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

Author

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

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

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

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

Author

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

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

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

Published
2020
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3. Changes in Fasting and Prandial Gut and Adiposity Hormones Following Vertical Sleeve Gastrectomy or Roux-en-Y-Gastric Bypass: an 18-Month Prospective Study

Author

Marion L. Vetter, Noel N. Williams, Scott Ritter, Rexford S. Ahima, Thomas A. Wadden, Lucy F. Faulconbridge, Louise Hesson, David B. Sarwer, James Loughead, Kelly C. Allison, Naji Alamuddin, Alyssa M. Minnick, Jesse Chittams, Ruben C. Gur, and Matthew R. Hayes

Subjects
Adult, Male, medicine.medical_specialty, Sleeve gastrectomy, Endocrinology, Diabetes and Metabolism, medicine.medical_treatment, Gastric Bypass, 030209 endocrinology & metabolism, Gastroenterology, 03 medical and health sciences, 0302 clinical medicine, Gastrectomy, Weight loss, Internal medicine, medicine, Humans, Prospective Studies, Prospective cohort study, Nutrition and Dietetics, business.industry, Leptin, digestive, oral, and skin physiology, Area under the curve, nutritional and metabolic diseases, Fasting, Roux-en-Y anastomosis, Ghrelin, Obesity, Morbid, Surgery, Female, 030211 gastroenterology & hepatology, medicine.symptom, business, Blood sampling
Abstract

Vertical sleeve gastrectomy (VSG) and Roux-en-Y gastric bypass (RYGB) produce substantial weight loss, both primarily through gastric restriction but with potentially different hormonal signaling. This prospective, observational study compared changes in gut-derived hormones in VSG, RYGB, and weight-stable participants at 6 and 18 months post-surgery. Sixty-four obese, non-diabetic women, including 18 VSG, 23 RYGB, and 23 weight-stable controls completed assessments at baseline and 6 months, before and after consuming a mixed-nutrient meal; blood sampling occurred for 180 min post-meal. Fifty-one participants completed the 18-month outcome. Change from baseline in post-prandial area under the curve (over 180 min) for GLP-1, PYY3–36, ghrelin, and leptin was measured at 6 and 18 months post-surgery. At 18 months, VSG and RYGB participants lost a mean (±SEM) of 25.5 ± 2.3% and 34.2 ± 4.2% of initial weight, respectively (p

Published
2016
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4. Changes in neural responsivity to highly palatable foods following roux-en-Y gastric bypass, sleeve gastrectomy, or weight stability: An fMRI study

Author

Kelly C. Allison, Amber Rochette, Ryan Hopson, Noel N. Williams, James Loughead, Thomas A. Wadden, Anthony N. Fabricatore, Ruben C. Gur, Lucy F. Faulconbridge, Scott Ritter, Louise Hesson, Allan Geliebter, David B. Sarwer, and Kosha Ruparel

Subjects
medicine.medical_specialty, Sleeve gastrectomy, Endocrinology, Diabetes and Metabolism, medicine.medical_treatment, Medicine (miscellaneous), 030209 endocrinology & metabolism, Gastroenterology, 03 medical and health sciences, 0302 clinical medicine, Endocrinology, Weight loss, Internal medicine, medicine, Prospective cohort study, Nutrition and Dietetics, Blood-oxygen-level dependent, business.industry, Roux-en-Y anastomosis, Ventral tegmental area, medicine.anatomical_structure, nervous system, Anesthesia, Gastrectomy, Ghrelin, medicine.symptom, business, psychological phenomena and processes, 030217 neurology & neurosurgery
Abstract

Objective This prospective, observational fMRI study examined changes over time in blood oxygen level dependent (BOLD) response to high- and low-calorie foods (HCF and LCF) in bariatric surgery candidates and weight-stable controls. Methods Twenty-two Roux-en-Y gastric bypass (RYGB) participants, 18 vertical sleeve gastrectomy (VSG) participants, and 19 weight-stable controls with severe obesity underwent fMRI before and 6 months after surgery/baseline. BOLD signal change in response to images of HCF vs. LCF was examined in a priori regions of interest. Results RYGB and VSG participants lost 23.6% and 21.1% of initial weight, respectively, at 6 months, and controls gained 1.0%. Liking ratings for HCF decreased significantly in the RYGB and VSG groups but remained stable in the control group. BOLD response in the ventral tegmental area (VTA) to HCF (vs. LCF) declined significantly more at 6 months in RYGB compared to control participants but not in VSG participants. Changes in fasting ghrelin correlated positively with changes in VTA BOLD signal in both RYGB and VSG but not in control participants. Conclusions Results implicate the VTA as a critical site for modulating postsurgical changes in liking of highly palatable foods and suggest ghrelin as a potential substrate requiring further investigation.

