Publications by authors named "Ronette L Kolotkin"

Aims: To summarize the effects of semaglutide 2.4 mg on weight-related quality of life (WRQOL) and health-related quality of life (HRQOL), focusing on the confirmatory secondary endpoint of physical functioning.

Materials And Methods: The STEP 1-4 Phase 3a, 68-week, double-blind, randomized controlled trials assessed the efficacy and safety of semaglutide 2.

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Purpose: Many patients seeking bariatric surgery experience reduced health-related quality of life (HRQOL). A simple clinical tool, the Patient-Reported Outcomes in Obesity (PROS), was developed to address patients' HRQOL concerns during clinical consultations and facilitate meaningful dialogue. The present study aims to explore its sensitivity to change.

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Background: Little is known about the comparative effects of various bariatric procedures on patient-reported outcomes. We aimed to compare 3-year effects of gastric bypass and sleeve gastrectomy on patient-reported outcome measures in patients with obesity and type 2 diabetes.

Methods: The Oseberg trial was a single-centre, parallel-group, randomised trial at Vestfold Hospital Trust, a public tertiary obesity centre in Tønsberg, Norway.

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We assessed the effect of semaglutide 2.4 and 1.7 mg versus placebo on weight-related quality of life (WRQOL) and health-related quality of life (HRQOL) in the STEP 6 trial.

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Introduction: Discussions of weight-management strategies between patients and healthcare providers can yield positive outcomes for people with overweight or obesity. Nonetheless, people with overweight or obesity encounter communication challenges and other barriers to pursuing effective weight-management strategies with their healthcare providers. The aim of this study was to develop a new self-completed assessment tool to initiate and facilitate conversations related to weight management between patients and healthcare providers.

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Background: Aerobic exercise is an important part of obesity treatment and may improve health-related quality of life (HRQOL). The objective of this study was to compare the effect of two different exercise programs on health-related quality of life in patients with severe obesity.

Methods: This was a single-center, open-label, randomized, parallel-group study comparing the effects of a 24-week moderate-intensity continuous training (MICT) program and a combined high-intensity interval training program with MICT (HIIT/MICT).

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Background/objectives: There is limited long-term data comparing the outcomes of sleeve gastrectomy (SG) and Roux-en-Y gastric bypass (RYGB) for severe obesity, both with respect to body weight, quality of life (QOL) and comorbidities. We aimed to determine 7-year trajectories of body mass index (BMI), QOL, obesity-related comorbidities, biomarkers of glucose and lipid metabolism, and early major complications after SG and RYGB.

Subjects/methods: Patients scheduled for bariatric surgery at two Norwegian hospitals, preferentially performing either SG or RYGB, were included consecutively from September 2011 to February 2015.

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The Norse Feedback (NF) is a questionnaire developed for patient-reported outcome monitoring with a clinical feedback system (PRO/CFS). As mental health is a concern after bariatric surgery, the use of the NF as part of PRO/CFS may be beneficial. The aim of this study is to test the reliability and validity of the NF in patients who have been accepted for or have undergone bariatric surgery.

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The Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) was developed to assess weight-related physical and psychosocial functioning in the context of clinical trials. Data from two pivotal trials of once-weekly subcutaneous semaglutide for the purpose of weight management (NCT03548935 and NCT03552757) were analysed to confirm the structure, reliability, validity, and responsiveness of the IWQOL-Lite-CT and evaluate the magnitude of meaningful within-patient change in patients with overweight or obesity, with and without type 2 diabetes. Factor analyses and inter-item correlations confirmed the IWQOL-Lite-CT structure and scoring algorithm.

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Background: Consultations before and after bariatric surgery should include structured assessments of patients' health-related quality of life (HRQOL) and mental health. One way to conduct this assessment is to implement patient-reported outcome monitoring with a clinical feedback system (PRO/CFS).

Aim: We will explore patients' and healthcare professionals' experiences when a PRO/CFS is an integrated part of bariatric surgery care.

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Background: Type 2 diabetes (T2DM) is associated with gastroesophageal reflux disease (GERD) in the general population, but the relationship between these conditions in candidates for bariatric surgery is uncertain. We compared the prevalence of GERD and the association between GERD symptoms and esophagitis among bariatric candidates with and without T2DM.

Methods: Cross-sectional study of baseline data from the Oseberg study in Norway.

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Objectives: Sleeve gastrectomy (SG) is the most frequently performed bariatric surgery procedure worldwide, but reports on long-term quality of life (QOL) outcomes are scarce. We investigated 5-year trajectories in QOL and their associations with weight loss after SG.

Design: A prospective cohort study.

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Introduction: Up to 30 % of patients undergoing bariatric surgery are dissatisfied with treatment outcomes in the long term. The aim of this study was to examine overall satisfaction with treatment 5 years after bariatric surgery and its association with body mass index (BMI) and health-related quality of life (HRQOL).

