barb Elnyczky, George A. Grove, Pat Harper, Janet Krulia, Juliet Mancino, Anne Mathews, Tracey Y. Murray, Joan R. Ritchea, Jennifer Rush, Karen Vujevich, Donna Wolf, Rena R. Wing, Renee Bright, Vincent Pera, John Jakicic, Deborah Tate, Amy Gorin, Kara Gallagher, Amy Bach, Barbara Bancroft, Anna Bertorelli, Richard Carey, Tatum Charron, Heather Chenot, Kimberley Chula-Maguire, Pamela Coward, Lisa Cronkite, Julie Currin, Maureen Daly, Caitlin Egan, Erica Ferguson, Linda Foss, Jennifer Gauvin, Don Kieffer, Lauren Lessard, Deborah Maier, J.P. Massaro, Tammy Monk, Rob Nicholson, Erin Patterson, Suzanne Phelan, Hollie Raynor, Douglas Raynor, Natalie Robinson, Deborah Robles, Jane Tavares, Steven M. Haffner, Maria G. Montez, Carlos Lorenzo, Steven E. Kahn, Brenda Montgomery, Robert Knopp, Edward Lipkin, Matthew L. Maciejewski, Dace Trence, Terry Barrett, Joli Bartell, Diane Greenberg, Anne Murillo, Betty Ann Richmond, April Thomas, William C. Knowler, Paula Bolin, Tina Killean, Cathy Manus, Jonathan Krakoff, Jeffrey M. Curtis, Justin Glass, Sara Michaels, Peter H. Bennett, Tina Morgan, Shandiin Begay, Bernadita Fallis, Jeanette Hermes, Diane F. Hollowbreast, Ruby Johnson, Maria Meacham, Julie Nelson, Carol Percy, Patricia Poorthunder, Sandra Sangster, Nancy Scurlock, Leigh A. Shovestull, Janelia Smiley, Katie Toledo, Christina Tomchee, Darryl Tonemah, Anne Peters, Valerie Ruelas, Siran Ghazarian Sengardi, Kathryn Graves, Sara Serafin-Dokhan, Mark A. Espeland, Judy L. Bahnson, Lynne Wagenknecht, David Reboussin, W. Jack Rejeski, Alain Bertoni, Wei Lang, Gary Miller, David Lefkowitz, Patrick S. Reynolds, Paul Ribisl, Mara Vitolins, Michael Booth, Kathy M. Dotson, Amelia Hodges, Carrie C. Williams, Jerry M. Barnes, Patricia A. Feeney, Jason Griffin, Lea Harvin, William Herman, Patricia Hogan, Sarah Jaramillo, Mark King, Kathy Lane, Rebecca Neiberg, Andrea Ruggiero, Christian Speas, Michael P. Walkup, Karen Wall, Michelle Ward, Delia S. West, Terri Windham, Michael Nevitt, Susan Ewing, Cynthia Hayashi, Jason Maeda, Lisa Palermo, Michaela Rahorst, Ann Schwartz, John Shepherd, Santica M. Marcovina, Greg Strylewicz, Ronald J. Prineas, Teresa Alexander, Lisa Billings, Charles Campbell, Sharon Hall, Susan Hensley, Yabing Li, Zhu-Ming Zhang, Elizabeth J. Mayer-Davis, Robert Moran, Richard Foushee, Nancy J. Hall, Barbara Harrison, Van S. Hubbard, Susan Z. Yanovski, Lawton S. Cooper, Jeffrey Cutler, Eva Obarzanek, Edward W. Gregg, David F. Williamson, and Ping Zhang

Subjects
Male, medicine.medical_specialty, Meal replacement, Diet, Reducing, Ethnic group, Type 2 diabetes, Overweight, Motor Activity, Article, law.invention, Body Mass Index, Nutrition Policy, Food group, Randomized controlled trial, law, Environmental health, Diabetes mellitus, Diet, Diabetic, medicine, Humans, Obesity, Precision Medicine, Diet, Fat-Restricted, Life Style, Meals, Aged, Foods, Specialized, Meal, Nutrition and Dietetics, business.industry, General Medicine, Middle Aged, medicine.disease, Combined Modality Therapy, United States, Diabetes Mellitus, Type 2, Physical therapy, Patient Compliance, Female, medicine.symptom, Snacks, business, Food Science
Abstract

