Weight Gain/Loss

Researchers are investigating whether a multifactorial lifestyle intervention involving a Mediterranean diet with reduced calories and increased physical activity can help middle-aged adults (30-50 years) with metabolic syndrome lose weight and maintain that weight loss over time. The study also aims to understand the social and demographic challenges people face in sticking to these healthy habits and to examine the lifestyle patterns of this group. Participants will be randomly assigned to one of two groups. One group will follow general lifestyle recommendations from primary healthcare providers, while the other will receive an intensive program that includes monthly individual and group sessions over 6 months to encourage a Mediterranean diet with 25% fewer calories and physical activity based on WHO guidelines. The goal for the intervention group is to reduce their initial weight by 5-10% within 6 months and maintain this loss after 12 months. Throughout the study, participants will undergo assessments including measurements of weight, waist size, blood sugar, triglycerides, and glycated hemoglobin to monitor changes in their health. Data on demographics, diet, clinical parameters, and laboratory tests will be collected. After the 6-month intervention, a follow-up at 12 months will evaluate how well participants maintain their lifestyle changes. The study emphasizes tracking adherence and identifying factors that help or hinder long-term weight loss maintenance.

Researchers are evaluating the effectiveness of a six-month virtually-delivered dietary education program called PEDALL to prevent overweight and obesity during maintenance chemotherapy in children and adolescents with acute lymphoblastic leukemia (ALL). The study focuses on English and Spanish speaking families and considers key genetic and sociodemographic risk factors that may affect weight gain during treatment. Participants will be randomly assigned to one of two groups: the PEDALL intervention group or the standard of care (SOC) group. The PEDALL group will receive 26 contact hours of specialized nutrition education through weekly one-hour virtual sessions over six months. The SOC group will receive printed educational materials and nutritional care according to their institution's usual practices. During the study, participants and their caregivers will engage in nutrition education and counseling sessions. Researchers will assess weight status, body mass index trajectories, lifestyle behaviors, and the influence of genetic and sociodemographic factors over time. The main goal is to prevent unhealthy weight gain during maintenance chemotherapy and improve long-term health outcomes for childhood ALL survivors. The study will last up to 3.5 years for primary outcomes, with additional follow-up extending to four years.

Researchers are investigating the relationship between obesity and type 2 diabetes, conditions influenced by both genetic and environmental factors. This study aims to better understand how different genetic variations affect gene expression in tissues involved in glucose and lipid metabolism, which may contribute to what is called "diabesity," a combined condition of diabetes and obesity. The study uses advanced genomic techniques and bioinformatics to analyze these factors in both humans and animal models. Participants in this observational study are grouped based on their body mass index (BMI) and diabetes or glucose intolerance status. Groups include individuals with BMI ≥ 35 kg/m2 with diabetes, glucose intolerance, or without diabetes, as well as those with BMI < 27 kg/m2 and BMI between 27 and 35 kg/m2 without diabetes. Samples are collected during abdominal surgeries such as bariatric surgery or cholecystectomy to study gene expression and metabolic pathways. During the study, researchers collect biological samples at baseline and follow participants over several years to assess changes in gene expression and insulin resistance. They also evaluate clinical and biological features before and after bariatric surgery at 1, 2, and 5 years. The primary measurement focuses on gene expression in tissues related to glucose metabolism. This long-term observation helps to understand the genetic and phenotypic factors influencing obesity and diabetes, with participation lasting up to 5 years.

Researchers are evaluating the safety, tolerability, and how the body processes Semaglutide Nasal Spray compared to a placebo and a known injection in adults who are overweight or obese. This Phase I clinical trial aims to better understand the effects of the nasal spray formulation of Semaglutide in this population. The study is sponsored by Shanghai World Leader Pharmaceutical Co., Ltd. and focuses on adults aged 18 to 65 years with specific body mass index ranges. Participants will receive either the Semaglutide Nasal Spray, placebo, or a Semaglutide injection (Wegovy®) in different randomized groups. The study involves a single-dose administration and includes several cohorts receiving various combinations of the nasal spray and placebo or the injection. Treatments are given once, and the study monitors the participants for up to 36 days after administration to assess drug levels and effects. During the study, participants will undergo various evaluations including blood tests, vital signs monitoring, physical examinations, electrocardiograms (ECGs), and urine analyses from Day 1 to Day 36. Researchers will measure how much of the drug reaches the blood, how long it stays, and any side effects that occur. Antibody levels against the drug will also be checked up to Day 29. Participants will be closely monitored for any safety concerns throughout the study period.

Researchers are evaluating enicepatide, a drug that acts on two receptors related to blood sugar and weight control, for its effects on weight management in people with obesity or overweight who also have Type 2 diabetes mellitus (T2DM). This Phase III study compares multiple doses of enicepatide to a placebo to assess both effectiveness and safety over a long period. Participants will be randomly assigned to one of four groups: three different dosing regimens of enicepatide or a placebo. Both enicepatide and placebo are given once weekly using an integrated drug-device combination product. The study uses a double-blind design, so neither participants nor researchers know who receives the active drug or placebo. Treatment lasts for 72 weeks, allowing detailed assessment of changes over time. Throughout the study, participants will regularly have their body weight measured to track percentage change from baseline, along with many other health indicators including blood sugar levels, cholesterol, blood pressure, and quality of life surveys. Safety will also be closely monitored through assessments of adverse events and specific health questionnaires. The total participation period extends through 72 weeks of treatment and follow-up to observe long-term effects.

