Look AHEAD: Action for Health in Diabetes
Principal Investigator: THOMAS A contact WADDEN
Affiliation: University of Pennsylvania
Abstract: Look AHEAD is randomized clinical trial examining the long-term health effects of an intensive weight loss intervention in approximately 5,145 overweight volunteers with type 2 diabetes. Participants are randomized to an intensive lifestyle intervention designed to achieve and maintain weight loss by decreased caloric intake and increased physical activity, or to a control program of diabetes support and education. The primary outcome of Look AHEAD is the aggregate occurrence of severe cardiovascular events (fatal and non-fatal Ml and stroke and cardiovascular deaths) over a planed follow-up of 11.5 years. The original grant application provided funding for the first 7 years of the study (1 year for study design and 6 for execution of the trial). The present grant application is for an additional 7 years of funding to complete the Look AHEAD trial. All aspects of the study have proceeded extremely well - the sample of 5,145 was recruited on time; retention has been excellent and the intervention has been effective in producing initial weight loss and maintaining it over time. All 16 clinical sites have been successful in recruitment, retention, and delivery of the intervention and the DSMB has been very positive about the execution of the trial. The present application reviews the overall design of Look AHEAD, progress to date, and plans for the future. Specific Aims are to retain the cohort over time, continue to complete annual in-person visits and semi-annual telephone interviews for outcome assessments and continue to administer the lifestyle intervention. These procedures will enable us to analyze the effects of the intervention on serious cardiovascular- related factors and complications, and cost-effectiveness of the intervention.
Funding Period: 1999-09-30 - 2013-07-31
more information: NIH RePORT
- Behavioral treatment of obesityThomas A Wadden
Department of Psychiatry, University of Pennsylvania School of Medicine, 3535 Market Street, Philadelphia, PA 19104, USA
Psychiatr Clin North Am 28:151-70, ix. 2005
- Impact of a weight management program on health-related quality of life in overweight adults with type 2 diabetesDonald A Williamson
Health Psychology Department, Pennington Biomedical Research Center, Louisiana State University System, 6400 Perkins Rd, Baton Rouge, LA 70808 4124, USA
Arch Intern Med 169:163-71. 2009..We tested the efficacy of a weight management program for improving HRQOL in overweight or obese adults diagnosed as having type 2 diabetes mellitus...
- One-year weight losses in the Look AHEAD study: factors associated with successThomas A Wadden
Department of Psychiatry, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania, USA
Obesity (Silver Spring) 17:713-22. 2009..The lifestyle intervention was clinically effective in all subsets of an ethnically and demographically diverse population...
- Erectile dysfunction in type 2 diabetic men: relationship to exercise fitness and cardiovascular risk factors in the Look AHEAD trialRaymond C Rosen
New England Research Institutes, 9 Galen Street, Watertown, MA, USA
J Sex Med 6:1414-22. 2009..Determinants of erectile dysfunction in diabetic men have not been adequately investigated as potential mediators of change...
- Obesity and albuminuria among adults with type 2 diabetes: the Look AHEAD (Action for Health in Diabetes) StudyHolly Kramer
Department of Preventive Medicine and Epidemiology, Division of Nephrology and Hypertension, Loyola University Medical Center, Maywood, Illinois, USA
Diabetes Care 32:851-3. 2009..To determine the association between obesity measures and albuminuria in adults with type 2 diabetes...
- Obstructive sleep apnea among obese patients with type 2 diabetesGary D Foster
Temple University, Philadelphia, Pennsylvania, USA
Diabetes Care 32:1017-9. 2009..To assess the risk factors for the presence and severity of obstructive sleep apnea (OSA) among obese patients with type 2 diabetes...
- Prevalence and risk factors for urinary incontinence in overweight and obese diabetic women: action for health in diabetes (look ahead) studySuzanne Phelan
Kinesiology Department, California Polytechnic State University, San Luis Obispo, California, USA
Diabetes Care 32:1391-7. 2009..Increasing obesity (BMI > or =35 kg/m(2)) was the strongest modifiable risk factor for overall incontinence and stress incontinence in this diverse cohort...
