This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. Primary support for the subproject and the subproject's principal investigator may have been provided by other sources, including other NIH sources. The Total Cost listed for the subproject likely represents the estimated amount of Center infrastructure utilized by the subproject, not direct funding provided by the NCRR grant to the subproject or subproject staff. The Look AHEAD, multicenter, randomized controlled clinical trial will examine the impact on several health outcomes of a lifestyle intervention program designed to produce weight loss. The primary study objective is to determine whether participation in a lifestyle intervention is effective in reducing the incidence of serious cardiovascular disease events in overweight adults with type 2 diabetes. Other important study objectives are to assess the impact of weight loss and fitness changes on a range of disease processes and outcomes and to evaluate the cost-effectiveness of the weight loss intervention. The study cohort will include 5,000 overweight (body mass index of at least 25 kg/m2) individuals with type 2 diabetes (as established by self-report with verification or treatment). Sixteen centers across the United States will each recruit approximately 313 persons into the trial. Individuals with or without a prior history of cardiovascular disease will be recruited. Participants will be stratified according to center, and randomly assigned to either Lifestyle Intervention or a control intervention, Diabetes Support and Education. The Lifestyle Intervention is designed to produce and maintain weight loss and increased fitness through a lifestyle program augmented, if indicated, by subsequent use of weight loss medication. This intervention includes individual and group sessions with weekly meetings for six months followed by decreasing frequency of contact over the remainder of the trial. The Diabetes Support and Education group will receive sessions of nutrition and physical activity education and social support. Participants in both arms will receive comparable education in issues related to diabetes management. Participants in Look AHEAD will receive their general medical care from a health care provider who is separate from the Look AHEAD staff. Participants will be followed annually until 2012, resulting in a maximum of 11.5 years of participant follow-up. Outcome measures include those that might be positively affected by weight loss (e.g. cardiovascular events) and those that might be negatively affected (e.g. bone mineral density). The study will also assess some of the potential mechanisms by which weight loss may influence cardiovascular events and mortality (e.g. through improved control of cardiovascular risk factors).

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR000188-47
Application #
8356762
Study Section
National Center for Research Resources Initial Review Group (RIRG)
Project Start
2010-12-01
Project End
2011-11-30
Budget Start
2010-12-01
Budget End
2011-11-30
Support Year
47
Fiscal Year
2011
Total Cost
$29,682
Indirect Cost
Name
Baylor College of Medicine
Department
Pediatrics
Type
Schools of Medicine
DUNS #
051113330
City
Houston
State
TX
Country
United States
Zip Code
77030
Hunsaker, Sanita L; Garland, Beth H; Rofey, Dana et al. (2018) A Multisite 2-Year Follow Up of Psychopathology Prevalence, Predictors, and Correlates Among Adolescents Who Did or Did Not Undergo Weight Loss Surgery. J Adolesc Health 63:142-150
Lanzieri, Tatiana M; Chung, Winnie; Leung, Jessica et al. (2018) Hearing Trajectory in Children with Congenital Cytomegalovirus Infection. Otolaryngol Head Neck Surg 158:736-744
Bollard, Catherine M; Tripic, Tamara; Cruz, Conrad Russell et al. (2018) Tumor-Specific T-Cells Engineered to Overcome Tumor Immune Evasion Induce Clinical Responses in Patients With Relapsed Hodgkin Lymphoma. J Clin Oncol 36:1128-1139
Michalsky, Marc P; Inge, Thomas H; Jenkins, Todd M et al. (2018) Cardiovascular Risk Factors After Adolescent Bariatric Surgery. Pediatrics 141:
Lau, Chantal (2018) Breastfeeding Challenges and the Preterm Mother-Infant Dyad: A Conceptual Model. Breastfeed Med 13:8-17
Gururangan, Sridharan; Reap, Elizabeth; Schmittling, Robert et al. (2017) Regulatory T cell subsets in patients with medulloblastoma at diagnosis and during standard irradiation and chemotherapy (PBTC N-11). Cancer Immunol Immunother 66:1589-1595
Lanzieri, T M; Leung, J; Caviness, A C et al. (2017) Long-term outcomes of children with symptomatic congenital cytomegalovirus disease. J Perinatol 37:875-880
El-Hattab, Ayman W; Zarante, Ana Maria; Almannai, Mohammed et al. (2017) Therapies for mitochondrial diseases and current clinical trials. Mol Genet Metab 122:1-9
Jin, Haoxing Douglas; Demmler-Harrison, Gail J; Coats, David K et al. (2017) Long-term Visual and Ocular Sequelae in Patients With Congenital Cytomegalovirus Infection. Pediatr Infect Dis J 36:877-882
Oh, Sam S; Du, Randal; Zeiger, Andrew M et al. (2017) Breastfeeding associated with higher lung function in African American youths with asthma. J Asthma 54:856-865

Showing the most recent 10 out of 459 publications