Mean Change In Body Mass Index Research Articles

Comparing Mobile-Based to Group-Based Education for Weight Reduction in a Developing Country: A Randomized Study.

This study compared the impact of Short Message Service (SMS)-based education with traditional group-based education and the control group on body mass index, weight, and lifestyle in obese and overweight patients in a limited-resource country. It also compared the direct financial costs between the two intervention groups. In this controlled randomized educational study, 90 overweight or obese adults from four family physician clinics in Shiraz, Iran were randomly allocated to three training groups: SMS-based education, group-based education, and a control group. The participants' weight, body mass index (BMI), and waist circumference were measured at baseline, and the Physical Activity Scale questionnaire was completed. Group-based training was conducted in 1-hour weekly sessions. The SMS group received a text message each morning. The control group received routine care from a family physician. The intervention lasted 12 weeks. All participants were re-examined for the studied variables. Additionally, the direct costs were estimated, calculated, and compared. The mean weight, BMI, and waist circumference changed significantly after 3 months compared to baseline in each group. The mean weight change differed significantly among the three groups (P-value=0.04), and the mean BMI changes were near significant (P-value=0.06). A post hoc comparison of changes in weight and BMI showed a significant difference between the control and SMS groups. SMS education incurred much lower costs for patients and healthcare services than group-based education. The study showed that SMS is an effective and cost-saving educational method for weight loss compared to group-based education, especially in developing countries.

Impact of weight reduction on structural and functional parameters of the optic nerve in idiopathic intracranial hypertension.

To evaluate the effect of weight reduction on the structural and functional parameters of the optic nerve in established cases of papilledema in Idiopathic Intracranial Hypertension (IIH). A prospective observational study in early and established cases of papilledema in IIH presenting from December 2019 to February 2021. Functional parameters (visual acuity, contrast sensitivity, mean deviation, VER), structural parameters (RNFL, GCL-IPL, and optic disc height), and clinical grading of papilledema were measured at baseline and every 6 weeks for 6 months. All patients underwent medical (oral acetazolamide) and diet therapy. Mean body mass index (BMI) at presentation was 26.32 ± 3.52 kg/m² and the mean change in BMI over 6 months was 1.27 ± 0.50 kg/m². 67% of eyes had papilledema of grades 2-3 at the presentation. At the end of 6 months, 75% of eyes had grade 1 papilledema while 13% showed complete resolution. A reduction of 5.32 ± 3.58 in mean deviation (r = 0.316; p-value 0.01) and gain in VER P100 amplitude of 4.2 ± 2.7 µV (r = 0.40; p-value 0.003) were noted over 6 months with reduction in BMI over 6 months. A statistically significant reduction in optic disc height (ODH) was noticed with BMI reduction over 6 months (p = 0.0007; r = 0.45).A reduction of 1.72 ± 0.90 kg/m² (equivalent to 6.53% weight loss) in BMI was associated with a four-grade change in clinical grading of papilledema. Reduction in BMI had a significant impact on both structural and functional parameters of the optic nerve in IIH. The involvement of a well-certified dietician should be an integral part of treatment in IIH.

Effect of the weight-loss program using daily self-weighing combined with personalized counseling led by village health volunteers in adults with obesity in a rural community, Thailand: a randomized controlled trial

BackgroundIn a remote rural community in central Thailand, obesity prevalence among adults significantly rose from 33.9% in 2012 to 44.8% in 2018. Limited information on weight reduction studies in Thai rural communities was available. The present study aims to evaluate the effect of daily self-weighing combined with personalized counseling in order to reduce body weight (BW) and body mass index (BMI) as well as blood pressure (BP).MethodsA randomized controlled trial was carried out in a rural community in central Thailand.One-hundred and seven adults were randomly allocated (1:2) to intervention and control groups. For 20 weeks, participants in the weight-loss program performed self-weighing twice daily and recorded their weight on the calendar. The program also offers weekly counseling visits by village health volunteers (VHV) who make home visits to participants. The primary outcomes were differences in mean change in BW at 20 weeks from baseline between the intervention and control groups.ResultsA total of 107 participants were initially recruited. Of these, 36 participants were allocated to the intervention group and 57 participants to the control group. Significant differences in mean change in BW and BMI at the twelve-, sixteen-, and twenty-week follow-up from baseline between the two groups were observed. At twenty weeks, the mean change in BW was -1.2 kg (95% CI: -2.2, -0.3) and 0.3 kg (95% CI: -0.3, 0.8) in the intervention and control groups, respectively, with p-value = 0.007. Over 20 weeks of the study period, the estimated mean change in BW among the intervention group was 1.0 kg (95% CI -1.7, -0.2) lower than in the control group, with p-value = 0.015. Furthermore, changes in mean BMI and BP over the 20-week follow-up period in intervention participants were recognized.ConclusionsOur study demonstrates that daily self-weighing combined with personalized counseling led by VHV is feasible and can induce weight loss among adults with obesity in a rural community. In addition, the weight-loss program may be a promising additional tool for reducing BP.Trial registrationTrial identification number was TCTR20201020004; first submitted date: 20/10/2020.