Researchers are evaluating the effects of enicepatide, a dual GLP-1/GIP receptor agonist, for weight management in adults with obesity or overweight who do not have Type 2 diabetes. This Phase III trial aims to assess the safety and effectiveness of multiple doses of enicepatide compared with placebo, focusing on body weight changes and related health outcomes. The study is sponsored by Hoffmann-La Roche and targets participants with specific body mass index criteria and weight-related health conditions. Participants will be randomly assigned to one of four groups: three different dosing regimens of enicepatide or a placebo. Both enicepatide and placebo are given once weekly using an integrated drug-device combination product. The treatment period lasts 72 weeks, during which the participants receive regular doses as per their assigned group. Throughout the study, participants will be monitored for changes in body weight, waist circumference, blood sugar levels, cholesterol, blood pressure, and quality of life measures. Assessments include physical exams, questionnaires, and imaging such as MRI to measure body composition. Safety is closely tracked through adverse event reporting and mental health assessments. The total participation duration extends through the 72-week treatment and evaluation period, with detailed follow-up on various health indicators.

Researchers are evaluating two approaches to increase fruit consumption among students in Swedish schools. The study is part of a Europe-wide project aiming to promote healthier eating habits and prevent childhood obesity by improving fruit availability in school settings. It compares providing free fruit stands alone versus fruit stands combined with a health-awareness campaign to see which better supports healthy eating. Participating schools are randomly assigned to either have fruit stands offering two types of fruit during school hours or fruit stands plus an educational campaign promoting healthy eating. Digital scales in the fruit stands monitor fruit uptake, while school staff record these measurements. Students use a mobile app to photograph and log all their meals and snacks before, during, and after the intervention to track fruit intake and eating patterns. Students contribute data during three periods: before the fruit stands are introduced, immediately after their introduction, and after the intervention ends to assess lasting effects. Researchers analyze changes in fruit consumption and eating behaviors, as well as monitor food waste using weight-based digital tracking. The study aims to identify effective strategies for promoting fruit intake in schools and supports broader efforts to encourage healthy diets among children and adolescents.

This research aims to evaluate a culturally relevant micronutrient-dense plant-rich (mNDPR) dietary intervention designed to reduce obesity and related disease risks among Native American employees of Twin Arrows Casino. Native Americans face higher rates of obesity and Type II diabetes compared to non-Hispanic Whites. The study involves a randomized controlled trial to assess improvements in physical health measures, wellness, and healthcare costs over one year. Participants will be randomly assigned to either an experimental group receiving a 12-week mNDPR nutrition program or a wait-list control group. The intervention includes a 2-hour initial group session followed by weekly 1-hour coaching sessions led by trained Native American Masters of Public Health students using Motivational Interviewing. Sessions provide nutrition education, cooking demonstrations, workplace dining tours, and social support. The wait-list control group will maintain usual eating habits during the first 12 weeks before receiving the same intervention. Participants will undergo health and wellness assessments at baseline and after 13 weeks, with additional diet recall at week 26 for the experimental group and follow-up measures for the control group. Healthcare utilization will be reviewed at 52 weeks. Researchers will measure changes in Hemoglobin A1c, fasting glucose, insulin, blood lipids, inflammatory markers, blood pressure, and wellness indicators like anxiety and sleep quality. Adherence to the diet will be monitored weekly, alongside attendance and self-monitoring of diet compliance.

Researchers are evaluating the feasibility and preliminary clinical outcomes of a personalized digital treatment designed for adolescents with eating disorders aged 15 to 18 years. The study aims to understand who benefits from this digital approach, how acceptable and credible it is to participants, and the cost-effectiveness of delivering such treatment in routine child and adolescent psychiatric outpatient care. The intervention includes a therapist-guided digital program consisting of 8 modules delivered over 10 weeks, with weekly therapist contact. Participants will complete self-report questionnaires before, during, and after the treatment, as well as at 3- and 6-month follow-ups. The study also involves semi-structured phone interviews with some participants to explore their experiences with the treatment. Participants will be asked to complete various validated questionnaires assessing eating disorder symptoms, general psychopathology, quality of life, and treatment satisfaction throughout the study period. Adherence to the treatment and participant experiences will be monitored, along with health and social outcomes such as school attendance and emotional regulation. Data collection occurs online, and the total follow-up extends to six months after treatment completion.

Researchers are conducting a Phase 1/2a study to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of ARO-ALK7 in adults with obesity, including those with and without Type 2 Diabetes Mellitus (T2DM). The study aims to understand how ARO-ALK7 behaves in the body and its effects, both alone and combined with tirzepatide, a medication used for diabetes and weight management. This research includes adults aged 18 to 65 years who do not have T2DM in the initial phase, expanding to include those with T2DM in later phases.