Background Little is known about diet quality with a reduced-energy, low-fat, partial meal replacement plan, especially in individuals with type 2 diabetes. The Action for Health in Diabetes (Look AHEAD) trial implemented a partial meal replacement plan in the Intensive Lifestyle Intervention. Objective To compare dietary intake and percent meeting fat-related and food group dietary recommendations in Intensive Lifestyle Intervention and Diabetes Support and Education groups at 12 months. Design A randomized controlled trial comparing Intensive Lifestyle Intervention with Diabetes Support and Education at 0 and 12 months. Participants/setting From 16 US sites, the first 50% of participants (aged 45 to 76 years, overweight or obese, with type 2 diabetes) were invited to complete dietary assessments. Complete 0- and 12-month dietary assessments (collected between 2001 and 2004) were available for 2,397 participants (46.6% of total participants), with 1,186 randomized to Diabetes Support and Education group and 1,211 randomized to Intensive Lifestyle Intervention group. Main outcome measures A food frequency questionnaire assessed intake: energy; percent energy from protein, fat, carbohydrate, polyunsaturated fatty acids, and saturated fats; trans -fatty acids; cholesterol; fiber; weekly meal replacements; and daily servings from food groups from the Food Guide Pyramid. Statistical analyses performed Mixed-factor analyses of covariance, using Proc MIXED with a repeated statement, with age, sex, race/ethnicity, education, and income controlled. Unadjusted χ 2 tests compared percent meeting fat-related and food group recommendations at 12 months. Results At 12 months, Intensive Lifestyle Intervention participants had a significantly lower fat and cholesterol intake and greater fiber intake than Diabetes Support and Education participants. Intensive Lifestyle Intervention participants consumed more servings per day of fruits; vegetables; and milk, yogurt, and cheese; and fewer servings per day of fats, oils, and sweets than Diabetes Support and Education participants. A greater percentage of Intensive Lifestyle Intervention participants than Diabetes Support and Education participants met fat-related and most food group recommendations. Within Intensive Lifestyle Intervention, a greater percentage of participants consuming two or more meal replacements per day than participants consuming less than one meal replacement per day met most fat-related and food group recommendations. Conclusions The partial meal replacement plan consumed by Intensive Lifestyle Intervention participants was related to superior diet quality.