SAT656 Weight Reduction After 6 Months Of Setmelanotide Treatment In Patients With Hypothalamic Obesity

Abstract Disclosure: C.L. Roth: Other; Self; Received research support from Rhythm Pharmaceuticals, Inc. A.H. Shoemaker: Advisory Board Member; Self; Received payments from Rhythm Pharmaceuticals, Inc and Saniona for advisory boards and lectures. Other; Self; Received research support from Rhythm Pharmaceuticals, Inc. M. Gottschalk: Advisory Board Member; Self; Received compensation for consulting and participation on advisory boards from Rhythm Pharmaceuticals, Inc. Other; Self; Received funding for clinical trials from Rhythm Pharmaceuticals, Inc. J. Miller: Other; Self; Received research support from Harmony Biosciences, Rhythm Pharmaceuticals, Inc, Soleno Therapeutics, and Tryp Therapeutics. G. Yuan: Employee; Self; Employee of Rhythm Pharmaceuticals, Inc. Stock Owner; Self; Has company-awarded RSU and options. S. Malhotra: Employee; Self; Employee of Rhythm Pharmaceuticals, Inc. Stock Owner; Self; Stockholder in in Rhythm Pharmaceuticals, Inc. C. Scimia: Employee; Self; Employee of Rhythm Pharmaceuticals, Inc. Stock Owner; Self; Has company-awarded RSU and options. M. Abuzzahab: Advisory Board Member; Self; Received compensation for advisory board participation from Consynance, Endo Pharmaceutical, Pfizer, and Rhythm Pharmaceuticals, Inc. Consulting Fee; Self; Received compensation for consulting from Consynance, Endo Pharmaceutical, Pfizer, and Rhythm Pharmaceuticals, Inc. Speaker; Self; Received compensation for speaking engagements from Consynance, Endo Pharmaceutical, Pfizer, and Rhythm Pharmaceuticals, Inc. Other; Self; Received research support from Ascendis, Levo Pharmaceuticals, Lumos, NovoNordisk, Rhythm Pharmaceuticals, Inc, Saniona, and Soleno. Background: Hypothalamic obesity (HO) is an acquired form of severe obesity characterized by rapid and excessive weight gain resulting from insult to the hypothalamus—primarily caused by tumor invasion, resection, or radiotherapy—that can impair melanocortin-4 receptor (MC4R) pathway signaling. Treatment with setmelanotide, an MC4R agonist, resulted in weight loss and hunger reduction at 16 weeks in a Phase 2 trial of patients with HO. Here, we report changes in age-appropriate weight-related parameters after 6 months of treatment with setmelanotide in patients with HO who entered a long-term extension (LTE) trial. Methods: A Phase 2, multicenter, open-label study (NCT04725240) examined the efficacy and safety of 16-week setmelanotide treatment in patients aged ≥6 to ≤40 years with a clinical diagnosis of HO. Patients who met the primary endpoint of ≥5% body mass index (BMI) reduction from baseline at Week 16 or experienced investigator-determined clinically meaningful benefit and demonstrated adequate safety were eligible to enroll in the LTE trial (NCT03651765). We assessed the proportion of patients who achieved ≥10% BMI reduction as well as changes in age-appropriate weight-related parameters (ie, mean percent change in body weight for adults [aged ≥18 years] and mean change in BMI Z score and percent of the 95th BMI percentile [%BMI95] for children [aged <18 years]) from index trial baseline to Month 6 of setmelanotide treatment. Results: Of 18 patients originally enrolled in the index trial, 14 (77.8%) continued into the LTE and 13 (72.2%) had received ≥6 months of setmelanotide treatment at the time of this analysis. HO was diagnosed in these patients secondary to treatment of craniopharyngioma (n=11), hypothalamic hamartoma (n=1), and juvenile pilocytic astrocytoma (n=1). At Month 6, 11 of 13 patients (84.6% [90% confidence interval, 59.0%–97.2%) achieved ≥10% BMI reduction from index trial baseline; the remaining 2 patients achieved ≥5% reduction from baseline at Month 6. In adults (n=2), the mean (standard deviation [SD]) percent change in body weight from baseline to Month 6 was −16.2% (7.2%). In children (n=11), the mean (SD) change from baseline in BMI Z score was −1.7 (1.1) and in %BMI95 was −34.8 (14.9) percentage points at Month 6. The most frequent adverse events were nausea (n=9 [69.2%]), skin hyperpigmentation (n=5 [38.5%]), and vomiting (n=4 [30.8%]). Four serious adverse events were reported in 2 patients (Clostridium difficile colitis in 1 patient; malaise, septic shock, and influenza in 1 patient) and were determined not related or unlikely related to study drug. Conclusions: In a heterogeneous population of patients with HO secondary to treatment of hypothalamic tumors, 6 months of setmelanotide treatment was associated with sustained meaningful improvements in weight and BMI with no new safety signals. Presentation: Saturday, June 17, 2023

OR10-06 Changes In Resting Energy Expenditure And Metabolic Adaptation In Adolescents Two Years After Sleeve Gastrectomy Compared With Non-surgical Controls And Determinants Of These Changes

Abstract Disclosure: V. Singhal: None. C.C. Pedreira: None. S. Tuli: None. L.A. Haidar: None. H. Lee: None. M.A. Bredella: None. M. Misra: None. Background: Weight loss is typically associated with reductions in resting energy expenditure (REE), which may limit the extent of weight loss after sleeve gastrectomy (SG), the most common metabolic and bariatric surgery (MBS) in youth. REE may be impacted by changes in body composition and gut peptides following SG. Current data regarding changes in measured REE (mREE) and metabolic adaptations in adolescents after MBS are limited. Objectives: To evaluate changes in mREE, estimated REE (eREE), metabolic adaptation (difference in mREE – eREE), body composition, and gut peptides in youth after SG compared to non-surgical controls (NS) over two years. Methods: Youth 14-22 years old undergoing SG (n=24) and NS controls with severe obesity (n=28) were enrolled in this study. mREE was determined by indirect calorimetry. The Mifflin equation was used to calculate eREE. To account for effects of changes in FFM and total body weight (TBW), we evaluated mREE/FFM, mREE/TBW, eREE/FFM, and eREE/TBW. Dual energy X-ray absorptiometry (DXA) was used to measure body composition. Fasting plasma levels of ghrelin, peptide YY (PYY), glucagon-like peptide 1 (GLP-1), and insulin were measured. All measurements were performed at baseline and two years later. Results: Mean age and sex did not differ across groups. Body mass index (BMI) at baseline trended higher in SG vs. NS [43.60 (39.81, 49.39) vs. 41.60 (37.83, 48.21) kg/m2, (p=0.051)]. Mean change in BMI was higher in SG than NS (–11.5 ± 1.21 vs. 1.47 ± 0.58 kg/m2, p<0.0001). SG had a within group decrease in mREE of 400.96 ± 69.49 kcal/d (p<0.0001) and in eREE of 325.68 ± 34.73 kcal/d (p<0.0001) over 2 years. While mREE and eREE decreased in SG, both measures increased in NS over 2 years (p<0.0001 for both). Changes in mREE/FFM, mREE/TBW, and eREE/FFM over 2 years did not differ between groups (p=0.14, 0.24 and 0.61 respectively) while eREE/TBW increased in SG and decreased in NS (p< 0.0001). Metabolic adaptation over 2 years did not differ between groups (p=0.335). Ghrelin and insulin levels decreased over 2 years following SG but PYY and GLP-1 did not change significantly. Within SG, metabolic adaptation was positively associated with 2-year change in FFM (Spearman ρ= 0.57 p=0.009), but not with changes in gut peptides over 2 years. Conclusion: Despite significant decreases in BMI after SG in youth, surgical and non-surgical groups did not differ for changes in mREE/FFM and metabolic adaptation over 2 years. Presentation: Friday, June 16, 2023

