Weight Loss Clinical Trials

Childhood obesity within the United States has been a growing concern over the past number of years, and if not addressed, leads to detrimental health outcomes for youth as they move into adulthood. The literature suggests that over-eating, especially when framed in terms of food addiction, plays a key role in this epidemic; however, treatment options are time intensive, posing a profound logistical barrier for both the child and parent and often limits or prevents engagement. As research within the field of mHealth has grown, technology-based interventions have gained traction, specifically interactive smartphone applications (apps). Displacement theory, although not new, has been understudied yet provides a strong explanation and treatment plan for addictive type behaviors. The core of this theory posits that problems which one feels they cannot face nor avoid leads to repetitive and irrepressible behaviors; however, if a healthy coping behavior can be learned and utilized, then the unhealthy behavior will cease. The theory lends itself well to being adapted into an mHealth format, making it more easily accessible and more widely used. Grounded in displacement theory, the proposed study aims to develop an app-based weight loss intervention for adolescents with obesity. Information gained regarding the feasibility and acceptability of such an intervention can potentially be replicated and applied to other populations with various addictive behaviors. Helping those with addictive behaviors in a format that has little to no logistical barriers can have a substantial impact on public health. A novel smartphone app will be designed by key stakeholders and refined through the course of the study. 46 total adolescents (14-18 years old) with %BMIp95 will be recruited via various sources (e.g., clinic referrals, flyers, social media advertising) to participate in one of two stages of the study: the beta testing stage or the trial stage. Beta testing will enroll two successive groups of eight teens to test the app for three weeks; participants will be assessed in-person pre- and post-intervention. After each group, the app will be modified to incorporate their feedback in order to promote youth engagement. The trial stage will enroll 30 adolescents to participate in a four-month intervention; participants will complete three assessments, baseline, post-intervention (both in-person) and one-month post-intervention (either in-person or virtually). The study will examine engagement and satisfaction with the app, as well as the intervention's impact on clinical outcome measures (weight and BMI, diet and snacking, and addictive behaviors related to food and substance use) and potential mediators/moderators (motivation for change, perceived stress, and distress tolerance). 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

The purpose of this study is to compare the effect on weight and metabolic outcomes of an enhanced intervention, comprised of evidence-based financial coaching plus a lifestyle intervention vs. the lifestyle intervention alone Read Less

Bariatric surgery is an effective treatment for severe obesity but results in loss of muscle mass. The investigators will test the hypothesis that consumption of an Essential Amino Acid-based nutritional formulation will maintain muscle mass while stimulating fat loss after bariatric surgery. Read Less

The purpose of this research is to determine patient-reported outcomes after weight loss surgery, including changes in health, mood, quality of life, health satisfaction, and emotional health, in low-risk patients. Weight loss surgery has been well studied for patients with body mass index (BMI) 35 kg/m^2 or more and those with weight-related medical problems who have a BMI 30 kg/m^2 or more. However, outcomes after weight loss surgery in patients with BMI under 35 kg/m^2 and without co-morbidities have not been well studied. Read Less

The purpose of the proposed study is to evaluate the impact of the Jump Start program to facilitate weight loss in a sample of overweight and obese men and women. The study will not only evaluate weight loss and changes in body-shape but will also assess the type of weight lost (fat vs. lean mass) and other health measures affected by obesity including lipids, glucose, insulin, resting heart rate and blood pressure, and perceived wellness. This study will contribute to the general weight loss literature by providing evidence for or against the use of a meal replacement centered one-week weight loss program to yield weight loss and other health-specific benefits. The hypothesis is that the Jump Start program will result in an average 3-5 pound weight loss, as well as improvements in bloodborne markers of health, from day 1 to day 8. Read Less