Weight Watchers International Research Articles

638-P: Social Media as a Source of Personalized Weight-Loss Information

People with obesity may seek clinical, nutritional, activity, and psychosocial guidance, but recommendations they receive in clinical settings may be inadequate or lack sufficient personalization to be implemented into their lives. Understanding unmet information needs may enable more tailored weight guidance. We used health narratives posted in a weight loss forum to research topics of information being sought. Public posts (N=52,576) from 1/2020-1/2022 were extracted from r/LoseIt, a Reddit weight loss forum of 3.8M members. From these, 63,006 questions were extracted using a research-purpose BERT language model tested and fine-tuned on 500 hand-annotated questions. Extracted questions were clustered into distinct topics by Top2Vec and hierarchical clustering. Excluding 2 uninterpretable topics, 27 of 28 (96%) topics represented requests for personalized recommendations. Topics focused on diet (7%), exercise (7%), sensemaking (11%), how to implement a behavior change or solve a weight-loss problem (11%), tips for specific stages of weight loss (beginning, plateau) (7%), and comparing weight loss experiences (11%). Weight-loss forum users requested personalized recommendations to support sensemaking of frustrating weight loss problems and ask for help choosing and deploying behavior change. Results call for interventions customized to individuals’ weight loss stage, process, experiences, and motivations. Disclosure C.Clark: Employee; UnitedHealth Group, Stock/Shareholder; UnitedHealth Group. J.Stremmel: None. R.G.Mccoy: Consultant; Emmi. M.Jarvis: Employee; Optum Labs, UnitedHealth Group, Stock/Shareholder; Oramed Pharmaceuticals, UnitedHealth Group, Dexcom, Inc., Apple, Hologic Inc., Intuitive Surgical. J.D.Ard: Advisory Panel; Novo Nordisk, Consultant; Eli Lilly and Company, Intuitive Surgical, Regeneron, Other Relationship; Optum Labs, Weight Watchers International, Research Support; Nestlé Health Science, Boehringer Ingelheim Inc., Epitomee, KVK Tech. N.Lambert: Employee; Optum Labs.

604-P: Effects of the OPTIFAST (OP) Total and Partial Meal Replacement Program (MRP) on Weight and Glycemic Outcomes in Adults with Normoglycemia (NG) or Dysglycemia—Exploratory Analysis of the OPTIWIN Study

Weight loss improves glycemia. We performed exploratory analysis of an RCT using the OP (n=135) MRP vs food-based (FB) diet (n=138), that showed significant weight loss at week (W) 26 (reduction phase) and W52 (maintenance), to evaluate potential differential glycemic/weight effects by glycemic status (NG: no type 2 diabetes [T2D], HbA1c < 5.7%, and FPG < 100 mg/dL, or dysglycemia: prediabetes or T2D). We assessed changes in anthropometrics and glycemia using a linear and logistic (Odds Ratio [OR]) mixed effects model. Baseline (BL) characteristics were similar within the OP/FB subgroups, but the NG (n=134) vs dysglycemia (n=139) group were slightly younger (mean age 44/50 yrs) and had a lower HbA1c (5.4/6.1%). FPG and HbA1c decreased at W26 within both groups (Table), with a differential effect for FPG favoring OP in those with NG. At W52, the pattern was similar, but with smaller reductions. Weight loss was numerically greater with OP vs FB in those with dysglycemia vs NG at both W26 and W52; ORweight loss ≥10% W26: 5.80 (2.62, 12.86), p<0.0001 vs NG: 3.36 (1.58, 7.15), p=0.002; ORweight loss ≥10% W52: 4.26 (1.85, 9.83), p=0.001 vs NG: 2.08 (0.97, 4.47), p=0.06). Although both groups significantly lost weight, those with dysglycemia at BL had greater weight loss and the higher protein content in the OP MRP may play a role. Disclosure A.E.Rothberg: None. J.D.Ard: Advisory Panel; Novo Nordisk, Consultant; Eli Lilly and Company, Intuitive Surgical, Regeneron, Other Relationship; Optum Labs, Weight Watchers International, Research Support; Nestlé Health Science, Boehringer Ingelheim Inc., Epitomee, KVK Tech. M.Dar: None. J.Loper: Advisory Panel; Nestlé Health Science. A.H.Hawkinson: Employee; Nestlé Health Science. S.S.Cohen: Consultant; Nestlé Health Science. O.Johansen: Employee; Nestlé Health Science. Funding Nestlé Health Science

1430-P: Early Real-World Experiences with Tirzepatide

Online communities offer real-world data about interactions with new treatments prior to visibility in clinical or administrative data assets. We evaluated early tirzepatide initiation experiences reported in online health narratives after its May 2022 FDA approval for type 2 diabetes. At data extraction, < 10 tirzepatide claims were in OptumLabs’ deidentified administrative data. We extracted all publicly available posts (N=786) from r/Mounjaro (5/22 to 9/22), a Reddit community of 16,200 members. Categorical coding (agreement = .99) assessed the demographics, clinical history, treatment effects, and side effects from SURPASS trials and captured open-ended details of experiences. Most posts (67.3%) posed a question and included the r/Mounjaro users’ tirzepatide status (78.1%). Of narratives describing active tirzepatide use (N=465; 59.2%), common SURPASS side effects were decreased appetite (21.9%), nausea (11.2%), abdominal discomfort (5.8%), and diarrhea (5.2%). Common poster-defined side effects were fatigue (6.5%), body aches/stiffness (4.1%), and burping (4.1%). Posters reported tirzepatide use for weight (8.4%) more than glucose (0.4%) and obtained prescriptions from virtual clinics (7.1%) more than primary care (4.1%) or obesity specialists (0.4%). While missing some clinical details, online health narratives offer accelerated insights and can inform practice prior to traditional observational data availability. Disclosure N.Lambert: Employee; Optum Labs. M.Jarvis: Employee; Optum Labs, UnitedHealth Group, Stock/Shareholder; Oramed Pharmaceuticals, UnitedHealth Group, Dexcom, Inc., Apple, Hologic Inc., Intuitive Surgical. J.Fester: None. R.G.Mccoy: Consultant; Emmi. J.D.Ard: Advisory Panel; Novo Nordisk, Consultant; Eli Lilly and Company, Intuitive Surgical, Regeneron, Other Relationship; Optum Labs, Weight Watchers International, Research Support; Nestlé Health Science, Boehringer Ingelheim Inc., Epitomee, KVK Tech. C.Clark: Employee; UnitedHealth Group, Stock/Shareholder; UnitedHealth Group.

