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1. Dynapenia and Metabolic Health in Obese and Nonobese Adults Aged 70 Years and Older: The LIFE Study

Author

Mylène Aubertin-Leheudre, Stephen Anton, Daniel P. Beavers, Todd M. Manini, Roger Fielding, Ann Newman, Tim Church, Stephen B. Kritchevsky, David Conroy, Mary M. McDermott, Anda Botoseneanu, Michelle E. Hauser, Marco Pahor, Thomas Gill, Carlos Fragoso, Jack M. Guralnik, Christiaan Leeuwenburgh, Connie Caudle, Lauren Crump, Latonia Holmes, Jocelyn Lee, Ching-ju Lu, Michael E. Miller, Mark A. Espeland, Walter T. Ambrosius, William Applegate, Robert P. Byington, Delilah Cook, Curt D. Furberg, Lea N. Harvin, Leora Henkin, Med John Hepler, Fang-Chi Hsu, Laura Lovato, Wesley Roberson, Julia Rushing, Scott Rushing, Cynthia L. Stowe, Michael P. Walkup, Don Hire, W. Jack Rejeski, Jeffrey A. Katula, Peter H. Brubaker, Shannon L. Mihalko, Janine M. Jennings, Evan C. Hadley, Sergei Romashkan, Kushang V. Patel, Denise Bonds, Bonnie Spring, Joshua Hauser, Diana Kerwin, Kathryn Domanchuk, Rex Graff, Alvito Rego, Timothy S. Church, Steven N. Blair, Valerie H. Myers, Ron Monce, Nathan E. Britt, Melissa Nauta Harris, Ami Parks McGucken, Ruben Rodarte, Heidi K. Millet, Catrine Tudor-Locke, Ben P. Butitta, Sheletta G. Donatto, Shannon H. Cocreham, Abby C. King, Cynthia M. Castro, William L. Haskell, Randall S. Stafford, Leslie A. Pruitt, Kathy Berra, Veronica Yank, Roger A. Fielding, Miriam E. Nelson, Sara C. Folta, Edward M. Phillips, Christine K. Liu, Erica C. McDavitt, Kieran F. Reid, Dylan R. Kirn, Evan P. Pasha, Won S. Kim, Vince E. Beard, Eleni X. Tsiroyannis, Cynthia Hau, Stephen D. Anton, Susan Nayfield, Thomas W. Buford, Michael Marsiske, Bhanuprasad D. Sandesara, Jeffrey D. Knaggs, Megan S. Lorow, William C. Marena, Irina Korytov, Holly L. Morris, Margo Fitch, Floris F. Singletary, Jackie Causer, Katie A. Radcliff, Anne B. Newman, Stephanie A. Studenski, Bret H. Goodpaster, Nancy W. Glynn, Oscar Lopez, Neelesh K. Nadkarni, Kathy Williams, Mark A. Newman, George Grove, Janet T. Bonk, Jennifer Rush, Piera Kost, Diane G. Ives, Anthony P. Marsh, Tina E. Brinkley, Jamehl S. Demons, Kaycee M. Sink, Kimberly Kennedy, Rachel Shertzer-Skinner, Abbie Wrights, Rose Fries, Deborah Barr, Thomas M. Gill, Robert S. Axtell, Susan S. Kashaf, Nathalie de Rekeneire, Joanne M. McGloin, Karen C. Wu, Denise M. Shepard, Barbara Fennelly, Lynne P. Iannone, Raeleen Mautner, Theresa Sweeney Barnett, Sean N. Halpin, Matthew J. Brennan, Julie A. Bugaj, Maria A. Zenoni, Bridget M. Mignosa, Jeff Williamson, Hugh C. Hendrie, Stephen R. Rapp, Joe Verghese, Nancy Woolard, Mark Espeland, Janine Jennings, Valerie K. Wilson, Carl J. Pepine, Mario Ariet, Eileen Handberg, Daniel Deluca, James Hill, Anita Szady, Geoffrey L. Chupp, Gail M. Flynn, John L. Hankinson, Carlos A. Vaz Fragoso, Erik J. Groessl, and Robert M. Kaplan

Subjects
Male, medicine.medical_specialty, Waist, Blood lipids, 030209 endocrinology & metabolism, 030204 cardiovascular system & hematology, Lower risk, Article, Body Mass Index, 03 medical and health sciences, 0302 clinical medicine, Risk Factors, Internal medicine, medicine, Humans, Muscle Strength, Obesity, General Nursing, Abdominal obesity, Aged, Aged, 80 and over, Metabolic Syndrome, business.industry, Health Policy, General Medicine, Odds ratio, medicine.disease, Endocrinology, Female, Waist Circumference, Geriatrics and Gerontology, Metabolic syndrome, medicine.symptom, business, Body mass index
Abstract