Published
2014

14. Implications of Look AHEAD for clinical trials and clinical practice

Author

Pamela Coward, Ping Zhang, Lea N. Harvin, Andrea Anderson, Limprevil Divers Dominique, Louise Hesson, Ruby Johnson, Lisa Keasler, Judith G. Regensteiner, Karen Wall, Vincent Pera, John A. Shepherd, Robert H. Knopp, Donna LaJames, Carolyn Gresham, Robert Moran, Jean Arceci, Joan R. Ritchea, Carlos C. Isaac, Michelle Hamilton, Joyce Lambert, Jeanne M. Clark, Tammy DeBruce, Sheikilya Thomas, Janet Crane, Valerie Goldman, Delia Smith West, Mace Coday, David Lefkowitz, Tricia Skarphol, Julie Currin, Elsayed Z. Soliman, Mary Barr, Dawn Jiggetts, Julia Rushing, Patricia H. Harper, Ann D. Tucker, Raymond Carvajal, Rebecca Danchenko, David M. Reboussin, Amy Brewer, Valerie Ruelas, Daniel Edmundowicz, Marsha Miller, Rena R. Wing, Melanie A. Jaeb, Monica Mullen, Amy Bach, Paula Bolin, Serafin Dokhan Sara, Debra Force, Diane F. Hollowbreast, Carol Percy, Deborah Maier, Quintero Varela Brenda, Susan Green, Kathy Michalski, David Bolen, Jeffrey M. Curtis, Abbas E. Kitabchi, Kati Konersman, Mayer Davis Elizabeth, Kerrin Brelje, Anthony N. Fabricatore, Anne Hubbell, Goebel Fabbri Ann, Jayne Thomas, Linda Foss, Richard S. Crow, Charles F. Coleman, Crystal Duncan, Cralen Davis, Martha Walker, Kirstie Craul, Carolyn White, Maria G. Montez, Theresa Michel, Douglas A. Raynor, David O. Garcia, Huang Chu-Chen, Thomas A. Wadden, Kristi Rau, Tamika Earl, Monica Lockett, Bernadita Fallis, Pi Sunyer Xavier, Cathy Roche, Shiriki K. Kumanyika, Allison Strate, Robert I. Berkowitz, Sara Michaels, B. Van Dorsten, S. Cooper, Elaine Tsai, Patrick S. Reynolds, Michael S. Lawlor, Jerry M. Barnes, Wei Lang, Tara D. Beckner, Lisa Hoelscher, Janet Turman, Juliet Mancino, Gabriela Rodriguez, Lynn Allen, Gabriela Rios, Amy D. Rickman, Cathy Manus, Julie Hu, James O. Hill, Lauren Lessard, Catherine M. Champagne, Lawrence J. Cheskin, Jeanne Charleston, Peter B. Jones, Barbara Cerniauskas, Maria Sowers, Ebenezer A Nyenwe, Jeanne Spellman, Debra Clark, Carolyne Campbell, Terri Windham, Nora Ramirez, Jennifer Patricio, Janet Wallace, Donald A. Williamson, Nayyar Iqbal, Carolyn Thorson, Elizabeth Beale, Lauren Cox, Teddy Thomas, Sarah Lee, Lin Ewing, L. Christie Oden, Steven E. Kahn, Deborah F. Tate, Jason Maeda, Renee Davenport, Linda M. Delahanty, Sarah Ledbury, Kathy Dotson, Carmen Pal, Vinod Gaur, Alain G. Bertoni, Sharon D. Jackson, Kim Landry, Lucy F. Faulconbridge, Gary D. Miller, Mark A. Espeland, Dianne Heidingsfelder, William C. Knowler, Helen Guay, Frank L. Greenway, Richard Carey, Siran Ghazarian, Heather Chenot, Osama Hamdy, Barbara Fargnoli, Morgan Taggart Ivy, Henry A. Glick, Rose Salata, Alan Wesley, Charlotte Bragg, Sarah A. Gaussoin, Hensley Susan, Vicki DiLillo, Ann McNamara, Haiying Chen, Terra Thompson, Patricia Lipschutz, Lisa Jones, Steven M. Haffner, Erin Patterson, Paul Bloomquist, Michelle Horowitz, Janelia Smiley, Andrea M. Kriska, Sarah Longenecker, Marisa Smith, Susan Copelli, Lane L. Liscum, Christina Morris, Holly R. Wyatt, Jason Griffin, Henry J. Pownall, John M. Jakicic, Frederick L. Brancati, Judy Bahnson, Loretta Rome, Jacqueline Wesche-Thobaben, Jessica Hurting, J. P. Massaro, Heather Turgeon, Jonathan