113-OR: The OPTIFAST (OP) Total and Partial Meal Replacement Program Improves Cardiometabolic Risk in Adults With Obesity—Secondary and Exploratory Analysis of the OPTIWIN Study

The effects of weight loss on atherosclerotic cardiovascular disease (ASCVD) risk factors using a partial or total meal replacement program (MRP) are not fully understood. We performed secondary and exploratory analyses of changes in blood pressure (BP), lipids, and global ASCVD risk in a randomized, controlled MRP trial using OP (n=135) compared with a low-calorie food-based (FB) dietary plan (n=138) that resulted in significant weight loss at week (W) 26 (reduction phase) and W52 (maintenance). Baseline characteristics were well balanced (mean [standard deviation] age OP/FB 47 [11]/47 [11] years, BMI 38.4 [5.5]/39.2 [6.2] kg/m2, females 86/79%, 10-year ASCVD risk <5% 87/74%, dysglycemia 52/50%). Changes in risk factors were estimated by a linear mixed model. At W26, systolic/diastolic BP were significantly reduced with OP vs FB (table), and a greater proportion achieved ≤ 130/80 mmHg (66.7% vs 53.6%, OR 2.11 [95% CI 1.10, 4.03], p=0.024). All lipid parameters significantly improved, as did the global ASCVD risk. A similar, but slightly attenuated pattern was observed at W52. In subgroup analysis by age (<40, 40-59, ≥ 60 years), SBP (</≥ 130 mmHg) and sex, greater treatment effects were generally seen with higher SBP and age, and in men. In people with obesity at low ASCVD risk, OP significantly improved CV risk factors and global ASCVD risk. Disclosure J.D.Ard: Advisory Panel; Novo Nordisk, Consultant; Eli Lilly and Company, Intuitive Surgical, Regeneron, Other Relationship; Optum Labs, Weight Watchers International, Research Support; Nestlé Health Science, Boehringer Ingelheim Inc., Epitomee, KVK Tech. I.Neeland: Consultant; Nestlé Health Science, Speaker's Bureau; Boehringer Ingelheim and Eli Lilly Alliance, Bayer Inc. A.E.Rothberg: None. R.Chilton: None. D.De luis: None. A.H.Hawkinson: Employee; Nestlé Health Science. S.S.Cohen: Consultant; Nestlé Health Science. O.Johansen: Employee; Nestlé Health Science. Funding Nestlé Health Science

1077-P: A Multicenter Initiative to Improve Care in Cardiometabolic Disease—Initial Report From Cardiometabolic Center Alliance (CMCA)

Background: Despite high risk, minority of individuals with Type 2 diabetes (T2D) and cardiovascular or chronic kidney disease (CVD/CKD) receives optimal guideline directed medical therapy (GDMT). Professional societies advocate for collaborative, team-based models to improve care in this group but successful multicenter implementation efforts are lacking. Methods: CMCA is a non for profit organization that seeks to transform care and outcomes in individuals with cardiometabolic disease. CMCA assists members in implementing team-based, coordinated care models (Cardiometabolic Centers) and GDMT driven pathways. Quality of care and outcomes are monitored via multicenter registry. Since launch in 2020, 14 US organizations joined CMCA. This initial report includes sites with data reported for ≥30 participants (each with ≥ 2 visits). Results: In total 606 individuals with T2D and CVD/CKD from 6 sites were evaluated (age 64 years, 44% women, 78% white, median follow up 6 months). After initiation of care at CMCA sites, large improvements in GDMT and reductions in weight, HbA1c, blood pressure, total/LDL cholesterol, triglycerides, and insulin requirements were observed (Figure panels 1 and 2; p< 0.001 for all). Conclusion: CMCA directed implementation of coordinated team-based care produced rapid and large improvements in GDMT and quality of care across multiple sites. Disclosure M.N.Kosiborod: Consultant; Alnylam Pharmaceuticals, Inc., Amgen Inc., Applied Therapeutics Inc., AstraZeneca, Bayer Inc., Boehringer Ingelheim Inc., Cytokinetics Inc., Dexcom, Inc., Eli Lilly and Company, ESPERION Therapeutics, Inc., Janssen Pharmaceuticals, Inc., Lexicon Pharmaceuticals, Inc., Merck & Co., Inc., Novo Nordisk, Pharmacosmos A/S, Pfizer Inc., Sanofi, Vifor Pharma Management Ltd., Youngene Therapeutics, Other Relationship; AstraZeneca, Research Support; AstraZeneca, Boehringer Ingelheim Inc. E.Fryoux: None. L.Harness: None. R.Heath: None. K.A.Miller: None. I.Neeland: Consultant; Nestlé Health Science, Speaker's Bureau; Boehringer Ingelheim and Eli Lilly Alliance, Bayer Inc. S.Patel: None. J.Plutzky: Advisory Panel; ESPERION Therapeutics, Inc., Consultant; Amgen Inc., Merck & Co., Inc., Novo Nordisk, Research Support; Boehringer Ingelheim Inc. R.K.Saalfeld: None. A.Stafos: None. S.Rajagopalan: Advisory Panel; Novartis, Novo Nordisk, Speaker's Bureau; Novo Nordisk. M.L.Magwire: Consultant; AstraZeneca, Novo Nordisk. D.S.Aistrope: None. E.Andaya: None. J.Butler: Consultant; Abbott,, Amgen, Applied Therapeutics, Array, Astra Zeneca, Bayer,, Boehringer Ingelheim, Bristol Myers Squibb, CVRx, G3 Pharma,, Impulse Dynamics, Innolife, Janssen, LivaNova, Luitpold, Medtronic, Merck, Novartis, NovoNordisk, Relypsa, Roche, Sequana Medical, Vifor, Speaker's Bureau; Novartis, Boehringer Ingelheim-Lilly, Astra Zeneca, Janssen. K.Cummings: None. L.Davis: Speaker's Bureau; Amgen Inc. R.H.Eckel: Advisory Panel; Amarin Corporation, 89bio, Inc., Novo Nordisk, Weight Watchers International, Board Member; Lexicon Pharmaceuticals, Inc., Consultant; Amgen Inc., Better Therapeutics, Inc, The Healthy Aging Company, Other Relationship; Arrowhead Pharmaceuticals, Inc. J.A.Fialkow: Speaker's Bureau; Amgen Inc., ESPERION Therapeutics, Inc., Amarin Corporation. Funding AstraZeneca; Boehringer Ingelheim; Novo Nordisk, Amgen Inc.; Eli Lilly and Company; Novartis

51-LB: Race Specific Effects of a Carbohydrate-Restricted Diet on Acute and Maximal C Peptide Response to Glucose in Adults with Type 2 Diabetes

