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NCT ID: NCT06468748 Not yet recruiting - Obesity Clinical Trials

The Effects of Semaglutide on Body Composition and Performance in Military Personnel

Start date: June 2024
Phase: Phase 4
Study type: Interventional

The obesity epidemic presents a growing concern in the United States, affecting more than 42% of adults. This epidemic extends its impact to chronic diseases and escalating healthcare expenses. Its reach has even influenced the military, with more than 20% of Soldiers being classified as obese, based on Body Mass Index ≥30 kg/m2. Current preventative and countermeasures have produced limited success, prompting consideration of pharmacotherapy. Within this context, glucagon-like peptide-1 receptor agonists (GLP-1RAs), such as semaglutide, have emerged as a promising treatment for obesity. Semaglutide can induce significant weight loss, primarily through fat reduction. However, questions persist regarding its effects on lean mass, physical performance, bone structure, and how it influences the underlying metabolic and hormonal milieu. Furthermore, no studies have been completed in military personnel, who must exercise regularly. Therefore, the investigators will conduct a single-center, open-label, observational trial. The trial will consist of a 24-week semaglutide treatment period and a non-treated 52-week follow-up period. We will test the feasibility and potential benefits of semaglutide in military populations, with a focus on understanding how semaglutide influences body composition, physical performance, hormones, and metabolism. This research holds military significance as obesity rates among service members continue to rise, undermining their medical readiness. Ultimately, it is important to understand if GLP-1RAs can provide a viable solution to obesity in military personnel and if there might be an unexpected effect on physical readiness due to the nature of the weight loss. This could cut down on healthcare expenses by reducing the reliance on weight-related initiatives and, consequently, lowering military separations.

NCT ID: NCT06466161 Not yet recruiting - Obesity Clinical Trials

Conical Forearm and Cylindrical Upper Arm Non-Invasive Blood Pressure (NIBP) Measurements in Pregnant Patients

Start date: August 1, 2024
Phase: N/A
Study type: Interventional

The diagnosis of hypertensive disease during pregnancy is predicated on strict blood pressure thresholds: 140/90 on at least two occasions measured four hours apart for both gestational hypertension and preeclampsia. An improvement in diagnostic accuracy of even 5mm Hg would be significant, as reflected by the US Association for the Advancement of Medical Instrumentation (AAMI), the British Hypertension Society, the European Society of Hypertension (ESH) Working Group on Blood Pressure (BP) Monitoring, and the International Organization for Standardization (ISO)consensus for validation of non-invasive blood pressure (NIBP) devices during pregnancy. Given the known inaccuracies of upper arm cylindrical cuff measurements in morbidly obese patients, a conical cuff which provides more accurate measurements will translate into direct patient benefit via more informed diagnosis and management. Fewer women may be exposed to unnecessary treatment, preterm delivery, and/or cesarean section. Recognizing the increasing prevalence of morbid obesity and hypertensive disease amongst pregnant women in the United States, the identification of a more accurate non-invasive cuff is desperately needed. Increasing the accuracy of NIBP measurements on Labor and Delivery has the potential to directly impact the management of tens of thousands of morbidly obese pregnant women diagnosed with hypertensive disease in the United States every year. Establishing the level of agreement between conical forearm and cylindrical upper arm cuffs will shed light on the presence and magnitude of any disparity between measurement methods. STUDY ENDPOINTS: Primary Outcome Measures: - Agreement between conical and cylindrical cuff systolic blood pressure across groups - Agreement between conical and cylindrical cuff diastolic blood pressure across groups Secondary Outcome Measures: • Agreement between conical and cylindrical cuff mean arterial pressure

NCT ID: NCT06464497 Not yet recruiting - Obesity, Childhood Clinical Trials

Whole Foods for Teens: A Pilot Dietary Intervention to Reduce Body Adiposity in Adolescents With Obesity

Start date: September 1, 2024
Phase: N/A
Study type: Interventional

This study will address the following aims: Aim 1: Conduct an 8-week pilot RCT to examine the effects of a whole foods diet intervention on body adiposity in adolescents with obesity. Aim 1a (Primary): Evaluate intervention effectiveness on total fat mass following the 8-week intervention. Hypothesis 1a: Adolescents randomized to the whole foods intervention will have lower total fat mass (kg) at the 8-week follow-up than those in the control group. Aim 1b: Evaluate intervention effectiveness on anthropometric changes following the 8-week intervention. Hypothesis 1b: Adolescents randomized to the whole foods intervention will have lower weight, BMI-z scores and/or waist circumference at the 8-week follow-up than those in the control group. Secondary Aims: Aim 2: Conduct an 8-week pilot RCT to examine the effects of a whole foods diet intervention on diet quality in adolescent and parent pairs during the study period. Hypothesis 2: Adolescents and parents randomized to the whole foods intervention will have higher diet quality scores at the 8-week follow-up than those in the control group. Aim 3: Conduct post-intervention family focus groups to identify how individual/family needs and preferences and social determinants of health (SDOH) may be perceived barriers and/or facilitators of diet adherence to a whole foods diet pattern.

NCT ID: NCT06463223 Not yet recruiting - Metabolic Disease Clinical Trials

HIBOC = Hepatic Imaging Biomarkers in Obese Children

Start date: October 2024
Phase:
Study type: Observational

The goal of this prospective, diagnostic observational study is to learn about how imaging based markers for components of liver disease appear in children with obesity. It aims to determine whether the imaging markers (ultrasound and MRI) for liver disease can be tools to improve diagnostics for liver affection in children with obesity and to ascertain how the markers are related to multiple clinical measures, for example BMI and serology measure, and treatment effects over time.