Objective The purpose of this study was to examine the relationship between dynapenia and metabolic risk factors in obese and nonobese older adults. Methods A total of 1453 men and women (age ≥70 years) from the Lifestyle Interventions and Independence for Elders (LIFE) Study were categorized as (1) nondynapenic/nonobese (NDYN-NO), (2) dynapenic/nonobese (DYN-NO), (3) nondynapenic/obese (NDYN-O), or (4) dynapenic/obese (DYN-O), based on muscle strength (Foundation for the National Institute of Health criteria) and body mass index. Dependent variables were blood lipids, fasting glucose, blood pressure, presence of at least 3 metabolic syndrome (MetS) criteria, and other chronic conditions. Results A significantly higher likelihood of having abdominal obesity criteria in NDYN-NO compared with DYN-NO groups (55.6 vs 45.1%, P ≤ .01) was observed. Waist circumference also was significantly higher in obese groups (DYN-O = 114.0 ± 12.9 and NDYN-O = 111.2 ± 13.1) than in nonobese (NDYN-NO = 93.1 ± 10.7 and DYN-NO = 92.2 ± 11.2, P ≤ .01); and higher in NDYN-O compared with DYN-O ( P = .008). Additionally, NDYN-O demonstrated higher diastolic blood pressure compared with DYN-O (70.9 ± 10.1 vs 67.7 ± 9.7, P ≤ .001). No significant differences were found across dynapenia and obesity status for all other metabolic components ( P > .05). The odds of having MetS or its individual components were similar in obese and nonobese, combined or not with dynapenia (nonsignificant odds ratio [95% confidence interval]). Conclusion Nonobese dynapenic older adults had fewer metabolic disease risk factors than nonobese and nondynapenic older adults. Moreover, among obese older adults, dynapenia was associated with lower risk of meeting MetS criteria for waist circumference and diastolic blood pressure. Additionally, the presence of dynapenia did not increase cardiometabolic disease risk in either obese or nonobese older adults.

Published
2017
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2. Neuropeptide Y Impairs Retrieval of Extinguished Fear and Modulates Excitability of Neurons in the Infralimbic Prefrontal Cortex

Author

Charles M. Dolgas, Sarah N. Schmeltzer, Renu Sah, Mark L. Baccei, Lauren L. Vollmer, Jennifer Rush, Rebecca Ahlbrand, and Jennifer Schurdak

Subjects
Male, 0301 basic medicine, Prefrontal Cortex, Neurotransmission, Arginine, Extinction, Psychological, Rats, Sprague-Dawley, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Corticosterone, mental disorders, Animals, Neuropeptide Y, Chronic stress, Prefrontal cortex, Neurons, Dose-Response Relationship, Drug, Glutamate Decarboxylase, Learning Disabilities, Working memory, General Neuroscience, Articles, Fear, Extinction (psychology), Synaptic Potentials, Neuropeptide Y receptor, humanities, Rats, Receptors, Neuropeptide Y, Cortex (botany), Disease Models, Animal, 030104 developmental biology, chemistry, Mental Recall, Calcium-Calmodulin-Dependent Protein Kinase Type 2, Psychology, Neuroscience, 030217 neurology & neurosurgery
Abstract

