Weight Management In Adults Research Articles

Evaluating the Adherence of Popular Diet and Nutrition Apps to Evidence-Based Guidelines for Adult Weight Management

ObjectivesTo assess the adherence of popular, commercially available diet and nutrition apps to the Academy of Nutrition and Dietetics’ Adult Weight Management (AWM) guideline recommendations and to discern associations between the guideline adherence and indicators of the perceived popularity of an app among consumers. MethodsA preliminary search for apps was conducted in Apple App Store and Google Play Store using keywords “diet” and “weight loss” in October 2020. Selection criteria screened to only include calorie-tracking apps with greater than 10 million installations, focused on weight management as a primary outcome. Apps addressing other health outcomes, disease management, or specific dietary approaches were excluded. Selected apps were assessed with iPads using a prescribed 7-day dietary intake and collected data were recorded. ResultsThere were no significant correlations between any of the individual recommendation categories and app metadata attributes (app ratings, installations, subscription cost). Greatest recommendation adherence was observed in those corresponding to nutrition intervention (n = 9 recommendations; 65.9%) and monitoring and evaluation categories (n = 2 recommendations; 75%). ConclusionsPopular, commercially available diet and nutrition apps offer limited adherence to expert guideline recommendations for adult weight management. Funding SourcesThe authors of this article disclose no funding source in support of this work.

Consuming a Protein and Fiber-Based Supplement Preload Promotes Weight Loss and Alters Metabolic Markers in Overweight Adults in a 12-Week, Randomized, Double-Blind, Placebo-Controlled Trial

BackgroundHigher protein and fiber diets promote weight management and metabolic health. ObjectivesThis study aimed to determine if greater weight loss and positive changes in metabolic outcomes could be achieved with twice-daily consumption of a high-protein and fiber-based multi-ingredient nutritional shake (HPF) compared with an isocaloric low-protein, lower fiber-based placebo (LPF). MethodsStudy procedures were conducted by an independent research organization under clinicaltrials.gov registration NCT03057873. Healthy overweight and obese adults [n = 206; BMI (kg/m2): 27–35; 70% female] were randomly assigned to HPF or LPF. All participants were prescribed an energy-restricted diet (500 kcal/d less than energy needs) and consumed a HPF (17 g protein, 6 g fiber) or LPF (1 g protein, 3 g fiber) shake 30 min before breakfast and lunch for 12 wk. Primary outcomes included body weight and total body fat percentage. Blood samples were collected at days (D) 0, 28, 56, and 84 for secondary analyses related to metabolic markers of health. ResultsAlthough weight loss occurred in both groups, HPF had greater weight loss at D84 compared with LPF (–3.3 kg vs. –1.8 kg, P < 0.05). Percentage body fat decreased in both groups (HPF: –1.33%, LPF: –1.09%; P < 0.001) with no differences between groups. Serum total cholesterol, LDL cholesterol, and oxidized LDL decreased between –5.1% to –8.3%, whereas adiponectin increased over time in both groups; these changes occurred to a greater extent in HPF compared with LPF (all P < 0.05). ConclusionsA multi-ingredient HPF nutritional supplement shake consumed as a preload before breakfast and lunch positively influenced weight management and metabolic outcomes in overweight adults compared with an LPF placebo. These findings suggest that specific nutrient factors (i.e., potentially including protein, fiber, and bioactive content) other than calorie reduction alone influence the success of a weight-loss regimen. This trial was registered at www.clinicaltrials.gov as NCT03057873,

Once-Weekly Semaglutide for Weight Management: A Clinical Review.

Objective: To review the efficacy, safety, and role of the glucagon-like peptide-1 (GLP-1) receptor agonist semaglutide for chronic weight management. Data Sources: A literature search of PubMed/MEDLINE and Google Scholar was performed using the search terms: semaglutide 2.4, weight, and obesity. Ongoing studies of semaglutide were identified utilizing clinicaltrials.gov. Study Selection and Data Extraction: All English-language articles evaluating the efficacy and safety of semaglutide 2.4 mg for weight management in humans were included. Data Synthesis: Once-weekly injectable semaglutide 2.4 mg is indicated as an adjunct to a reduced-calorie diet and increased exercise for chronic weight management in adults with a body mass index (BMI) ≥30 kg/m2 or ≥27 kg/m2 with at least one weight-related comorbidity, such as hypertension, type 2 diabetes mellitus, or dyslipidemia. Semaglutide 2.4 mg has consistently demonstrated clinically significant weight loss across all phase 3 STEP (semaglutide treatment effect in people with obesity) trials, and long-term efficacy and safety have been confirmed for up to 2 years. Gastrointestinal side effects were the most frequently reported side effects, including nausea, vomiting, constipation, and diarrhea. Safety data for semaglutide 2.4 mg were consistent with that reported previously for the GLP-1 receptor agonist class. Conclusions: Semaglutide 2.4 mg is a highly efficacious agent for weight management, with a safety profile similar to that of other GLP-1 receptor agonists. It is a feasible option for chronic weight management, with data for up to 2 years. It is currently the only once-weekly weight loss medication, although cost may limit its utilization.