Beta-cell response to glucose is compromised in individuals with type 2 diabetes (T2D), possibly due to lipid infiltration of the pancreas from excessive carbohydrate consumption. This study was conducted to determine if a eucaloric carbohydrate restricted diet (~9% energy from carbohydrate, 65% energy from fat), compared to a eucaloric fat restricted diet (~55% energy from carbohydrate, 20%energy from fat), would improve beta-cell response to glucose in participants with T2D. Participants were 43 African American and European American adults with T2D not using insulin. Medications were discontinued 1-2 weeks (depending upon the medication) prior to baseline testing. A hyperglycemic clamp was used to assess the acute (first-phase) and maximal (arginine-stimulated) C-peptide responses to glucose at baseline and after 12 weeks of controlled diet therapy (all food provided). Based on the detection of a race-by-diet interaction (P=0.06), data were analyzed within each race group. At 12 weeks, a significant effect of diet was observed by ANCOVA on acute C-peptide response in African Americans (2-fold greater with the carbohydrate restricted diet, P<0.05), and on maximal C-peptide response in European Americans (50% greater with the carbohydrate restricted diet, P<0.01), after adjusting for change in body weight. Paired t-test revealed an improvement in acute C-peptide response within African Americans on the carbohydrate restricted diet (P<0.01) from baseline to week 12, and an improvement in maximal C-peptide response within European Americans on the carbohydrate restricted diet (P<0.01). No changes in beta-cell function were observed in response to the fat restricted diet. These results suggest that a carbohydrate restricted diet has beneficial effects on beta-cell function that are race-specific and independent of weight loss. Disclosure B. Gower: Consultant; Abbott. A. M. Goss: Advisory Panel; Novo Nordisk, Consultant; Weight Watchers International. W. Garvey: Advisory Panel; Boehringer-Ingelheim, Novo Nordisk, Eli Lilly and Company, Merck & Co., Inc., Alnylam Pharmaceuticals, Inc., Fractyl Health, Inc., Inogen, Research Support; Novo Nordisk, Eli Lilly and Company, Epitomee, Pfizer Inc., Neurovalens. Funding National Institutes of Health (R01DK116726)

590-P: Disparities in the Utilization of Bariatric Surgery among Obese Patients with or without Type 2 Diabetes: Evidence from the OneFlorida Clinical Research Consortium

Background: Contemporary data characterizing the utilization of metabolic and bariatric surgery (MBS) by type 2 diabetes mellitus (T2DM) status are limited. Methods: In this study, we analyzed data from patients 18-88 years of age eligible for MBS seen in the OneFlorida (https://onefloridaconsortium.org/) between 1/1/ 2012 to 12/31/2018. MBS eligibility was defined by any of the following criteria: (1) an encounter with a body mass index (BMI) ≥ 40 kg/m2; or (2) BMI ≥ 35 kg/m2 with at least one obesity-related comorbidity, including T2DM, hypertension, or hyperlipidemia. We compared patients’ characteristics stratified by T2DM status and whether they underwent common bariatric procedures including Roux-en-Y gastric bypass (RYGB), sleeve gastrectomy (SG), and adjustable gastric banding (AGB). We performed multivariable logistic regression to identify factors independently associated with receipt of MBS among diabetic patients. Results: Among 190,606 patients with T2DM, 4103 (2.2%) of them underwent BS. Patients with diabetes were more likely to receive RYGB than those without T2DM (47.6% vs. 37.7%). We also observed that patients without diabetes aged between 18-44 years had a higher rate of MBS utilization than patients in that age range with diabetes (58.7% vs. 37.4%). The logistic regression results showed that female, higher pre-surgical BMI, had pre-surgical hypertension were strong indicators associated with bariatric treatment among patients with diabetes. Conclusion: In this study, we observed that patients with obesity and T2DM still had relatively low rates of MBS. The observed differences in rates of MBS among different demographic subgroups could inform interventions that target reductions in these disparities. Disclosure G. Chen: None. W. T. Donahoo: None. M. Cardel: Consultant; Spouse/Partner; Weight Watchers International, Inc. A. Holgerson: None. A. L. Ayzengart: None. M. J. Gurka: None.

516-P: Objective and Subjective Physical and Mental Health Benefits in Older Adults with Cardiometabolic Risk after Diabetes Prevention Program (DPP)-Based Lifestyle Intervention

Physical function, health-related quality of life (HRQoL), and depressive symptoms are key outcomes for older adults (≥65y) enrolled in behavioral weight management, but less is known about relationships among these variables. We evaluated associations between changes in these measures after a 1-year DPP-based lifestyle program. Participants (N=322) were M±SD age 71.2y±4.3, BMI 33.8±5.1, 77% women, 13% Black, averaged 4 chronic conditions, and 31% had prediabetes. Most took blood pressure (67%) and lipid (52%) medications. Participants attended 12 in-person weekly groups, then were randomized to continued monthly contact by phone or newsletter, losing 7.4% (CI) (-8.9, -5.9) and 6.1% (-8.6, -3.6) of weight at 1 year, respectively. Goals included reducing calorie/fat intake, increasing lean protein, ≥150 minutes aerobic activity/week, and strength training. Physical function was measured via Short Physical Performance Battery (SPPB) gait speed, chair rise, and balance tests, perceived HRQoL via SF-12 Physical and Mental Component Summary (PCS and MCS), and mood via Center for Epidemiologic Studies Depression Scale (CES-D) at pre- and post-intervention. Associations between baseline-12 month changes in SPPB, HRQoL and CES-D were estimated in mixed-effect models. SPPB improved by 0.3±1.4 (p=0.001) in phone and 0.3±1.7 (p=0.02) in newsletter. Increased SPPB was associated with improved PCS (β=1.18, SE=0.20, p<0.001) and CES-D (β=-0.50, SE=0.17, p=0.002) in all participants, and improved MCS in phone (β=0.19, SE=0.28, p=0.049) and decreased MCS in newsletter (β=-0.37, SE=0.22, p=0.049). After weight loss, regardless of follow-up mode, modestly improved physical function relates to greater perceived physical HRQoL and mood, but less change in perceived mental HRQoL. Future weight loss trials in high risk elders should evaluate how to optimize physical function and subjective well-being outcomes. Disclosure H. J. Stern: None. R. G. Miller: None. R. P. K. Conlon: None. M. D. Levine: None. M. D. Marcus: Advisory Panel; Self; Weight Watchers International, Inc. E. M. Venditti: None. Funding National Institute of Diabetes and Digestive and Kidney Diseases (R18DK096405)

1226-P: Three Year Outcomes after Metabolic Surgery or Medical/Lifestyle Intervention: The ARMMS-T2D Trial

