View clinical trials related to Obesity.
Filter by:Obesity disproportionately impacts sexual minority women. Behavioral weight loss programs are the gold standard treatment for mild to moderate obesity. The investigators have developed an online behavioral weight loss program that is effective, low-cost, and highly scalable. However, existing research suggests that tailoring treatment to address 3 well-established weight loss barriers in sexual minority women will be critical for maximizing the relevance and efficacy of behavioral weight loss for this group. In the Preparation Phase of this K23, the investigators developed 3 novel treatment components targeting sexual minority women's weight loss barriers (i.e., minority stress, low social support, and negative body image), the investigators piloted the program among sexual minority women of higher weight, and the investigators conducted individual qualitative interviews to elicit feedback on the intervention's acceptability, cultural relevance, usability, and feasibility, and this feedback was used to refine the program. In the Optimization Phase of this K23 (the current phase), 88 women will receive 12 weeks of Rx Weight Loss and will be randomized to receive 0-3 tailored components in a full factorial design with 23 (8) distinct combinations of components. Novel components that increase mean weight loss (by ≥2%) or the proportion of women achieving clinically meaningful weight loss (by ≥10%) at 6 months will be retained in a finalized obesity treatment package that the investigators will evaluate in a future randomized controlled trial (RCT) (Evaluation Phase). The aims of this study are to: Aim 2A (Optimization): Use a factorial experiment to determine how 3 novel components impact mean weight loss and the proportion of women achieving a 5+% weight loss at 6 months. Aim 2B (Mediation): Clarify how tailored components impact weight loss by testing hypothesized mechanisms of action (i.e., coping with stress, perceived social support, weight and shape concerns). This project will tailor and optimize an evidence-based online behavioral obesity treatment to enhance weight loss outcomes in sexual minority women.
The study is a follow-up of a Randomized Controlled Trial (RCT) performed in 2007-10 - the "Lifestyle in Pregnancy" LiP study. The LiP study included 360 pregnant women with BMI ≥30 kg/m2 from Odense University Hospital and Aarhus University Hospital. The women were randomized to intervention with low-calorie diet and physical activity from gestational age 10-14 in pregnancy and until delivery - or to a standard care control group. The objective of the LiPO-Teen project is to perform a clinical follow-up study of the eligible 301 mothers who completed the trial until delivery with a liveborn child, and their 14 year-old offspring. The overall ambition is to understand whether lifestyle intervention in pregnancy prevents obesity and its complications across generations, with a specific focus on modifiable factors.
This study relates to men with hypogonadism, a condition describing a deficiency of androgens such as testosterone. Deficiency of these hormones occurs in men due to testicular (primary) or hypothalamic-pituitary (secondary) problems or may be observed in men undergoing androgen deprivation therapy for prostate cancer. Testosterone plays an important role in male sexual development and health, but also plays a key role in metabolism and energy balance. Men with testosterone deficiency have higher rates of metabolic dysfunction. This results in conditions such as obesity, nonalcoholic fatty liver disease, diabetes, and cardiovascular disease. Studies have confirmed that treating testosterone deficiency with testosterone can reduce the risk of some of these adverse metabolic outcomes, however cardiovascular mortality remains higher than the general population. We know that testosterone deficiency therefore causes metabolic dysfunction. However, research to date has not established the precise mechanisms behind this. In men with hypogonadism there is a loss of skeletal muscle bulk and function. Skeletal muscle is the site of many critical metabolic pathways; therefore it is likely that testosterone deficiency particularly impacts metabolic function at this site. Men with testosterone deficiency also have excess fat tissue, this can result in increased conversion of circulating hormones to a type of hormone which further suppresses production of testosterone. The mechanism of metabolic dysfunction in men with hypogonadism is therefore multifactorial. The purpose of this study is to dissect the complex mechanisms linking obesity, androgens and metabolic function in men. Firstly, we will carry out a series of detailed metabolic studies in men with testosterone deficiency, compared to healthy age- and BMI-matched men. Secondly, we will perform repeat metabolic assessment of hypogonadal men 6 months after replacement of testosterone in order to understand the impact of androgen replacement on metabolism. Lastly, we will perform the same detailed metabolic assessment in men with prostate cancer before and after introduction of a drug which causes testosterone deficiency for therapeutic purposes.
Abstract Introduction: This pilot study will determine the recruitment feasibility, retention, and adhesion for a motivational interviewing program for weight loss in adults according to the processes of change in weight loss. Methods and Analysis: The single-arm pilot study will be a feasibility study of the Motivation to Lose Weight version 1 (MLW v.1). The study includes presential and online sessions. Participants will be recruited through advertisements on social media and selected according to the inclusion criteria. Participants will receive 8 sessions of approximately 30-45 minutes of motivational interviewing (MI) according to the processes of change in weight loss, as measured by the S-Weight scale. The results will be evaluated at the beginning and the end of the program, which will last 8 weeks. The primary outcome of the study is feasibility. The intervention will be feasible if adherence to the proposed activities in the sessions is greater than 70%, we can recruit 10 patients within 8 weeks, the proportion of interested people and registered participants is greater than 30%, and more than 75% of participants attend the final study visit. The secondary outcome is weight loss, fat mass percentage, muscle mass, waist and hip measurements, and the scores of behavioral scales. Ethics and discussion: The feasibility of this project consists of proposing an individualized intervention based on MI strategy(s) for each participant, according to the stage of readiness, and thus, help to evolve in the process of losing weight. This intervention aims to increase the participant's confidence level to implement actions that lead to the progression of behavior and, consequently, the action and maintenance of the lost weight. This study was approved by the Research Ethics Committee (REC) of the Hospital de Clínicas de Porto Alegre (HCPA) under number 20220209 CAAE 59573622300005327.
