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NCT ID: NCT03505658 Recruiting - Obesity Clinical Trials

Abriendo Caminos 2: Clearing the Path to Hispanic Health

Start date: April 10, 2015
Phase: N/A
Study type: Interventional

Obesity is significantly higher in specific ethnic groups and, in particular, Hispanics. There is an urgent need to implement culturally-sensitive lifestyle interventions and educational programs to decrease the burden of obesity and obesity-related metabolic diseases in Hispanic populations. Accordingly, our overreaching goal is to tailor an existing and successful community-based program, Abriendo Caminos, to leverage effectiveness in promoting healthy nutrition and life-style behaviors among low income, low literacy Hispanic-heritage families. Our multi-function integrated project proposes to (a) adapt Abriendo Caminos for 6-18 year-old children from Mexican and Puerto Rican heritage in five different locations (California, Illinois, Iowa, Puerto Rico, and Texas) and (b) Train existing professionals (in Extension and community agencies) and future professionals (Hispanic university students) to meet the specific needs of this population. Our central hypothesis is that participation in a 6-week community-based program will prevent childhood obesity/maintain healthy weight by significantly increasing: (a) healthy dietary behavior patterns and basic knowledge of nutrition; (b) physical activity levels; and (c) the organization of collective/shared family mealtimes. The implementation of this culturally sensitive, workshop-based curriculum in different regions across the country will help to train the next generation of professionals in Extension and communities to deliver programs that meet the needs of Hispanic families. The integration of Hispanic college students in program implementation via an experiential learning course will further strengthen the program, as well as increase recruitment and retention of Hispanic students, increasing the capacity of Hispanic communities to meet their own needs in the future.

NCT ID: NCT03504319 Recruiting - Obesity Clinical Trials

The Role of Physical Activity During Pregnancy on Metabolic Function, Inflammation, and Maternal and Neonatal Outcomes

Start date: May 1, 2016
Study type: Observational

Maternal obesity during pregnancy is a serious public health concern as it contributes to inflammation, insulin resistance, and excessive gestational weight gain- all of which negatively impact maternal and neonatal health. Fortunately, physical activity during pregnancy improves obstetric and infant outcomes associated with obesity. Specifically, data from our group demonstrated that irrespective of body weight, women who were physically-active during pregnancy had lower levels of systemic inflammation; however, the mechanism/s driving these changes are poorly understood. Previous studies in non-gravid populations suggest obesity-associated overnutrition may contribute to inflammation and this subsequent inflammation may lead to further metabolic dysfunction- perpetuating a vicious cycle. However, the connections between physical activity, inflammation, and metabolic dysfunction (i.e. metabolic inflexibility), particularly in response to a high-fat meal (similar to that which is typically consumed in a Western diet), among lean and obese pregnant women have not been studied. Thus, this study will examine the impact of a physically-active lifestyle on inflammatory and metabolic responses to a high-fat meal in lean and obese pregnant women. Understanding mechanisms connecting maternal physical activity to improved outcomes will better inform future targeted intervention strategies. The goal of this study is to determine the role of a physically-active lifestyle during pregnancy on metabolic function and inflammation following a high-fat meal in lean and obese pregnant women.

NCT ID: NCT03504267 Recruiting - Obesity Clinical Trials

Evidence-based Educational Materials and Local Resources for Improving Exercise-related Outcomes During Pregnancy

Start date: May 1, 2016
Phase: N/A
Study type: Interventional

Despite the well-established benefits of physical activity, only 23% of pregnant women report exercising in accordance with guidelines recommended by the American Congress of Obstetricians and Gynecologists. Further, pregnant women report receiving little or no advice about physical activity during pregnancy from their health care provider; thus, the scientific evidence supporting physical activity during pregnancy does not appear to be translating into the clinic and the community. The goal of this project is to determine if the distribution of evidence-based educational materials and local resources will increase knowledge regarding the benefits of physical activity during pregnancy, patient-provider communication about physical activity during pregnancy, and physical activity levels during pregnancy. Hypothesis A: Pregnant women who receive evidence-based educational materials and local resources will have increased knowledge regarding the benefits of physical activity during pregnancy. Hypothesis B: Pregnant women who receive evidence-based educational materials and local resources will have more communication with their health care provider about physical activity. Hypothesis C: Pregnant women who receive educational information and local resources will report increased physical activity levels. Hypothesis D: Pregnant women who receive evidence-based educational materials and local resources will have improved pregnancy outcomes including lower gestational weight gain, lower insulin resistance (as determined by their clinical oral glucose tolerance test), and healthier neonatal birthweight.

NCT ID: NCT03500640 Recruiting - Obesity Clinical Trials

Reducing Cardiometabolic Risk and Promoting Functional Health in Older Adults With Obesity and Prediabetes

Start date: March 27, 2018
Phase: N/A
Study type: Interventional

Obesity and pre-diabetes threatens the overall health and functional independence of elders but lifestyle weight management for diabetes prevention, soon to be reimbursed by Medicare, can reduce this burden. The current 24-month study will enroll adults, ages 60 and older, through senior community centers. The investigators will study how two long term weight loss maintenance programs, using group telephone sessions to support health behavior change, impact meaningful health outcomes. If successful, this project will provide a sustainable intervention model for healthy aging services that can benefit older adults and society.