There is limited Level-1 evidence from well-powered randomized controlled trials (RCTs) examining improved glycemic control after metabolic surgery in patients with type 2 diabetes (T2D) and obesity. ARMMS-T2D is a multi-center consortium conducting a follow-up study of 4 merged RCTs in 256 patients with baseline Class 1-3 obesity and T2D, randomly assigned to metabolic surgery (MS; Roux-en-Y gastric bypass, sleeve gastrectomy, or gastric banding) or intensive Medical/Lifestyle Intervention (MLI). Three years after randomization, T2D remission rates were higher after MS than MLI (37.5%, 60/160 vs. 2.6%, 2/76, respectively, P<0.001). Adjusting for treatment allocation, baseline HbA1c, and T2D duration, the probability of remission with MS was 41.6% (95% CI, 29.6-58.3%) compared to 1% (95% CI, 0.2-4.0%) with MLI (P<0.001). MS patients experienced greater reductions than MLI in HbA1c (-1.9±2.0 vs. -0.1±2.0%, P<0.001) and fasting plasma glucose ( -52 [-105, 5] vs. -12 [-48, 26] mg/dL, P<0.001). Compared to MLI, MS patients had greater reductions in BMI (-22.0±9.4 vs. -4.8±7.9 kg/m2, P<0.001) and waist circumference (-17.5 ±10.2 vs. -2.1±9.6 cm, P<0.001), greater increases in HDL-C (35.5± 27.6 vs. 9.1±24.1, P<0.001), greater reductions in triglycerides (-33[-52, -2] vs. -10 [-36, 14] P<0.001), and similar changes in LDL-C (9.5±41.5 vs. 4.2±31.6 mg/dL). MS and MLI rendered similar reductions in albumin/creatinine ratio (-2 [-13, 1] vs. 0 [-4, 4]) and eGFR (-3.1±16.7 vs. -4.6±19.5 mL/min/1.73 m2). Also, MS patients required fewer medications for diabetes, hypertension, and dyslipidemia compared to MLI (P<0.001). In summary, this 3-year follow-up of the largest cohort of patients randomized to metabolic surgery vs. non-surgical treatment demonstrates that surgery is more effective than intensive medical/lifestyle therapy in achieving extended diabetes remission, BMI reduction, and improved metabolic disease biomarkers while reducing medication requirements. Disclosure J. P. Kirwan: None. J. M. Jakicic: Advisory Panel; Self; Naturally Slim, Spark360, Weight Watchers International, Inc. M. Patti: Consultant; Self; Cello Health, Fractyl Laboratories, Inc., MBX, Poxel SA, WGBH, Other Relationship; Self; Xeris Pharmaceuticals, Inc., Research Support; Self; Dexcom, Inc. K. Wolski: None. P. Schauer: Advisory Panel; Self; GI Dynamics, Keyron, Mediflix, Persona, Consultant; Self; Ethicon, Inc., Medtronic, Research Support; Self; Ethicon, Inc., Medtronic, Pacira. A. Courcoulas: None. D. E. Cummings: Advisory Panel; Self; DyaMx, GI Dynamics. A. Goldfine: Employee; Self; Novartis AG. S. Kashyap: Advisory Panel; Self; Fractyl Laboratories, Inc., GI Dynamics. D. C. Simonson: Stock/Shareholder; Spouse/Partner; Phase V Technologies, Inc. D. Arterburn: None. W. F. Gourash: None. A. H. Vernon: None. Funding National Institutes of Health (DK114156); Ethicon Endo-Surgery; Covidien

554-P: Diabetes Distress in Young Adults with Youth-Onset Type 2 Diabetes: TODAY Study Results

Aims: Diabetes distress (DD) is associated with poor health outcomes. Little is known about level of DD in young adults (YAs) with youth-onset type 2 diabetes (T2D) or individual factors associated with DD. Aims were to assess level of DD, and factors associated with high DD, in the Treatment Options for type 2 Diabetes in Adolescents and Youth (TODAY2) cohort. Methods: YAs completed the Diabetes Distress Scale (DDS), PHQ-9 (depressive symptoms) and GAD7 (anxiety), at the end-of-study visit. Factors that may relate to DD were demographics (sex, race/ethnicity, age, education, income), medical history (HbA1c, BMI, complications), and social/economic factors (# persons in household, parent status, healthcare coverage, access to diabetes care provider). Univariate logistic regressions found factors associated with high DD. Multivariate regression controlled for sex, HbA1c, healthcare coverage, anxiety, depressive symptoms and retinopathy. Results: Of 457 YAs, mean age=26.7 yrs, 65% were female, 20% non-Hispanic white, 38% non-Hispanic Black, 20% Hispanic, 62% <$25K income. High DD (DDS ≥2) was reported by 108 (23.6%). Subscales found 39.8% with high “regimen distress,” 29.8% with high “emotional burden” (29.8%). Unadjusted results: Sex (p=0.001), HbA1c (p<0.0001), no healthcare coverage (p=0.043), hypertension (p=0.036) and retinopathy (p=0.005) were associated with DD. Moderate-severe depressive symptoms (PHQ-9 ≥10) and anxiety (GAD≥5) were also associated with DD (p<0.0001). In multivariate analyses, female sex, anxiety, HbA1c (p<0.0001 for all), and no healthcare coverage (p=0.022) remained associated with DD. Individual microvascular complications, BMI, depressive symptoms, race/ethnicity, age, education, income, # persons in household, or having a diabetes care provider did not relate to adjusted DD. Conclusion: In young adults with youth-onset T2D, high DD was significantly more likely in females, and those with anxiety, high HbA1c, and without healthcare coverage. Disclosure P. M. Trief: None. M. S. Rayas: Research Support; Self; National Center for Advancing Translational Sciences. R. S. Weinstock: Research Support; Self; Boehringer Ingelheim International GmbH, Diasome Pharmaceuticals, Inc., Eli Lilly and Company, Insulet Corporation, Kowa Research Institute, Inc., Medtronic, Tolerion, Inc. D. Uschner: None. M. Tung: None. L. Chao: None. R. M. Farrell: Stock/Shareholder; Self; Tandem Diabetes Care. J. Keady: None. S. A. Macleish: Advisory Panel; Self; Insulet Corporation. M. D. Marcus: Advisory Panel; Self; Weight Watchers International, Inc. Funding National Institute of Diabetes and Digestive and Kidney Diseases (U01DK61212, U01DK61230, U01DK61239, U01DK61242, U01DK61254)

83-OR: Influence of Baseline Characteristics on Weight Loss with Semaglutide 2.4 mg in Adults with Overweight/Obesity and Type 2 Diabetes (STEP 2)