It is essential to delve deeper into the molecular and tissue aspects that allow us to recognize the roles of adipose tissue and its interaction with the musculoskeletal (i.e., adipomyokines) to facilitate the identification of biomarkers that can complement the assessment of body composition. Thus, investigators posed the following research question: what characteristics of adipose tissue can investigators consider to rethink assessment for the diagnosis and treatment of obesity? The 'Project ATA' is a cross-sectional study based on the Strengthening the Reporting of Observational Studies in Epidemiology-Nutritional Epidemiology (STROBE-nut) guidelines, an Extension of the STROBE Statement. The FINER strategy (Feasible, Interesting, Novel, Ethical, and Relevant) and previously published guidelines for organizing a multicenter study will be followed. The 'Project ATA' will test the associations of several morphological metrics and adipomyokines in order to both profile populations with excess body fat and to establish practical geographical-based recommendations for practitioners.
The purpose of this pilot study is to conduct a 12-week pilot feasibility study testing usability of a reinforcement learning model (AdaptRL) in a weight loss intervention (ADAPT study). Building upon a previous just-in-time adaptive intervention (JITAI), a reinforcement learning model will generate decision rules unique to each individual that are intended to improve the tailoring of brief intervention messages (e.g., what behavior to message about, what behavior change techniques to include), improve achievement of daily behavioral goals, and improve weight loss in a sample of 20 adults.
Weight loss is of paramount importance to ameliorate obesity-related complications. Endoscopic sleeve gastroplasty is a new therapeutic option to obtain significant weight reduction in obese patients. Nevertheless, a only a part of patients experience sufficient weight loss to improve comorbidities. A better understanding of mechanisms driving body weight trajectory after endoscopic sleeve gastroplasty may help patient selection and improve efficacy. The main aim of this study is to identify factors associated with weight reduction after endoscopic sleeve gastroplasty in patients with overweight or morbid obesity without indication to bariatric surgery. For this purpose, the investigators conduct a retro-prospective cohort study including patients with overweight or moderate obesity undergoing endoscopic sleeve gastroplasty between March 2017 and March 2023
This study investigates the safety and efficacy of sodium pentaborate pentahydrate in improving the body weight and glycemic profile of patients with overweight or obesity compared to the placebo group.
Diet interventions (e.g., low-energy diets) are recommended as a treatment for obesity, obese patients with osteoarthritis, hypertension (HTN), and type 2 diabetes (T2D). However, these diets are not a common part of the care plan partly because it is not financially feasible to discuss and offer them in medical offices reimbursed with the standard fee-for-service model. New reimbursement models, like value-based care (VBC), exist. It may be financially feasible to offer diet interventions, like premade and delivered meal plans to address these medical issues. This pilot study will help determine if a more extensive prospective study of the clinical effects of a delivered, premade low-energy diet (LED) on clinical markers of these disorders, as well as future cost-benefit analyses. Methods: A case series of five obese subjects with knee osteoarthritis, HTN, and T2D receive a LED for 12 weeks. The primary outcome is the change in the Numeric Pain Rating Scale (NPRS) at 12 weeks. Secondary outcome measures include the change in other patient-reported outcomes between the start and end of the study, changes in weight, changes in measures of HTN and T2D, and the proportion of subjects using non-protocol interventions. Hypothesis: Subjects randomized to the diet intervention will demonstrate a clinically significant improvement in NRPS score (2 points), a clinically significant weight reduction (15%), a 50% improvement in systolic and diastolic blood pressure, 1.0% reduction in Hemoglobin A1C levels (HgA1C), and lower utilization of non-protocol treatments at 12 weeks.
This study will utilize a randomized control trial design, with participants randomly assigned to a theoretically-based culturally tailored intervention or standard of care group. Baseline (Week 0), 12-week, and 3-month follow-up (Week 24). Body composition and adherence will be tracked throughout the study. The exercise intervention will include a total body resistance training protocol and will take place at local fitness center. Participants will be randomized to either the theoretical-based culturally tailored intervention group or the standard exercise group in which each will be facilitated and supervised by a Black-trained research personnel following culturally tailored recommendations. All participants will attend a 10-week resistance training program twice per week for a total of 20 sessions from Weeks 2-11. Week 1 will be used to familiarize the participants with the resistance training exercises. Those randomized to the culturally tailored intervention group will receive health education, weekly text messages and self-regulatory strategies to overcome barriers to exercise. Participants will return for post testing at weeks 12 and 24.