Abstract 10: Efficacy and safety of semaglutide 2.4 mg once- weekly in adults with overweight or obesity and type 2 diabetes (STEP 2)

Background: In people with overweight/obesity and type 2 diabetes (T2D), achievement of weight loss can be a challenge. STEP 2 investigated the efficacy and safety of semaglutide 2.4 mg for weight management in adults with overweight/obesity and T2D.Methods: This randomized, double-blind, double-dummy, placebo-controlled, phase 3 trial was conducted at 149 sites across 12 countries (NCT03552757). Adults aged ≥18 years with body mass index (BMI) ≥27 kg/m2, T2D, HbA1c between 7–10% (53–86 mmol/mol), and receiving ≤3 oral glucose-lowering agents were randomized 1:1:1 to once-weekly subcutaneous (s.c.) semaglutide 2.4 mg or 1.0 mg, or placebo, as adjunct to a reduced-calorie diet and increased physical activity for 68 weeks. The co-primary endpoints were percentage change in body weight and proportion of participants achieving weight loss ≥5% for semaglutide 2.4 mg vs placebo. Cardiovascular risk factors, glycemia and safety/tolerability were also assessed. Two estimands were defined: treatment policy and trial product; results are presented for the treatment policy estimand, unless stated otherwise.Results: 1,210 participants (mean: age 55 years, body weight 99.8 kg, BMI 35.7 kg/m2, HbA1c 8.1%, diabetes duration 8.0 years; 50.9% female) were randomized. Mean body weight change from baseline to week 68 was −9.6% with semaglutide 2.4 mg vs −3.4% with placebo (estimated treatment difference [ETD]: −6.2%; 95% confidence interval [CI]: −7.3, −5.2; p<0.0001) and −7.0% for semaglutide 1.0 mg (ETD for semaglutide 2.4 mg vs 1.0 mg: −2.7%; 95% CI: −3.7, −1.6; p<0.0001). Similar results were obtained with the trial product estimand: mean body weight change −10.6% for semaglutide 2.4 mg vs −3.1% for placebo (ETD: −7.6%; 95% CI: −8.6, −6.6; p<0.0001) and 7.6% for semaglutide 1.0 mg (ETD vs semaglutide 2.4 mg: −3.1%; 95% CI: −4.1, −2.1; p<0.0001). Participants on semaglutide 2.4 mg were more likely to achieve weight loss ≥5%, ≥10%, ≥15% and ≥20% vs placebo (68.8% vs 28.5%, 45.6% vs 8.2%, 25.8% vs 3.2% and 13.1% vs 1.6%, respectively; p value for odds ratios <0.0001 for all). Mean change in HbA1c from baseline to week 68 was −1.6% for semaglutide 2.4 mg vs −0.4% for placebo (p<0.0001). Greater improvements with semaglutide 2.4 mg vs placebo were also seen in waist circumference, BMI, systolic blood pressure, fasting plasma glucose, C-reactive protein, and lipids (HDL, VLDL, free fatty acids, and triglycerides) (p<0.05 for all). The most frequent adverse events were gastrointestinal disorders (typically transient and mild-to-moderate), occurring in 57.5%, 63.5% and 34.3% of participants receiving semaglutide 1.0 mg, 2.4 mg and placebo, respectively.Conclusion: Semaglutide 2.4 mg, as adjunct to lifestyle intervention, was efficacious and well tolerated for weight management in adults with overweight or obesity and T2D, providing significantly greater weight loss vs placebo and semaglutide 1.0 mg at week 68.

Qualitative inquiry with primary care providers and specialists about adult weight management care and referrals.

Obesity is a highly prevalent disease and providers are expected to offer or refer patients for weight management yet increasingly fewer clinical visits address obesity. Challenges to offering care are known but less is known about referrals and how specialists who treat obesity-related comorbidities address care and referrals. This study explored perceptions of primary care providers (PCPs) and specialty providers regarding care and referrals for weight management, specifically referrals to programs in the community setting. A qualitative design was used to interview 33 PCPs (mean age 54 years) and 31 specialists (cardiology, gynecology, endocrinology, and orthopedics [mean age 62 years]) in the USA during 2019. Each interview was conducted by telephone, audio-recorded, and transcribed verbatim. Inductive analysis was used and followed the constant comparative method. Four themes emerged from the data including (a) Clinical guidelines and provider discretion influence obesity care; (b) Facilitators and barriers to discussing weight and small step strategies; (c) Informal referrals are made for weight management in community settings; and (d) Opportunities and challenges for integrating clinical and community services for weight management. Facilitating referrals to effective programs, ideally with a feedback loop could coordinate care and enhance accountability, but education, compliance, and cost issues need addressed. Care may be offered but not be well-aligned with clinical guidelines. Knowledge gaps regarding community programs’ offerings and efficacy were evident. Referrals could be systematically promoted, facilitated, and tracked to advance weight management objectives.

Semaglutide for weight loss and cardiometabolic risk reduction in overweight/obesity.