- Describing patterns of weight changes using principal components analysis: results from the Action for Health in Diabetes (Look AHEAD) research groupMark A Espeland
Department of Biostatistical Sciences, Wake Forest University School of Medicine and Winston Salem, NC 27157, USA
Ann Epidemiol 19:701-10. 2009..To demonstrate how principal components analysis can be used to describe patterns of weight changes in response to an intensive lifestyle intervention...
- Action for Health in Diabetes (Look AHEAD) trial: baseline evaluation of selected nutrients and food group intakeMara Z Vitolins
Department of Epidemiology and Prevention, Division of Public Health Sciences, Wake Forest University School of Medicine, Winston Salem, NC 27104, USA
J Am Diet Assoc 109:1367-75. 2009..Little has been reported regarding food and nutrient intake in individuals diagnosed with type 2 diabetes, and most reports have been based on findings in select groups or individuals who self-reported having diabetes...
- Effects of weight loss intervention on erectile function in older men with type 2 diabetes in the Look AHEAD trialRena R Wing
The Miriam Hospital Brown Medical School, Providence, RI, USA
J Sex Med 7:156-65. 2010..Overweight men with diabetes often report erectile dysfunction (ED), but few studies have examined effects of weight loss on this problem...
- Constructing common cohorts from trials with overlapping eligibility criteria: implications for comparing effect sizes between trialsDavid L Mount
Wake Forest University School of Medicine, Winston Salem, NC, USA
Clin Trials 6:416-29. 2009..Comparing findings from separate trials is necessary to choose among treatment options, however differences among study cohorts may impede these comparisons...
- Effect of a lifestyle intervention on change in cardiorespiratory fitness in adults with type 2 diabetes: results from the Look AHEAD StudyJ M Jakicic
Department of Health and Physical Activity, Physical Activity and Weight Management Research Center, University of Pittsburgh, Pittsburgh, PA 15203, USA
Int J Obes (Lond) 33:305-16. 2009..To examine the effect of an intensive lifestyle weight loss intervention (ILI) compared to diabetes support and education (DSE) on changes in fitness and physical activity in the Look AHEAD trial...
- Binge eating and weight loss outcomes in overweight and obese individuals with type 2 diabetes: results from the Look AHEAD trialAmy A Gorin
Department of Psychology, Center for Health, Intervention, and Prevention, University of Connecticut, 2006 Hillside Rd, Unit 1248, Storrs, CT 06269 1248, USA
Arch Gen Psychiatry 65:1447-55. 2008..Binge eating (BE) is common in overweight and obese individuals with type 2 diabetes mellitus, but little is known about how BE affects weight loss in this population...
- Weight loss treatment influences untreated spouses and the home environment: evidence of a ripple effectA A Gorin
Department of Psychology, Center for Health, Intervention and Prevention, University of Connecticut, Storrs, CT, USA
Int J Obes (Lond) 32:1678-84. 2008..To examine whether a weight loss program delivered to one spouse has beneficial effects on the untreated spouse and the home environment...
- Health-related quality of life and symptoms of depression in extremely obese persons seeking bariatric surgeryAnthony N Fabricatore
Department of Psychiatry, University of Pennsylvania School of Medicine, Philadelphia, PA 19128 3309, USA
Obes Surg 15:304-9. 2005..This study examined the relationships among BMI, HRQoL, and symptoms of depression in persons with extreme obesity...
- The Look AHEAD study: a description of the lifestyle intervention and the evidence supporting itThomas A Wadden
University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania, USA corrected
Obesity (Silver Spring) 14:737-52. 2006..After Year 4, participants are offered monthly individual visits. The intervention is delivered by a multidisciplinary team that includes medical staff who monitor participants at risk of hypoglycemic episodes...
