
APOLO-Teens, a Web-based Intervention For Adolescents With Overweight/Obesity
Pediatric ObesityWith the demand for weight-loss interventions likely to continue its upward trend over the next decades, the question remains on how to continuously monitor and support overweight and obese adolescents, particularly in the long-term. Moreover, as the burden of the obesity rates increases in health care centers, the development of alternative delivering strategies gains attention. In an environment of limited resources, the development of new-technology based programs seems a promising area to deliver cost-effective interventions to a wide number of individuals. However, the existing studies present several limitations and a challenging aspect of treating obesity in adolescents is the presence of high rates of disordered eating behaviors. The objective of this study is to develop and test the effectiveness of a web-based Cognitive Behavioral Therapy intervention, for adolescents with overweight/obesity. A Randomized Controlled Trial will compare a control group receiving medical treatment as usual (TAU), and an intervention group receiving TAU plus a psychological/behavioral intervention delivered via the internet.

Xla1 Christensenella Minuta, Phase I, Randomized, Partially Placebo-controlled Double-blind Protocol,...
ObesityMetabolic DiseaseXla1 Christensenella minuta, phase I, randomized, placebo-controlled double-blind protocol, evaluating safety, tolerability and impact on the gut microbiota in healthy volunteers, overweight and obese adults. This study is designed as a FIH, Phase I, daily oral single dose, clinical trial evaluating safety, tolerability and the impact on the gut microbiota following introduction of Xla1 performed in 2 parts: Part 1: An open phase in normal weight healthy volunteers (HV) receiving all Xla1. Part 2: A randomized, parallel, double-blind, placebo-controlled phase in overweight or obese (stage 1) adult patients receiving either Xla1 or placebo.

Wellness Education Intervention
Overweight and ObesityEating Disorders2 moreIndividuals suffering from depression and anxiety have an increased risk of obesity due to multiple factors such as side effects to psychotropic medications, associated appetite dysregulation, disruption of sleep, anergia leading to psychomotor retardation or inactivity, and increased stress hormones through the disruption in the hypothalamic-pituitary-adrenal (HPA) axis. Though not a causal relationship, an intimate bidirectional connection exists between the two conditions, which subsequently impacts the journey of weight loss. The impact mental health can have on weight loss is evident as concurrent depression and anxiety in individuals with obesity predicts poorer outcomes like decreased adherence and less success with weight loss interventions. Here, we will determine if delivery of psychoeducation regarding the primitive brain and model of safety in a group setting to those with obesity seeking weight loss intervention has an impact on not only psychiatric symptoms of depression and anxiety but also weight loss, eating behaviors, sleeping patterns, activity level, and health-related quality of life. This project will improve our understanding of the role of mental health and the stress response in obesity.

Research Study to Investigate How Well Semaglutide Tablets Taken Once Daily Work in People Who Are...
ObesityOverweightThis study is being conducted to see if semaglutide tablets can be used as a treatment to help people living with overweight or obesity lose weight. This study will look at the change in participants body weight. Participants will either get semaglutide tablets (new medicine) or placebo tablets ('dummy' medicine that looks like semaglutide but has no effect on the body). For a fair comparison, people are divided into two groups at random by a computer. This process is called randomisation. Semaglutide tablets are new medicine being tested to treat overweight and obesity. Doctors in many countries can already prescribe semaglutide tablets at lower doses to treat type 2 diabetes. Participants will get semaglutide or placebo tablets for 68 weeks and will need to take 1 tablet every morning In addition to taking the medicine, participants will have talks with study staff about: healthy food choices how to be more physically active what participants can do to lose weight The study will last for about 1½ year.Participants will have 14 clinic visits and 7 phone calls with the study doctor. Blood samples will be taken at 10 visits. Participants will have a test to check their heart done at 3 visits. Women cannot take part if pregnant, breast-feeding or plan to get pregnant during the study period. If participant is a woman and is able to become pregnant, participant will be checked for pregnancy via urine tests.

