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Showing 1-20 of 27 trials
NCT07340580
A public health priority exists for the U.S. healthcare sector to integrate physical activity (PA) as a part of the patient care model. This research will provide valuable information on facilitating optimal implementation of a clinic-to-community model that identifies, refers, and enrolls physically inactive patients to community-based PA programs for the prevention and treatment of chronic diseases. Further, this work will provide evidence on the cost-effectiveness of integrating PA in healthcare systems as a population health management strategy.
NCT07049861
This project will compare two training approaches for US Preventive Services Task Force recommended obesity care in Federally Qualified Health Centers (FQHC) across four aims. Aim 1 compares patient-level effectiveness \[i.e., patient relative weight change and the proportion of patients who achieve clinically significant weight loss\]. Aim 2 compares reach (patient treatment utilization). Aim 3 compares primary care provider (PCP) referrals to USPSTF-recommended care at 12 (adoption) and 24 months (maintenance) and short- and long-term changes in provider obesity care competencies . Aim 4 compares implementation and service costs.
NCT06623669
The experience of chronic pain powerfully and negatively affects quality of life and functional independence in aging. Unfortunately, while as many as three in four older adults experience chronic pain, few have access to effective non-pharmacological pain management strategies. Participating in regular physical activity, avoiding sustained sitting, and maintaining a healthy weight are important and interrelated lifestyle inputs to chronic pain, and socially rich behavioral interventions informed by contemporary theories of behavior change appear important for engaging in activity and healthy eating in the long term. Our group has demonstrated in a series of Stage I trials that a group-mediated behavioral intervention combining dietary behavior change and a physical activity program focused on moving often throughout the day contributes to meaningful weight loss, and lasting weight maintenance, with pilot data suggesting this may contribute to improved pain, physical function, and health-related quality of life among older adults with chronic pain. As these were NIH Stage I trials, there are several important gaps to be addressed in the present trial: (1) both studies of chronic pain recruited small samples and were 12 weeks in duration, limiting our ability to establish efficacy and the durability of changes to activity, HRQOL, and pain outcomes; (2) participants included anyone with chronic pain, regardless of pain type, a likely contributor to heterogeneous pain intensity and interference findings; and (3) the investigators have yet to examine behavioral maintenance. The overarching goal of the proposed Stage II "mobile intervention to reduce pain and improve health-III (MORPH-III)" is to establish the efficacy of the intervention for enhancing physical activity via steps (primary), and for reducing pain interference and body weight while enhancing physical function (secondary) among older adults with chronic knee or hip osteoarthritic (OA) pain. The investigators will recruit 200 older adults with knee or hip osteoarthritic pain to engage in a 6-month remotely delivered intervention comprising weekly group or individual intervention meetings plus brief individual goal-setting coaching calls. This will be followed by a 12-month no-contact maintenance period, where participants will attempt to sustain behavioral goals on their own. The Specific Aims are: Specific Aim 1: To examine the impact of MORPH on ActivPAL-assessed daily steps relative to an enhanced usual care control. Hypotheses: MORPH will significantly increase steps relative to control at month 6. Specific Aim 2: To examine the impact of MORPH on pain interference, change in body weight, and physical function relative to the enhanced usual care control. Hypotheses: MORPH will result in significant reductions in pain interference and body weight and improvement in physical function relative to control at month 6. Exploratory Aims: Aim 1: To investigate the impact of the MORPH intervention on steps, weight change, pain interference, and physical function at month 18. Aim 2: If the MORPH intervention results in reduced pain interference at 6 and/or 18 months, the investigators will examine the extent to which 6-month change in steps, weight, pain self-efficacy, and catastrophizing mediate change in interference at 6 and/or 18 months.
NCT07012226
Total RNA is extracted from isolated white blood cells, and cDNA is synthesized from these samples. Subsequently, the expression levels of the SIRT1 and leptin receptor genes are determined through quantitative PCR.
NCT06976307
This is a sub-study to NCT04745572 to include a new cohort of participants with disabilities. This 16-week study will use an experimental approach called the Sequential Multiple Assignment Randomized Trial to help determine which combination and sequence of weight loss program features are most effective in people who are at risk for type 2 diabetes. Participants in the study will be initially randomized to consume either a high or reduced carbohydrate diet. After 4 weeks, participants will be identified as Responders (greater than or equal to 2.5% weight loss) or Non-Responders (less than 2.5% weight loss). Responders will continue with their initial randomized group for the remainder of the trial. Non-responders will be re-randomized to 2nd stage interventions of either including additional exercise counseling and training or beginning a time restricted eating protocol for the remainder of the trial.