Krakoff, Diane M. Greenberg, Patti Laqua, Mary E. Larkin, Yuliis Bell, Kathryn Hayward, Jennifer Arceneaux, Jackie Roche, Cora E. Lewis, Helen P. Hazuda, Susan K. Ewing, Carrie C. Williams, Kari Galuski, Anne Murillo, Sarah Bain, Miranda Smart, Amelia Hodges, Van S. Hubbard, Caitlin M. Egan, Christine Stevens, Mary T. Korytkowski, Cecilia Wang, Sharon Griggs, Kristina Spellman, Missy Lingle, Natalie Robinson, Molly Gee, Tatum Charron, Maschak Carey Barbara, Paul M. Ribisl, Helen Lambeth, Sandra Sangster, David M. Nathan, Lisa Palermo, Tammy Monk, Effoe E. Sammah, Donna Green, Kathy Lane, Richard Foushee, Valerie H. Myers, April Thomas, Yabing Li, Tina Killean, Jennifer Perault, Edward W. Gregg, Peter H. Bennett, Sara Hannum, Edward W. Lipkin, Jane Tavares, Helen Chomentowski, Enrico Cagliero, Andre Morgan, Paulette Cohrs, Dalane W. Kitzman, Susan Harrier, Kerry Ovalle, Maureen Daly, Susan Z. Yanovski, George A. Bray, Basma Fattaleh, W. Jack Rejeski, Diane G. Ives, David E. Kelley, J. Bruce Redmon, Patricia Poorthunder, Erica Ferguson, Michaela Rahorst, Katie Toledo, J. Lee Taylor, Elizabeth Smith, Birgitta I. Rice, Edward S. Horton, Zhu Ming Zhang, George L. Blackburn, Renate H. Rosenthal, Karen Quirin, Vicki A. Maddy, Jennifer Schmidt, Veronica Holley, Therese Ockenden, April Hamilton, Mary A. Hontz, Brenda Montgomery, Barbara Harrison, Carolyn Johnson, Cindy Puckett, A. Enrique Caballero, Valle Fagan Thania Del, Cynthia Hayashi, Ellen J. Anderson, Christos S. Mantzoros, Diane Hirsch, Kerry J. Stewart, Renee Bright, Santica M. Marcovina, Virginia Harlan, Mary Evans, Michael P. Walkup, Danielle Diggins, Barbara Bancroft, Lynne Lichtermann, Kathy Tyler, Anne L. Peters, Lee Swartzc, Karen C. Johnson, Mario Stylianou, Elizabeth Bovaird, Robert C. Kores, Donna H. Ryan, Susan S. Voeller, Lisa Cronkite, Lori Lambert, Clark C. Gardner, Rebecca H. Neiberg, Laurie Bissett, L B. Coelho, Don Kieffer, John P. Bantle, L. Brancati, Ann V. Schwartz, Jennifer Gauvin, Mara Z. Vitolins, Jolanta Socha, Debbie Bochert, Susanne Danus, Chula Maguire Kimberley, Gary D. Foster, Caitlin Egan, Eugene Leshchinskiy, Sara Evans, Stephen P. Glasser, Barbara Elnyczky, John J. Albers, Richard R. Rubin, Gracie Cunningham, Julieta Palencia, Beate Griffin, Kathy Hathaway, Michele Burrington, Tracey Y. Murray, Lewis H. Kuller, Lynne E. Wagenknecht, Edgar Ramirez, Ann A. Richmond, Robert W. Jeffery, Monika M. Safford, Stanley Schwartz, John P. Foreyt, Nancy J. Hall, Candace Goode, Jere T. Hamilton, Maureen Malloy, Robert Kuehnel, Mark King, Don Hire, David F. Williamson, Lavallade DeLee, R.J. Prineas, Amy A. Gorin, Anne A. Holowaty, Donna Valenski, Moana Mosby, Anna Bertorelli, Carlos Lorenzo, Susan Cantu-Lumbreras, Kara I. Gallagher, Tandaw E. Samdarshi, Dace L. Trence, Michelle Begnaud, Melanie Franks, Amy Dobelstein, Jane King, Deborah Robles, Hollie A. Raynor, Ashok Balasubramanyam, Diane Wheeler, Rob Nicholson, Suzanne Phelan, Cara Walcheck, Michael C. Nevitt, Julie A. Nelson, Maria Meacham, Rebecca S. Reeves, Leigh A. Shovestull, Seth Braunstein, Mia Johnson, Chanchai Sapun, Lawrence M. Friedman, Lolline Chong, Daniel P. Beavers, Patricia E. Hogan, Domingo Granado, Lisa Martich, Timothy S. Church, Andrea Crisler, and Peter Kaufman