Cardiovascular disease is the most common cause of morbidity and mortality worldwide, and the risk is heightened in the presence of obesity. We review semaglutide, a drug recently approved for chronic weight management in adults with obesity or who are overweight. On 4 June 2021, the US Food and Drug Administration approved semaglutide injection at 2.4 mg once weekly for chronic weight management in adults with obesity or overweight with at least one weight-related condition such as high blood pressure, type 2 diabetes mellitus, or high cholesterol. This subcutaneous injection is the first approved drug for chronic weight management in adults with general obesity or overweight since 2014. The drug is indicated for weight management in patients with a BMI of 27 kg/m2 or greater who have at least one weight-related ailment or in patients with a BMI of 30 kg/m2 or greater. Semaglutide offers adults with obesity or overweight a new treatment in conjunction with a weight management program consisting of reduced calorie diet and increased physical activity.

Semaglutide once a week in adults with overweight or obesity, with or without type 2 diabetes in an east Asian population (STEP 6): a randomised, double-blind, double-dummy, placebo-controlled, phase 3a trial

Semaglutide 2·4 mg once weekly has been investigated for weight management in global populations. Differences exist between Asian and non-Asian populations in terms of body composition and definitions of obesity. In the Semaglutide Treatment Effect in People with obesity (STEP) 6 trial, we assessed the effect of semaglutide versus placebo for weight management in adults from east Asia with obesity, with or without type 2 diabetes. This randomised, double-blind, double-dummy, placebo-controlled, phase 3a superiority trial was done at 28 outpatient clinics in Japan and South Korea. Eligible participants were adults (aged ≥18 years in South Korea; ≥20 years in Japan) with a BMI of at least 27·0 kg/m2 with two or more weight-related comorbidities or a BMI of 35·0 kg/m2 or more with one or more weight-related comorbidity (one comorbidity had to be either hypertension, dyslipidaemia, or, in Japan only, type 2 diabetes) who had at least one self-reported unsuccessful dietary attempt to lose bodyweight. Participants were randomly assigned (4:1:2:1) to once-weekly subcutaneous semaglutide 2·4 mg or matching placebo, or semaglutide 1·7 mg or matching placebo, plus lifestyle recommendations for 68 weeks. Data for the placebo groups were pooled in statistical analyses. The primary endpoints were percentage change in bodyweight from baseline at week 68 and the proportion of participants who had achieved a reduction of at least 5% of baseline bodyweight at week 68. Change in abdominal visceral fat area was assessed as a supportive secondary endpoint using computed tomography scanning in a subset of participants. Efficacy outcomes were assessed in the full analysis set, which included all randomly assigned participants according to the intention-to-treat principle. Safety was assessed in all participants who received at least one dose of the study drug. This trial was registered with ClinicalTrials.gov, NCT03811574. Between Jan 21, 2019 and June 4, 2019, 437 participants were screened, of whom 401 were randomly assigned to semaglutide 2·4 mg (n=199), semaglutide 1·7 mg (n=101), or placebo (n=101) and included in the intention-to-treat analysis. Estimated mean change in bodyweight from baseline to week 68 was -13·2% (SEM 0·5) in the semaglutide 2·4 mg group and -9·6% (0·8) in the semaglutide 1·7 mg group versus -2·1% (0·8) in the placebo group (estimated treatment difference [ETD] -11·1 percentage points [95% CI -12·9 to -9·2] for semaglutide 2·4 mg vs placebo; -7·5 percentage points [95% CI -9·6 to -5·4] for semaglutide 1·7 mg vs placebo; both p<0·0001). At week 68, a larger proportion of participants had achieved a 5% or higher reduction in baseline bodyweight in the semaglutide 2·4 mg group (160 [83%] of 193 participants) and semaglutide 1·7 mg group (71 [72%] of 98 participants) than in the placebo group (21 [21%] of 100 participants); odds ratio [OR] 21·7 [95% CI 11·3 to 41·9] for semaglutide 2·4 mg vs placebo; OR 11·1 [95% CI 5·5 to 22·2] for semaglutide 1·7 mg vs placebo; both p<0·0001). Abdominal visceral fat area was reduced by 40·0% (SEM 2·6) among participants in the semaglutide 2·4 mg group and 22·2% (3·7) among participants in the semaglutide 1·7 mg group versus 6·9% (3·8) in the placebo group (ETD -33·2% [95% CI -42·1 to -24·2] for semaglutide 2·4 mg vs placebo; -15·3% [95% CI -25·6 to -4·9] for semaglutide 1·7 mg vs placebo). 171 (86%) of 199 participants in the semaglutide 2·4 mg group, 82 (82%) of 100 participants in the semaglutide 1·7 mg group, and 80 (79%) of 101 participants in the placebo group reported adverse events. Gastrointestinal disorders, which were mostly mild to moderate, were reported in 118 (59%) of 199 participants in the semaglutide 2·4 mg group, 64 (64%) of 100 participants in the semaglutide 1·7 mg group, and 30 (30%) of 101 participants in the placebo group. Adverse events leading to trial product discontinuation occurred in five (3%) of 199 participants in the semaglutide 2·4 mg group, three (3%) of 100 participants in the semaglutide 1·7 mg group, and one (1%) of 101 participants in the placebo group. Adults from east Asia with obesity, with or without type 2 diabetes, given semaglutide 2·4 mg once a week had superior and clinically meaningful reductions in bodyweight, and greater reductions in abdominal visceral fat area compared with placebo, representing a promising treatment option for weight management in this population. Novo Nordisk. For the Korean and Japanese translations of the abstract see Supplementary Materials section.