Published
2016
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5. Four-Year Change in Cardiorespiratory Fitness and Influence on Glycemic Control in Adults With Type 2 Diabetes in a Randomized Trial

Author

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

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

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

Published
2013
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6. An open-label efficacy trial of escitalopram for night eating syndrome

Author

Andrew B. Newberg, Jacob Dubroff, Stacia K. Studt, Robert I. Berkowitz, Kelly C. Allison, Albert J. Stunkard, Louise Hesson, and Reneé H. Moore

Subjects
Adult, Male, medicine.medical_specialty, Citalopram, Hyperphagia, Chronobiology Disorders, Night eating syndrome, law.invention, Feeding and Eating Disorders, Randomized controlled trial, Quality of life, law, Binge-eating disorder, Internal medicine, medicine, Insomnia, Humans, Escitalopram, Psychiatry, Middle Aged, medicine.disease, Psychiatry and Mental health, Clinical Psychology, Eating disorders, Treatment Outcome, Mood, Female, medicine.symptom, Psychology, Selective Serotonin Reuptake Inhibitors, medicine.drug
Abstract

Objective Night eating syndrome (NES) has become increasingly recognized as a disorder in need of effective treatments. Selective serotonin reuptake inhibitors have shown efficacy in previous trials, so we sought to expand our understanding of the efficacy of escitalopram in the current trial. Method Thirty-one adults with NES participated in a 12-week open-label trial of escitalopram. Outcome measures included the Night Eating Symptom Scale (NESS), percent of daily intake after the evening meal (% intake) and number of nocturnal ingestions/week (NI), weight, total awakenings/week, mood, and quality of life. Mixed-effects models were used to assess change over time. Results Significant reductions were observed from week 0 to week 12 for the NESS (30.2 to 15.2), % intake (46% to 17%), NI (5.8 to 1.2), weight (90.2 to 88.6 kg), awakenings (8.1 to 2.7), and BDI-II (12.1 to 7.7). Outcomes did not differ significantly by gender, age, race, or psychiatric co-morbidity status. Eighteen of 31 completed 12 weeks of treatment. Discussion This open-label trial of escitalopram showed significant reductions in symptoms associated with NES. Randomized controlled trials are warranted to test these findings. Trial Registration: clinicaltrials.gov identifier: NCT01401595 .

Published
2013
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8. Effect of the Look AHEAD Study Intervention on Medication Use and Related Cost to Treat Cardiovascular Disease Risk Factors in Individuals With Type 2 Diabetes

Author

Maria G. Montez, Henry A. Glick, Brenda Montgomery, Louise Hesson, Patricia Feeney, J. Bruce Redmon, Michael S. Lawlor, Stephen P. Glasser, Stephanie Connelly, Alain G. Bertoni, and Frank L. Greenway

Subjects
Male, medicine.medical_specialty, Endocrinology, Diabetes and Metabolism, Physical fitness, Type 2 diabetes, Overweight, law.invention, Randomized controlled trial, Weight loss, law, Risk Factors, Diabetes mellitus, Weight Loss, Internal Medicine, medicine, Humans, Hypoglycemic Agents, Obesity, Risk factor, Exercise, Antihypertensive Agents, Original Research, Aged, Hypolipidemic Agents, Advanced and Specialized Nursing, business.industry, Clinical Care/Education/Nutrition/Psychosocial Research, Middle Aged, medicine.disease, Surgery, Diabetes Mellitus, Type 2, Cardiovascular Diseases, Emergency medicine, Female, medicine.symptom, business, Energy Intake
Abstract

OBJECTIVE To examine the effect of a lifestyle intervention to produce weight loss and increased physical fitness on use and cost of medications to treat cardiovascular disease (CVD) risk factors in people with type 2 diabetes. RESEARCH DESIGN AND METHODS Look AHEAD is a multicenter randomized controlled trial of 5,145 overweight or obese individuals with type 2 diabetes, aged 45–76 years. An intensive lifestyle intervention (ILI) involving group and individual meetings to achieve and maintain weight loss through decreased caloric intake and increased physical activity was compared with a diabetes support and education (DSE) condition. Medications prescribed to treat diabetes, hypertension, and hyperlipidemia were compared at baseline and 1 year. Medication costs were conservatively estimated using prices from a national online pharmacy. RESULTS Participants randomized to an ILI had significantly greater improvements in CVD risk parameters and reduced medication use and cost compared with those assigned to DSE. At 1 year, average number of medications prescribed to treat CVD risk factors was 3.1 ± 1.8 for the ILI group and 3.6 ± 1.8 for the DSE group (P < 0.0001), with estimated total monthly medication costs of $143 and $173, respectively (P < 0.0001). DSE participants meeting optimal care goals at 1 year were taking an average of 3.8 ± 1.6 medications at an estimated cost of $194/month. ILI participants at optimal care required fewer medications (3.2 ± 1.7) at lower cost ($154/month) (P < 0.001). CONCLUSIONS At 1 year, ILI significantly improved CVD risk factors, while at the same time reduced medication use and cost. Continued intervention and follow-up will determine whether these changes are maintained and reduce cardiovascular risk.