Subjects
Research design, Blood Glucose, Male, medicine.medical_specialty, Time Factors, Endocrinology, Diabetes and Metabolism, Blood Pressure, Type 2 diabetes, Overweight, Article, law.invention, Endocrinology, Randomized controlled trial, Patient Education as Topic, law, Weight loss, Diabetes mellitus, Surveys and Questionnaires, Weight Loss, Internal Medicine, medicine, Humans, Obesity, Triglycerides, Aged, Monitoring, Physiologic, business.industry, Incidence, Cholesterol, HDL, Cholesterol, LDL, Middle Aged, medicine.disease, United States, Clinical trial, Diabetes Mellitus, Type 2, Cardiovascular Diseases, Research Design, Physical therapy, Female, medicine.symptom, business, Risk Reduction Behavior, Biomarkers, Follow-Up Studies
Abstract

Look AHEAD (Action for Health in Diabetes) was a randomized clinical trial designed to examine the long-term health effects of weight loss in overweight and obese individuals with type 2 diabetes. The primary result was that the incidence of cardiovascular events over a median follow-up of 9.6 years was not reduced in the Intensive Lifestyle Group relative to the control group. This finding is discussed, with emphasis on its implications for design of trials and clinical treatment of obese persons with type 2 diabetes.

Published
2014

15. 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

Author

David M. Reboussin, W. Jack Rejeski, Mace Coday, Barbara J. Maschak-Carey, Robert W. Jeffery, Monika M. Safford, John P. Foreyt, Brent Van Dorsten, Jacqueline Wesche-Thobaben, Thomas A. Wadden, John M. Jakicic, Karen C. Johnson, Xavier Pi-Sunyer, Susan Z. Yanovski, Steven E. Kahn, Sara Michaels, James O. Hill, Richard R. Rubin, Valerie Goldman, Brenda Montgomery, Lynne E. Wagenknecht, Jennifer Patricio, Tricia Skarphol, George A. Bray, Maria G. Montez, Caitlin Egan, Abbas E. Kitabchi, Edward W. Gregg, Cora E. Lewis, Helen P. Hazuda, Jeanne M. Clark, Steven M. Haffner, Judy Bahnson, Donald A. Williamson, Van S. Hubbard, Mark A. Espeland, Rena R. Wing, Tina Killean, Henry J. Pownall, Delia S. West, Edward S. Horton, Anne L. Peters, David M. Nathan, and Cathy Manus

Subjects
Risk, Blood Glucose, Male, medicine.medical_specialty, Time Factors, Physical fitness, Blood Pressure, Type 2 diabetes, Overweight, Severity of Illness Index, Article, Time, Body Mass Index, Diabetes Complications, Patient Education as Topic, Weight loss, Risk Factors, Internal medicine, Diabetes mellitus, Weight Loss, Internal Medicine, medicine, Humans, Obesity, Life Style, Triglycerides, Glycemic, Aged, business.industry, Cholesterol, HDL, Type 2 Diabetes Mellitus, Cholesterol, LDL, Middle Aged, medicine.disease, United States, Hemoglobin A, Treatment Outcome, Diabetes Mellitus, Type 2, Cardiovascular Diseases, Physical Fitness, Physical therapy, Female, medicine.symptom, business, Biomarkers
Abstract

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.

Published
2010

16. Consent for Genetics Studies Among Clinical Trial Participants: Findings from Action for Health in Diabetes (Look AHEAD)