NCT06935838
This is a prospective cohort study of 12 overweight (with one or more weight-related condition) or obese adults with well controlled HIV-1 on antiretroviral therapy (ART). An initial dose of tirzepatide (TZP) 2.5 mg subcutaneous (SQ) once weekly will be given, escalated by 2.5 mg at 4-week intervals to a final dose of 7.5mg. The investigators will collect the following information via review of the medical record: age, race/ethnicity, sex, medical conditions, medications, most recent standard of care HIV labs (including T-cell panel and HIV-1 viral load). The primary outcome will be the change in baseline body weight at 12 weeks. Secondary outcomes will be changes in body composition, liver fat content and liver stiffness, inflammatory markers, cardiometabolic markers (lipids and HbA1c), and monocytes at 12 weeks. There will be a 4-week safety follow up off TZP.
NCT06845943
This is a first-in-human study evaluating the safety, tolerability, pharmacokinetics, immunogenicity and pharmacodynamics of single and multiple doses of HCR-188 administered as subcutaneous injection(s).
NCT06588218
The goal of this clinical trial is to evaluate the effect of daily fresh watermelon consumption for 6-weeks on gut health, including microbiome diversity, gut barrier and immune function in young adults with overweight and obesity. The main questions it aims to answer are: 1. Will consuming fresh watermelon daily for 6-weeks will improve intestinal barrier health and increase microbiome diversity such as an increased population of beneficial 'probiotic' bacteria when compared to control participants consuming a low-fat snack? 2. Will consuming fresh watermelon daily for six-weeks will improve other health measures, including body-composition, blood pressure, blood vessel function, blood lipid profiles, and measures of inflammation, as compared to control participants consuming a low-fat snack for the same time period?
NCT06847399
The purpose of this study is to assess the efficacy and safety of tirzepatide in adults with obesity and binge-eating disorder, comparing tirzepatide against placebo and lisdexamfetamine dimesylate. All participants will receive guided self-help cognitive behavioral therapy.
NCT06773299
The purpose of the ENHANCE-CVH study is to promote intergenerational cardiovascular health (CVH) of women and children in Abuja and the surrounding Federal Capital Territory of Nigeria. The study team plans to achieve this through an adaptation of an existing evidence based intervention - Parents as Teachers (PAT) curriculum + Healthy Eating Active Living Taught at Home (HEALTH) - among pregnant women with obesity and their children in Nigeria. The aim of the study is to evaluate the effectiveness and implementation of community health educator-led delivery of the PAT+HEALTH intervention via home visits to answer the following main questions: * Will the women participating in the intervention have a greater change in weight from baseline to 18-month follow up compared to the women who do not? * Will the women and children in the intervention group display better CVH promoting lifestyle behaviors compared to those in the control group? Participants in the study will complete baseline surveys and have clinical data, lab data, and body measurements captured. Participants will also have these procedures repeated at birth and every 6 months up to 24 months post-delivery. Once randomized to the intervention group, participants will complete 40 biweekly PAT+HEALTH curriculum delivery sessions, each lasting approximately 60-90 minutes.
NCT07026903
The goal of this randomized control study is to learn if continuous glucose monitoring (CGM) can aid in weight loss in overweight/obese women with no other chronic condition. The primary hypothesis is that insights from CGM aid in greater weight loss, and the secondary hypothesis is that the use of CGM reduces the dropout rate from a three-month exercise program. Research will compare the results of weight loss after inclusion into 3 month physical exercise and diet counselling program between experimental group (women assigned to wear CGM) and control group (women without CGM). All participants will be included in the same physical exercise program with a fitness coach (3 times weekly for 60 minutes per sessions, three different resistance trainings), and will be given a calorie-controlled diet based on a weekly menu.
NCT06673433
The present study was designed to include obese patients diagnosed with obesity in the First Affiliated Hospital of Chongqing Medical University and a healthy control population. By analysing the relationship between metabolic parameters and macrogenomes in obesity, identifying key metabolic and macrogenomic differences between obese patients and healthy populations, and establishing the association between environmental factors and obesity-related metabolic disorders, the investigators will be able to provide new biomarkers and intervention targets for obesity prevention and treatment.