Neuropeptide Y (NPY), a 36 aa peptide, regulates stress and emotional behaviors. Preclinical and clinical studies support an association of NPY with trauma-evoked syndromes such as posttraumatic stress disorder (PTSD), although the exact contribution of NPY is not clear. In the current study, we examined functional attributes of NPY in the infralimbic (IL) cortex, an area that regulates fear memories and is reported to be hypoactive in PTSD. Carriers of NPY gene polymorphism rs16147 have been reported to have elevated prefrontal NPY expression. Infusion of NPY into the IL cortex in rats significantly impaired fear extinction memory without affecting conditioned fear expression or acquisition of extinction. Neuroendocrine stress response, depression-like behavior, and working memory performance were not affected by NPY infusion into the IL. The NPY Y1receptor antagonist BIBO3304 completely abolished NPY effects on fear extinction retrieval. Y1receptor expression was localized on CaMKII-positive pyramidal projection neurons and GAD67-positive interneurons in the IL. Patch-clamp recordings revealed increased inhibitory synaptic transmission onto IL projection neurons in the presence of NPY. Thus, NPY dampens excitability of IL projection neurons and impairs retrieval of extinction memory by inhibiting consolidation of extinction. Of relevance to PTSD, elevation of prefrontal NPY attributable to the genetic polymorphism rs16147 may contribute to IL hypoactivity, resulting in impaired extinction memory and susceptibility to the disorder.SIGNIFICANCE STATEMENTNeuropeptide Y (NPY), a stress modulatory transmitter, is associated with posttraumatic stress disorder (PTSD). Contribution of NPY to PTSD symptomology is unclear. PTSD patients have reduced activity in the infralimbic (IL) subdivision of the medial prefrontal cortex (mPFC), associated with compromised extinction memory. No information exists on fear modulation by NPY in the IL cortex, although NPY and NPY receptors are abundant in these areas. This study shows that IL NPY inhibits consolidation of extinction, resulting in impaired retrieval of extinction memory and modulates excitability of IL projection neurons. In addition to providing a novel perspective on extinction memory modulation by NPY, our findings suggest that elevated mPFC NPY in gene polymorphism rs16147 carriers or after chronic stress could increase susceptibility to PTSD.

Published
2016
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3. Applying a perceptions and practicalities approach to understanding nonadherence to antiepileptic drugs

Author

Sanjay M. Sisodiya, Rona Eade, Sarah Chapman, Simona Balestrini, Rob Horne, and Jennifer Rush

Subjects
Adult, Male, Health Knowledge, Attitudes, Practice, medicine.medical_specialty, Adolescent, Cross-sectional study, Psychological intervention, Nice, Disease, Logistic regression, Medication Adherence, Young Adult, Epilepsy, Quality of life (healthcare), Surveys and Questionnaires, medicine, Humans, Young adult, Psychiatry, Aged, computer.programming_language, Aged, 80 and over, business.industry, Age Factors, Middle Aged, medicine.disease, Cross-Sectional Studies, Neurology, Anticonvulsants, Female, Neurology (clinical), Power, Psychological, business, computer
Abstract

Summary Objective Nonadherence to antiepileptic drugs (AEDs) is a common cause of poor seizure control. This study examines whether reported adherence to AEDs is related to variables identified in the National Institute for Health and Clinical Excellence (NICE) Medicines Adherence Guidelines as being important to adherence: perceptual factors (AED necessity beliefs and concerns), practical factors (limitations in capability and resources), and perceptions of involvement in treatment decisions. Methods This was a cross-sectional study of people with epilepsy receiving AEDs. Participants completed an online survey hosted by the Epilepsy Society (n = 1,010), or as an audit during inpatient admission (n = 118). Validated questionnaires, adapted for epilepsy, assessed reported adherence to AEDs (Medication Adherence Report Scale [MARS]), perceptions of AEDs (Beliefs about Medicines Questionnaire [BMQ]), and patient perceptions of involvement in treatment decisions (Treatment Empowerment Scale [TES]). Results Low adherence was related to AED beliefs (doubts about necessity: t(577) = 3.90, p < 0.001; and concerns: t(995) = 3.45, p = 0.001), reported limitations in capability and resources (t(589) = 7.78, p < 0.001), and to perceptions of a lack of involvement in treatment decisions (t(623) = 4.48, p < 0.001). In multiple logistic regression analyses, these factors significantly (p < 0.001) increased variance in reported adherence, above that which could be explained by age and clinical variables (seizure frequency, type, epilepsy duration, number of AEDs prescribed). Significance Variables identified in the NICE Medicines Adherence Guidelines as potentially important factors for adherence were found to be related to adherence to AEDs. These factors are potentially modifiable. Interventions to support optimal adherence to AEDs should be tailored to address doubts about AED necessity and concerns about harm, and to overcome practical difficulties, while engaging patients in treatment decisions.