NCT ID: NCT06461273 Not yet recruiting - Obesity Clinical Trials

Food is Medicine vs Lifestyle Medicine For Cardiovascular Kidney Metabolic (CKM) Syndrome

FiLMED
Start date: August 1, 2024
Phase: N/A
Study type: Interventional

The investigators are piloting a 3 month community-based lifestyle medicine program that incorporates experiences and education in urban agriculture, nutrition, culinary arts, and physical fitness to test the hypothesis whether this improves clinical and socio-behavioral outcomes of participants with Cardiovascular Kidney Metabolic (CKM) syndrome (high blood pressure, diabetes, high cholesterol, heart disease, and obesity) in comparison to the current medical care model (usual care) or providing healthy produce (medically tailored groceries).

NCT ID: NCT06460272 Not yet recruiting - Obesity Clinical Trials

Nutrition Outreach and Understanding: Research In Serving Hearts Through Healthy Eating And Tailored Support

NOURISH HEARTS
Start date: June 19, 2024
Phase: N/A
Study type: Interventional

This study is a human-centered, three-arm, parallel-group, randomized control, implementation trial (n=75) to compare MTM (Medically Tailored Meals) only (14 meals delivered weekly for 10 weeks) vs. MTM + SMA (Shared Medical Appointments; once weekly sessions for 10 weeks) vs. a wait-list control group (MTM-Later) in patients with hypertension, type 2 diabetes, obesity, and/or metabolic syndrome. All intervention components will be culturally congruent (e.g., MTMs will include food that converges with culturally relevant diets and SMAs will be delivered by individuals with racial concordance to the target community). Primary outcomes will be implementation (recruitment and retention rates) and feasibility (engagement and satisfaction). Participants will be recruited from Cleveland Clinic's South Pointe Hospital in Warrensville Heights, a predominantly Black community with low socioeconomic status and high cardiovascular disease morbidity.

NCT ID: NCT06455995 Not yet recruiting - Obesity Clinical Trials

Daily Eating Patterns for Total Health Study

DEPTH
Start date: June 2024
Phase: N/A
Study type: Interventional

The goal of this randomized controlled trial is to learn how the time of day when calories are eaten affects weight loss in the long-term (12 months). The main aims are to learn: 1. The influence of time-based energy intake goals on longer-term weight loss. 2. The influence of time-based energy intake goals on eating temporal patterns, sleep regularity, and appetite regulation. Researchers will compare whether goals to eat most of a person's calories in the morning or evening work to treat obesity. Participants will: 1. Eat a reduced-calorie, low-fat diet (some participants will have goals to eat their calories at certain times of day based on their group) 2. Be physically active at least 200 minutes 3. Receive a cognitive behavioral intervention

NCT ID: NCT06454123 Not yet recruiting - Obesity Clinical Trials

Feasibility of a Digital Therapeutic for Adults With Binge Eating and Obesity

Start date: September 2024
Phase: N/A
Study type: Interventional

The primary objective of this study is to test the feasibility of a digital therapeutic to address comorbid binge eating and obesity in adults.

NCT ID: NCT06450847 Not yet recruiting - Obesity Clinical Trials

Effect of Soleus Muscle Push Ups on Oxidative Stress and Inflammatory Markers, Soleus Endurance, and Adipocytokines Between Type 2 Diabetic, Overweight/Obese and Normal Weight Individuals.

Start date: June 2024
Phase: N/A
Study type: Interventional

The study aims to investigate the impact of Soleus Push Ups (SPU) on Soleus Muscle endurance, Oxidative Stress Markers, Inflammatory markers and Adipocytokines among people in the United Arab Emirates. This will be a pre-post intervention study with participants divided into three groups: Lean normal metabolic profile, metabolically healthy overweight/obese, and patients with Type 2 Diabetes Mellitus. Assessment of anthropometry and body composition, Soleus Muscle Endurance, blood tests for Inflammatory Markers, Oxidative Stress Markers, and Adipocytokines will be conducted pre and post-intervention.

NCT ID: NCT06444464 Not yet recruiting - Clinical trials for Overweight and Obesity

The BEE-Power Study (Boosting Exercise for Excellent Pediatric Blood Pressure)

Start date: July 1, 2024
Phase: N/A
Study type: Interventional

The goal of this study is to compare two types of exercises, isometric exercise (like squats and planks) and aerobic exercise (such as running), to see which one is more effective at improving blood pressure in teenagers aged 13 to 17.5 years. The main question the study aims to answer is: - Do the effects of one session of isometric exercise on the blood pressure of adolescents compare to the effects of one session of aerobic exercise? Adolescents diagnosed with high blood pressure may qualify for this study. Participants will be randomly assigned to either a single session of isometric exercise or a single session of aerobic exercise. - Participants will attend 3 study visits in total. - Study visits should be completed within 4 weeks of enrollment. - At the initial visit, samples (example: blood) will be collected and body measurements will be taken. - Participants will be asked to answer questionnaires (diet, growth, and others) - At visit 2, participants will have their blood pressure measured using a 24 hour blood pressure monitor. - At visit 3, participants will participate in a single session of either aerobic or isometric exercise. They will wear a 24-hour blood pressure monitor immediately after the exercise session.