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1. Nursing Practice Environments in Hospitals: A Comparative Study between Portugal and Brazil

Author

Olga Maria Pimenta Lopes Ribeiro, Alessandro Rodrigues Perondi, Jane Tavares Gomes, João Miguel Almeida Ventura-Silva, Marlene Patrícia Ribeiro, Susana Filipa Mendes de Castro, Tânia Dionísia Ferreira Oliveira, and Letícia de Lima Trindade

Subjects
hospitals, nursing, professional practice, work environment, Nursing, RT1-120
Abstract

Background: Assessing the elements of nursing practice environments is crucial, as investing in their improvement will enhance outcomes for nurses, patients, and organizations. Moreover, comparing practice environments from different countries improves the definition of cross-cutting guidelines that can be applied in various contexts. Thus, this study aims to evaluate nursing practice environments in hospitals in Portugal and Brazil. Methods: A multicenter and cross-sectional study was conducted in eight Portuguese and eight Brazilian hospitals. Five hundred eighty-two nurses completed a survey regarding their sociodemographic and professional attributes, as well as the Scale for the Environments Evaluation of Professional Nursing Practice. The data were subjected to comparative analyses between the two countries. We adhered to ethical requirements in both participating countries. Results: In Brazil, the Structure, Process, and Outcome components were considered favorable to the quality of care and well-being of nurses. In Portugal, nurses considered the Structure and Outcome components favorable and the Process component very favorable. Statistically significant differences were found between the two countries in several dimensions of the three subscales. The Structure and Outcome components scored significantly better in hospitals in Brazil, and the Process component scored better in Portuguese hospitals. Conclusions: These conclusions underscore the urgent need for investment in continuous training and a culture of evaluation that promotes continuous improvement. Additionally, promoting the involvement and participation of nurses could simultaneously contribute to the development of more sustainable health systems.

Published
2024
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2. Nursing Practice Environments in Hospitals: A Comparative Study between Portugal and Brazil.

Author

Ribeiro, Olga Maria Pimenta Lopes, Perondi, Alessandro Rodrigues, Gomes, Jane Tavares, Ventura-Silva, João Miguel Almeida, Ribeiro, Marlene Patrícia, Castro, Susana Filipa Mendes de, Oliveira, Tânia Dionísia Ferreira, and Trindade, Letícia de Lima

Subjects
CROSS-sectional method, CORPORATE culture, MEDICAL quality control, WORK environment, HOSPITAL nursing staff, STATISTICAL sampling, QUESTIONNAIRES, HOSPITALS, NURSING, QUANTITATIVE research, DESCRIPTIVE statistics, MANN Whitney U Test, ORGANIZATIONAL structure, NURSING practice, RESEARCH, NURSES' attitudes, HEALTH facilities, COMPARATIVE studies, DATA analysis software, INDUSTRIAL hygiene
Abstract

Background: Assessing the elements of nursing practice environments is crucial, as investing in their improvement will enhance outcomes for nurses, patients, and organizations. Moreover, comparing practice environments from different countries improves the definition of cross-cutting guidelines that can be applied in various contexts. Thus, this study aims to evaluate nursing practice environments in hospitals in Portugal and Brazil. Methods: A multicenter and cross-sectional study was conducted in eight Portuguese and eight Brazilian hospitals. Five hundred eighty-two nurses completed a survey regarding their sociodemographic and professional attributes, as well as the Scale for the Environments Evaluation of Professional Nursing Practice. The data were subjected to comparative analyses between the two countries. We adhered to ethical requirements in both participating countries. Results: In Brazil, the Structure, Process, and Outcome components were considered favorable to the quality of care and well-being of nurses. In Portugal, nurses considered the Structure and Outcome components favorable and the Process component very favorable. Statistically significant differences were found between the two countries in several dimensions of the three subscales. The Structure and Outcome components scored significantly better in hospitals in Brazil, and the Process component scored better in Portuguese hospitals. Conclusions: These conclusions underscore the urgent need for investment in continuous training and a culture of evaluation that promotes continuous improvement. Additionally, promoting the involvement and participation of nurses could simultaneously contribute to the development of more sustainable health systems. [ABSTRACT FROM AUTHOR]