Published
2015
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4. Association of Accelerometry-Measured Physical Activity and Cardiovascular Events in Mobility-Limited Older Adults: The LIFE (Lifestyle Interventions and Independence for Elders) Study

Author

Shannon K. Cochrane, Shyh‐Huei Chen, Jodi D. Fitzgerald, John A. Dodson, Roger A. Fielding, Abby C. King, Mary M. McDermott, Todd M. Manini, Anthony P. Marsh, Anne B. Newman, Marco Pahor, Catrine Tudor‐Locke, Walter T. Ambrosius, Thomas W. Buford, Mark A. Espeland, William Applegate, Daniel P. Beavers, Robert P. Byington, Delilah Cook, Curt D. Furberg, Lea N. Harvin, Leora Henkin, John Hepler, Fang‐Chi Hsu, Laura Lovato, Wesley Roberson, Julia Rushing, Scott Rushing, Cynthia L. Stowe, Michael P. Walkup, Don Hire, W. Jack Rejeski, Jeffrey A. Katula, Peter H. Brubaker, Shannon L. Mihalko, Janine M. Jennings, June J. Pierce, Sergei Romashkan, Kushang V. Patel, Denise Bonds, Bonnie Spring, Joshua Hauser, Diana Kerwin, Kathryn Domanchuk, Rex Graff, Alvito Rego, Steven N. Blair, Valerie H. Myers, Ron Monce, Nathan E. Britt, Melissa Nauta Harris, Ami Parks McGucken, Ruben Rodarte, Heidi K. Millet, Ben P. Butitta, Sheletta G. Donatto, Shannon H. Cocreham, Cynthia M. Castro, William L. Haskell, Randall S. Stafford, Leslie A. Pruitt, Kathy Berra, Veronica Yank, Stephen D. Anton, Susan Nayfield, Michael Marsiske, Bhanuprasad D. Sandesara, Jeffrey D. Knaggs, Megan S. Lorow, William C. Marena, Irina Korytov, Holly L. Morris, Margo Fitch, Floris F. Singletary, Jackie Causer, Katie A. Radcliff, Stephanie A. Studenski, Bret H. Goodpaster, Nancy W. Glynn, Oscar Lopez, Neelesh K. Nadkarni, Kathy Williams, Mark A. Newman, George Grove, Janet T. Bonk, Jennifer Rush, Piera Kost, Diane G. Ives, Tina E. Brinkley, Jamehl S. Demons, Kaycee M. Sink, Kimberly Kennedy, Rachel Shertzer‐Skinner, Abbie Wrights, Rose Fries, Deborah Barr, Robert S. Axtell, Susan S. Kashaf, Nathalie de Rekeneire, Joanne M. McGloin, Karen C. Wu, Denise M. Shepard, Barbara Fennelly, Lynne P. Iannone, Raeleen Mautner, Theresa Sweeney Barnett, Sean N. Halpin, Matthew J. Brennan, Julie A. Bugaj, Maria A. Zenoni, Bridget M. Mignosa, Hugh C. Hendrie, Stephen R. Rapp, Joe Verghese, Nancy Woolard, Mark Espeland, Janine Jennings, Valerie K. Wilson, Eileen Handberg, Gail M. Flynn, Thomas M. Gill, John L. Hankinson, Carlos A. Vaz Fragoso, and Robert M. Kaplan

Subjects
Gerontology, Male, Aging, Health Knowledge, Attitudes, Practice, Time Factors, Epidemiology, physical activity, 030204 cardiovascular system & hematology, 0302 clinical medicine, Risk Factors, Cardiovascular Disease, Clinical Studies, Medicine, 030212 general & internal medicine, media_common, Original Research, Aged, 80 and over, Incidence, cardiovascular, Age Factors, Prognosis, Exercise Therapy, Cardiovascular Diseases, Female, Cardiology and Cardiovascular Medicine, media_common.quotation_subject, Physical activity, Fitness Trackers, 03 medical and health sciences, Patient Education as Topic, Predictive Value of Tests, Lifestyle intervention, accelerometry, Humans, Mobility Limitation, Association (psychology), Exercise, Geriatric Assessment, Aged, business.industry, Exercise therapy, Actigraphy, Protective Factors, Independence, United States, business, Risk Reduction Behavior
Abstract