Semaglutide for Weight Loss: Was It Worth the Weight?

Obesity is a major public health issue with an increasing prevalence worldwide. Excess body fat is associated with various comorbidities, as well as increased overall mortality risk. The benefits of weight loss are evident by the reductions in morbidity and mortality. The foundation for most weight loss programs involves strict lifestyle modification, including dietary change and exercise. Unfortunately, many individuals struggle with weight loss and chronic weight management due to difficulty adhering to long-term lifestyle modification and the metabolic adaptations that promote weight regain. The use of adjunctive pharmacotherapy has been employed to help patients not only achieve greater weight loss than lifestyle modification alone but also to assist with long-term weight management. Historically, antiobesity drugs have produced only modest weight loss and required at least once daily administration. Glucagon-like peptide-1 (GLP-1), a hormone with significant effects on glycemic control and weight regulation, has been explored for use as adjunctive pharmacotherapy for weight loss. Semaglutide, a GLP-1 receptor agonist, was recently approved by the Food and Drug Administration for chronic weight management in adults with obesity or who are overweight. The approval came after the publication of the Semaglutide Treatment Effect in People with Obesity clinical trials. In these 68-week trials, semaglutide 2.4 mg was associated with significantly greater weight loss compared to placebo. Semaglutide differs from other GLP-1 receptor agonists by having a longer half-life and producing greater weight loss. This article provides an overview of the discovery and mechanism of action of semaglutide 2.4 mg, and the clinical trials that led to its approval.

Integration of Healthy Eating Habits and Physical Activity through Nutrition Care Process to Tackle the Obesity Epidemic: A Narrative Review of the Evidence

Background: Obesity is a rising global health problem which is already at epidemic proportions. Effective methods of treatment are required and should be imparted by efficient means to dietitians and other health professionals dealing with weight management. Research shows that behavioral modification techniques are the most effective way to achieve and maintain a healthy weight compared to diet and physical activity alone. &#x0D; Aim: This narrative review focusses on diet and physical activity behavioral modification techniques to promote effective weight management for sedentary and active adults using the Nutrition Care Process (NCP). &#x0D; Methods: PubMed, Scopus, Embase, Science Direct, Web of Science and Pro-Quest databases were searched for relevant articles. &#x0D; Results: A healthy eating habit is one of the contributing factors to improved health. Physical activities also help improve and maintain one’s health. This article discusses the importance of eating habits and physical activities among school students. In addition, health issues related to eating habits and the practice of physical activities are also highlighted. Overall, the results revealed that healthy eating habits and regular physical activities help in maintaining good health.&#x0D; Conclusion: NCP is a systematic approach to provide high-quality nutrition care. Using the NCP does not mean that all clients get the same care. Use of a care process provides a framework for the dietitian to individualize care, taking into account clients’ needs and values, and using the best evidence available to make decisions.&#x0D; Keywords: obesity, weight control, physical activity, nutrition knowledge, eating habits, nutrition care process

Using self-monitoring technology for nutritional counseling and weight management.

Self-monitoring of weight, dietary intake, and physical activity is a key strategy for weight management in adults with obesity. Despite research suggesting consistent associations between more frequent self-monitoring and greater success with weight regulation, adherence is often suboptimal and tends to decrease over time. New technologies such as smartphone applications, e-scales, and wearable devices can help eliminate some of the barriers individuals experience with traditional self-monitoring tools, and research has demonstrated that these tools may improve self-monitoring adherence. To improve the integration of these tools in clinical practice, the current narrative review introduces the various types of self-monitoring technologies, presents current evidence regarding their use for nutrition support and weight management, and provides guidance for optimal implementation. The review ends with a discussion of barriers to the implementation of these technologies and the role that they should optimally play in nutritional counseling and weight management. Although newer self-monitoring technologies may help improve adherence to self-monitoring, these tools should not be viewed as an intervention in and of themselves and are most efficacious when implemented with ongoing clinical support.