FRI066 Treatment History And Comorbidities Reported By Patients With Hypothalamic Obesity Treated With Setmelanotide In A Phase 2 Trial

Abstract Disclosure: C.L. Roth: Other; Self; Study funding from Rhythm Pharmaceuticals, Inc. A.H. Shoemaker: Advisory Board Member; Self; Rhythm Pharmaceuticals, Inc., Saniona. Other; Self; Study funding from Rhythm Pharmaceuticals, Inc. M. Gottschalk: Advisory Board Member; Self; Rhythm Pharmaceuticals, Inc. Other; Self; Study funding from Rhythm Pharmaceuticals, Inc. J. Miller: Other; Self; Study funding from Rhythm Pharmaceuticals, Inc. G. Yuan: Employee; Self; Rhythm Pharmaceuticals, Inc. Stock Owner; Self; Rhythm Pharmaceuticals, Inc. S. Malhotra: Employee; Self; Rhythm Pharmaceuticals, Inc. Stock Owner; Self; Rhythm Pharmaceuticals, Inc. C. Scimia: Employee; Self; Rhythm Pharmaceuticals, Inc. Stock Owner; Self; Rhythm Pharmaceuticals, Inc. M.J. Abuzzahab: Consulting Fee; Self; Pfizer, Inc., Consynance, Rhythm Pharmaceuticals, Inc., Endo Pharmaceuticals. Background: Hypothalamic obesity (HO) is an acquired form of severe obesity that can occur following surgical resection or radiotherapy of brain tumors. Multiple factors associated with the development of HO—including degree of hypothalamic damage from tumor treatment, comorbidities (eg, pituitary deficiencies), polypharmacy used to treat comorbidities, and unique pathophysiology—confer treatment challenges; HO is often unresponsive to lifestyle modifications and traditional obesity pharmacotherapies. In a Phase 2, 16-week trial of setmelanotide in patients with HO, 16 of 18 patients (88.9% [90% confidence interval, 69.0%-98.0%]; P<0.0001) achieved ≥5% body mass index (BMI) reduction from baseline, with a mean percent BMI change of −15.4% in patients adhering to treatment (n=17). We assessed patient histories (ie, tumor treatments, prior attempts to lose weight, and comorbidities) reported in the trial to further characterize this patient population. Methods: Patients aged ≥6 to ≤40 years with documented evidence of HO were enrolled in an open-label Phase 2 trial (NCT04725240) and received setmelanotide once daily for 16 weeks. The primary endpoint was the proportion of patients with ≥5% BMI reduction from baseline at Week 16. Tumor treatments, prior attempts to lose weight, and comorbidities are summarized narratively. Results: Eighteen patients with HO (age range, 6-24 years) were treated with setmelanotide. HO was diagnosed in patients following treatment of craniopharyngioma (n=14), hamartoma (n=3), or juvenile pilocytic astrocytoma (n=1). Six patients (33.3%) had tumor recurrence and/or multiple tumor treatments. Thirteen patients (72.2%) reported prior lifestyle modifications (ie, calorie restriction [n=4], low-carbohydrate diet [n=6], dietary tracking/modification [n=4], food access restriction [n=1], personal training [n=1]) and/or pharmacotherapy use (ie, exenatide [n=3], semaglutide [n=1], liraglutide [n=2], metformin [n=2], methylphenidate [n=2], dextroamphetamine [n=1], lisdexamfetamine [n=2], naltrexone [n=3], oxytocin [n=3], phentermine [n=1]) without substantial benefit. Comorbidities occurring in ≥25% of patients were diabetes insipidus (n=14), hypothyroidism (n=14), growth hormone deficiency (n=11), adrenal insufficiency (n=10), hypogonadism (n=8), pan/hypopituitarism (n=8), psychiatric disorders (n=8), vision problems (n=6), gastrointestinal symptoms (n=6), obstructive sleep apnea (n=5), and hypothalamic-pituitary disorder (n=3). All patients adhering to treatment (n=17, including those with pituitary deficiencies and common comorbidities)) experienced BMI reductions with setmelanotide. Conclusions: Despite complex medical histories, hypothalamic damage, and various prior failed interventions, setmelanotide reduced BMI in patients with HO in a Phase 2 trial. Presentation: Friday, June 16, 2023

FRI065 Trial Design Of A Double-blind, Randomized, Placebo-controlled, Phase 3 Study Of Setmelanotide In Patients With Hypothalamic Obesity