Background Data are sparse regarding the value of physical activity ( PA ) surveillance among older adults—particularly among those with mobility limitations. The objective of this study was to examine longitudinal associations between objectively measured daily PA and the incidence of cardiovascular events among older adults in the LIFE (Lifestyle Interventions and Independence for Elders) study. Methods and Results Cardiovascular events were adjudicated based on medical records review, and cardiovascular risk factors were controlled for in the analysis. Home‐based activity data were collected by hip‐worn accelerometers at baseline and at 6, 12, and 24 months postrandomization to either a physical activity or health education intervention. LIFE study participants (n=1590; age 78.9±5.2 [ SD ] years; 67.2% women) at baseline had an 11% lower incidence of experiencing a subsequent cardiovascular event per 500 steps taken per day based on activity data (hazard ratio, 0.89; 95% confidence interval, 0.84–0.96; P =0.001). At baseline, every 30 minutes spent performing activities ≥500 counts per minute (hazard ratio, 0.75; confidence interval, 0.65–0.89 [ P =0.001]) were also associated with a lower incidence of cardiovascular events. Throughout follow‐up (6, 12, and 24 months), both the number of steps per day (per 500 steps; hazard ratio, 0.90, confidence interval, 0.85–0.96 [ P =0.001]) and duration of activity ≥500 counts per minute (per 30 minutes; hazard ratio, 0.76; confidence interval, 0.63–0.90 [ P =0.002]) were significantly associated with lower cardiovascular event rates. Conclusions Objective measurements of physical activity via accelerometry were associated with cardiovascular events among older adults with limited mobility (summary score >10 on the Short Physical Performance Battery) both using baseline and longitudinal data. Clinical Trial Registration URL : http://www.clinicaltrials.gov . Unique identifier: NCT 01072500.

Published
2017

5. Predictors of Change in Physical Function in Older Adults in Response to Long-Term, Structured Physical Activity: The LIFE Study

Author

Andrew S. Layne, Fang-Chi Hsu, Steven N. Blair, Shyh-Huei Chen, Jennifer Dungan, Roger A. Fielding, Nancy W. Glynn, Alexandra M. Hajduk, Abby C. King, Todd M. Manini, Anthony P. Marsh, Marco Pahor, Christine A. Pellegrini, Thomas W. Buford, Jack M. Guralnik, Christiaan Leeuwenburgh, Connie Caudle, Lauren Crump, Latonia Holmes, Jocelyn Lee, Ching-ju Lu, Michael E. Miller, Mark A. Espeland, Walter T. Ambrosius, William Applegate, Daniel P. Beavers, Robert P. Byington, Delilah Cook, Curt D. Furberg, Lea N. Harvin, Leora Henkin, John Hepler, Laura Lovato, Wesley Roberson, Julia Rushing, Scott Rushing, Cynthia L. Stowe, Michael P. Walkup, Don Hire, W. Jack Rejeski, Jeffrey A. Katula, Peter H. Brubaker, Shannon L. Mihalko, Janine M. Jennings, Evan C. Hadley, Sergei Romashkan, Kushang V. Patel, Denise Bonds, Mary M. McDermott, Bonnie Spring, Joshua Hauser, Diana Kerwin, Kathryn Domanchuk, Rex Graff, Alvito Rego, Timothy S. Church, Valerie H. Myers, Ron Monce, Nathan E. Britt, Melissa Nauta Harris, Ami Parks McGucken, Ruben Rodarte, Heidi K. Millet, Catrine Tudor-Locke, Ben P. Butitta, Sheletta G. Donatto, Shannon H. Cocreham, Cynthia M. Castro, William L. Haskell, Randall S. Stafford, Leslie A. Pruitt, Kathy Berra, Veronica Yank, Miriam E. Nelson, Sara C. Folta, Edward M. Phillips, Christine K. Liu, Erica C. McDavitt, Kieran F. Reid, Won S. Kim, Vince E. Beard, Stephen D. Anton, Susan Nayfield, Michael Marsiske, Bhanuprasad D. Sandesara, Jeffrey D. Knaggs, Megan S. Lorow, William C. Marena, Irina Korytov, Holly L. Morris, Margo Fitch, Floris F. Singletary, Jackie Causer, Katie A. Radcliff, Anne B. Newman, Stephanie A. Studenski, Bret H. Goodpaster, Oscar Lopez, Neelesh K. Nadkarni, Kathy Williams, Mark A. Newman, George Grove, Janet T. Bonk, Jennifer Rush, Piera Kost, Diane G. Ives, Stephen B. Kritchevsky, Tina E. Brinkley, Jamehl S. Demons, Kaycee M. Sink, Kimberly Kennedy, Rachel Shertzer-Skinner, Abbie Wrights, Rose Fries, Deborah Barr, Thomas M. Gill, Robert S. Axtell, Susan S. Kashaf, Nathalie de Rekeneire, Joanne M. McGloin, Karen C. Wu, Denise M. Shepard, Barbara Fennelly, Lynne P. Iannone, Raeleen Mautner, Theresa Sweeney Barnett, Sean N. Halpin, Matthew J. Brennan, Julie A. Bugaj, Maria A. Zenoni, Bridget M. Mignosa, Jeff Williamson, Hugh C. Hendrie, Stephen R. Rapp, Joe Verghese, Nancy Woolard, Mark Espeland, Janine Jennings, Carl J. Pepine, Mario Ariet, Eileen Handberg, Daniel Deluca, James Hill, Anita Szady, Geoffrey L. Chupp, Gail M. Flynn, John L. Hankinson, Carlos A. Vaz Fragoso, Erik J. Groessl, and Robert M. Kaplan