The effectiveness of acceptance and commitment therapy upon weight management and psychological well‐being of adults with overweight or obesity: A systematic review

Several studies have examined acceptance and commitment therapy's (ACT) effectiveness for addressing physical and psychological distress people with obesity can face. Nevertheless, no review focusing specifically on ACT analysing randomized controlled trials (RCT) has been done up to date in this field. The present systematic review was developed following the PRISMA statement and aimed to examine ACT's effects on weight management and psychological well-being of adults with overweight or obesity. A conjunction of keywords related to ACT and excess weight was searched in four databases (Medline, PubMed, Psycinfo and Scopus) for articles meeting inclusion criteria. The literature search yielded 2,074 papers, and 16 were included in the review, finally. In 71.43% of the studies, ACT was effective to enhance psychological well-being; in 50% effectively targeted process variables and health behaviours related to weight management; in 31.82% of studies, physical variables were improved; and 21.38% of studies showed evidence in favour of ACT for eating behaviour modification. The present review supports ACT for promoting emotional aspects of individuals immersed in such weight-related battles and highlights the benefits of psychological well-being-oriented ACT in the context of obesity treatment. More studies targeting psychological well-being primarily and with longer follow-ups are required.

Recent advances in therapies utilizing superabsorbent hydrogel technology for weight management: A review

Long‐term therapeutic benefit of treatments for weight management in patients with overweight (also termed preobesity) or obesity may be limited by variable safety, tolerability, and efficacy profiles, and patient adherence to treatment regimens. There is a medical need for nonsystemic treatments that promote weight loss in patients with overweight or early obesity. This report reviews four different approaches of utilizing superabsorbent hydrogel technology for weight management at varying stages of preclinical and clinical development. The first is a nonsystemic, oral superabsorbent hydrogel created from naturally derived building blocks used in foods (cellulose‐based), designed to mix homogenously with and change the properties of the ingested meal throughout the gastrointestinal tract (stomach and small intestine). This is the first‐in‐class to be cleared by the Food and Drug Administration (FDA) to aid in weight‐management for adults with BMI of 25–40 kg/m2 in conjunction with diet and exercise. In contrast, the other three approaches in development utilize superabsorbent hydrogel technologies to support an intragastric balloon‐like structure, solely occupying space in the stomach and displacing the meal: (1) a pufferfish‐inspired device; (2) Epitomee, a pH‐sensitive self‐expanding hydrogel device; and (3) a light‐degradable hydrogel used to control balloon deflation. These new approaches that utilize superabsorbent hydrogel technology offer a wide range of clinical applicability and have the potential to broaden the weight management treatment landscape. Over time, increasing the number of patients treated with superabsorbent hydrogel technologies will provide important information on long‐term efficacy and safety.

The association between binge eating disorder and weight management in overweight and obese adults: A systematic literature review.

Aim: Weight loss is shown to improve obesity-related health problems as long as it is maintained for a long term. The purpose of this systematic review was to investigate the association between binge eating disorder and weight management in overweight and obese adults. Methods: A systematic search following the preferred reporting items for systematic reviews and meta-analyses guidelines was conducted across PubMed, Ebsco and Cochrane Library from inception through December 2020 to identify studies that assessed the association between binge eating disorder and weight management (e.g., weight loss, weight gain and weight loss maintenance) in overweight and obese adults. We included studies that examined adults (≥18 years old) being overweight and obese with and without binge eating behaviour. Two authors independently screened and evaluated studies for methodological quality. Results: Nine articles were selected, including 3685 participants. Three of the included studies were randomised control trials and the remaining were observational studies. The majority of the studies included support that people who have binge eating disorder may have an additional barrier maintaining their weight loss compared to people who do not suffer from binge eating disorder. Conclusion: Our systematic review revealed that binge eating disorder may have a negative association with weight loss maintenance. Further well-conducted prospective cohort studies and randomised clinical trials are required to investigate the possible mechanisms and whether any such mechanisms are modifiable. These will lead us to more efficient strategies targeting weight management.

Are Dietary Proteins the Key to Successful Body Weight Management? A Systematic Review and Meta-Analysis of Studies Assessing Body Weight Outcomes after Interventions with Increased Dietary Protein.

The primary aim was to systematically review the current evidence investigating if dietary interventions rich in protein lead to improved body weight management in adults with excessive body weight. The secondary aim was to investigate potential modifying effects of phenotyping. A systematic literature search in PubMed, Web of Science, and Cochrane Library identified 375 randomized controlled trials with 43 unique trials meeting the inclusion criteria. The Cochrane collaboration tool was used for a thorough risk of bias assessment. Based on 37 studies evaluating effects of dietary protein on body weight, the participants with increased protein intake (ranging from 18–59 energy percentage [E%]) were found to reduce body weight by 1.6 (1.2; 2.0) kg (mean [95% confidence interval]) compared to controls (isocaloric interventions with energy reduction introduced in certain studies). Individuals with prediabetes were found to benefit more from a diet high in protein compared to individuals with normoglycemia, as did individuals without the obesity risk allele (AA genotype) compared to individuals with the obesity risk alleles (AG and GG genotypes). Thus, diets rich in protein would seem to have a moderate beneficial effect on body weight management.