Abstract Disclosure: C.L. Roth: Other; Self; Study funding from Rhythm Pharmaceuticals, Inc. A.H. Shoemaker: Advisory Board Member; Self; Rhythm Pharmaceuticals, Inc., Saniona. Other; Self; Study funding from Rhythm Pharmaceuticals, Inc. M. Gottschalk: Advisory Board Member; Self; Rhythm Pharmaceuticals, Inc. Consulting Fee; Self; Rhythm Pharmaceuticals, Inc. Other; Self; Study funding from Rhythm Pharmaceuticals, Inc. J.L. Miller: Other; Self; Study funding from Rhythm Pharmaceuticals, Inc. G. Yuan: Employee; Self; Rhythm Pharmaceuticals, Inc. Stock Owner; Self; Rhythm Pharmaceuticals, Inc. S. Malhotra: Employee; Self; Rhythm Pharmaceuticals, Inc. Stock Owner; Self; Rhythm Pharmaceuticals, Inc. C. Scimia: Employee; Self; Rhythm Pharmaceuticals, Inc. Stock Owner; Self; Rhythm Pharmaceuticals, Inc. S. McCormack: None. M.J. Abuzzahab: Consulting Fee; Self; Pfizer, Inc., Rhythm Pharmaceuticals, Inc., Consynance. Other; Self; Study funding from Rhythm Pharmaceuticals, Inc., Ascendis, NovoNordisk, Levo Pharmaceuticals, Lumos, Saniona, and Soleno. Background: Damage to the hypothalamus via physical trauma, tumors, surgical resection, and/or radiotherapy can impair the melanocortin signaling pathway and reduce energy expenditure, potentially leading to hypothalamic obesity, a severe form of obesity with no current specific therapeutic option. Recently, the selective melanocortin-4 receptor agonist setmelanotide demonstrated reduction in weight and hunger for patients with hypothalamic obesity who were treated in a Phase 2 trial. We describe the study design of a planned double-blind, randomized, placebo-controlled, Phase 3 trial of setmelanotide in patients with hypothalamic obesity. Methods: Approximately 120 patients will be enrolled across ≤35 sites globally. Eligibility criteria include age ≥4 years with documented evidence of acquired hypothalamic obesity with associated weight gain before and/or with tumor treatment and body mass index (BMI) ≥30 kg/m2 (≥18 years) or BMI ≥95th percentile (≥4 to <18 years). Key exclusion criteria include diagnosis of syndromic obesity, weight or BMI loss >2% based on age in the prior 3 months, bariatric surgery within the past 2 years, glycated hemoglobin >11.0%, and glomerular filtration rate <30 mL/min/1.73 m2. Patients will be randomized 2:1 and stratified by age to receive setmelanotide or placebo. Setmelanotide will be titrated over 2-8 weeks to a maximum daily subcutaneous dose of 1.5-3.0 mg based on age and weight. Double-blind treatment will continue for up to 60 weeks, with visits (in-clinic, at-home, or telehealth) at Weeks 20, 28, 36, 44, and 52 and at an end-of-treatment clinic visit at Week 60. The primary endpoint is the mean percent change in BMI after 52 weeks of treatment for setmelanotide versus placebo. Key secondary endpoints after 52 weeks are the proportion of patients aged ≥18 years with ≥5% reduction in BMI, proportion of patients aged <18 years with ≥0.2-point reduction in BMI Z score, and mean change in weekly average of the daily “most hunger” score in patients aged ≥12 years. Additional secondary endpoints include proportion of patients achieving ≥2-point reduction in weekly average of the daily maximal hunger score, Symptoms of Hyperphagia total score, additional weight-related parameters, and quality of life outcomes. Exploratory endpoints include change after 52 weeks in physical activity (measured by acDetigraphy), fatigue (via Functional Assessment of Chronic Illness Therapy [FACIT]-Fatigue©/Peds FACIT-F© scale), Impacts of Hyperphagia score, caregiver health status (via EuroQol-5-Dimension scale), cardiometabolic parameters, and waist circumference. Safety will be assessed by the frequency and severity of adverse events. Conclusions: This Phase 3 trial designed to assess the efficacy and safety of setmelanotide for weight loss and hunger reduction in patients ≥4 years of age with acquired hypothalamic obesity is planned to initiate in early 2023. Presentation: Friday, June 16, 2023

Is Morbid Obesity a Modifiable Risk Factor in Patients Who Have Severe Knee Osteoarthritis and do Not Have a Formal Perioperative Optimization Program?

BackgroundObesity is considered a modifiable risk factor prior to total knee arthroplasty (TKA); however, little data support this hypothesis. Our purpose was to evaluate patients who have a body mass index (BMI) >40 presenting for TKA to determine the incidence of: (1) patients who achieved successful weight loss through nutritional modification or bariatric surgery and (2) patients who underwent TKA over the study period without the presence of a formal optimization program. MethodsThis was a retrospective, single-center analysis. Inclusion criteria included: Kellgren and Lawrence grade 3 or 4 knee osteoarthritis, BMI >40 at presentation, and minimum 1-year follow-up (mean 45 months) (N = 624 patients). Demographics, weight loss interventions, pursuit of TKA, maximum BMI change, and Patient-Reported Outcomes Measurement Information System scores were collected. Multivariable logistic and linear regressions evaluated associations of underlying demographic and treatment characteristics with outcomes. ResultsThere were 11% of patients who ended up pursuing TKA over the study period. Bariatric surgery was 3.7 times more likely to decrease BMI by minimum 10 compared to nonsurgical intervention (95% confidence interval [CI] [1.7, 8.1]; P = .001). Bariatric surgery resulted in mean BMI change of −3.3 (range, 0 to 22) compared to nonsurgical interventions (−2.6 [range, 0 to 12]) and no intervention (0.4 [range, 0 to 15]; P < .0001). Bariatric surgery patients were 3.1 times more likely to undergo TKA (95% CI [1.3, 7.1]; P = .008), and nonsurgical interventions were 2.4 times more likely to undergo TKA (95% CI [1.3, 4.5]; P = .006) compared to no intervention. Non-White patients across all interventions were less likely to experience loss >5 BMI compared to White patients (95% CI [0.2, 0.9]; P = .018). ConclusionsMost patients were unable to reduce BMI more than 5 to 10 over a mean 4-year period without a formal weight optimization program. Utilization of bariatric surgery was most successful compared to nonsurgical interventions, although ultimate pursuit of TKA remained low in all cohorts.