Subjects
Gerontology, Male, medicine.medical_specialty, Time Factors, medicine.medical_treatment, Psychological intervention, Physical activity, Physical Therapy, Sports Therapy and Rehabilitation, Blood Pressure, Article, Body Mass Index, 03 medical and health sciences, 0302 clinical medicine, Accelerometry, medicine, Humans, 030212 general & internal medicine, Mobility Limitation, Exercise, Health Education, Aged, Aged, 80 and over, Rehabilitation, Hazard ratio, Age Factors, Resistance Training, Odds ratio, Confidence interval, Walking Speed, Lower Extremity, Physical therapy, Patient Compliance, Health education, Female, Sedentary Behavior, Psychology, Body mass index, 030217 neurology & neurosurgery, Physical Conditioning, Human
Abstract

To evaluate the extent of variability in functional responses in participants in the Lifestyle Interventions and Independence for Elders (LIFE) study and to identify the relative contributions of intervention adherence, physical activity, and demographic and health characteristics to this variability.Secondary analysis.Multicenter institutions.A volunteer sample (N=1635) of sedentary men and women aged 70 to 89 years who were able to walk 400m but had physical limitations, defined as a Short Physical Performance Battery (SPPB) score of ≤9.Moderate-intensity physical activity (n=818) consisting of aerobic, resistance, and flexibility exercises performed both center-based (2times/wk) and home-based (3-4times/wk) sessions or health education program (n=817) consisting of weekly to monthly workshops covering relevant health information.Physical function (gait speed over 400m) and lower extremity function (SPPB score) assessed at baseline and 6, 12, and 24 months.Greater baseline physical function (gait speed, SPPB score) was negatively associated with change in gait speed (regression coefficient β=-.185; P.001) and change in SPPB score (β=-.365; P.001), whereas higher number of steps per day measured by accelerometry was positively associated with change in gait speed (β=.035; P.001) and change in SPPB score (β=.525; P.001). Other baseline factors associated with positive change in gait speed and/or SPPB score include younger age (P.001), lower body mass index (P.001), and higher self-reported physical activity (P=.002).Several demographic and physical activity-related factors were associated with the extent of change in functional outcomes in participants in the LIFE study. These factors should be considered when designing interventions for improving physical function in older adults with limited mobility.

Published
2016

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
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7. 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

8. Making the Most of Your Healthcare intervention for older adults with multiple chronic illnesses

Author

Juhee Song, Alan B. Stevens, Lisa Sklar, Angela Hochhalter, and Jennifer Rush

Subjects
Male, medicine.medical_specialty, Health Status, Psychological intervention, law.invention, Quality of life (healthcare), Randomized controlled trial, Nursing, Patient Education as Topic, law, Intervention (counseling), Health care, Medicine, Humans, Patient participation, Aged, Self-efficacy, Aged, 80 and over, Primary Health Care, business.industry, General Medicine, Middle Aged, Self Efficacy, Telephone, Self Care, Treatment Outcome, Telephone interview, Health Communication, Socioeconomic Factors, Family medicine, Chronic Disease, Quality of Life, Female, Patient Participation, business, Delivery of Health Care
Abstract

Objective This study tested the efficacy of a patient engagement intervention for older adults with multiple chronic illnesses. Methods Seventy-nine participants were randomly assigned to receive the intervention (Intervention Group), contacts on a different topic (Safety Group), or Usual Care. The Intervention and Safety Groups attended a 2-h workshop and participated in phone calls; one before and one after a naturally-occurring medical encounter. The Intervention Group discussed patient engagement concepts from publicly distributed content. The Safety Group discussed general safety (e.g., fire safety, identity theft). Self-report measures were gathered by telephone interview at Baseline and 6-months following Baseline. Results We did not find expected improvements in patient activation and health-related quality of life. However, the Intervention Group was the only group to show a statistically significant improvement in self-efficacy for self-management. Conclusion The intervention shows promise for improving quality of life and/or health, but requires refinement to reach persons not already engaged in their healthcare and to strengthen its effects. Practice implications Patient-directed skills training interventions may be a successful way to support clinicians' and others' efforts to encourage older patients to be actively involved in their care.

Published
2009

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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