31-LB: Limited Physical Activity among Overweight and Obese Young Adults with Type 1 Diabetes: Results from Advancing Care for Type 1 Diabetes and Obesity Network (ACT1ON)

This pilot and feasibility study aimed to identify dietary strategies to optimize glycemic control and weight management in overweight or obese young adults with T1D. In a sequential multiple assignment randomized trial, participants were randomized to a hypocaloric low-carbohydrate (CHO; 20-25% CHO), hypocaloric moderately low fat (30% energy fat), or Mediterranean (not calorie restricted) diet, with advice to maintain usual physical activity (PA). PA data were collected in a convenience sample of participants from 06/20 to 02/21. Young adults with T1D (n=27, age 25±3 years, 78% female, A1c 7.3±1.2%, BMI 30.7±3.4) wore PA trackers for 2-week periods during diet assignments. Median (IQR) daily steps were 4,931 (3,443-7,363), 5,562 (4,191-9,931), 6,457 (4,394-9,655) for Low CHO, Look AHEAD, and Mediterranean diets, respectively and daily moderate-to-vigorous PA (MVPA) mins were 16 (4-31), 18 (5-31), and 22 (6-32), respectively. Daily steps, active time, or MVPA did not differ by diet (p>0.05). We demonstrate that in a pilot study emphasizing diet and weight loss in young adults with T1D, PA was often below the recommended target of 30 mins MVPA/day (or 150 mins/week). Thus, a larger, adaptive weight management intervention will need to incorporate diet as well as safe and effective PA strategies for overweight and obese young adults with T1D. Disclosure D. P. Zaharieva: None. D. M. Maahs: Advisory Panel; Self; Abbott Diabetes, Dompe, Eli Lilly and Company, Medtronic, Novo Nordisk, Consultant; Self; aditxt. For the act1on study: n/a. F. R. Muntis: None. N. Arrizon- ruiz: None. J. Thomas: None. E. J. Mayer-davis: None. A. Addala: None. M. A. Clements: Consultant; Self; Eli Lilly and Company, Employee; Self; Glooko, Inc., Research Support; Self; Abbott Diabetes, Dexcom, Inc. A. Kollu: None. M. Riddell: Advisory Panel; Self; Zealand Pharma A/S, Consultant; Self; Lilly Diabetes, Research Support; Self; Dexcom, Inc., Insulet Corporation, Speaker’s Bureau; Self; Novo Nordisk Inc., Sanofi, Stock/Shareholder; Self; Zucara Therapeutics Inc. Funding National Institute of Diabetes and Digestive and Kidney Diseases (1DP3DK113358)

Efficacy and Safety of Semaglutide 2.4 MG Once-Weekly in Adults With Overweight or Obesity and Type 2 Diabetes (STEP 2)

Background: In people with overweight/obesity and type 2 diabetes (T2D), achievement of weight loss can be a challenge. STEP 2 investigated the efficacy and safety of semaglutide 2.4 mg for weight management in adults with overweight/obesity and T2D. Methods: This randomized, double-blind, double-dummy, placebo-controlled, phase 3 trial was conducted at 149 sites across 12 countries (NCT03552757). Adults aged ≥18 years with body mass index (BMI) ≥27 kg/m2, T2D, HbA1c between 7–10% (53–86 mmol/mol), and receiving ≤3 oral glucose-lowering agents were randomized 1:1:1 to once-weekly subcutaneous (s.c.) semaglutide 2.4 mg or 1.0 mg, or placebo, as adjunct to a reduced-calorie diet and increased physical activity for 68 weeks. The co-primary endpoints were percentage change in body weight and proportion of participants achieving weight loss ≥5% for semaglutide 2.4 mg vs placebo. Cardiovascular risk factors, glycemia and safety/tolerability were also assessed. Two estimands were defined: treatment policy and trial product; results are presented for the treatment policy estimand, unless stated otherwise. Results: 1,210 participants (mean: age 55 years, body weight 99.8 kg, BMI 35.7 kg/m2, HbA1c 8.1%, diabetes duration 8.0 years; 50.9% female) were randomized. Mean body weight change from baseline to week 68 was −9.6% with semaglutide 2.4 mg vs −3.4% with placebo (estimated treatment difference [ETD]: −6.2%; 95% confidence interval [CI]: −7.3, −5.2; p<0.0001) and −7.0% for semaglutide 1.0 mg (ETD for semaglutide 2.4 mg vs 1.0 mg: −2.7%; 95% CI: −3.7, −1.6; p<0.0001). Similar results were obtained with the trial product estimand: mean body weight change −10.6% for semaglutide 2.4 mg vs −3.1% for placebo (ETD: −7.6%; 95% CI: −8.6, −6.6; p<0.0001) and 7.6% for semaglutide 1.0 mg (ETD vs semaglutide 2.4 mg: −3.1%; 95% CI: −4.1, −2.1; p<0.0001). Participants on semaglutide 2.4 mg were more likely to achieve weight loss ≥5%, ≥10%, ≥15% and ≥20% vs placebo (68.8% vs 28.5%, 45.6% vs 8.2%, 25.8% vs 3.2% and 13.1% vs 1.6%, respectively; p value for odds ratios <0.0001 for all). Mean change in HbA1c from baseline to week 68 was −1.6% for semaglutide 2.4 mg vs −0.4% for placebo (p<0.0001). Greater improvements with semaglutide 2.4 mg vs placebo were also seen in waist circumference, BMI, systolic blood pressure, fasting plasma glucose, C-reactive protein, and lipids (HDL, VLDL, free fatty acids, and triglycerides) (p<0.05 for all). The most frequent adverse events were gastrointestinal disorders (typically transient and mild-to-moderate), occurring in 57.5%, 63.5% and 34.3% of participants receiving semaglutide 1.0 mg, 2.4 mg and placebo, respectively. Conclusion: Semaglutide 2.4 mg, as adjunct to lifestyle intervention, was efficacious and well tolerated for weight management in adults with overweight or obesity and T2D, providing significantly greater weight loss vs placebo and semaglutide 1.0 mg at week 68.