Published
2024
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6. The effect of the right care, right place, right time ( <scp>R3</scp> ) initiative on Medicare health service use among older affordable housing residents

Author

Jane Tavares, Liz Simpson, Edward Alan Miller, Pamela Nadash, and Marc Cohen

Subjects
Health Policy
Abstract

To determine the effect of an affordable housing-based supportive services intervention, which partnered with health and community service providers, on Medicare health service use among residents.Analyses used aggregated fee-for-service Medicare claims data from 2017 to 2020 for beneficiaries living in 34 buildings in eastern Massachusetts.Using a quasi-experimental design, a "difference-in-differences" framework was employed to isolate changes in outcomes, focusing on changes in pre- and post-intervention health service use across two stages of the intervention. Phase 1 encompassed the initial implementation period, and Phase 2 introduced a strategy to target residents at high risk of poor health outcomes. Key health service outcomes included hospitalizations, 30-day hospital readmission, and emergency department use.Medicare claims data for 10,412 individuals were obtained from a Quality Improvement Organization and aggregated at the building level.Analyses for Phase 1 found that hospital admission rates, emergency department admissions and payments, and hospital readmission rates grew more slowly for intervention sites than comparison sites. These findings were strengthened after the introduction of risk-targeting in Phase 2. Compared to selected control buildings, residents in intervention buildings experienced significantly lower rates of increases in inpatient hospitalization rates (-16% vs. +6%), hospital admission days (-25% vs. +29%), average hospital days (-12% vs. +14%), hospital admission payments (-22% vs. +33%), and 30-day hospital readmission rates (-22% vs. +54%). When accounting for the older age of the intervention residents, the size of the decline recorded in emergency department admissions was 6.7% greater for the intervention sites than the decline in comparison sites.A wellness-focused supportive services intervention was effective in reducing select health service use. The introduction of risk-targeting further strengthened this effect. Age-friendly health systems would benefit from enhanced partnerships with affordable housing sites to improve care and reduce service use for older residents.

Published
2022
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7. Are Wealthy Older Adults who use Medicaid Opportunistically Accessing the Program?

Author

Marc A. Cohen and Jane Tavares

Subjects
Life-span and Life-course Studies, Gerontology, Demography
Abstract

Medicaid is the largest payer of long-term services and supports (LTSS) and millions of older Americans rely on this means-tested program, especially during late life. There has been longstanding concern that wealthy older adults may be accessing the program by opportunistically divesting assets in order to qualify for coverage rather than by having high medical or LTSS expenses on which they spend down their resources to eligibility levels. Few current studies analyze this question longitudinally. Thus, questions remain about whether states need to tighten asset eligibility rules to prevent opportunistic asset divestiture. This analysis explores robust longitudinal data to determine the extent to which older, wealthier Americans accessing Medicaid do so by engaging in opportunistic asset transfer. Our findings demonstrate that this may occur among a relatively small proportion of wealthy people, and that tightening Medicaid eligibility criteria would likely have only a very modest impact on program expenditures.

Published
2022

8. LONG-TERM GENDERED PATHWAYS OF RELIGIOUS INVOLVEMENT POST WIDOWHOOD

Author

Frances Hawes and Jane Tavares

Subjects
Health (social science), Life-span and Life-course Studies, Health Professions (miscellaneous)
Abstract