Author

W. Jack Rejeski, Deborah F. Tate, Ray Carvajal, Renee Davenport, Shandiin Begay, Peter B. Jones, Roque M. Murillo, Laurie Bissett, Valerie Goldman, Maria G. Montez, Karen C. Johnson, Lynne E. Wagenknecht, Ann V. Schwartz, Alain G. Bertoni, Sharon D. Jackson, Virginia Harlan, Jeffrey M. Curtis, E. S. Kahn, Paula Bolin, K. Dotson, Erica Ferguson, Abbas E. Kitabchi, Donald A. Williamson, Elizabeth Bovaird, Renee Bright, Patricia E. Hogan, Barbara Bancroft, Richard S. Crow, Elizabeth Tucker, Maureen Malloy, Kathy Lane, Tricia Skarphol, Julie Currin, Anne E. Mathews, Linda M. Delahanty, Jennifer Gauvin, Mara Z. Vitolins, Theresa Michel, Shiriki K. Kumanyika, Mark A. Espeland, Jennifer Rush, Kristina P. Schumann, Anna Bertorelli, Allison Strate, Denise G. Simons-Morton, David E. Kelley, Carrie Combs, Nita Webb, Eva Obarzanek, Wei Lang, Rebecca S. Reeves, M. Patricia Snyder, Douglas A. Raynor, Susan Green, Robert Kuehnel, Richard Ginsburg, John P. Bantle, Gary D. Miller, L. Christie Oden, Richard Carey, Sarah Michaels, Rebecca Danchenko, Linda Foss, Gary D. Foster, Caitlin Egan, Jeanne Carls, Brenda Montgomery, Carlos Lorenzo, Lori Lambert, Medhat Botrous, Sarah Bain, Minnie Roanhorse, Heather McCormick, Michael T. McDermott, Edward W. Lipkin, Jane Tavares, Jason Maeda, Kathryn Hayward, Ann Goebel-Fabbri, Ann McNamara, Sandra Sangster, Cathy Roche, Cecilia Farach, David M. Nathan, Cathy Manus, Donna Wolf, William H. Herman, Paulette Cohrs, Patricia Lipschutz, P. J. Foreyt, Kara I. Gallagher, Thomas A. Wadden, Ronald J. Prineas, Kristi Rau, Tina Killean, Kerrin Brelje, Jennifer Perault, Justin Glass, George L. Blackburn, Edward W. Gregg, Anthony N. Fabricatore, Charles Campbell, Vicki A. Maddy, Steven E. Kahn, Emily A. Finch, Janet Bonk, Lauren Lessard, C. W. Knowler, M. Montez, Barbara Harrison, Barbara J. Maschak-Carey, Stephen P. Glasser, Molly Gee, Brandi Armand, Tatum Charron, Kristin Wallace, Jennifer Patricio, John A. Shepherd, Monica Mullen, Robert H. Knopp, Heather Chenot, Connie Mobley, Richard R. Rubin, Elizabeth J. Mayer-Davis, David M. Reboussin, Judith G. Regensteiner, Bernadette Todacheenie, Alan McNamara, Amelia Hodges, Mary Anne Holowaty, S. M. Haffner, Robert S. Schwartz, Paul M. Ribisl, B. Montgomery, Carol Percy, B. D. W. Harrison, Mohammed F. Saad, Frank L. Greenway, Osama Hamdy, Van S. Hubbard, Dace L. Trence, Magpuri Perpetua, Mandy Shipp, Sharon Hall, Kim Landry, William C. Knowler, Christian Speas, Louise Hesson, Ruby Johnson, Deborah Maier, David F. Williamson, Deborah Robles, Zhu Ming Zhang, Janelia Smiley, Jennifer Mayer, Henry J. Pownall, Andrea M. Kriska, A. S. Jaramillo, Nancy Scurlock, Vicki DiLillo, Karen T. Vujevich, S. Terry Barrett, James O. Hill, Amy Dobelstein, Clara Smith, Heather Turgeon, Sarah Ledbury, Kathy Dotson, JoAnn A. Phillipp, Carmen Pal, A. Enrique Caballero, Natalie Robinson, Jonathan Krakoff, Debi Celnik, Sheikilya Thomas, J. P. Massaro, Mary Lou Klem, Ellen J. Anderson, Amy A. Gorin, Stanley Schwartz, Jeanne M. Clark, Enrico Cagliero, Leigh A. Shovestull, Didas Fallis, Siran Ghazarian, Lawton S. Cooper, Kathy Horak, Pamela Coward, Carolyn Thorson, Diane Hirsch, Robert I. Berkowitz, Stanley Heshka, Matthew L. Maciejewski, Salma Benchekroun, Erin Patterson, Rita Donaldson, La Donna James, Tina Morgan, Robert W. Jeffery, Monika M. Safford, John P. Foreyt, Xavier Pi-Sunyer, Barbara Steiner, Michelle Chan, Leeann Carmichael, Barb Elnyczky, Charlotte Bragg, Delia S. West, Jacqueline Wesche-Thobaben, Canice E. Crerand, Lisa Palermo, Tammy Monk, Amy Keranen, April Hamilton, Patrick Reddin, Helen Chomentowski, Peter H. Bennett, Kati Szamos, Cynthia Hayashi, Kerry J. Stewart, Kerry Ovalle, Judy Bahnson, Pat Harper, John M. Jakicic, Janet Krulia, J. Bruce Redmon, Vincent Pera, Michaela Rahorst, Trena Johnsey, Maureen Daly, Susan Z. Yanovski, George A. Bray, Lindsey Munkwitz, Birgitta I. Rice, Edward S. Horton, Lawrence J. Cheskin, Daniel Edmundowicz, Marsha Miller, Therese Ockenden, Rena R. Wing, Christos S. Mantzoros, Santica M. Marcovina, Greg Strylewicz, Carolyne Campbell, Ken C. Chiu, Cora E. Lewis, Richard F. Hamman, Staci Gilbert, Don Kieffer, Frederick L. Brancati, Brent VanDorsten, Lynne Lichtermann, Juliet Mancino, Jeanne Charleston, Helen Lambeth, Suzanne Phelan, Cara Walcheck, Kimberley Chula-Maguire, Michael C. Nevitt, Donna H. Ryan, Hollie A. Raynor, Lewis H. Kuller, Ashok Balasubramanyam, Rob Nicholson, and Loretta Rome