Efficacy and Safety of Once-Weekly Subcutaneous Semaglutide 2.4 MG in Adults With Overweight or Obesity (STEP 1)

Background: Despite the increasing global adverse health impact of obesity, there are few pharmacological options for effective weight management. STEP 1 investigated the efficacy and safety of the glucagon-like peptide-1 analogue, subcutaneous (s.c.) semaglutide, for weight management in adults with overweight or obesity. Methods: This randomized, double-blind, placebo-controlled, phase 3 trial was conducted at 129 sites across 16 countries (NCT03548935). Adults aged ≥18 years with either body mass index (BMI) ≥30 kg/m2 or BMI ≥27 kg/m2 with ≥1 weight-related comorbidity, without type 2 diabetes, were randomized 2:1 to 68 weeks’ treatment with once-weekly s.c. semaglutide 2.4 mg or placebo, both as adjunct to lifestyle intervention. The co-primary endpoints were percentage change in body weight and achievement of weight loss ≥5%. Cardiometabolic risk factors, patient-reported outcomes, and safety/tolerability were also assessed. Two estimands were defined: treatment policy (effect regardless of treatment adherence and use of rescue intervention) and trial product (effect assuming treatment adherence and without rescue intervention); results are presented for the treatment policy estimand, unless stated otherwise. P values for parameters marked with # were not controlled for multiplicity. Results: 1961 randomized participants (mean age 46 years, body weight 105.3 kg, BMI 37.9 kg/m2; 74.1% female) were included. Mean body weight change from baseline to week 68 was −14.9% in the semaglutide group vs −2.4% with placebo (estimated treatment difference [ETD]: −12.4%; 95% confidence interval (CI): −13.4, −11.5; p<0.0001). Similar results were obtained with the trial product estimand: mean body weight change# was -16.9% for semaglutide vs -2.4% for placebo (ETD: -14.4%; 95% CI: -15.3, -13.6; p<0.0001). Participants were more likely to achieve weight loss ≥5%, ≥10%, ≥15%, and ≥20%# with semaglutide vs placebo (86.4% vs 31.5%, 69.1% vs 12.0%, 50.5% vs 4.9%, and 32.0% vs 1.7%, respectively; p<0.0001 for all). Greater improvements were seen with semaglutide vs placebo in waist circumference, BMI#, systolic and diastolic# blood pressure, glycated hemoglobin#, fasting plasma glucose#, C-reactive protein#, fasting lipid profile#, and self-reported physical functioning (p<0.05 for all). No new safety signals with semaglutide were observed. The most frequent adverse events with semaglutide were gastrointestinal disorders (typically transient and mild-to-moderate). Conclusion: In adults with overweight or obesity, once-weekly s.c. semaglutide 2.4 mg plus lifestyle intervention induced a mean weight loss of approximately 15% by week 68. Clinically beneficial weight loss of ≥10% was achieved by over two-thirds of participants and ≥20% by one-third of participants, along with associated improvements in cardiometabolic risk factors and physical functioning.

Semaglutide 2·4 mg once a week in adults with overweight or obesity, and type 2 diabetes (STEP 2): a randomised, double-blind, double-dummy, placebo-controlled, phase 3 trial