Weight loss (WL) with semaglutide 2.4 mg vs. placebo (PBO) in the STEP 2 trial was analyzed according to baseline characteristics. STEP 2 was a 68-week RCT (NCT03552757). Adults (N=1210) with BMI ≥27 kg/m2 and type 2 diabetes (T2D; HbA1c 7-10% [53-86 mmol/mol]) were randomized to once‑weekly s.c. semaglutide 2.4 mg, 1.0 mg (data not shown) or PBO. Categorical WL was evaluated at week 68 by baseline age, sex, race, body weight (BW), HbA1c, and diabetes therapy. The odds of achieving WL ≥5% or ≥10% for these parameters were compared using post-hoc logistic regression analyses (not controlled for multiplicity). At week 68, the proportions of patients (pts) with WL ≥5% and ≥10% were 73.2% and 49.9% for semaglutide 2.4 mg vs. 27.6% and 7.1% for PBO. Pts were significantly more likely to achieve WL ≥5% or ≥10% with semaglutide 2.4 mg vs. PBO in most subgroups (Table). There were no significant interactions for any subgroups, except sex; the odds ratios for achieving WL ≥5% or ≥10% with semaglutide 2.4 mg vs. PBO were more than double for females vs. males (p Disclosure I. Lingvay: Advisory Panel; Self; Bayer Healthcare Pharmaceuticals Inc., Lilly Diabetes, Consultant; Self; TARGET PharmaSolutions, Other Relationship; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Merck Sharp & Dohme Corp., Novo Nordisk, Pfizer Inc., Zealand Pharma A/S, Research Support; Self; Mylan N. V., Sanofi. W. Garvey: None. L. Faerch: Employee; Self; Novo Nordisk A/S, Stock/Shareholder; Self; Novo Nordisk A/S. A. Koroleva: Employee; Self; Novo Nordisk A/S. R. F. Kushner: Advisory Panel; Self; Novo Nordisk A/S. C. Le roux: Advisory Panel; Self; Boehringer Ingelheim International GmbH, GI Dynamics, Herbalife International of America, Inc., Johnson & Johnson, Medtronic, Novo Nordisk A/S. S. Lim: None. O. Mosenzon: Advisory Panel; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., BOL Pharma, Eli Lilly and Company, Merck & Co., Inc., Novo Nordisk, Sanofi, Research Support; Self; AstraZeneca, Novo Nordisk, Speaker’s Bureau; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, Merck & Co., Inc., Novo Nordisk, Sanofi. T. A. Wadden: Advisory Panel; Self; Novo Nordisk, Weight Watchers International, Inc. S. O. R. Wallenstein: Employee; Self; Novo Nordisk. Funding Novo Nordisk A/S

Extended follow-up data: impact of selective loss to follow-up in a trial of secondary prevention of coronary artery disease

Abstract Background We performed an extended follow-up of the RESPONSE-2 trial, which evaluated a new secondary prevention strategy for patients with coronary artery disease (CAD). Selective loss to follow-up (LTFU) however, may induce biased results. Objectives To assess LTFU and its implications on the internal validity of the trial at extended follow-up. Methods RESPONSE-2 (N=824) was a randomised trial of nurse-coordinated referral of CAD patients to ≤3 commercial lifestyle interventions, on top of usual-care, or to usual-care alone. The primary outcome was assessed at 1-year follow-up, after which the interventions were discontinued. An extended follow-up was performed two years later. We evaluated overall selective LTFU, between-group selective LTFU and within-group selective LTFU, by comparing baseline characteristics, compliance with the lifestyle interventions (intervention group only) and achievement of lifestyle-related risk factor (LRF) targets at 1-year follow-up for attendees and non-attendees of the extended follow-up. In all variables a standardized mean difference (SMD) of ≥0.2 with a p-value <0.05, based on an independent t-test for continuous data and fisher's test for discrete data, was considered evidence of selective LTFU. Results In total, 520 patients attended the extended follow-up: 266/411 in the intervention and 254/413 in the control group. Patients LTFU were generally younger (56.5 vs. 59.3 years; SMD=0.299), more often baseline smokers (37% vs. 22%; SMD=0.334) and had less often quit smoking directly after hospitalization (17% vs. 25%; SMD=0.203). We found no evidence of between-group selective LTFU and several indications of within-group selective LTFU (table). Intervention group attendees were more compliant with the lifestyle interventions compared with non-attendees (weight loss: SMD=0.450; p≤0.05 and physical activity: SMD=0.516; p≤0.01) Conclusion Baseline LRF control, compliance with the lifestyle interventions and achievement of LRF targets were less favourable for non-attendees of the extended follow-up. Effective handling of missing data is recommended to minimize loss of contrast due to within-group selective LTFU and to ensure generalizability of results. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): The RESPONSE-2 trial was sponsored by Weight Watchers International, Inc. (New York, New York) and Philips Consumer Lifestyle (the Netherlands). The sponsors had no role in the design, data collection, data analysis, data interpretation, and writing of the manuscript.

Successful lifestyle modification in older patients with coronary artery disease: results from the RESPONSE-2 trial

Abstract Introduction Interventions to reduce lifestyle-related risk factors (LRFs) such as overweight, physical inactivity and smoking are effective in the secondary prevention of cardiovascular events. However, evidence of the effects of lifestyle-related secondary prevention programmes in older patients with coronary artery disease (CAD) is less conclusive than in younger patients. Purpose To compare the treatment effect on lifestyle-related risk factors (LRFs) in older (≥65 years) versus younger (<65 years) patients with CAD in The Randomised Evaluation of Secondary Prevention by Outpatient Nurse SpEcialists 2 (RESPONSE-2) trial. Methods The RESPONSE-2 trial was a community-based lifestyle intervention trial (N=824) comparing nurse-coordinated referral to a comprehensive set of three lifestyle interventions (physical activity, weight reduction and/or smoking cessation) to care as usual. The primary outcome was the proportion of patients with improvement at 12 months follow-up (N=711) in at least 1 LRF (without deterioration in the other LRFs). In the current analysis, we assessed if the overall beneficial treatment effect of the RESPONSE-2 intervention varied by age. Results At baseline, older patients (n=245, 69.2±3.9) had significantly more serious cardiovascular risk profiles and comorbidities (hypertension, diabetes mellitus and peripheral artery disease) than younger patients (n=579, 53.7±3.9). The overall treatment effect did not vary by age (OR overall 1.67, 95% CI 1.22 - 2.31). However, older patients were more likely to achieve ≥5% weight loss (OR old 5.58, 95% CI 2.77–11.26 vs. OR young 1.57, 95% CI 0.98 - 2.49, P interaction=0.003) and younger patients were more likely to show non-improved individual LRFs (OR old 0.38, 95% CI 0.22–0.67 vs. OR young 0.88, 95% CI 0.61–1.26, P interaction=0.01). Conclusion Despite more serious cardiovascular risk profiles and comorbidities among older patients, nurse-coordinated referral to community-based lifestyle interventions was at least as successful in improving LRFs in older as in younger patients. Higher age alone should not be a reason to withhold lifestyle interventions in patients with CAD. LRFs at 12 months follow-up Funding Acknowledgement Type of funding source: Private company. Main funding source(s): The RESPONSE-2 trial was sponsored by Weight Watchers International, Inc. (New York, New York) and Philips Consumer Lifestyle (the Netherlands). This work was also supported by the Netherlands Organisation for Scientific Research (NWO) to PJ.

