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Obesity clinical trials

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NCT ID: NCT03315845 Not yet recruiting - Obesity Clinical Trials

Neuraxial Anaesthesia: Does BMI Relate to Ease of Neuraxial Anaesthesia?

Start date: October 23, 2017
Phase: N/A
Study type: Observational

Neuraxial anaesthesia can be more difficult and associated with more complications if the patient's bony landmarks are difficult to palpate. They are more likely to be difficult to palpate if a patient has a high Body Mass Index (BMI), (>30kg/m2). The depth that the spinal or epidural needle must be inserted is usually longer in these patients with high BMIs. We wish to palpate the backs of at least 100 such patients to see how many of them have impalpable bony landmarks. We then wish to use ultrasound to measure the distance from skin to the posterior epidural complex to discover if this length is longer than the standard needle length. If it is longer in the majority of people we study, we will recommend changing standard practice to start using a longer needle for all first attempts at neuraxial anaesthesia in this patient population.

NCT ID: NCT03315247 Not yet recruiting - Obesity Clinical Trials

Tele-CBT Following Bariatric Surgery: Randomized Control Trial

Start date: November 2017
Phase: N/A
Study type: Interventional

Bariatric (weight loss) surgery is the most effective treatment for extreme obesity, but surgery does not treat underlying psychological and behavioural issues. Currently, psychotherapy ("talk therapy") for eating problems is not routinely offered with surgery, and many people start to regain weight one year later. Objective: This study will examine if adding a convenient and accessible psychotherapy by phone one year after surgery will lead to increased weight loss two years after surgery. Primary Hypothesis: Relative to the Control group (who will get routine care), the group of individuals who get psychotherapy will have lower weights 2 years after surgery. Secondary Hypotheses: Relative to the Control group, the psychotherapy group will report significantly less maladaptive eating behaviours and medical burden, and significantly greater quality of life. Method: Participants recruited from the Bariatric Surgery Programs at Toronto Western Hospital will be randomly assigned to 1 of 2 groups: 1) Control (Usual Standard of Care) or 2) Tele-CBT (a 7-session telephone-based cognitive behavioural therapy [a type of "talk therapy"] intervention focused on developing coping skills to improve maladaptive thoughts, emotions, and eating behaviours, specifically designed for bariatric surgery patients, delivered 1 year post-surgery). They will have their weight measured and will complete measures of eating behaviour and quality of life prior to the intervention, and again at several time points extending to 2 years post-surgery. Implications: If Telephone-Cognitive Behavioural Therapy (CBT) is found to improve bariatric surgery outcomes, it could become the standard of care in Canadian bariatric surgery programs and beyond, and be routinely offered to patients who cannot feasibly attend CBT sessions due to physical or practical barriers.

NCT ID: NCT03311230 Not yet recruiting - Obesity Clinical Trials

Social Incentives To Encourage Physical Activity and Understand Predictors

STEPUP
Start date: October 2017
Phase: N/A
Study type: Interventional

This study tests the effectiveness of three social incentive-based gamification interventions to increase physical activity using a 24-week intervention period with a 12-week follow-up.

NCT ID: NCT03309787 Not yet recruiting - Obesity Clinical Trials

Health Coaching & Technology in a Weight Loss Center

Start date: November 1, 2017
Phase: N/A
Study type: Observational

The national epidemic of obesity is associated with considerable morbidity, disability and early mortality. Conventional weight loss programs beyond a primary care setting have the potential to reduce weight, but are difficult to access for adults with obesity in rural areas due to lack of transportation and access to specialty care. Routine intensive behavioral therapy, while effective, is often not supplemented with adjuncts that could be helpful in engaging participants in behavioral change. The overarching goal of this SYNERGY pilot project is to overcome barriers rural adults face by using video-conferencing to deliver specialty obesity care that otherwise is inaccessible to most adults faced with this disease. It also intends to use emerging mobile health (mHealth) technology which has shown considerable promise in providing motivational feedback. This proposal highlights T3/T4 translation bridging technologists, allied health staff, and clinicians in the development and implementation of new therapeutic modalities. The study aims to evaluate a telehealth-based health coaching program that is embedded in the Dartmouth-Hitchcock Weight and Wellness Center that integrates novel remote monitoring technology in effecting behavioral change using Amulet, a Dartmouth Computer Science developed mHealth device over a 16-week period. First, the feasibility and accessibility of an eHealth-delivered health coaching obesity intervention using remote monitoring and video-conferencing (Aim 1) will be evaluated. The potential effectiveness of achieving the primary outcome of 5% weight loss, with secondary outcomes of improved physical function and self reported health (Aim 2) will be ascertained. The intervention's impact on implementation outcomes of workflow, adoption, and organizational change that could affect further scalability and generalizability in other high-risk population groups (Aim 3) will be assessed. These preliminary findings will be used in a future competitive application for an extramural R01 designed to assess the effectiveness of our intervention in achieving weight loss in rural obese adults. If successful, this application has the potential to redesign care using applied methods of telehealth translated to community-based, rural populations to facilitate behavioral change. The project also meets criteria of the NIH Strategic Plan for Obesity and the Institute of Medicine's need for Telehealth research.

