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1. 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

2. Weight Change During the Postintervention Follow-up of Look AHEAD

Author

Rena R. Wing, Rebecca H. Neiberg, Judy L. Bahnson, Jeanne M. Clark, Mark A. Espeland, James O. Hill, Karen C. Johnson, William C. Knowler, KayLoni Olson, Helmut Steinburg, Xavier Pi-Sunyer, Thomas A. Wadden, Holly Wyatt, Lee Swartz, Dawn Jiggetts, Jeanne Charleston, Lawrence Cheskin, Nisa M. Maruthur, Scott J. Pilla, Danielle Diggins, Mia Johnson, George A. Bray, Frank L. Greenway, Donna H. Ryan, Catherine Champagne, Valerie Myers, Jeffrey Keller, Tiffany Stewart, Jennifer Arceneaux, Karen Boley, Greta Fry, Lisa Jones, Kim Landry, Melissa Lingle, Marisa Smith, Cora E. Lewis, Sheikilya Thomas, Stephen Glasser, Gareth Dutton, Amy Dobelstein, Sara Hannum, Anne Hubbell, DeLavallade Lee, Phyllis Millhouse, L. Christie Oden, Cathy Roche, Jackie Grant, Janet Turman, David M. Nathan, Valerie Goldman, Linda Delahanty, Mary Larkin, Kristen Dalton, Roshni Singh, Melanie Ruazol, Medha N. Munshi, Sharon D. Jackson, Roeland J.W. Middelbeek, A. Enrique Caballero, Anthony Rodriguez, George Blackburn, Christos Mantzoros, Ann McNamara, Jeanne Anne Breen, Marsha Miller, Debbie Bochert, Suzette Bossart, Paulette Cohrs, Susan Green, April Hamilton, Eugene Leshchinskiy, Loretta Rome, John P. Foreyt, Molly Gee, Henry Pownall, Ashok Balasubramanyam, Chu-Huang Chen, Peter Jones, Michele Burrington, Allyson Clark Gardner, Sharon Griggs, Michelle Hamilton, Veronica Holley, Sarah Lee, Sarah Lane Liscum, Susan Cantu-Lumbreras, Julieta Palencia, Jennifer Schmidt, Jayne Thomas, Carolyn White, Charlyne Wright, Monica Alvarez, Beate Griffin, Mace Coday, Donna Valenski, Karen Johnson, Robert W. Jeffery, Tricia Skarphol, John P. Bantle, J. Bruce Redmon, Kerrin Brelje, Carolyne Campbell, Mary Ann Forseth, Soni Uccellini, Mary Susan Voeller, Blandine Laferrère, Jennifer Patricio, Jose Luchsinger, Priya Palta, Sarah Lyon, Kim Kelly, Barbara J. Maschak-Carey, Robert I. Berkowitz, Ariana Chao, Renee Davenport, Katherine Gruber, Sharon Leonard, Olivia Walsh, John M. Jakicic, Jacqueline Wesche-Thobaben, Lin Ewing, Andrea Hergenroeder, Mary Korytkowski, Susan Copelli, Rebecca Danchenko, Diane Ives, Juliet Mancino, Lisa Martich, Meghan McGuire, Tracey Y. Murray, Linda Semler, Kathy Williams, Caitlin Egan, Elissa Jelalian, Jeanne McCaffery, Kathryn Demos McDermott, Jessica Unick, Kirsten Annis, Jose DaCruz, Ariana Rafanelli, Helen P. Hazuda, Juan Carlos Isaac, Prepedigna Hernandez, Steven E. Kahn, Edward J. Boyko, Elaine Tsai, Lorena Wright, Karen Atkinson, Ivy Morgan-Taggart, Jolanta Socha, Heidi Urquhart, Paula Bolin, Harelda Anderson, Sara Michaels, Ruby Johnson, Patricia Poorthunder, Janelia Smiley, Anne L. Peters, Siran Ghazarian, Elizabeth Beale, Edgar Ramirez, Gabriela Rodriguez, Valerie Ruelas, Sara Serafin-Dokhan, Martha Walker, Marina Perez, Lynne E. Wagenknecht, David Reboussin, Mike E. Miller, Peter Brubaker, Nicholas Pajewski, Michael Bancks, Jingzhong Ding, Gagan Deep, Kathleen Hayden, Stephen R. Rapp, Felicia Simpson, Haiying Chen, Bonnie C. Sachs, Denise Houston, Shyh-Huei Chen, Andrea Anderson, Jerry M. Barnes, Mary Barr, Tara D. Beckner, Delilah R. Cook, Carrie C. Williams, Joni Evans, Katie Garcia, Sarah A. Gaussoin, Carol Kittel, Lea Harvin, Marjorie Howard, James Lovato, June Pierce, Debbie Steinberg, Christopher Webb, Jennifer Walker, Michael P. Walkup, Carolyn Watkins, Santica M. Marcovina, Jessica Hurting, John J. Albers, Vinod Gaur, Michael Nevitt, Ann Schwartz, John Shepherd, Michaela Rahorst, Lisa Palermo, Susan Ewing, Cynthia Hayashi, and Jason Maeda

Subjects
Advanced and Specialized Nursing, Endocrinology, Diabetes and Metabolism, Internal Medicine, Clinical Care/Education/Nutrition/Psychosocial Research
Abstract

OBJECTIVE Patients with type 2 diabetes are encouraged to lose weight, but excessive weight loss in older adults may be a marker of poor health and subsequent mortality. We examined weight change during the postintervention period of Look AHEAD, a randomized trial comparing intensive lifestyle intervention (ILI) with diabetes support and education (DSE) (control) in overweight/obese individuals with type 2 diabetes and sought to identify predictors of excessive postintervention weight loss and its association with mortality. RESEARCH DESIGN AND METHODS These secondary analyses compared postintervention weight change (year 8 to final visit; median 16 years) in ILI and DSE in 3,999 Look AHEAD participants. Using empirically derived trajectory categories, we compared four subgroups: weight gainers (n = 307), weight stable (n = 1,561), steady losers (n = 1,731), and steep losers (n = 380), on postintervention mortality, demographic variables, and health status at randomization and year 8. RESULTS Postintervention weight change averaged −3.7 ± 9.5%, with greater weight loss in the DSE than the ILI group. The steep weight loss trajectory subgroup lost on average 17.7 ± 6.6%; 30% of steep losers died during postintervention follow-up versus 10–18% in other trajectories (P < 0001). The following variables distinguished steep losers from weight stable: baseline, older, longer diabetes duration, higher BMI, and greater multimorbidity; intervention, randomization to control group and less weight loss in years 1–8; and year 8, higher prevalence of frailty, multimorbidity, and depressive symptoms and lower use of weight control strategies. CONCLUSIONS Steep weight loss postintervention was associated with increased risk of mortality. Older individuals with longer duration of diabetes and multimorbidity should be monitored for excessive unintentional weight loss.

Published
2021

3. 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

4. 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

5. 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

6. 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

7. 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

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

Author

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

Published
2015
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9. 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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