274-OR: Effect of Testosterone Treatment on Type 2 Diabetes Incidence in High-Risk Men Enrolled in a Lifestyle Program: A Two-Year Randomized Placebo-Controlled Trial

In men with obesity and IGT, serum testosterone (T) is inversely associated with incident T2D. Hypothesizing that T treatment prevents or reverses T2D beyond the effects of a lifestyle program alone, we conducted a multi-center, double-blinded placebo-controlled trial. Men (N=1007), aged 50-74 yrs., waist circumference (WC)>95cm, serum T≤14nmol/L (chemiluminescent assay), and IGT or newly diagnosed T2D, established by an OGTT, were randomized to receive, on a 1:1 basis, either IM T undecanoate (Reandron, Bayer) (1000mg/4ml) or vehicle (V) at baseline, 6 weeks and then 3-monthly for 2 yrs. All participants were enrolled in a lifestyle program (Weight Watchers® (WW)). Co-primary 2-yr outcomes: (1) OGTT 2-hr glucose ≥11 mmol/L: 55/443 (12.4%) in the T and 87/413 (21.1%) in V groups; RR (95% CI) 0.59 (0.43-0.80), P<0.001; and (2) mean change from baseline in 2-hr glucose: -1.70 mmol/L and -0.95 mmol/L in the T and V groups, respectively (mean difference -0.75 (95% CI -1.10 to -0.40) P<0.001). The treatment effect was independent of baseline serum T. Secondary 2-year outcomes: Greater decreases from baseline in fasting glucose by 0.17 mmol/L, WC by 2.1 cm, total fat mass by 2.7kg, and abdominal fat mass by 2.3%, and greater increases in total muscle mass by 1.7kg, arm muscle mass by 0.36kg and hand grip strength by 2.2kg, occurred in the T vs. V group (all P<0.004). Compliance with the WW program was similar in the T (30%) vs. V (28%) groups (P=0.89). Safety: Hematocrit ≥ 0.54: 106/491 (21.6%) vs. 6/484 (1.2%) in the T vs. V groups (P<0.001). SAEs in T vs. V groups (total events 55 vs. 42): Arrythmias (8 vs. 3), IHD (7 vs. 13), cerebrovascular disease (4 vs. 3), BPH (8 vs. 3), prostate cancer (4 vs. 5), other cancers (10 vs. 4), depression (1 vs. 3). There were 2 deaths in each group. Beyond a lifestyle program, T treatment reduced the RR of T2D by ∼40% at least partially mediated by favorable changes in body composition. Clinical Trial Registration: ACTRN12612000287831. Disclosure G.A. Wittert: Research Support; Self; Bayer Inc., Lawley Pharmaceuticals, Lilly, Weight Watchers International, Inc. Speaker’s Bureau; Self; Besins. K.P. Robledo: None. M. Grossmann: Research Support; Self; Bayer Healthcare Pharmaceuticals Inc., Lilly Diabetes, Novartis Pharmaceuticals Canada Inc., Otsuka Pharmaceutical Co., Ltd., Weight Watchers International, Inc. Speaker’s Bureau; Self; Besins Healthcare, Otsuka Pharmaceutical Co., Ltd. K. Bracken: None. B.B. Yeap: Advisory Panel; Self; Sanofi. Research Support; Self; Bayer AG, Lawley Pharmaceuticals. Speaker’s Bureau; Self; Besins, Sanofi. B.G.A. Stuckey: None. R.I. McLachlan: None. D.J. Handelsman: None. C. Allan: Advisory Panel; Self; Ferring Pharmaceuticals. Speaker’s Bureau; Self; Besins. W. Inder: Research Support; Self; Bayer Healthcare Pharmaceuticals Inc. Speaker’s Bureau; Self; Amgen, Novo Nordisk Inc., Pfizer Inc. D. Jesudason: Other Relationship; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company. A.C. Keech: Advisory Panel; Self; Amgen, Kowa Research Institute, Inc. Consultant; Self; Sanofi-Aventis. Speaker’s Bureau; Self; Abbott, Amgen. A. Jenkins: Advisory Panel; Self; Abbott, Medtronic. Research Support; Self; Abbott, GlySens Incorporated, Medtronic, Sanofi-Aventis. M. Ng Tang Fui: None. M. Daniel: None. Funding National Health and Medical Council of Australia (1030123); Eli Lilly and Company; Bayer AG; Weight Watchers; University of Adelaide

716-P: Reduced Carbohydrate and Increased Protein and Fat in the Diet Augment the Positive Effect of Weight Loss on Glucose Control in Type 2 Diabetes Patients

Background: We hypothesized that dietary carbohydrate reduction will add to the effect of a diet-induced 6% body-weight loss on glycemic control and hepatic fat content in patients with type 2 diabetes (T2D). Methods: Forty-four persons of mean HbA1c 56.4 mmol/mol and 9 years of T2D were randomized 1:1 for 6-weeks full food provision, a hypo-caloric carbohydrate-reduced high-protein (CRHP) or a conventional diabetes (CD) diet (carbohydrate 30E%/50E%, protein 30E%/17E% and fat 40E%/33E%). Body-weight loss was aimed at 6% and reinforced bi-weekly by adjustment of hypo-caloric diets. Hepatic fat content was estimated by Magnetic Resonance (MR) spectroscopy and analyzed by a MR research technician, blinded to the protocol. Results: Six weeks of a hypo-caloric CRHP diet compared with a CD diet improved HbA1c (mean±SD) by further 2 mmol/mol (-8.7±4.6 mmol/mol vs. -6.7±3.9 mmol/mol, p=0.04) with comparable weight losses, 5.5±1.7 kg (5.6 %) and 5.6±2.2 kg (5.9 %) of body-weight, respectively. Hepatic fat content (median (IQR) was reduced significantly while consuming the CRHP diet (5.2% (1.3-6.9)) and CD diet (2.6% (1.6-6.5)), but with no difference between diets (p=0.40). Conclusion: Reducing carbohydrate and increasing protein and fat adds clinical relevance to the positive effects of body-weight loss on glucose control in T2D patients. Disclosure M.N. Thomsen: None. M.J. Skytte: None. A. Samkani: None. M.H. Carl: None. P. Weber: None. A. Astrup: Advisory Panel; Self; Gelesis, Novo Nordisk A/S, Saniona, Weight Watchers International, Inc. Research Support; Self; Arla Food for Health, Gelesis, Novo Nordisk A/S. Speaker’s Bureau; Self; Arla Food for Health. Stock/Shareholder; Self; Gelesis. T.M. Larsen: Advisory Panel; Self; Advisor for Sense diet programme. J. Frystyk: None. J.J. Holst: Advisory Panel; Self; AstraZeneca, Merck Sharp & Dohme Corp., Novo Nordisk A/S, Zealand Pharma A/S. Other Relationship; Spouse/Partner; Antag Therapeutics. B. Hartmann: None. H. Thomsen: None. E. Chabanova: None. S. Madsbad: Advisory Panel; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Merck Sharp & Dohme Corp., Novo Nordisk A/S, Sanofi-Aventis. Research Support; Self; Boehringer Ingelheim International GmbH, Novo Nordisk A/S. Speaker’s Bureau; Self; AstraZeneca, Boehringer Ingelheim International GmbH, Novo Nordisk A/S. S.B. Haugaard: None. T. Krarup: None.