NCT06992349
Dysmenorrhea is the most common health problem in women in the reproductive age(Bakhsh et al., 2022). The primary dysmenorrhea starts shortly after the menarche the pain lasting 1 to 3 days that start just before or at the onset of menstruation with the absence of other gynecological symptoms (Itani et al., 2022). Primary dysmenorrhea can reduce the quality of life and social activities of women(Esan et al., 2024). There is a relationship between body mass composition and primary dysmenorrhea and as the value of body mass index and body fat percentages goes on increasing in females, the severity of primary dysmenorrhea also increased (Wu et al., 2022). BIOPTRON® Light therapy system is a device that contains an optical unit. This unit emits light with an electromagnetic spectrum produced by the sun, but without the ultraviolet rays and it is significant with four main characteristics which are Polarization, Polychromatic, Incoherence and low energy light (Raeissadat et al., 2014). The Purpose of the Study The aim of the study is to investigate the effect of bioptron© light therapy on primary dysmenorrhoea outcomes as pain and quality of life among obese adolescence.
NCT06968728
The primary aim of the NNF study is to investigate both cross-sectional and longitudinal associations between sleep patterns-measured over two consecutive weeks at baseline and again one year later-and indicators of glycemic control and brain health in a cohort of middle-aged adults. Through this effort, the investigators hope to identify potential sleep-related biomarkers and behavioral targets for early intervention to support metabolic and cognitive health.
NCT06935513
The purpose of this study is to evaluate the control effect of smart wearable devices on key risk factors in the high-risk populations for stroke
NCT06845033
The naturally occurring peptide hormone liver-expressed antimicrobial peptide 2 (LEAP2) in an antagonist/inverse agonist towards the ghrelin receptor. Ghrelin administration has previously been shown to increase food cue reactivity in brain regions related to appetite and reward using functional MRI scans. The aim of this clinical study is to investigate the effects of LEAP2 infusion on food cue reactivity in brain regions related to appetite and reward. Since LEAP2 is an antagonist/inverse agonist towards the ghrelin receptor we hypothesize, that LEAP2 infusion will decrease food cue reactivity in the above-mentioned regions compared to placebo infusion. Participants with obesity (BMI 30-50 kg/m2) will be included and complete two experimental days with either LEAP2 or placebo infusion in a randomized crossover manner. On experimental days, participants will undergo a MRI scan with functional and anatomical modalities. The study will attribute to gain a deeper understanding of the ghrelin system and its interaction with appetite regulation.
NCT06722443
Obesity is one of the most severe and prevalent non-communicable diseases worldwide, affecting an estimated one-third of the population in Spain. It is a multifactorial disease that, in extreme cases such as morbid obesity, can become highly disabling and is associated with significant morbidity and mortality. This is because it serves as a risk factor for numerous chronic diseases, including metabolic conditions (type 2 diabetes mellitus), cardiovascular diseases (hypertension, atherosclerosis, etc.), and even cancer. The exact etiopathogenic mechanisms are not fully understood, but subclinical inflammation is considered to form the basis of the metabolic (diabetes) and cardiovascular (endothelial dysfunction, dyslipidemia, etc.) disturbances that almost invariably accompany obesity. Additionally, alterations in the composition of the gut microbiota, or dysbiosis, are now recognized as playing a key role in the pathogenesis of obesity. This makes the gut microbiota a highly attractive therapeutic target for both the prevention and treatment of obesity, including less severe forms and morbid obesity. In this context, the use of probiotics or extracts with prebiotic properties represents a particularly interesting strategy against obesity, offering a combination of efficacy and safety for treating these patients. Consequently, the general objective is proposed to evaluate the impact of dietary interventions aimed at modulating dysbiosis through the administration of a probiotic (Lactobacillus fermentum CECT5716), a standardized olive leaf extract with prebiotic properties, or a synbiotic (a combination of the olive leaf extract and L. fermentum CECT5716) on the clinical response of patients with moderate or morbid obesity. This will include determining its relationship with the immuno-metabolic system and the characteristic cardiovascular complications of obesity. Furthermore, the evaluation of these treatments in experimental models of obesity, including morbid obesity requiring surgery, is also proposed. These models will include trials involving fecal material transfer into germ-free mice. These results will add significant value to the project by advancing our understanding of the underlying mechanisms of the disease. This will aid in the establishment of new diagnostic, prognostic, and therapeutic biomarkers, which are of great interest in reducing the incidence and prevalence of this current obesity epidemic. The estimated duration for completing the project is 12 months, with its conclusion anticipated by March 2024.
