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1. 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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2. 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

3. 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

4. Inconsistent Associations of Caffeine-containing Beverages with Blood Pressure and with Lipoproteins

Author

John E. Hilner, Ellen Funkhouser, Charlotte Bragg, Alan R. Dyer, James M. Raczynski, Cora E. Lewis, Mary Anne Armstrong, Gary D. Friedman, Bette Cann, and Peter J. Savage

Subjects
medicine.medical_specialty, Epidemiology, Cholesterol, business.industry, Hemodynamics, chemistry.chemical_compound, Blood pressure, Endocrinology, chemistry, Internal medicine, Cohort, medicine, lipids (amino acids, peptides, and proteins), business, Caffeine, Body mass index, Negroid, Lipoprotein
Abstract

The authors examined associations of caffeine and caffeinated beverage intakes with blood pressure and with lipoproteins in 5,115 black and white men and women aged 18-30 years during 1985-1986. Caffeine and beverage intakes were not consistently associated with blood pressure in analyses controlling for race, sex, Keys score, sucrose intake, physical activity, oral contraceptive use, body mass index, alcohol use, age, and smoking. Associations of caffeine and beverage intakes with cholesterol, triglycerides, high-density lipoprotein cholesterol, and high-density lipoprotein2 cholesterol were also inconsistent. There is little or no association of caffeine with lipoproteins or with blood pressure in this cohort of healthy young adults.

Published
1993
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5. Quality control of dietary data collection in the CARDIA study

Author

Charlotte Bragg, Carey Smoak, Janet Wittes, Robert Birch, Arline McDonald, Joan E. Hilner, Martha L. Slattery, Linda Van Horn, and Bette J. Caan

Subjects
Adult, Male, Quality Control, medicine.medical_specialty, Adolescent, media_common.quotation_subject, Coronary Disease, computer.software_genre, Automated data, Risk Factors, medicine, Humans, Quality (business), Longitudinal Studies, media_common, Pharmacology, Data collection, business.industry, Data Collection, Diet, Dietary history, Monitor quality, Physical therapy, Female, Data mining, business, computer
Abstract

The Coronary Artery Risk Development in (Young) Adults (CARDIA) Study developed and implemented quality control (QC) measures to minimize misclassification associated with dietary data. Manual and automated data inspection were used to monitor quality. Of the 5111 participants who completed a dietary history, 717 (14%) had dietary forms reviewed and 153 (3%) had the interview audiotaped. Results show that for the 717 forms reviewed, the overall form completion error rate was 0.22% and the "critical" error rate (i.e., those errors impacting on nutrient computations) was 0.12%. The proportion of forms free of any type of error increased over time (p less than 0.0001). The discrepancy rate in recording and interviewing methods as estimated from the 153 audiotaped interviews was 0.7%. Inter-interviewer differences were small as indicated by the audiotaped interviews and the proportion of error-free forms completed by interviewers. The results indicate that the dietary data collected in CARDIA were completely and accurately recorded for use in analysis.

Published
1992
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6. Diet, Body Size, and Plasma Lipids-Lipoproteins in Young Adults: Differences by Race and Sex

Author

Bette J. Caan, Linda Van Horn, Joan E. Hilner, Carol Ballew, Gregory L. Burke, Kiang Liu, Martha L. Slattery, David R. Jacobs, Arline McDonald, Peter J. Savage, Charlotte Bragg, and S. Sidney

Subjects
medicine.medical_specialty, Epidemiology, business.industry, Cholesterol, Saturated fat, Blood lipids, Physiology, chemistry.chemical_compound, Endocrinology, High-density lipoprotein, chemistry, Internal medicine, Medicine, lipids (amino acids, peptides, and proteins), Risk factor, Young adult, business, Body mass index, Lipoprotein
Abstract

The Coronary Artery Risk Development in Young Adults (CARDIA) study completed baseline dietary assessment, measurement of body mass index, and lipid and lipoprotein analyses on 5,111 participants. CARDIA includes black and white men and women between 18 and 30 years of age at baseline (1985-1986), recruited in Birmingham, Alabama, Chicago, Illinois, Minneapolis, Minnesota, and Oakland, California. Diet was assessed by a detailed interviewer-administered diet history that measured the usual eating pattern over the past month. Possible sex, race, age, and educational differences in diet, body size, and lipids-lipoproteins were explored. Nutrient analyses indicate that the Keys score, a measure of dietary fat composition, is significantly correlated with plasma cholesterol in older (aged 25-30 years) white men (r = 0.12, p less than 0.01) and older white women (r = 0.12, p less than 0.001). In multiple linear regression analyses, body mass index was positively and significantly associated with total cholesterol and low density lipoprotein cholesterol and inversely associated with high density lipoprotein cholesterol across all race-sex groups. The Keys score was significantly associated with total cholesterol and low density lipoprotein cholesterol in white men and women. Education was associated with high density lipoprotein cholesterol in black and white women and white men. In these young adults, dietary fat intake and body mass index were related to blood lipids in certain subgroups. In black and white men and black women, blood cholesterol increased with age across race-sex groups independently of these covariates. In view of the many factors affecting plasma cholesterol and the limitations of the dietary history method, these cross-sectional data are useful in characterizing diet and lipid differences. There appears to be general disparity between recommended dietary intake of total fat, saturated fat, and other nutrients and actual dietary intake in young adults, regardless of age and educational level.