This trial assessed the efficacy and safety of the GLP-1 analogue once a week subcutaneous semaglutide 2·4 mg versus semaglutide 1·0 mg (the dose approved for diabetes treatment) and placebo for weight management in adults with overweight or obesity, and type 2 diabetes. This double-blind, double-dummy, phase 3, superiority study enrolled adults with a body-mass index of at least 27 kg/m2 and glycated haemoglobin 7-10% (53-86 mmol/mol) who had been diagnosed with type 2 diabetes at least 180 days before screening. Patients were recruited from 149 outpatient clinics in 12 countries across Europe, North America, South America, the Middle East, South Africa, and Asia. Patients were randomly allocated (1:1:1) via an interactive web-response system and stratified by background glucose-lowering medication and glycated haemoglobin, to subcutaneous injection of semaglutide 2·4 mg, or semaglutide 1·0 mg, or visually matching placebo, once a week for 68 weeks, plus a lifestyle intervention. Patients, investigators, and those assessing outcomes were masked to group assignment. Coprimary endpoints were percentage change in bodyweight and achievement of weight reduction of at least 5% at 68 weeks for semaglutide 2·4 mg versus placebo, assessed by intention to treat. Safety was assessed in all patients who received at least one dose of study drug. This study is registered with ClinicalTrials.gov, NCT03552757 and is closed to new participants. From June 4 to Nov 14, 2018, 1595 patients were screened, of whom 1210 were randomly assigned to semaglutide 2·4 mg (n=404), semaglutide 1·0 mg (n=403), or placebo (n=403) and included in the intention-to-treat analysis. Estimated change in mean bodyweight from baseline to week 68 was -9·6% (SE 0·4) with semaglutide 2·4 mg vs -3·4% (0·4) with placebo. Estimated treatment difference for semaglutide 2·4 mg versus placebo was -6·2 percentage points (95% CI -7·3 to -5·2; p<0·0001). At week 68, more patients on semaglutide 2·4 mg than on placebo achieved weight reductions of at least 5% (267 [68·8%] of 388 vs 107 [28·5%] of 376; odds ratio 4·88, 95% CI 3·58 to 6·64; p<0·0001). Adverse events were more frequent with semaglutide 2·4 mg (in 353 [87·6%] of 403 patients) and 1·0 mg (329 [81·8%] of 402) than with placebo (309 [76·9%] of 402). Gastrointestinal adverse events, which were mostly mild to moderate, were reported in 256 (63·5%) of 403 patients with semaglutide 2·4 mg, 231 (57·5%) of 402 with semaglutide 1·0 mg, and 138 (34·3%) of 402 with placebo. In adults with overweight or obesity, and type 2 diabetes, semaglutide 2·4 mg once a week achieved a superior and clinically meaningful decrease in bodyweight compared with placebo. Novo Nordisk.

Dyadic reports of weight control practices, sedentary behaviors, and family functioning and communication between adult weight management patients and their children.

BackgroundParents are increasingly pursuing weight loss in medical weight management programs, yet little is known about the presenting behaviors and practices of children who have parents initiating these programs.ObjectiveTo describe congruence in weight control practices, sedentary and screen time behaviors, and family functioning and communication between parents initiating a medical weight management program and their children (ages 7–18).MethodsTwenty‐three dyads were enrolled and had measured height/weight and research packets completed including perceived weight status, weight control practices, sedentary and screen‐time behaviors, and family functioning and communication. Paired t‐tests and intraclass correlations assessed congruence; independent t‐tests determined differences based on child demographics (age, sex, and weight status).ResultsParents underestimated children's use of weight control practices compared to child reports. Children with overweight, males, and older in age had increased weight control practices and sedentary and screen‐time behaviors. Children who perceived themselves to have overweight reported more impaired family communication than children perceived to be a healthy weight.ConclusionsThis study highlights the discrepancy between dyads' reports of children's behaviors, and identifies that specific child populations with overweight, older in age, and males are at‐risk of experiencing less healthy behaviors and impaired family communication. Future research should monitor changes over time in parental weight management programs to determine effects based on parental weight loss.

Effectiveness of companion-intensive multi-aspect weight management in Chinese adults with obesity: a 6-month multicenter randomized clinical trial

BackgroundObesity is a globally increasing health epidemic requiring early lifestyle intervention. Our main objective was to examine the effectiveness of companion-intensive multi-aspect weight management (CIMWM) in Chinese adults with obesity.MethodsIn this 6-month, prospective, open-label, multicenter, randomized controlled clinical trial, we recruited 272 obese adults aged 18–50 years with a body mass index (BMI) ≥ 28.0 kg/m2 and capable of using smartphones. CIMWM (n = 136) offered both daily online instructions and monthly face-to-face guidance by physicians, dietitians, and health managers along with the provision of meal replacements in the first 3 months. Traditional multi-aspect weight management (TMWM, n = 136) provided monthly face-to-face guidance by the same panel of professionals and the same meal replacements as CIMWM group, but required subjects to complete daily self-monitoring instead of offering daily online instructions. Body composition and metabolic parameters were assessed at baseline, 1, 2, 3, and 6 months by physicians. The primary outcomes were clinically-significant weight loss and changes in BMI and body composition.ResultsParticipants in both groups showed significantly reduced BMI, body fat mass (BFM), visceral fat area (VFA), and HOMA-IR (p < 0.05). CIMWM was shown to be superior to TMWM in the improvement of clinically-significant weight loss, BMI, total cholesterol (TC), the body composition parameters BFM and the skeletal muscle mass-to-visceral fat area ratio (S/V) (p < 0.05). The non-alcoholic fatty liver disease score (NFS) was negatively related to S/V at baseline. After weight management, NFS was lowered among individuals with levels in the highest tertile (p < 0.05). Metabolic memory in terms of the continuous reduction of BMI, BFM, and TC was retained up to 6 months in spite of participants transferring to self-monitoring assessment in the final 3 months.ConclusionsThe CIMWM strategy in obese Chinese adults is proved to be more effective than TMWM in weight loss, and motivates greater adherence to intervention and lifestyle reprogramming.Trial registration Chinese Clinical Trial Registry, ChiCTR1800017463, Registered July 31, 2018. http://www.chictr.org.cn/showproj.aspx?proj=29649.