NCT06856291
Incretin mimetics are widely used pharmacological treatments for weight loss, known for their high efficacy and favorable safety profile. As the most commonly prescribed drug in this class, semaglutide is effective in both diabetic and non-diabetic individuals. However, treatment responses vary significantly, with non-diabetic individuals typically experiencing better weight loss outcomes. Despite this, up to 10% of non-diabetic individuals show little or no response to treatment, and the reasons for this variability remain unclear. The TRIM-IR study aims to investigate the role of insulin resistance (IR) in weight loss outcomes among non-diabetic obese individuals receiving semaglutide. This single-center, observational study will assess the impact of IR on weight loss, body composition, and adipose tissue function during the first 16 weeks of semaglutide therapy. The study will also explore molecular markers of adipose tissue dysfunction, focusing on the transition from dysfunctional to healthy adipose tissue. The investigators hypothesize, that individuals with lower IR will experience greater weight loss than those with higher IR, and that the glucose infusion rate (GIR) during hyperinsulinemic euglycemic clamp testing will correlate with weight loss variability. Secondary objectives include comparing changes in fat and lean mass, reductions in visceral fat, and improvements in adipose tissue function before and after 16 weeks of treatment. Exploratory analyses will assess adipocyte subpopulations and their response to insulin sensitivity changes. A total of 40 participants, equally distributed by gender, will be enrolled to ensure statistical power for detecting clinically relevant differences. The study aims to optimize semaglutide use for personalized obesity treatment and provide insights into the relationship between obesity, insulin resistance, and adipose tissue plasticity, with implications for improving obesity management and cardiovascular health outcomes.
NCT06882200
The goal of this clinical trial is to learn if a combined minfulness-diving program has an impact on emotional eating in adults with obesity. The main questions it aims to answer are: Does the BathysMed protocol have an impact on emotional eating after the 2 months diving protocol? Researchers will compare the diving program to a control group of adult patients with obesity. Participants will be asked to participate in the combined mindfulness-diving protocol for 2 months, and complete the questionnaires at baseline, 2, 5, and 8 months follow up.
NCT06874270
This study aims to develop a simple, clinically applicable method for metabolic phenotyping to personalize obesity therapy in morbidly obese individuals. The underlying concept is that the way a person's resting metabolic rate (RMR) responds to a 24-hour fast can help distinguish between two metabolic phenotypes. Individuals with a "thrifty" metabolism show a significant drop in RMR during fasting, which may make them less responsive to conventional weight loss interventions. In contrast, those with a "spendthrift" metabolism exhibit little to no drop-or even a slight increase-in RMR, suggesting they may lose weight more readily. The trial is designed as a prospective, single-center, longitudinal cohort study involving 20 morbidly obese patients (BMI \>40 kg/m²) who are already participating in a multimodal obesity therapy program. The study is divided into three phases. In the baseline phase, participants undergo comprehensive screening, which includes physical examinations, blood tests, and body composition assessments. RMR is measured using indirect calorimetry both before and after a 24-hour fasting period, and a device (Lumen™) is used to assess whether the body is primarily burning carbohydrates or fats. After the fasting measurements, participants perform a low-protein meal test by consuming a specially calibrated chocolate beverage. Their RMR is then monitored at several time points to determine the energy required for digestion. Following this, the study moves into the very-low-calorie diet (VLCD) phase, where participants consume approximately 800 kcal per day using formula meals tailored to meet their nutritional needs despite the calorie restriction. During this 12-week phase, changes in body weight, composition, and metabolic parameters are closely monitored. The final phase of the study is a 12-week weight maintenance period, during which the focus is on sustaining the achieved weight loss. In addition to RMR and dietary assessments, advanced techniques such as metabolomics are employed. Blood, urine, and saliva samples are collected to analyze metabolic profiles and identify potential hormonal biomarkers-such as leptin, FGF21, and adrenaline-that could further differentiate the "thrifty" and "spendthrift" phenotypes. Body composition is also assessed using methods like bioimpedance analysis (BIA), quantitative magnetic resonance imaging (qMR), and air displacement plethysmography (BodPod). By correlating the changes in RMR with metabolic and hormonal markers, the study tests the hypothesis that individuals with a marked RMR decrease during fasting (the "thrifty" phenotype) may experience less weight loss during a hypocaloric diet compared to those with minimal RMR change (the "spendthrift" phenotype). If validated, this approach could allow clinicians to predict weight loss outcomes more accurately and tailor obesity treatments to the individual's unique metabolic profile.