Obesity Clinical Trials

This project evaluates the effectiveness of an evidence-based intervention (HEALTH-P2) to prevent excessive weight gain from pregnancy through 12 months postpartum when disseminated and implemented in real-world settings, through Parents as Teachers. To enhance the impact of HEALTH-P2, the study also evaluates implementation outcomes from the training curriculum (implementation strategy) and external validity when HEALTH-P2 is implemented within this national home visiting organization. This partnership has potential for significant impact on obesity and chronic diseases such as cardiovascular disease and diabetes. Read Less

Approximately 70% of American adults have overweight/obesity, which increases risk of major medical issues and preventable death (Abdelaal et. al, 2017). Many individuals with overweight/obesity attempt to lose weight through behavioral strategies, e.g., adopting a reduced-calorie diet and/or increased physical activity. However, it is exceedingly difficult to consistently adhere to a reduced-calorie diet and high levels of physical activity; as such, most individuals attempting to lose weight via these methods experience repeated instances of non-adherence, i.e., dietary and physical activity lapses. These lapses are a core driver of weight loss failure, undermining individuals' ability to achieve weight control (Forman et al, 2017). As such, it is important to understand what predicts these lapses, which in turn allows for better lapse prevention. The current study proposes to measure these risk factors in an ecologically valid manner, i.e., in the moment they occur and in the context of individuals' everyday lives, using advanced technology. Specifically, the current study will use ecological momentary assessments (EMA; brief, repeated surveys delivered in one's natural environment, typically via a smartphone) and sensor technology (e.g., Fitbit and sensors on smartphone devices) to measure momentary risk factors of dietary and physical activity lapse, as well as the lapses themselves. Findings from this research project will lay the groundwork for a sophisticated just-in-time adaptive intervention (JITAI), a tailored, personalized intervention that targets momentary risk factors (e.g., cravings) via in-the-moment support, thereby reducing lapse occurrence and improving adherence to behavioral weight control prescriptions. Read Less

Men in the United States have an exceptionally high prevalence of overweight and obesity, i.e., 71.3%, and 42% of men are currently attempting weight loss. However, men are dramatically underrepresented in weight loss programs. Attempts to modestly adapt standard weight loss programs have seen only minimal success. Mobile applications (mHealth apps) have attractive features, but have low male enrollment and poor efficacy as conventionally delivered. A gamified mHealth program offers the possibility of engaging men and enhancing efficacy given that (1) video gaming is highly appealing to men; (2) gamification features (e.g., digital rewards for attaining "streaks" and milestones, competition) are known enhance enjoyment and motivation and facilitate desired behaviors; and (3) "neurotraining" video games featuring repetitive action mechanics, adaptive difficulty, and feedback can train inhibitory control, a basic brain capacity to inhibit intrinsically-generated approach responses that is strongly linked to body mass and the consumption of high-calorie foods. This project evaluates long-term engagement and outcomes of a professionally-designed, game-based weight loss program. As such, 228 overweight men will be randomized to: (1) a 12-month mHealth weight loss program that includes digital self-monitoring, simplified and self-selected dietary targets, physical activity and a control (sham) non-game neurotraining, or (2) a fully-gamified version of this same program, comprised of a behavior change program featuring team-based competition, digital reinforcers for attainment of streaks and milestones, and an integrated neurotraining video game. Aims include evaluating the efficacy of the gamified program in terms of weight loss, diet and physical activity at 12 months, as well as evaluating hypothesized mediators (inhibitory control and engagement), (enjoyment and compliance) and moderators (baseline frequency of video game play and implicit preferences for Inhibitory Control Training-targeted foods). Read Less

Exercise is very important for living healthier and longer lives. For people with obesity and osteoarthritis, exercise is even more important because it can help them feel less pain in their joints. Also, the more intense the exercise is, the larger the health benefits will be. The most common ways to exercise are running and riding a stationary bicycle. However, these two types of exercise can cause problems for people with obesity and osteoarthritis. Fast running creates large loads in the knees because of the impact of the foot on the ground. On the other hand, studies in cycling show limited improvement in pain because cycling does not allow the feet to move freely, which is important for reducing pain in people with osteoarthritis. This study introduces a new way to exercise using a hip flexion feedback system (HFFS). The subjects will exercise by increasing how much they lift their knees while walking on treadmill. The exercise will also involve controlling the impact of the feet on the treadmill. The HFFS monitors the subject's heart rate during the exercise using a standard heart rate monitor. A TV placed in front of the treadmill shows how high individuals need to lift their knees. How much participants need to lift their knees is calculated by the HFFS based on real-time heart rate readings. Therefore, the HFFS can help people stay at a specific exercise intensity by controlling how high it tells them lift their knees during the exercise. This study will have participants with osteoarthritis and obesity in two groups. One group will exercise using the HFFS. Another group will not exercise. The exercise group will do a 12-week high intensity exercise program. Our first goal is to determine how much fitness, pain, and the ability to move improve due to the exercise program. With this study we are looking to introduce a better and safer way to exercise for people with osteoarthritis and obesity. The results of this study will also allow for further development of home-based exercise and telemedicine. Read Less