Widowhood is associated with decreased emotional well-being, particularly increased depression. Prior research suggests that religiosity may help improve mental health among widowed individuals. However, longitudinal studies exploring the role of religiosity on emotional well-being among widowed older adults is lacking, as are studies which examine different dimensions of religiosity. This longitudinal study analyzed data from the 2006-2018 waves of the nationally representative Health and Retirement Study (HRS). Ordinary least squares (OLS) regression analysis was used to examine the relationship between widowhood and depression as well as the role of religiosity as a moderator of this association. Analysis was stratified by gender to further explore these interactions. Results show that men and women show similar levels of depression at widowhood, but men are far less likely to be depressed prior to widowhood. Women also show a better recovery pattern over time post-widowhood. Furthermore, religiosity (particularly attending church) is an effective way of coping with widowhood and mitigating depression for both genders. However, men are significantly less religious than women. This study highlights the long-term effects of widowhood on depressive symptomology among older adults. Practical implications of this study include intervention development around increased screening and treatment for depression for widowed older adults (in particular, for widowers) as well as connecting this vulnerable population with resources. These findings may also inform program outreach (such as hospice bereavement services) that aim to facilitate healthy grieving among widowed older adults.

Published
2022
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9. THE IMPACT OF THE R3 PROGRAM ON HEALTH SERVICES UTILIZATION AND COSTS

Author

Jane Tavares, Elizabeth Simpson, Edward Miller, Pamela Nadash, and Marc Cohen

Subjects
Health (social science), Life-span and Life-course Studies, Health Professions (miscellaneous)
Abstract

Relatively few housing with services evaluations use rigorous designs when assessing program impacts on health services utilization. This study thus employed a pre/post difference-in-difference quasi-experimental design, including building-level comparisons using Medicare fee-for-service claims data across two stages of the R3 intervention. Intervention sites included seven buildings with roughly 1,200 individuals. Key outcomes included hospital admissions, 30-day hospital readmission, and emergency department admissions. Results indicate that adding the R3 intervention to low-income housing sites led to meaningful reductions in service utilization and costs when compared to buildings where the program was not operating. The introduction of risk-targeting in the second stage of the intervention further strengthened this effect. Findings demonstrate that residents of affordable senior housing communities, who tend to be in poorer health than their counterparts in the community, benefit from the R3 program and that additional investment in this type of initiative would benefit the health care system.

Published
2022
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10. PERSON-CENTERED CARE: WHY TAKING INDIVIDUALS' CARE PREFERENCES INTO ACCOUNT MATTERS

Author

Frances Hawes, Jane Tavares, Marc Cohen, and Ann Hwang

Subjects
Health (social science), Life-span and Life-course Studies, Health Professions (miscellaneous)
Abstract

Person-centered care has been recognized as an integral part of a high-quality health care system. Utilizing the 2014 to 2018 waves of the Health and Retirement Study, we explore trends in person-centered care among those 50 and older by examining the extent to which they feel their care preferences are being taken into account, that is, that they are being heard by providers. We analyze the impact of not receiving person-centered care on health care utilization, health outcomes, and preventative care utilization. One-third of respondents reported that their care preferences were “sometimes” or “never” considered. Findings show that wealth and racial disparities in person-centered care are worsening over time. From 2014 to 2018, the percentage of non-Hispanic White respondents who reported that their care preferences were never taken into account decreased while the percentage for Hispanic and non-Hispanic Black individuals increased. Similar trends were seen for low-income individuals. Having a usual source of care was associated with a greater likelihood of having care preferences considered as well as significantly better control of chronic condition and greater use of preventive care. When care preferences are not being taken into account, there is less utilization of health care services, less preventive care usage, poorer control of chronic conditions, and increased risk for higher health care costs. These findings highlight the importance of assuring that people feel listened to by health care providers and emphasize a need for strategies to advance person-centered care for people of color and low-income populations.

