Objective: This study evaluated weight changes after cessation of the 10-year intensive lifestyle intervention (ILI) in the Look AHEAD (Action for Health in Diabetes) study. It was hypothesized that ILI participants would be more likely to gain weight during the 2-year observational period following termination of weight-loss–maintenance counseling than would participants in the diabetes support and education (DSE) control group. Methods: Look AHEAD was a randomized controlled trial that compared the effects of ILI and DSE on cardiovascular morbidity and mortality in participants with overweight/obesity and type 2 diabetes. Look AHEAD was converted to an observational study in September 2012. Results: Two years after the end of the intervention (EOI), ILI and DSE participants lost a mean (SE) of 1.2 (0.2) kg and 1.8 (0.2) kg, respectively (P = 0.003). In addition, 31% of ILI and 23.9% of DSE participants gained ≥ 2% (P < 0.001) of EOI weight, whereas 36.3% and 45.9% of the respective groups lost ≥ 2% of EOI weight (P = 0.001). Two years after the EOI, ILI participants reported greater use of weight-control behaviors than DSE participants. Conclusions: Both groups lost weight during the 2-year follow-up period, but more ILI than DSE participants gained ≥ 2% of EOI weight. Further understanding is needed of factors that affected long-term weight change in both groups.
Bibliographical noteFunding Information:
This research was funded by the NIH through cooperative agreements with the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): DK57136, DK57149, DK56990, DK57177, DK57171, DK57151, DK57182, DK57131, DK57002, DK57078, DK57154, DK57178, DK57219, DK57008, DK57135, and DK56992. Additional funding was provided by the National Heart, Lung, and Blood Institute, the National Institute of Nursing Research, the National Institute on Minority Health and Health Disparities, the NIH Office of Research on Women’s Health, and the Centers for Disease Control and Prevention. This research was supported in part by the Intramural Research Program of the NIDDK. The Indian Health Service provided personnel, medical oversight, and use of facilities. The opinions expressed in this article are those of the authors and do not necessarily reflect the views of the Indian Health Service or the other funding sources. Additional support was received from The Johns Hopkins Medical Institutions Bayview General Clinical Research Center (M01RR02719); the Massachusetts General Hospital Mallinckrodt General Clinical Research Center and the Massachusetts Institute of Technology General Clinical Research Center (M01RR01066); the Harvard Clinical and Translational Science Center (RR025758‐04); the University of Colorado Health Sciences Center General Clinical Research Center (M01RR00051) and Clinical Nutrition Research Unit (P30 DK48520); the University of Tennessee at Memphis General Clinical Research Center (M01RR0021140); the University of Pittsburgh General Clinical Research Center (M01RR000056) and the Clinical and Translational Research Center, funded by Clinical and Translational Science Award UL1 RR 024153 and NIH grant DK 046204; the US Department of Veterans Affairs Puget Sound Health Care System Medical Research Service; and the Frederic C. Bartter General Clinical Research Center (M01RR01346). The following organizations have committed to making major contributions to Look AHEAD: FedEx Corporation; Health Management Resources; LifeScan, Inc., a Johnson & Johnson Company; OPTIFAST of Nestle HealthCare Nutrition, Inc.; Hoffmann‐La Roche Inc.; Abbott Nutrition; and Slim‐Fast brand of Unilever, North America. AMC was supported, in part, by the National Institute of Nursing Research of the National Institutes of Health under Award Number K23NR017209.
AMC reports serving on the Scientific Advisory Board for Shire Pharmaceuticals and consulting for WW International, Inc. (formerly known as Weight Watchers International, Inc.). TAW discloses serving on advisory boards for Novo Nordisk and WW International as well as receiving grant support on behalf of the University of Pennsylvania from Novo Nordisk. LMD reports personal fees from WW International, Omada Health, Inc., and Jana Care outside the submitted work. JOH is a partner in Shakabuku LLC outside the submitted work. DKH reports grants from Wake Forest University during the conduct of the study. JMJ is on the Scientific Advisory Board for WW International. AP reports personal fees from Abbott Diabetes Care, Boehringer Ingelheim, Eli Lilly and Company, Livongo, MannKind, Merck, Novo Nordisk, Sanofi, and Pendulum Therapeutics; grant support from Dexcom and vTv Therapeutics; personal fees from Novo Nordisk; and other support from Mellitus Health, Omada Health, Stability Health, Pendulum Therapeutics, and Livongo outside the submitted work. The other authors declared no conflict of interest.
Look AHEAD data are available through the NIH/NIDDK Central Repository (https://repository.niddk.nih.gov/home/). These data sets include deidentified participant-level data. At this time, data are available beginning with the recruitment and randomization of participants (2001) through the end of the Look AHEAD intervention (2012) or for approximately 9 years of trial data on each participant. The study protocol, data collection forms, and data dictionaries are provided at this link. Requests for data are made through the NIDDK.
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