Published
2010

9. 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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12. 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

13. 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

14. Changes in symptoms of depression with weight loss: results of a randomized trial

Author

Thomas A. Wadden, Louise Hesson, David B. Sarwer, Robert I. Berkowitz, Leslie G. Womble, Anthony N. Fabricatore, Albert J. Stunkard, and Lucy F. Faulconbridge

Subjects
Adult, Behavior Control, Male, medicine.medical_specialty, Personality Inventory, Endocrinology, Diabetes and Metabolism, Medicine (miscellaneous), Article, law.invention, Interviews as Topic, Endocrinology, Pharmacotherapy, Randomized controlled trial, Rimonabant, Thinness, law, Weight loss, Behavior Therapy, Internal medicine, Appetite Depressants, Weight Loss, medicine, Humans, Obesity, Psychiatry, Suicidal ideation, Life Style, Depression (differential diagnoses), Nutrition and Dietetics, business.industry, Depression, Middle Aged, medicine.disease, Affect, Female, medicine.symptom, business, Cyclobutanes, Sibutramine, medicine.drug
Abstract

Recent studies of rimonabant have re-awakened interest in the possible adverse psychiatric effects of weight loss, as well as of weight loss medications. This study examined changes in symptoms of depression in 194 obese participants (age = 43.7 +/- 10.2 years; BMI = 37.6 +/- 4.1 kg/m(2)) in a 1-year randomized trial of lifestyle modification and medication. Participants were assigned to (i) sibutramine alone; (ii) lifestyle modification alone; (iii) sibutramine plus lifestyle modification (i.e., combined therapy); or (iv) sibutramine plus brief therapy. Participants completed the Beck Depression Inventory-II (BDI-II) at baseline and weeks 6, 10, 18, 26, 40, and 52. At 1 year, participants in combined therapy lost the most weight and those in sibutramine alone the least (12.1 +/- 8.8% vs. 5.5 +/- 6.5%; P0.01). Mean BDI-II scores across all participants declined from 8.1 +/- 6.9 to 6.2 +/- 7.7 at 1 year (P0.001), with no significant differences among groups. Despite this favorable change, 13.9% of participants (across the four groups) reported potentially discernible increases (or= 5 points on the BDI-II) in symptoms of depression at week 52. They lost significantly less weight than participants in the rest of the sample (5.4 +/- 7.8% vs. 9.0 +/- 7.8%, respectively; P0.03). The baseline prevalence of suicidal ideation was 3.6%. Seven new cases of suicidal ideation were observed during the year, with three in lifestyle modification alone. Further research is needed to identify characteristics of obese patients at risk of negative mood changes (and suicidal ideation) in response to behavioral and pharmacologic therapies.

Published
2009

15. Metabolic syndrome and health-related quality of life in obese individuals seeking weight reduction

Author

Louise Hesson, Rebecca A. Rothman, David B. Sarwer, Suzanne Phelan, Adam G. Tsai, Robert I. Berkowitz, Leslie G. Womble, and Thomas A. Wadden

Subjects
Gerontology, Adult, Male, medicine.medical_specialty, Endocrinology, Diabetes and Metabolism, Medicine (miscellaneous), Endocrinology, Quality of life, Weight loss, Predictive Value of Tests, Outcome Assessment, Health Care, Weight Loss, medicine, Humans, Psychology, Obesity, Life Style, Depression (differential diagnoses), Health related quality of life, Metabolic Syndrome, Nutrition and Dietetics, business.industry, Stressor, Middle Aged, medicine.disease, Mental health, humanities, Physical therapy, Quality of Life, Regression Analysis, Female, medicine.symptom, Metabolic syndrome, business, Psychosocial
Abstract

Background: No previous research has examined the association between metabolic syndrome (MetSyn) and health-related quality of life (HRQoL) using standard criteria for defining MetSyn. We hypothesized that MetSyn would be associated with lower HRQoL on measures of physical and mental health. Methods and Procedures: Participants were 361 individuals in two randomized weight loss trials. MetSyn was defined by the National Cholesterol Education Panel criteria. The Medical Outcomes Study, Short Form-36 (SF-36) was used to assess HRQoL. Differences in HRQoL and in clinical and psychosocial characteristics were compared among participants with and without MetSyn. Multiple regression was used to determine predictors of HRQoL. Results: MetSyn was associated with lower scores on the physical function and general health subscales of the SF-36 and on the physical component summary (PCS) score. This association remained after controlling for age or depression but was eliminated by controlling for BMI. MetSyn was not associated with lower mental quality of life, a higher depression score, tobacco or alcohol use, or a higher rate of psychosocial stressors. Discussion: Individuals with MetSyn reported lower HRQoL. This appeared to be an effect of increased weight, rather than a unique effect of MetSyn. Larger studies are needed to assess whether MetSyn may have an independent effect on HRQoL.