919 The Effect of the Covid-19 Pandemic on BMI in Patients Awaiting Total Knee Replacement

Abstract Aim Obesity increases the risk of postoperative complications following Total Knee Replacement (TKR). The Covid-19 pandemic has increased waiting times for TKR in the United Kingdom. It is therefore important to understand whether these prolonged waiting times are impacting patient Body Mass Index (BMI) at the time of surgery. The aim of our study was to assess for changes in BMI whilst awaiting TKR. Method Prospective data was collected for 54 patients who attended the pre-assessment-clinic (PAC) from January - March of 2022, before undergoing TKR. This included demographics, waiting times for surgery, and BMI on referral to Orthopaedics versus BMI at PAC. Results Of the 54 patients studied, 29 were female and 25 were male with a mean age of 69 years (SD 8.07). 42 patients waited ≥ 3 months for surgery, 29 waited ≥ 6 months and 2 waited ≥ 12 months. Mean waiting time was 191.5 days (SD 114.23). 33 of the 54 patients (61%) were obese (BMI ≥ 30) when listed for surgery, with a mean BMI of 31.7 (SD 4.59). Between listing for surgery and PAC review, 72% saw an increase in BMI, 24% saw a decrease and 4% saw no change. Mean BMI at PAC was 33.2 (SD 4.97) with a mean change in BMI of +1.5 since listing (SD 2.51). Conclusions In this study, 72% of patients gained weight while awaiting surgery and surgical waiting times were considerably higher than pre-pandemic targets (&amp;lt;3 months). This increase in BMI may result in increased risk of complications and patients should be counselled about it.

17-year trends of body mass index, overweight, and obesity among adolescents from 2005 to 2021, including the COVID-19 pandemic: a Korean national representative study.

There is a lack of pediatric studies that have analyzed trends in mean body mass index (BMI) and the prevalence of obesity and overweight over a period that includes the mid-stage of the COVID-19 pandemic. Thus, we aimed to investigate trends in BMI, overweight, and obesity among Korean adolescents from 2005 to 2021, including the COVID-19 pandemic. We used data from the Korea Youth Risk Behavior Web-based Survey (KYRBS), which is nationally representative of South Korea. The study included middle- and high-school students between the ages of 12 and 18. We examined trends in mean BMI and prevalence of obesity and/or overweight during the COVID-19 pandemic and compared these to those of pre-pandemic trends in each subgroup by gender, grade, and residential region. Data from 1,111,300 adolescents (mean age: 15.04 years) were analyzed. The estimated weighted mean BMI was 20.48 kg/m2 (95% CI, 20.46-20.51) between 2005 and 2007, and this was 21.61 kg/m2 (95% CI, 21.54-21.68) in 2021. The prevalence of overweight and obesity was 13.1% (95% CI, 12.9-13.3%) between 2005 and 2007 and 23.4% (95% CI, 22.8-24.0%) in 2021. The mean BMI and prevalence of obesity and overweight have gradually increased over the past 17 years; however, the extent of change in mean BMI and in the prevalence of obesity and overweight during the pandemic was distinctly less than before. The 17-year trends in the mean BMI, obesity, and overweight exhibited a considerable rise from 2005 to 2021; however, the slope during the COVID-19 pandemic (2020-2021) was significantly less prominent than in the pre-pandemic (2005-2019). These findings enable us to comprehend long-term trends in the mean BMI of Korean adolescents and further emphasize the need for practical prevention measures against youth obesity and overweight.

Trends in body mass index, overweight and obesity among adults in the USA, the NHANES from 2003 to 2018: a repeat cross-sectional survey

ObjectivesTo analyse detailed trends in adult obesity from 2003 to 2018 in the USA, and provide the latest national estimates of adult obesity in 2017–2018.Design, setting and participantsAnalysis of data,...

OR10-1 Body Mass Index and Weight Reductions in Patients With Obesity Due to Heterozygous Variants in POMC, PCSK1, and LEPR After 1 Year of Setmelanotide

Abstract Background The melanocortin-4 receptor (MC4R) pathway is a key regulator of energy balance. Heterozygous variants of the genes for proopiomelanocortin (POMC), leptin receptor (LEPR), and proprotein convertase subtilisin/kexin type 1 (PCSK1) upstream of MC4R can result in impaired signaling in the MC4R pathway. This impaired signaling can lead to hyperphagia and early-onset, severe obesity. Setmelanotide (SET), an MC4R agonist, reduced weight and hunger after 3 months in patients with obesity due to these heterozygous variants in an earlier Phase 2 study. The current analysis is the first to assess continued efficacy of an additional year of SET treatment in patients with obesity due to heterozygous affectation of POMC, PCSK1, and LEPR. Methods Patients aged ≥6 years with obesity due to heterozygous variants in POMC, PCSK1, and LEPR were eligible for this long-term extension (LTE) trial (NCT03651765) after completing an index trial in which they received SET and demonstrated clinical benefit and acceptable safety as determined by the investigator. Patients received a minimum of 4 months of SET treatment in the index trial and began the LTE immediately following the completion of the index trial. Study visits occurred every 3 months and evaluated changes in body weight measures and assessed safety and tolerability. The current analysis reports outcomes after 1 year total of SET treatment across the index and LTE trials, relative to index trial baseline. Results As of October 29, 2021, 35 patients with obesity heterozygous for POMC, PCSK1, and LEPR had enrolled in the index trial, with 16, 17, and 17 patients continuing into the LTE trial and receiving at least 6, 9, and 12 months of treatment with SET, respectively. At index trial baseline, mean (standard deviation [SD]) body mass index (BMI) for all index trial patients was 50.26 (9.41) kg/m2, body weight in patients ≥18 years old was 142.97 (28.70) kg, and BMI Z score in patients &amp;lt;18 years old was 4.04 (0.65). Mean (SD) percent change in BMI was −6.93% (9.13%; n=16), −8.14% (10.13%; n=17), and −7.83% (9.69%; n=17) after 6, 9, and 12 months of treatment, respectively. Of 15 patients ≥18 years old, the mean (SD) percent change in body weight was −10.24% (7.90%; n=15) after 12 months. For the 1 patient &amp;lt;18 years old, mean change in BMI Z score was 0.64 after 12 months. No new safety concerns emerged during the LTE and 1 patient discontinued due to an adverse event, likely unrelated to treatment. Conclusions Treatment with SET had continued efficacy in patients with obesity due to heterozygous variants in POMC, PCSK1, and LEPR after 1 year of treatment. These data support the continued investigation of SET in these patients, which is underway in the Phase 3 EMANATE trial (NCT05093634). Presentation: Sunday, June 12, 2022 11:00 a.m. - 11:15 a.m.