Published
2022
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12. Effects of mulching on above and below ground pests and beneficials in a green onion agroecosystem

Author

Cerruti R. R. Hooks, Marisol A. Quintanilla-Tornel, Koon-Hui Wang, and Jane Tavares

Subjects
0106 biological sciences, Soil health, Agroecosystem, Ecology, Soil solarization, 04 agricultural and veterinary sciences, Biology, biology.organism_classification, 01 natural sciences, 010602 entomology, Agronomy, Living mulch, 040103 agronomy & agriculture, Crotalaria juncea, 0401 agriculture, forestry, and fisheries, Animal Science and Zoology, Cropping system, Cover crop, Agronomy and Crop Science, Mulch
Abstract

In 2013 and 2014, different mulching systems were investigated for their potential to suppress above and below ground pests, and enhance beneficial arthropods and soil health in green onion (Allium cepa) plantings. Three types of mulch systems (organic, living and solarization mulch) were evaluated and compared. Green onions were grown in four pre-plant treatments: (1) organic mulch generated by flail mowing a sunn hemp (Crotalaria juncea) cover crop (SH) followed by a no-till cropping system, (2) soil solarization (Sol), (3) sunn hemp-solarization mulch in which the sunn hemp was incorporated into the soil followed by soil solarization (SHSol), and (4) bare ground with insecticides (BG). Sol, SHSol and BG were practiced in conventional tilled system. SH (in 2013 and 2014) and SHSol (in 2014) treatments included strips of buckwheat and cowpea along the crop border to serve as living mulch or insectary plants. Green onion plants in SH had lower thrips and leaf miners damage than other treatments in both study years. When insectary borders were added to SHSol in 2014, thrips and leaf miners damages were also reduced in SHSol compared to Sol and BG. Incidence of purple blotch was reduced in SH and SHSol treatments in 2014. The SH treatment contained an increased abundance and richness of detritivores, predatory arthropods, parasitoids and beneficial free-living nematodes (particularly bacterivores and fungivores). Although weeds and initial populations of plant-parasitic nematodes were lower in solarization (Sol, SHSol) than other treatments, green onion yield was greatest in SH organic mulch systems in both study years. Overall, the integration of surface organic, living and solarization mulches into a green onion agroecosystem provided multiple ecosystem services including suppression of above and below ground pest organisms.

Published
2016
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13. An evaluation of insectary plants for management of insect pests in a hydroponic cropping system

Author

Koon-Hui Wang, Cerruti R. R. Hooks, and Jane Tavares

Subjects
Integrated pest management, Aphid, Sativum, biology, Agronomy, Insect Science, Brassica rapa, Crotalaria juncea, Hoverfly, PEST analysis, Cropping system, biology.organism_classification, Agronomy and Crop Science
Abstract

Eleven plants were evaluated for their potential to serve as insectary plants and attract beneficial arthropods. Buckwheat (Fagopyrum esculentum), cilantro (Coriandrum sativum) and dill (Anethum graveolens) attracted more numerous and diverse beneficial arthropods among the plants evaluated. However, the flowering period of dill was too short and cilantro did not grow well in hydroponic system, thus buckwheat was chosen for further evaluation as part of an insectary plant system (IPS). The overall goal was to evaluate non-chemical based arthropod pest management methods for hydroponic crops. The IPS treatment consisted of the vegetable and buckwheat planted within holes of the hydroponic box, along with an attached wasp nesting block and sunn hemp (Crotalaria juncea) on the ground on one side of the box to attract different predatory arthropods and parasitoids. Metallic board was included as another potential non-chemical pest management tactic. These two methods were compared to an untreated control for their abilities to reduce pest infestations on green onion (Allium cepa) and pak choi (Brassica rapa cv. Chinensis). The IPS failed to suppress thrips damage on green onion despite enhancing several natural enemies of arthropod pests and increasing green onion yield. However, caterpillar damage and aphid populations on pak choi were lower in the IPS. The pest suppressive effect of IPS improved over time when repeated in the same locations, and resulted in lower unmarketable yield than in metallic board and control treatments. The implications of using insectary plants and wasp nesting blocks as part of a hydroponic cropping system are discussed.

Published
2015
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15. 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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16. 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

17. 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

19. 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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