Subjects
Research design, Male, medicine.medical_specialty, Genetic Research, Alternative medicine, Type 2 diabetes, 01 natural sciences, Article, Ethics, Research, 010104 statistics & probability, 03 medical and health sciences, 0302 clinical medicine, Patient Education as Topic, Weight loss, Informed consent, Medicine, Humans, Multicenter Studies as Topic, 030212 general & internal medicine, 0101 mathematics, Aged, Pharmacology, Genetics, Research ethics, Clinical Trials as Topic, Informed Consent, business.industry, General Medicine, Middle Aged, medicine.disease, humanities, Clinical trial, Diabetes Mellitus, Type 2, Research Design, Female, medicine.symptom, business, Risk Reduction Behavior, Cohort study, Ethics Committees, Research
Abstract

Background Increasingly, genetic specimens are collected to expand the value of clinical trials through study of genetic effects on disease incidence, progression or response to interventions. Purpose and methods We describe the experience obtaining IRB-approved DNA consent forms across the 19 institutions in the Action for Health in Diabetes (Look AHEAD), a clinical trial examining the effect of a lifestyle intervention for weight loss on the risk of serious cardiovascular events among individuals with type 2 diabetes. We document the rates participants provided consent for DNA research, identify participant characteristics associated with consent, and discuss implications for genetics research. Results IRB approval to participate was obtained from 17 of 19 institutions. The overall rate of consent was 89.6% among the 15 institutions that had completed consenting at the time of our analysis, which was higher than reported for other types of cohort studies. Consent rates were associated with factors expected to be associated with weight loss and cardiovascular disease and to affect the distribution of candidate genes. Non-consent occurred more frequently among participants grouped as African-American, Hispanic, female, more highly educated or not dyslipidemic. Limitations The generalizabilty of results is limited by the inclusion/exclusion criteria of the trial. Conclusions Barriers to obtaining consent to participate in genetic studies may differ from other recruitment settings. Because of the potentially complex associations between personal characteristics related to adherence, outcomes and gene distributions, differential rates of consent may introduce biases in estimates of genetic relationships.

Published
2006

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