NCT ID: NCT03308721 Not yet recruiting - Obesity Clinical Trials

Research Study Investigating Study Medicine (NNC9204-1177) for Weight Management in People With Overweight or Obesity

Start date: October 17, 2017
Phase: Phase 1
Study type: Interventional

This study looks at a new study medicine for weight management in people with overweight or obesity. The aim of this study is to find out how safe and tolerable the study medicine is. The study also looks at how the study medicine behaves in the body and how it is removed from the body. Participants will either get NNC9204-1177 (the new study medicine) or placebo (a formula that looks like the study medicine but does not have active ingredients). Which treatment participants get will be decided by chance. NNC9204-1177 has not been approved by the United States Food and Drug Administration. Its use in this study is experimental. Participants will get 1 or more injections into the skin of the stomach area once each week for 12 weeks. The study will last for about 5 months. Participants will have 19 clinic visits with the study doctor. At certain times during the study, participants will have blood draws and 3 different kinds of electrocardiograms. Participants will answer mental health questionnaires. Women: Women cannot take part if pregnant, breast-feeding or plan to become pregnant during the study period.

NCT ID: NCT03306771 Not yet recruiting - Metabolic Syndrome Clinical Trials

The Relationship Between Morbid Obesity and Carotid Artery Stenosis

Start date: December 2017
Phase: N/A
Study type: Observational

The correlation between metabolic syndrome and carotid artery stenosis is well established. The purpose of this study is to evaluate the relationship between morbid obesity and carotid artery stenosis.

NCT ID: NCT03305237 Not yet recruiting - Obesity Clinical Trials

The Meal Time Study

Start date: October 2017
Phase: N/A
Study type: Interventional

This weight loss study will investigate the impact of calorie distribution across a day (large breakfast meals and smaller evening meals versus small breakfast meals and large evening meals) on body weight, and physiological and behavioral mechanisms regulating energy balance. Participants will undergo 2 x 4 week energy restriction protocols in a randomized cross over design; big breakfast (45% of calories in the morning meal, 20% at dinner) and big dinner (45% of calories in the evening meal, 20% at breakfast). We predict that timing of eating will influence energy balance, because morning energy expenditure is amplified in comparison to the evening. This study will allow us to assess whether the increased energy expenditure in the morning is linked to natural biological circadian rhythm or behavioral adaptions.

NCT ID: NCT03302481 Not yet recruiting - Obesity Clinical Trials

Mitochondrial Metabolism and Hepatic Complications of Obesity

DMSO
Start date: January 2, 2018
Phase: N/A
Study type: Interventional

The study aims to characterize mitochondrial metabolism in the liver of obesity surgery patients and to study its relationships with hepatic steatosis, inflammation, and fibrosis.

NCT ID: NCT03301545 Not yet recruiting - Obesity Clinical Trials

The Metabolic Impact of Bariatric Surgery Compared to Best Diabetic Care on Manitoba's Urban Indigenous Population

Start date: March 2018
Phase: N/A
Study type: Interventional

Obesity and type 2 diabetes mellitus (T2DM) are major global health concerns as they commonly co-occur and are associated with significant morbidity, mortality, and health care expenditures. The Indigenous (First Nations, Metis and Inuit) population bears a disproportionate burden of T2DM in Canada. The prevalence of obesity among Indigenous individuals is approximately 31.2% compared to 18.6% for the non-Indigenous population. In 2011, 16.7% of Manitoba's population, or four times the Canadian average, identified as Indigenous. At the same time, prevalence of T2DM in Manitoba is on the rise. Bariatric surgery is an effective treatment modality for the improvement and resolution of T2DM in patients who are obese. We aim to compare the effectiveness of bariatric surgery with conventional medical treatment in treating metabolic diseases in Indigenous people; the findings of which will assist in future treatment and program planning. Our objective is to determine whether Manitoba's urban Indigenous population will achieve better diabetic control and improved rates of remission of T2DM with bariatric surgery compared to best diabetic medical care.

NCT ID: NCT03297359 Not yet recruiting - Obesity Clinical Trials

WAVe Study - Weight Adjusted Dalteparin for Patients Over 90 kg With Acute Cancer Associated Venous Thromboembolism

WAVe
Start date: January 1, 2018
Phase: Phase 2
Study type: Interventional

Cancer patients that develop blood clots are treated with low molecular weight heparin injections (LMWH). One kind of these LMWHs, dalteparin, has its dose determined based on a patient's weight using a formula of 200 international units (IU) per kilogram (kg). The current dosing of dalteparin approved by Health Canada has a maximum daily dose of 18 000 IU/day which is weight-adjusted for patients up to 90 kg. Any patient weighing more than 90 kg would take the same dosage regardless of their weight. The aim of this study is to assess the safety of using weight-adjusted dalteparin in cancer-associated venous thromboembolism patients that weigh more than 90 kg.