Radiographic and Clinical Outcomes After Arthroscopic Microfracture for Osteochondral Lesions of the Talus: 5-Year Results in 355 Consecutive Ankles.

Background:Arthroscopic microfracture for osteochondral lesion of the talus (OLT) has shown good functional outcomes in the short and long term.Purpose:To investigate 5-year radiographic and clinical outcomes after arthroscopic microfracture in treatment of OLT and the effectiveness of adjunct therapies including platelet-rich plasma (PRP) and hyaluronic acid (HA).Study Design:Cohort study; Level of evidence, 2.Methods:We prospectively enrolled 432 patients who underwent arthroscopic microfracture for OLT from May 1, 2011, to May 31, 2015. Magnetic resonance imaging (MRI) and weightbearing radiographs were performed annually after the initial surgery. The MOCART (magnetic resonance observation of cartilage repair tissue) score was used to evaluate the structure of the repaired cartilage on MRI, and patient-reported outcomes (American Orthopaedic Foot and Ankle Society ankle-hindfoot scale [AOFAS] and the Foot and Ankle Outcome Score) were collected annually. The primary outcome measure was 5-year AOFAS score. We recorded baseline characteristics including age, body mass index (BMI), and lesion size, and other potentially related factors including number of PRP/HA injection and change in BMI from baseline.Results:Included were 355 patients, all with minimum 5-year follow-up data. The overall reoperation rate was 9.0% (32 of 355). According to multivariable analysis, 5-year AOFAS scores were associated with number of PRP injections (correlation coefficient, 3.12 [95% CI, 2.36 to 3.89]; P < .001), BMI at baseline (correlation coefficient, -0.222 [95% CI, -0.363 to -0.082]; P = .002), and mean BMI change from baseline (correlation coefficient, -1.15 [95% CI, -1.32 to -0.98]; P < .001). When comparing number of PRP injections (0, 1-2, or ≥3), we found that patients who had serial PRP injection (≥3 with at least a 3-month interval between injections) had diminished functional and radiographic deterioration over time.Conclusion:Arthroscopic microfracture improved patient-reported and structural outcomes for patients with OLT at 5 years after surgery. Serial PRP injections and reduction in BMI from baseline were able to slow radiographic and functional deterioration. Future trials regarding the combination of microfracture and PRP in treatment of OLT should focus on the efficacy of longer term, intra-articular, serial injections of PRP instead of single injections.

Efficacy of liraglutide 3.0 mg treatment on weight loss in patients with weight regain after bariatric surgery

PurposeBariatric surgery, as Roux-en-Y gastric bypass (RYGB), laparoscopic gastric banding (LGB), and laparoscopic sleeve gastrectomy (LSG), is considered the gold standard treatment to achieve long-term weight loss in severe obesity. In patients who fail to maintain the achieved weight, pharmacological treatment may be required. Here, we reported our real-life experience on the efficacy of liraglutide therapy in 62 patients who regained weight after bariatric surgery.MethodsWe retrospectively evaluated 62 (60 F-2 M; mean age: 43.6 ± 9.9 years) patients received liraglutide for weight loss after bariatric surgery (17 RYGB, 22 LGB, and 23 LSG). Body mass index (BMI) before and after surgery was, respectively, of 45.4 ± 5.5 kg/m2 and 29.5 ± 4.9 kg/m2. Patients were followed up from 2016 until 2021. Liraglutide was administered after weight regain once-daily subcutaneously at starting dose of 0.6 mg and with weekly increases up to 3.0 mg. Treatments were administered when a weight regain of 10–15% occurred after reaching a minimum weight loss from bariatric surgery or if weight loss after bariatric surgery was unsatisfactory.ResultsAfter a mean of 70.7 ± 43.7 months from any bariatric surgery, all patients started liraglutide therapy. At this time, mean BMI was 34.2 ± 4.8 kg/m2 (mean increased BMI: 4.7 ± 2.8 kg/m2). After a mean of 10.5 ± 4.4 months from the beginning of liraglutide, 9 patients achieved normal weight (BMI 24.1 ± 0.9 kg/m2), and 28 were overweight (BMI 26.9 ± 1.6 kg/m2). Twenty patients achieved grade I (BMI 32.1 ± 1.5 kg/m2), 5 grade II (BMI 37.3 ± 2.0 kg/m2) obesity, and none had grade III obesity (mean BMI change: − 5.1 ± 2.5 kg/m2). The treatment was well tolerated, and no serious adverse events were recorded.ConclusionThese data confirm the efficacy and safety of liraglutide in patients who experienced weight regain after bariatric surgery. Considering the long-term follow-up, patients should be followed up regularly and the pharmacological treatment should be adapted to the weight fluctuations observed during the clinical history.Level of evidenceV. Opinions of authorities, based on descriptive studies, narrative reviews, clinical experience, or reports of expert committees.