2227-PUB: The Experience of Spanish Speakers in the Real Health Study

The REAL HEALTH Diabetes study was a pragmatic trial of an intensive lifestyle intervention (ILI) for patients with type 2 diabetes (T2DM) adapted from Look AHEAD for delivery in routine primary care settings in English and Spanish. Given the high prevalence of T2DM in the Latino population, underrepresentation of this population in research, and disparities in outcomes, we evaluated the experience of Spanish speakers, as compared to English speakers, screened for and enrolled in REAL HEALTH. The trial screened 715 patients who spoke Spanish as a primary language, of whom 17 subjects (8.1% of enrollees, 2.4% of screened Spanish speakers) enrolled in the study. Compared to English speakers, Spanish speakers were less likely to decline participation due to lack of interest (OR 0.43, p<0.01) and equally likely to attend a screening visit (p=0.54) but more likely to be lost to recruitment due to inability to contact the patient for a phone screen (OR 2.0, p<0.01). Engagement of Spanish speakers was lower than among English speakers, with lower rates of completion of the ILI (OR 0.22, p=0.04) and a trend for lower attendance for medical nutrition therapy. Despite this, Spanish-speakers had higher increases in (p=0.01) and final levels of (p=0.03) self-reported physical activity. Weight loss at 12 months in the ILI did not significantly differ between groups (2.8kg among Spanish-speakers vs. 4.8kg among English speakers, p=0.11). It is important to recognize barriers to clinical trial and ILI engagement, as well as the nuances of experiences and outcomes within clinical trials. Enrollment of Spanish speakers was limited by difficulty contacting potential subjects, despite extensive recruitment efforts by study staff. Enrolled participants engaged differently but had similar weight loss compared to English speakers in the ILI. Spanish-speakers represent a unique group who may benefit from tailored interventions. Disclosure S. Cromer: Employee; Spouse/Partner; Johnson & Johnson. A.R. Rodriguez: None. L. Bissett: None. A. Dushkin: None. V.M. Goldman: None. J. McCarthy: None. L.M. Delahanty: Advisory Panel; Self; Jana Care Inc., Omada Health, Weight Watchers International, Inc. D.J. Wexler: Other Relationship; Self; Novo Nordisk A/S. Funding National Institutes of Health (T32DK007028)

143-OR: All-Cause Mortality over 16 Years in Look AHEAD

Whether intentional weight loss reduces mortality in overweight/obese individuals with diabetes is unclear. Look AHEAD, a randomized trial of intensive lifestyle intervention (ILI) and diabetes support and education (DSE) (control) in 5145 individuals with overweight/obesity and type 2 diabetes, is ideal for examining this due to large sample, extended follow-up, excellent retention, and sustained difference in weight loss (y1: 8.6% ILI; 0.7% DSE; y10: 6.1% ILI; 3.9% DSE). After 10 years of intervention, participants had 6-month calls and biennial visits. The primary outcome for the current phase is all-cause mortality from randomization to 16 years. Data were analyzed with proportional hazards regression stratified by clinical site; significance was based on the likelihood ratio. All-cause mortality was 9% lower in ILI compared to DSE, not a statistically significant difference (Fig 1). Deaths by arm were: ILI 496/2570 and DSE 530/2575. Interactions of treatment with prespecified subgroups (sex, CVD history, age) were not significant. In post-hoc analyses, ILI participants who lost >10% at 1year had an 18% reduced risk (HR=.82, CI 0.68,0.97) and ILI participants who gained or lost <2% had a 29% higher risk (HR=1.29, CI 1.01,1.67) relative to all DSE. The difference in mortality between ILI and DSE was not statistically significant. Post-hoc analyses suggest an association between magnitude of weight change and all-cause mortality in ILI. Disclosure R.R. Wing: None. J. Clark: None. E.W. Gregg: None. S.B. Kritchevsky: None. C.E. Lewis: None. D.M. Reboussin: None. T.A. Wadden: Board Member; Self; Novo Nordisk Inc., Weight Watchers International, Inc. L.E. Wagenknecht: None. S.Z. Yanovski: None. Funding National Institutes of Health

687-P: Support Vector Regression Model Predicts Glucose Changes during Exercise in Type 1 Diabetes

People with type 1 diabetes (T1D) have difficulty controlling glucose during exercise. Different types, intensities, and durations of exercise impact glucose differently. There is currently no algorithm that can accurately predict glucose changes during aerobic, resistance, interval, and free-living exercise. A support vector regression (SVR) model was designed to predict the maximum change in glucose during exercise. The model was trained and validated on 30-minute exercise sessions collected twice weekly over 4 weeks from 33 people with T1D (age 33±13 years, BMI 26.3±2.9 kg/m2, 18±12 years since diagnosis). Participants completed study assigned aerobic (n = 40), resistance (n= 33), or interval (n=20) exercise sessions in addition to their typical exercise regimen (n = 254). Participants wore a Dexcom (G5 or G6) or Medtronic CGM and used their own insulin pen (n = 10) or pump to administer insulin. The exercise information and food consumed was reported using a custom app. Heart rate, accelerometry, and sleep metrics were acquired using a Garmin vivosmart watch. Training was done on 90% of the observations while 10% of data were used for testing using 10-fold cross validation. The mean absolute error (MAE) of the model-predicted change in glucose during exercise was 23.59 mg/dL. The SVR algorithm may be useful within a decision support tool to help people with T1D better manage their glucose levels during exercise. Disclosure G. Young: None. Z. Li: None. P. Calhoun: Stock/Shareholder; Self; Dexcom, Inc. R.L. Gal: None. R. Beck: None. J.R. Castle: Advisory Panel; Self; Novo Nordisk Inc. Consultant; Self; ADOCIA, Dexcom, Inc., Zealand Pharma A/S. Other Relationship; Self; Pacific Diabetes Technologies, Roche Diabetes Care. M.A. Clements: Consultant; Self; Glooko, Inc. Other Relationship; Self; Glooko, Inc. E. Dassau: Consultant; Self; Eli Lilly and Company. Research Support; Self; Dexcom, Inc., DreaMed Diabetes, Tandem Diabetes Care, Xeris Pharmaceuticals, Inc. Speaker’s Bureau; Self; Roche Diabetes Care. Other Relationship; Self; Dexcom, Inc., Insulet Corporation, Roche Diabetes Care. F.J. Doyle: Research Support; Self; DreaMed Diabetes, Tandem Diabetes Care, Xeris Pharmaceuticals, Inc. Stock/Shareholder; Self; Mode AGC. Other Relationship; Self; Dexcom, Inc., Insulet Corporation, Roche Diabetes Care. M.B. Gillingham: None. C.K. Martin: Advisory Panel; Self; EHE Health, NaturallySlim. Consultant; Self; Florida Hospital, Gila Therapeutics, OpenFit, Zafgen, Inc. Research Support; Self; Egg Board, Helmsley Trust, IDEA Public Schools, National Institutes of Health, NIHR, Patient-Centered Outcomes Research Institute, USDA, Weight Watchers International, Inc. Other Relationship; Self; Academy of Nutrition and Dietetics, Louisiana State Univ./Pennington Biomedical Research Center. M.R. Rickels: Consultant; Self; Semma Therapeutics, Inc. Research Support; Self; Xeris Pharmaceuticals, Inc. S.R. Patton: None. M. Riddell: Advisory Panel; Self; Zucara Therapeutics Inc. Consultant; Self; Lilly Diabetes. Research Support; Self; Dexcom, Inc., Insulet Corporation. Speaker’s Bureau; Self; Medtronic, Novo Nordisk A/S. P.G. Jacobs: Consultant; Self; SFC Fluidics. Research Support; Self; Dexcom, Inc. Stock/Shareholder; Self; Pacific Diabetes Technologies. Other Relationship; Self; AgaMatrix. Funding Exercise in Diabetes Initiative (T1-DEXI Main Study)