- Correlates of health-related quality of life in overweight and obese adults with type 2 diabetesW Jack Rejeski
Department of Health and Exercise Science, Wake Forest University, Winston Salem, NC 27109, USA
Obesity (Silver Spring) 14:870-83. 2006..Analyses examined the relationship that demographic characteristics, disease burden, and cardiovascular fitness had with HRQL: the Short Form 36 (SF-36) and the Beck Depression Inventory (BDI) II...
- Lifestyle modification in the treatment of obesity: an educational challenge and opportunityL R Jones
Department of Psychiatry, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania, USA
Clin Pharmacol Ther 81:776-9. 2007..The latter term, as applied to weight control, refers to a set of principles and techniques to help patients adopt new diet and exercise habits that can be sustained long term to promote health...
- Reduction in weight and cardiovascular disease risk factors in individuals with type 2 diabetes: one-year results of the look AHEAD trialXavier Pi-Sunyer
St Luke s Roosevelt Hospital Center, USA
Diabetes Care 30:1374-83. 2007..This report describes 1-year changes in CVD risk factors in a trial designed to examine the long-term effects of an intensive lifestyle intervention on the incidence of major CVD events...
- Exercise capacity and cardiovascular/metabolic characteristics of overweight and obese individuals with type 2 diabetes: the Look AHEAD clinical trialPaul M Ribisl
Health and Exercise Sciences, Department of Biostatistical Sciences, Wake Forest University, Wake Forest Road, Winston Salem, NC 27109, USA
Diabetes Care 30:2679-84. 2007..0 kg/m2) men and women with type 2 diabetes who were randomized participants for the Look AHEAD (Action for Health in Diabetes) clinical trial...
- Fitness, fatness, and cardiovascular risk factors in type 2 diabetes: look ahead studyRena R Wing
Weight Control and Diabetes Research Center, Providence, RI 02903, USA
Med Sci Sports Exerc 39:2107-16. 2007..The present study examined the association of cardiorespiratory fitness and obesity with CVD risk factors in an ethnically diverse sample of overweight/obese individuals with type 2 diabetes...
- Suboptimal control of glycemia, blood pressure, and LDL cholesterol in overweight adults with diabetes: the Look AHEAD StudyAlain G Bertoni
Division of Public Health Sciences, Department of Epidemiology and Prevention, Wake Forest University Health Sciences, Winston Salem, NC 27157, USA
J Diabetes Complications 22:1-9. 2008..The characteristics associated with meeting goals for glycemia, blood pressure (BP), and low-density lipoprotein (LDL) cholesterol for participants with diabetes were examined...
- Weight loss strategies associated with BMI in overweight adults with type 2 diabetes at entry into the Look AHEAD (Action for Health in Diabetes) trialHollie A Raynor
Department of Psychiatry and Human Behavior, Brown Medical School The Miriam Hospital, Providence, Rhode Island, USA
Diabetes Care 31:1299-304. 2008....
- Measurement characteristics of the ankle-brachial index: results from the Action for Health in Diabetes studyMark A Espeland
Department of Biostatistical Sciences, Wake Forest University School of Medicine, Winston Salem, NC 27157, USA
Vasc Med 13:225-33. 2008..Replicating SBP measurements reduces the error and bias of ABI. Averaging leg-specific values may increase power for characterizing cardiovascular disease risk...
- A randomized study on the effect of weight loss on obstructive sleep apnea among obese patients with type 2 diabetes: the Sleep AHEAD studyGary D Foster
Center for Obesity Research and Education, Temple University, 3223 N Broad St, Ste 175, Philadelphia, PA 19140, USA
Arch Intern Med 169:1619-26. 2009..The belief that weight loss improves obstructive sleep apnea (OSA) has limited empirical support. The purpose of this 4-center study was to assess the effects of weight loss on OSA over a 1-year period...