Trends in body mass index changes among Korean adolescents between 2005-2020, including the COVID-19 pandemic period: a national representative survey of one million adolescents.

The impact of the coronavirus disease 2019 (COVID-19) pandemic on weight gain in children and adolescents remains unknown. We aimed to identify an estimated 15-year trend in mean body mass index (BMI) changes and prevalence of obesity and overweight among Korean adolescents from 2005 to 2020, including the period of the COVID-19 pandemic. We analyzed data taken from a nationwide survey (Korea Youth Risk Behavior Survey), between 2005 and 2020. Representative samples of one million Korean adolescents aged 13-18 years (n=1,057,885) were examined. The 15-year trends in mean BMI and proportion of obesity or overweight, and the changes due to the COVID-19 pandemic were analyzed. The data of 1,057,885 Korean adolescents were analyzed (mean age: 14.98 years; females, 48.4%). The estimated weighted mean BMI was 20.5 kg/m2 [95% confidence interval (CI), 20.4-20.5] from 2005 to 2008 and 21.5 kg/m2 (95% CI, 21.4-21.6) in 2020 (during the COVID-19 pandemic). Although the 15-year trend of mean BMI gradually increased, the change in mean BMI before and during the pandemic significantly lessened (βdiff, -0.027; 95% CI, -0.028 to -0.026). The 15-year (2005-2020) trend changes in the prevalence of obesity and overweight were similar (obesity prevalence from 2005-2008, 3.2%; 95% CI, 3.1-3.3 vs. obesity prevalence in 2020, 8.6%; 95% CI, 8.2-9.0; βdiff, -0.309; 95% CI, -0.330 to -0.288). The 15-year trend of overall mean BMI and obesity and overweight prevalence demonstrated a significant increase; however, its slope decreased during the pandemic. These landmark results suggest the need for the development of precise strategies to prevent pediatric obesity and overweight during the COVID-19 pandemic.

1433-P: Comparative Weight Loss with GLP-1 Receptor Agonists vs. Bariatric Surgery in Obesity: A Systematic Review and Pair-Wise Meta-analysis

Background: One in three adults suffers from obesity.1 Glucagon-like peptide-1 (GLP-1) receptor agonists have been associated with 15-20% weight loss, a range previously only achieved with bariatric surgery.2,3,4 This systematic review and meta-analysis compares weight loss between GLP-1 receptor agonists and bariatric surgery. Methods: MEDLINE, Medline-in-Process, Medline EPUBS Ahead of Print, EMBASE Classic + EMBASE (OvidSP) ; and Cochrane (Wiley) databases were searched from inception to April 21, 2021. We included randomized controlled trials (RCTs) and observational studies. Two independent reviewers extracted data, reported risk of bias, and graded certainty of evidence. Risk of bias was reported using Risk of Bias 2 (RoB 2) tool for RCTs and Risk of Bias in Non-randomized Studies- of Interventions (ROBINS-I) tool for observational studies. Data were pooled separately for RCTs and observational studies using random effects models. Change in weight, body mass index (BMI) , and glycated hemoglobin (HbA1C) were summarized. Results: Seven included studies encompassed 11patients. Among RCTs, mean difference in weight between bariatric surgery and GLP-1 receptor agonist was −22.68 (95% CI: −31.41, −13.96) , mean difference in BMI was −8.18 (95% CI: −11.59, −4.77) , and mean difference in HbA1C was −1.28 (95% CI: −1.94, −0.61) . Among observational studies, mean difference in weight was −16.56 (95% CI: −36.53, 3.42) and mean change in BMI was −10.60 (95% CI:−17.22, −3.98) . These effects all favoured bariatric surgery. Conclusion: In adults with obesity, bariatric surgery still confers highest reductions in weight and BMI compared to GLP-1 receptor agonists, but similar effects in glycemic control. Word count: 248 Disclosure P. Palcu: None. Funding Clinician Investigator Program, University of Toronto

Effects of a laughter program on body weight and mental health among Japanese people with metabolic syndrome risk factors: a randomized controlled trial

BackgroundWhile there have been several intervention studies on the psychological effects of laughter, few have examined both the psychological and physical effects. This study investigates the effects of a laughter program on body weight, body mass index (BMI), subjective stress, depression, and health-related quality of life (HRQOL) among Japanese community-dwelling individuals using a randomized controlled trial with a waitlist.MethodsOverall, 235 participants (37 men and 198 women) aged 43–79 years (mean 66.9, median 67.0) were randomized into laughter intervention and control groups (n = 117 and n = 118, respectively) to participate in a 12-week laughter program. Body weight, subjective stress, subjective well-being, and HRQOL were measured at the baseline, with a 12-week follow-up. The laughter program intervention’s effects on these factors were analyzed using an analysis of covariance adjusted by age, sex, risk factors, medication, and area. Furthermore, Pearson’s correlation and a general linear model analyzed the relationship between participants’ BMI and psychological index changes.ResultsThe comprehensive laughter program significantly improved the mean body weight (p = 0.008), BMI (p = 0.006), subjective stress (p = 0.004), subjective well-being (p = 0.002), optimism (p = 0.03), and physical component summary (PCS) scores of HRQOL (p = 0.04). A similar tendency occurred for the mean changes in BMI and subjective stress score by area, sex, and age. Moreover, there was a significant and negative correlation between the change in BMI and PCS change (p = 0.04).ConclusionThe comprehensive 12-week laughter intervention program, mainly comprising laughter yoga, significantly improved physical and psychological functions such as body weight, BMI, subjective stress, subjective well-being, and HRQOL among predominantly elderly Japanese community-dwelling individuals with metabolic syndrome risk factors. Moreover, PCS improved among participants who reduced BMI after the intervention. These results suggest that the laughter program may help reduce body weight in participants with metabolic syndrome risk factors by reducing stress and improving HRQOL and mental health factors, such as subjective well-being and optimism.Trial registrationRegistered with the University Hospital Medical Information Network Clinical Trials Registry UMIN-CTR000027145 on 27/04/2017.