Published
1991
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7. 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

8. Fecal incontinence in obese women with urinary incontinence: prevalence and role of dietary fiber intake

Author

Holly E. Richter, Leslee L. Subak, Alexandra L. Hernandez, Charlotte Bragg, Kathryn L. Burgio, and Alayne D. Markland

Subjects
Adult, Dietary Fiber, medicine.medical_specialty, Stress incontinence, Diet therapy, Urinary Incontinence, Stress, Urinary incontinence, Overweight, Severity of Illness Index, Article, Body Mass Index, Risk Factors, Weight loss, Surveys and Questionnaires, Internal medicine, Weight Loss, Prevalence, Humans, Medicine, Fecal incontinence, Obesity, Exercise, Gynecology, business.industry, Obstetrics and Gynecology, Middle Aged, medicine.disease, Nutrition Assessment, Female, medicine.symptom, business, Body mass index, Fecal Incontinence
Abstract

Objective This study estimates the prevalence of fecal incontinence (FI) in overweight and obese women with urinary incontinence and compares dietary intake in women with and without FI. Study Design A total of 336 incontinent and overweight women in the Program to Reduce Incontinence by Diet and Exercise clinical trial were included. FI was defined as monthly or greater loss of mucus, liquid, or solid stool. Dietary intake was quantified using the Block Food Frequency Questionnaire. Results Women had a mean (± SD) age of 53 ± 10 years, body mass index of 36 ± 6 kg/m 2 , and 19% were African American. Prevalence of FI was 16% (n = 55). In multivariable analyses, FI was independently associated with low fiber intake, higher depressive symptoms, and increased urinary tract symptoms (all P Conclusion Overweight and obese women report a high prevalence of monthly FI associated with low dietary fiber intake. Increasing dietary fiber may be a treatment for FI.

Published
2009
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9. Long-Term Weight Loss and Changes in Blood Pressure: Results of the Trials of Hypertension Prevention, Phase II

Author

Amy Brewer, Eva Obarzanek, Marian Millstone, Nancy R. Cook, Charlotte Bragg, James M. Raczynski, Bali Singh, Victor J. Stevens, Jerome D. Cohen, Lorna Belden, I-Min Lee, Delia Smith West, Lawrence J. Appel, N. Carole Milas, and Mildred Mattfeldt-Beman

Subjects
Adult, Counseling, Male, medicine.medical_specialty, Time Factors, Blood Pressure, Overweight, law.invention, Pharmacotherapy, Randomized controlled trial, Behavior Therapy, Risk Factors, Weight loss, law, Internal medicine, Weight Loss, Internal Medicine, medicine, Humans, Myocardial infarction, Prospective cohort study, Exercise, business.industry, fungi, Social Support, food and beverages, General Medicine, Middle Aged, medicine.disease, Diet, Surgery, Primary Prevention, Clinical trial, Blood pressure, Hypertension, Cardiology, Regression Analysis, Female, medicine.symptom, business, Follow-Up Studies
Abstract

Weight loss appears to be an effective method for primary prevention of hypertension. However, the long-term effects of weight loss on blood pressure have not been extensively studied.To present detailed results from the weight loss arm of Trials of Hypertension Prevention (TOHP) II.Multicenter, randomized dinical trial testing the efficacy of lifestyle interventions for reducing blood pressure over 3 to 4 years. Participants in TOHP II were randomly assigned to one of four groups. This report focuses only on participants assigned to the weight loss (n = 595) and usual care control (n = 596) groups.Men and women 30 to 54 years of age who had nonmedicated diastolic blood pressure of 83 to 89 mm Hg and systolic blood pressure less than 140 mm Hg and were 110% to 165% of their ideal body weight at baseline.The weight loss intervention included a 3-year program of group meetings and individual counseling focused on dietary change, physical activity, and social supportWeight and blood pressure data were collected every 6 months by staff who were blinded to treatment assignmentMean weight change from baseline in the intervention group was -4.4 kg at 6 months, -2.0 kg at 18 months, and -0.2 kg at 36 months. Mean weight change in the control group at the same time points was 0.1, 0.7, and 1.8 kg. Blood pressure was significantly lower in the intervention group than in the control group at 6, 18, and 36 months. The risk ratio for hypertension in the intervention group was 0.58 (95% CI, 0.36 to 0.94) at 6 months, 0.78 (CI, 0.62 to 1.00) at 18 months, and 0.81 (CI, 0.70 to 0.95) at 36 months. In subgroup analyses, intervention participants who lost at least 4.5 kg at 6 months and maintained this weight reduction for the next 30 months had the greatest reduction in blood pressure and a relative risk for hypertension of 0.35 (CI, 0.20 to 0.59).Clinically significant long-term reductions in blood pressure and reduced risk for hypertension can be achieved with even modest weight loss.

Published
2001
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10. Cancer: what is prevention?

Author

Charlotte Bragg and Jack Hataway

Subjects
Oncology, medicine.medical_specialty, business.industry, Public Health, Environmental and Occupational Health, Cancer, Health Promotion, medicine.disease, United States, Internal medicine, Neoplasms, medicine, Humans, Public Health, business
Published
1984

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