Methods: Patients were surveyed 5 years after bariatric surgery; 108 patients had duodenal switch (DS) and 153 patients had laparoscopic sleeve gastrectomy (LSG).

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Objective: To compare the effects of a 2-year camp-based immersion family treatment for obesity with an outpatient family-based treatment for obesity on health-related quality of life (HRQoL) in two generations.

Design: Randomised controlled trial.

Setting: Rehabilitation clinic, tertiary care hospital and primary care.

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Introduction: Bariatric surgery is increasingly recognised as an effective treatment option for subjects with type 2 diabetes and obesity; however, there is no conclusive evidence on the superiority of Roux-en-Y gastric bypass or sleeve gastrectomy. The Oseberg study was designed to compare the effects of gastric bypass and sleeve gastrectomy on remission of type 2 diabetes and β-cell function.

Methods And Analysis: Single-centre, randomised, triple-blinded, two-armed superiority trial carried out at the Morbid Obesity Centre at Vestfold Hospital Trust in Norway.

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: Our aim was to explore how differing attitudes, expectations, and experiences among people with obesity (PwO) and healthcare providers (HCPs) might have an impact on effectively implementing current obesity treatment guidelines. : Online surveys were conducted among 3,008 adult PwO (BMI≥30 by self-reported height and weight) and 606 HCPs. : PwO with weight loss ≥ 10% during the previous three years were more likely to have been diagnosed with obesity and to have discussed a weight loss plan with an HCP.

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The Impact of Weight on Quality of Life-Lite (IWQOL-Lite) is widely used in evaluations of weight-loss interventions, including pharmaceutical trials. Because this measure was developed using input from individuals undergoing intensive residential treatment, the IWQOL-Lite may include concepts not relevant to clinical trial populations and may be missing concepts that are relevant to these populations. An alternative version, the IWQOL-Lite Clinical Trials Version (IWQOL-Lite-CT), was developed and validated according to the US Food and Drug Administration's (FDA's) guidance on patient-reported outcomes.

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Patient-centred care is an essential component of high-quality health care, shown to improve clinical outcomes and patient satisfaction, and reduce costs. While there are several authoritative models of obesity pathophysiology and treatment algorithms, a truly patient-centred model is lacking. We describe the development of a patient-centric obesity model.

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Importance: Short-term improvements in sexual functioning are reported after bariatric surgery, but to our knowledge, little is known about the durability of these improvements.

Objective: To determine the percentage of adults with impairment in sexual functioning who experience durable improvements in sexual functioning after bariatric surgery and to identify factors associated with improvements.

Design, Setting, And Participants: The Longitudinal Assessment of Bariatric Surgery-2 is an observational cohort study conducted at 10 hospitals in 6 US clinical centers.

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Background: A person's confidence to control eating, eating self-efficacy (ESE), has been identified as a target for long-term weight management in nonsurgical weight loss interventions, but has to a limited extent been studied after bariatric surgery.

Objective: We investigated the association between ESE, weight loss, and obesity-specific quality of life (QOL) after sleeve gastrectomy (SG).

Setting: A single-center longitudinal study.

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We investigated whether a seven-month (November 2014 to June 2015), school-based cluster-randomized controlled physical activity intervention improved health-related quality of life (HRQoL) in 10-year old children. The participants ( = 1229) from 57 elementary schools in Sogn og Fjordane County, Norway, were cluster-randomized by school either to the intervention (I) or control (C) group. The planned intervention in the 28 I-schools was 300 min of physical activity per week, compared to 135 min in the 29C-schools.

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Background: Few prospective studies compare long-term health-related quality of life (HRQOL) outcomes between bariatric surgery patients and individuals with severe obesity who do not undergo bariatric surgery.

Objectives: This 12-year, prospective study evaluated the trajectory and durability of HRQOL changes in gastric bypass patients (surgery group; n = 418) and compared these changes to 2 nonsurgical groups. The nonsurgery group 1 (n = 417) sought but did not have surgery; nonsurgery group 2 (n = 321) had severe obesity but did not seek surgery.

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Objective: ACTION (Awareness, Care, and Treatment in Obesity maNagement) examined obesity-related perceptions, attitudes, and behaviors among people with obesity (PwO), health care providers (HCPs), and employer representatives (ERs).

Methods: A total of 3,008 adult PwO (BMI ≥ 30 by self-reported height and weight), 606 HCPs, and 153 ERs completed surveys in a cross-sectional design.

Results: Despite several weight loss (WL) attempts, only 23% of PwO reported 10% WL during the previous 3 years.

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Background: Few long-term or controlled studies of bariatric surgery have been conducted to date. We report the 12-year follow-up results of an observational, prospective study of Roux-en-Y gastric bypass that was conducted in the United States.

Methods: A total of 1156 patients with severe obesity comprised three groups: 418 patients who sought and underwent Roux-en-Y gastric bypass (surgery group), 417 patients who sought but did not undergo surgery (primarily for insurance reasons) (nonsurgery group 1), and 321 patients who did not seek surgery (nonsurgery group 2).

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