Published
2008

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

Author

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

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

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

Published
2006

17. Randomized trial of lifestyle modification and pharmacotherapy for obesity

Author

Robert K. Cato, David B. Sarwer, Thomas A. Wadden, Rosalind Kaplan, Albert J. Stunkard, Suzette Y. Osei, Leslie G. Womble, Louise Hesson, Suzanne Phelan, and Robert I. Berkowitz

Subjects
Adult, Counseling, Male, medicine.medical_specialty, Randomization, law.invention, Pharmacotherapy, Randomized controlled trial, law, Weight loss, Risk Factors, Appetite Depressants, Weight Loss, Medicine, Humans, Obesity, Exercise, Life Style, business.industry, General Medicine, Middle Aged, medicine.disease, Combined Modality Therapy, Clinical trial, Regimen, Cardiovascular Diseases, Physical therapy, Psychotherapy, Group, Female, medicine.symptom, business, Cyclobutanes, Selective Serotonin Reuptake Inhibitors, Sibutramine, medicine.drug
Abstract

background Weight-loss medications are recommended as an adjunct to a comprehensive program of diet, exercise, and behavior therapy but are typically prescribed with minimal or no lifestyle modification. This practice is likely to limit therapeutic benefits. methods In this one-year trial, we randomly assigned 224 obese adults to receive 15 mg of sibutramine per day alone, delivered by a primary care provider in eight visits of 10 to 15 minutes each; lifestyle-modification counseling alone, delivered in 30 group sessions; sibutramine plus 30 group sessions of lifestyle-modification counseling (i.e., combined therapy); or sibutramine plus brief lifestyle-modification counseling delivered by a primary care provider in eight visits of 10 to 15 minutes each. All subjects were prescribed a diet of 1200 to 1500 kcal per day and the same exercise regimen. results At one year, subjects who received combined therapy lost a mean (±SD) of 12.1±9.8 kg, whereas those receiving sibutramine alone lost 5.0±7.4 kg, those treated by lifestyle modification alone lost 6.7±7.9 kg, and those receiving sibutramine plus brief therapy lost 7.5±8.0 kg (P

Published
2005

18. A randomized comparison of a commercially available portion-controlled weight-loss intervention with a diabetes self-management education program

Author

Barbara J. Maschak-Carey, Marion L. Vetter, Lisa Diewald, N R Barbor, Brooke A. Bailer, Louise Hesson, Carol J. Homko, Thomas A. Wadden, Gary D. Foster, Caitlin LaGrotte, S S Vander Veur, Eugene Komaroff, and Sharon J. Herring

Subjects
portion control, Gerontology, obesity, medicine.medical_specialty, diabetes, business.industry, Endocrinology, Diabetes and Metabolism, diabetes education, Alternative medicine, MEDLINE, Diabetes self management, medicine.disease, Weight loss, Intervention (counseling), Diabetes mellitus, glycemic control, Internal Medicine, medicine, Physical therapy, Original Article, medicine.symptom, business
Abstract

Objective: This study examined the efficacy of a commercially available, portion-controlled diet (PCD) on body weight and HbA1c over 6 months in obese patients with type 2 diabetes. Research Design and Methods: One-hundred participants with a mean±s.d. age of 55.6±10.6 year, body weight of 102.9±18.4 kg and HbA1c of 7.7±1.3% were randomly assigned to a 9-session group lifestyle intervention that included a PCD or to a 9-session group program of diabetes self-management education (DSME). Participants in the two groups were prescribed the same goals for energy intake (1250–1550 kcal per day) and physical activity (200 min per week). Results: While both groups produced significant improvements in weight and HbA1c after 6 months of treatment, PCD participants lost 7.3 kg [95% confidence interval (CI): −5.8 to −8.8 kg], compared with 2.2 kg (95% CI: −0.7 to −3.7 kg) in the DSME group (PPP1c declined by 0.7% (95% CI: −0.4 to −1.0%) in the PCD group, compared with 0.4% (95% CI: −0.1 to −0.7%) in DSME (P1c (r=0.52, P Conclusions: These findings demonstrate that a commercially available portion-controlled meal plan can induce clinically meaningful improvements in weight and glycemic control in obese individuals with type 2 diabetes. These data have implications for the management of obesity in primary care, as now provided by the Centers for Medicare and Medicaid Services.

Published
2013
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