694-P: Effect of Exercise on Sleep and Nocturnal Glucose in Type 1 Diabetes (T1D)

Exercise increases nocturnal hypoglycemia risk which may impact sleep in T1D. Adults with T1D (n=25; 19 CSII; age 33±14yrs; HbA1c 7.6±1.3%; T1D duration 15yrs [IQR: 10, 22]) were divided into 3 exercise groups: aerobic, interval, or resistance, performed twice/week using instructional videos for 4 weeks. Participants used CGM, and wore an activity/sleep monitor (Garmin Vivosmart 3). Sleep duration was lower on nights following interval exercise compared to nights following sedentary days (p=0.04, Figure 1a). Participants experienced hypoglycemia earlier in the night following interval or aerobic exercise, compared to sedentary or resistance exercise (Figure 1b). Exercise types differentially impact sleep loss and nocturnal hypoglycemia. Disclosure P.G. Jacobs: Consultant; Self; SFC Fluidics. Research Support; Self; Dexcom, Inc. Stock/Shareholder; Self; Pacific Diabetes Technologies. Other Relationship; Self; AgaMatrix. Z. Li: None. P. Calhoun: Stock/Shareholder; Self; Dexcom, Inc. R.L. Gal: None. R. Beck: None. J.R. Castle: Advisory Panel; Self; Novo Nordisk Inc. Consultant; Self; ADOCIA, Dexcom, Inc., Zealand Pharma A/S. Other Relationship; Self; Pacific Diabetes Technologies, Roche Diabetes Care. M.A. Clements: Consultant; Self; Glooko, Inc. Other Relationship; Self; Glooko, Inc. E. Dassau: Consultant; Self; Eli Lilly and Company. Research Support; Self; Dexcom, Inc., DreaMed Diabetes, Tandem Diabetes Care, Xeris Pharmaceuticals, Inc. Speaker’s Bureau; Self; Roche Diabetes Care. Other Relationship; Self; Dexcom, Inc., Insulet Corporation, Roche Diabetes Care. F.J. Doyle: Research Support; Self; DreaMed Diabetes, Tandem Diabetes Care, Xeris Pharmaceuticals, Inc. Stock/Shareholder; Self; Mode AGC. Other Relationship; Self; Dexcom, Inc., Insulet Corporation, Roche Diabetes Care. M.B. Gillingham: None. C.K. Martin: Advisory Panel; Self; EHE Health, NaturallySlim. Consultant; Self; Florida Hospital, Gila Therapeutics, OpenFit, Zafgen, Inc. Research Support; Self; Egg Board, Helmsley Trust, IDEA Public Schools, National Institutes of Health, NIHR, Patient-Centered Outcomes Research Institute, USDA, Weight Watchers International, Inc. Other Relationship; Self; Academy of Nutrition and Dietetics, Louisiana State Univ./Pennington Biomedical Research Center. M.R. Rickels: Consultant; Self; Semma Therapeutics, Inc. Research Support; Self; Xeris Pharmaceuticals, Inc. S.R. Patton: None. M. Riddell: Advisory Panel; Self; Zucara Therapeutics Inc. Consultant; Self; Lilly Diabetes. Research Support; Self; Dexcom, Inc., Insulet Corporation. Speaker’s Bureau; Self; Medtronic, Novo Nordisk A/S. Funding The Leona M. and Harry B. Helmsley Charitable Trust (T1-DEXI Main Study)

170-OR: Association of Timing of Physical Activity Bouts with Cardiorespiratory Fitness in Adults with Type 2 Diabetes in the Look AHEAD Study

Background: Moderate-to-vigorous physical activity (MVPA) is an important treatment in type 2 diabetes (T2D). Few studies examine the timing of MVPA, as there are no established methods to characterize the MVPA bout timing throughout the day. We determined the timing of MVPA bouts in adults with T2D, and examined whether cardiorespiratory fitness and odds of cardiovascular disease (CVD) history relate to timing of MVPA bouts in men and women. Methods: Baseline data from Look AHEAD participants (n=2153, 57% women) were analyzed. Cardiorespiratory fitness assessed by VO2max test was expressed as METs. MVPA bouts (≥3METs in ≥10mins bouts) were determined using the hip-worn RT3 accelerometer for 7 days. Participants were categorized into six groups based on the time of day with the major amount of MVPA bouts (MET-min): ≥50% of MVPA bouts during the same time window (Early morning, Late morning, Afternoon, or Evening, N=214-280/group), <50% of MVPA bouts in any time category (Mixed; reference group, N=436), and ≤1 day with MVPA bouts per week (Inactive, N=624). Results: Cardiorespiratory fitness differed by timing of MVPA bout category (P<0.0001). In a multivariate adjusted model, the association of timing of MVPA bouts with fitness varied by sex (P=0.002). In women, the evening group had higher fitness (β 0.35 [0.04, 0.66] METs). After further adjustment for individual total bout-MVPA (MET-min) per week, in men, the early morning group was associated with higher fitness (β 0.46 [0.06, 0.85] METs). Interestingly, in men, but not in women, the early morning group also had higher odds of CVD history (OR 2.4 [1.38, 4.21]). Conclusion: Higher cardiorespiratory fitness associated with evening MVPA bouts in women, and with early morning MVPA bouts in men independent of total amount of bout-MVPA. Prospective studies are needed to investigate the relationship between timing of MVPA and cardiovascular outcomes to optimize MVPA benefits in adults with T2D. Disclosure J. Qian: None. M.P. Walkup: None. S. Chen: None. P.H. Brubaker: None. D. Bond: None. P.A. Richey: None. J.M. Jakicic: Advisory Panel; Self; Weight Watchers International, Inc. K. Hu: None. F.A. Scheer: None. R. Middelbeek: None.