The PREDICT 3 study will build on previous research in over 2,000 individuals to further refine machine learning models that predict individual responses to foods, with the aim of advancing precision nutrition science and individualized dietary advice. The study incorporates both standardized and controlled dietary intervention, for the purpose of testing postprandial responses to specific mixed meals, in addition to a free-living period with a dietary record for measuring responses to a large variety of meals consumed in a realistic context, where the role of external factors (e.g. exercise, sleep, time of day) on postprandial responses may be determined. For the first time this PREDICT study is built on top of a commercial product which will allow access to a much larger group of participants who are already collecting large amounts of data through digital and biochemical devices that can contribute to science. Read Less

This will be a prospective, registry study of an investigational procedure for at least 12 standard of care visits up to 1 year after subject consents for study. Subjects will be enrolled between 8/1/2018 and 8/1/2023. Subjects will undergo a clinically indicated endoscopic procedure and subsequent follow up clinic visits as part of their standard medical care. Disclaimer: To undergo the procedure there is an out of pocket expense for $9000. Read Less

Exercise acutely increases gut permeability and inflammation, even in healthy populations. However, whether this response differs in groups at-risk for CVD that present with low-grade inflammation (e.g., normal-weight obesity) has yet to be examined. The investigators aim to measure serum indicators of gut permeability in those with normal-weight obesity pre- and post-short, intense exercise and sustained, moderate exercise Read Less

Approximately 20-40% of patients with ulcerative colitis (UC) are obese. The investigators have demonstrated that obesity adversely impacts disease course in patients with UC, leading to higher risk of persistently active disease, surgery, hospitalization, and treatment failure, particularly in biologic-treated patients. Intentional weight loss is effective in improving disease outcomes in patients with inflammatory arthritis, but there is limited data on its impact in UC. While dietary interventions for weight loss have limited efficacy and endoscopic bariatric interventions may be too invasive in patients with UC with active gastrointestinal symptoms, pharmacological weight loss with a highly effective oral agent may be a novel strategy to induce weight loss and augment the efficacy of biologic therapy in UC. Hence, the investigators are conducting a pilot, phase 2A, 22-week, randomized, placebo-controlled clinical trial of phentermine-topiramate in obese patients with active UC starting on a new biologic agent (infliximab, adalimumab, golimumab, vedolizumab). The overall objective is to (1) evaluate the efficacy, safety and tolerability of phentermine-topiramate, and (2) to assess the impact of pharmacological weight loss on clinical outcomes, inflammatory burden and biologic trough concentration in patients with UC. The central hypothesis is that phentermine-topiramate will be safe, effective, and well tolerated in patients with UC, and weight loss would achieve higher rates of clinical and biochemical remission, and higher biologic trough concentration. Read Less

Childhood obesity is a national epidemic that disproportionately burdens low income and ethnic minority populations. By preschool, nearly one-third of low income children are already overweight or obese, setting the stage for adverse health outcomes over their life course. Evidence is mounting that individual-focused, single-component interventions fail to produce long-term population-level changes in obesity-related outcomes. Evidence increasingly supports creating entire environments (e.g., schools) in which the healthy choice is the default option. The investigators will conduct a pragmatic cluster randomized trial to evaluate the effectiveness of a multilevel (organization, teacher, parent, child) intervention to support healthy eating and physical activity in preschools. The study is being conducted in partnership with Child Care Resource Center (CCRC), a non-profit organization dedicated to ensuring that all children receive high quality preschool experiences. The investigators will randomly assign 60 preschool sites (stratified by size), located in underserved areas of Los Angeles, to the intervention or a usual practice control conditions. The investigators will evaluate the effectiveness of the intervention on child BMI z-scores (primary outcome) and parent-reported child nutrition and physical activity (secondary outcomes). The investigators will systematically examine the implementation process to understand factors that may facilitate or hinder intervention uptake and success. The findings from this work will be critical for informing future dissemination efforts. Read Less

Obesity is pro-inflammatory, impairs metabolism, and physically limiting. Specifically, muscle in obese persons does not synthesize proteins normally. This further increases metabolic and physical dysfunction. As such, obesity programs should not only focus on weight loss, but muscle metabolic health. Dairy nutrients have anti-inflammatory and anabolic properties, but mostly evaluated in isolation and/or pre-clinical designs. Also, it is unknown if the circulating benefits extend to the muscle. We hypothesize that dairy full-fat milk will improve these obesity characteristics. Read Less

This study is investigating the effect of different intensities of exercise on levels of the hormone, ghrelin. In addition, we will be examining the relationship between any exercise induced changes in ghrelin and insulin sensitivity, obesity, and vascular function. Read Less

The primary aim of this randomized clinical trial is to compare the effects of three different HIIT protocols and a control group on cardiometabolic health in young adults with obesity. Participants will be randomly assigned to one of the following three groups, with each having varying work-to-rest ratios: 1) HIIT-A, 2) HIIT-B, 3) HIIT-C, and 4) control group. HIIT-A, HIIT-B, and HIIT-C groups will participate in six sessions of a running based HIIT program over a 2-week training period. Pre-clinical markers of cardiovascular disease, blood lipids and fasting glucose will be measured at the following three time points: baseline, post-intervention, and 2 weeks after the training cessation (i.e., measure for detraining effect). All measurements will be performed three days before the training program and three days after the intervention to avoid the effect of the last training session. Afterwards, the detraining test will be measured 2 weeks post intervention. Read Less