The Effectiveness and Safety of HIIT in Overweight Male Subjects
OverweightOverweight or ObesityIncreased prevalence of overweight and obesity is one of the main health problems recently. Energy balance from nutrition intake and energy expenditure through physical activity, especially structured physical activity, is needed to prevent overweight individuals become obese individuals. This research objective is to explore the effectiveness and safety of structured high intensity interval training in male young adults subjects with overweight based on change of body composition, oxidative stress and inflammatory markers. This research used experimental model to test structured high intensity interval training program with pre-post test in single group. Comprehensive analysis of training effect in this research consists of measurement of several parameters, such as body composition, inflammatory markers, and oxidative stress markers as the benchmark of training safety. Browning white adipose tissue and cognitive function are complement parameters to the assessment of training effectiveness. Daily food record and physical activity for 3 x 24 hours will be carried out periodically to control confounding factors.

A First-in-human Study Looking at the Safety of ZP8396 and How it Works in the Body of Healthy Trial...
OverweightHealthy VolunteersThe research study will investigate the safety and tolerability of ZP8396 in healthy study participants. In addition, the study will investigate how ZP8396 works in the body (pharmacokinetics and pharmacodynamics). Participants will receive 1 single dose either as an injection under the skin (subcutaneous, s.c.) or an injection into a vein of one arm (intravenous, i.v.). Participants will have 9 visits with the study team. One of these visits consists of 8 overnight stays at the study site. For each participant, the study will last up to 66 days.

Plant Stanol Esters and COVID-19 Vaccination Response
Overweight and ObesityPlant stanols are known to lower low-density lipoprotein cholesterol (LDL-C). However, studies have suggested that these compounds also beneficially influence the immune system, e.g. increasing vaccine-specific antibody titers. BMI has previously been negatively associated to vaccination responses. If plant stanols indeed have beneficial effect on the immune system, people with overweight or obesity might benefit from consuming plant stanols prior to receiving the COVID-19 vaccination. The primary objective of this study is to demonstrate clinical benefits of consumption of plant stanols (delivered via products enriched with plant stanol esters) on the vaccination response to a COVID-19 vaccine in overweight or obese patients. The main study endpoint is vaccination response to a COVID-19 vaccine. Secondary endpoints include amongst others hematological, inflammatory and immunological parameters (e.g. hs-CRP, leukocyte differential count) and metabolic markers (e.g. blood lipid profiles, plasma glucose, serum insulin, HOMA-IR).

Targeting Body Image Among Women of Higher Body Weight
ObesityOverweight1 moreThe goal of this study is to modify the evidence-based Body Project intervention to more powerfully target weight and shape concern among women with BMI between 25-40 using exploratory sequential mixed methodology (using both quantitative and focus group data). Initial modifications to the intervention will be made to incorporate content targeting weight stigma and to ensure the materials are developmentally appropriate for adult women. Then a small group (n=5-10) of women with high weight and shape concern will receive the 4 week body project intervention; we will collect pre-post questionnaire data on weight and shape concern, thin ideal and weight stigma, and use ecological momentary assessment to examine in-the-moment thoughts about weight and shape. The body project intervention will then be revised using this information in combination with participant feedback elicited during a focus group session. The next iteration of the intervention will then be tested in another small group of n=5-10; it is estimated that it will take 4-6 iterations to achieve a more robust intervention program that is acceptable to the target sample. Subgroups (race/ethnicity, BMI class) will be evaluated to ensure suitability across groups.

Teaching Obesity Treatment Options to Adult Learners Intervention Via VA Video Connect
Overweight and ObesityThe goal of this study is to assess the feasibility and acceptability of Teaching Obesity Treatment Options to Adult Learners (TOTAL intervention), which includes an educational video about obesity treatment options within VA in conjunction with three telemedicine motivational sessions to increase obesity treatment initiation. 10 participants will be recruited from the Madison VA Medical Center. Participation involves 3.5 hours of total time with study follow up to 18 months.

Evaluation of the Effect of Epitomee Device on Gastric Emptying Rate in Healthy Subjects
Overweight and ObesityEvaluation of the effect of Epitomee Device on Gastric Emptying Rate in healthy subjects