Advanced Telemedicine Training and Clinical Outcomes in Type II Diabetes: A Pilot Study.

Background: COVID-19 caused a dramatic increase in the scope and utilization of telemedicine. However, the sustainability of the permanent integration of telemedicine in the management of chronic disease beyond the pandemic is still enigmatic. The purpose of this retrospective chart review was to analyze the effect of advanced training in telemedicine on clinical outcomes in type II diabetes mellitus (T2DM) in the United States.Methods: A retrospective chart review was conducted in 104 deidentified patients with diabetes from 28 specialized telemedicine agency physicians who had received specialized telemedicine training. After establishing exclusion criteria, the charts of 59 T2DM patients were evaluated. Glycated hemoglobin (HbA1c) percentage and body mass index (BMI) were used as quantitative endpoints. Visit consistency, mediation data, and compliance data were also studied.Results: The mean change in HbA1c for the 42 patients who met the inclusion criteria for evaluating HbA1c (n = 42) was −0.429%. The largest decrease in HbA1c was 5.4%, and the most significant increase was 3.9%. The mean change in BMI for the 16 patients who met the inclusion criteria for evaluating BMI (n = 16) was −2.175 kg/m2. The largest decrease in BMI was 9.5 kg/m2 and the largest increase was +0.7 kg/m2. The average number of visits for patients with a decrease in HbA1c was 3.45. The average number of visits for patients with an increase in HbA1c was 2.62.Conclusions: Outcomes of telemedicine providers with training are comparable with the standard of care. Advanced telemedicine training and its effect on clinical outcomes in the management of chronic disease warrant further investigation. For telemedicine to become a mainstay in U.S. medicine, a standard of best practices should be evaluated and available for providers who wish to continue telehealth care delivery.

Weight Loss, Type 2 Diabetes, and Nutrition in 355 Patients with Obesity Undergoing Sleeve Gastrectomy with Transit Bipartition: Two-Year Outcomes.

This study examined whether 355 obese patients with type 2 diabetes (T2D) of varying duration and severity experienced equivalent weight loss and T2D remission following a newer sleeve gastrectomy (SG) procedure - SG with transit bipartition (SG-TB). Primary outcomes were changes in body mass index (BMI), total weight loss (TWL), excess BMI loss (EBMIL), A1C, and diabetes medication use through 24 months. Between December 2015 and December 2019, 399 patients who underwent SG-TB reached the 2-year time point. Follow-up was possible in 355 patients (89.0%): 206 females (58.0%), mean age 51.5 years (24.0-73.0), BMI 34.0 kg/m2 (28.0-50.5), and T2D duration 12.0 years (4.0-37.0). At 2 years, total sample respective mean TWL and EBMIL were 20.2 ± 6.1% (95% CI: 19.5, 20.8) and 87.7 ± 35.2% (84.1, 91.4) corresponding to mean BMI change of 7.0 ± 2.7 kg/m2 (6.7, 7.3) (p < 0.001). T2D duration and severity subgroups experienced comparable BMI and A1C change from baseline (p < 0.001); 281 (79.2%) maintained complete remission. ANOVA showed significant mean increases in vitamin D, calcium, and albumin: overall complication rate, 10.2%; no mortality. In 355 patients with obesity who underwent SG-TB, excellent weight loss, T2D, and nutritional outcomes were seen at 2-year follow-up regardless of preoperative T2D duration and severity.

Does Obesity Influence Body Mass Index Changes in Nulliparous Adolescent Users of Long-Acting Reversible Contraceptives?

To compare body mass index (BMI) changes in adolescents using long-acting reversible contraceptives (LARCs), specifically, the etonogestrel subdermal implant (ENG-implant), levonorgestrel intrauterine device (LNG-IUD), and copper IUD (Cu-IUD), by initial BMI category from the time of LARC insertion to within 6-18 months after insertion. This was a single-center retrospective cohort study. We reviewed electronic health records from our large health system to identify and follow a cohort of 196 adolescents aged 14-19 years with LARCs inserted from 2010 to 2016. We excluded adolescents with conditions or medications affecting weight, including childbirth. BMI change from LARC insertion to first BMI documented after 6-18 months RESULTS: Mean age was 17.2 ± 0.2 years; 59% of the cohort was Hispanic and 29% Black. Mean BMI was 26.4 ± 7.1 kg/m2. Of the total cohort of adolescents, 51% were underweight/normal, 24% overweight, and 25% obese. Mean time to first BMI documented after LARC insertion was 10.1 ± 3.2 months. Mean BMI change for the total cohort was +0.73 ± 1.8 kg/m2, indicating weight gain. Mean BMI change for the ENG-implant+LNG-IUD users (n=127) was larger than for Cu-IUD users (n=69) (+0.92 ± 1.9 kg/m2 vs +0.37 ± 1.6 kg/m2, respectively, P < .05). Two-way analysis of variance showed that both initial BMI category (P=.001) and type of LARC (P=.011) had an independent significant main effect on BMI change. A significant interaction effect (P=.017) showed that obese adolescents had a larger increase in BMI when they were using a progestin-releasing LARC, either ENG-implant or LNG-IUD, as compared to a Cu-IUD (P < .05). Adolescents using progestin-releasing LARCs had a larger increase in BMI within 6-18 months after device insertion than those using Cu-IUDs. The disproportionate increase in BMI with progestin-releasing LARCs was primarily contributed by obese users.