NCT ID: NCT03500016 Recruiting - Insulin Resistance Clinical Trials

Abnormalities in the Effects of Insulin and Exercise on Glucose- and Lipid Metabolism in Obesity and Type 2 Diabetes

Start date: February 26, 2018
Phase: N/A
Study type: Interventional

Type 2 diabetes are characterized by insulin resistance in skeletal muscle. Insulin resistance plays a major role for the increased risk of heart disease seen in type 2 diabetes. No specific treatment of insulin resistance is currently available, except from increased physical activity and weight-loss. Insulin resistance is characterized by abnormalities in the use of glucose and fat in the muscle, and is associated with abnormal function and content of mitochondria (the power houses of our cells) as well as increased levels of fat within the muscle. The investigators believe that abnormalities in the use of glucose and fat in muscle cells in response to insulin and exercise can explain why insulin resistance is associated with abnormal function and content of mitochondria and an increased amount of fat in skeletal muscle of patients with type 2 diabetes and individuals with obesity. The major purpose of our project is, therefore, to investigate the effect of insulin in physiological concentrations and the effect of both acute exercise and 8 weeks of exercise-training on 1. insulin sensitivity and energy metabolism, 2. insulin signaling, 3. mitochondrial dynamics and mitophagy, 4. regulators of storage of fat into lipid droplets and their interaction with mitochondria in skeletal muscle 5. acetylation and phosphorylation of enzymes (proteins) in major metabolic and signaling pathways, as well as 6. transcriptional and signalling networks regulating mitochondrial biogenesis and substrate metabolism. The effects of insulin in physiological concentrations and novel exercise-interventions combining biking and rowing will be studied in a comprehensive study of obese patients with type 2 diabetes compared with weight-matched obese and lean healthy controls. The effects of insulin and exercise on whole-body metabolism will be evaluated by measurement of maximal oxygen consumption, and well-known methods to determine insulin-stimulated glucose utilization and use of glucose and fat. Skeletal muscle and fat tissue samples obtained under these conditions will be used for assessment of tissue-levels of specific sets of genes and enzymes known to be involved in insulin action, quality and size of mitochondria, and storage of fat into lipid droplets and their interaction with mitochondria. This project is expected to provide important and novel insight into the causal relationship between insulin resistance, accumulation of fat and abnormal content and function of mitochondria in skeletal muscle in type 2 diabetes. The investigators ultimately expect that our findings will help us to identify novel molecules or enzymatic pathways, which can be used to develop drugs that can enhance or mimic the effects of insulin and exercise, and hence be used in the prevention and treatment of type 2 diabetes and heart disease.

NCT ID: NCT03498781 Recruiting - Obesity Clinical Trials

Good Intentions Study

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

The purpose of this study is to explore the effects of an intervention designed to help increase physical activity and decrease screen time.

NCT ID: NCT03493620 Recruiting - Obesity Clinical Trials

Efficacy and Results of Endoscopic Gastroplasty Using Overstitch in Patients With Class I and II Obesity

Start date: January 8, 2018
Phase: N/A
Study type: Interventional

Obesity is a chronic disease that has grown to epidemic proportions in Brazil and throughout the world in recent years. Bariatric surgery has been the most effective method for the treatment and prophylaxis of complications caused by morbid obesity, thereby increasing the longevity and quality of life of patients. The treatment of patients with Class III obesity or higher or Class II with comorbidities is already well established with bariatric surgery being the best option. However, there is no consensus as to the best treatment in cases of Class I or II obesity without comorbidities. The objective of this research will be to make a gastric tube similar to that obtained by surgical gastroplication but using endoscopic intragastric sutures.

NCT ID: NCT03490747 Recruiting - Obesity Clinical Trials

Evaluation of a Physical Activity Referral Scheme

Start date: March 12, 2018
Phase: N/A
Study type: Interventional

The study will evaluate the effectiveness of a co-developed exercise referral scheme. Participants will be recruited to one of three groups 1. Co-developed exercise referral scheme, 2. Usual care exercise referral scheme, 3. No treatment control (no intervention). The study will measure effectiveness by observing change in cardiorespiratory fitness at 6 months follow-up. Intervention cost-effectiveness will also be evaluated.

NCT ID: NCT03490734 Recruiting - Obesity Clinical Trials

Neurobehavioral Plasticity to Regular Sugar-Sweetened Beverage Intake: An fMRI Experiment

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

The proposed project will examine the strength, specificity and persistence of neurobehavioral adaptions that occur in the initial period of repeated consumption of a branded sugar sweetened beverage (SSB).

NCT ID: NCT03490513 Recruiting - Obesity Clinical Trials

Aromatase Inhibitors and Weight Loss in Severely Obese Men With Hypogonadism

Start date: April 15, 2018
Phase: Phase 4
Study type: Interventional

The investigators have preliminary data suggesting that obese patients with hypogonadotropic hypogonadism (HHG) have minimal benefit from testosterone therapy likely because of its conversion to estradiol by the abundant aromatase enzyme in the adipocytes. The increased conversion of androgens into estrogens in obese men results in a negative feedback of high estradiol levels on hypothalamus and pituitary, inhibiting the production of gonadotropin-releasing hormone (GnRH), luteinizing hormone (LH) and follicle stimulating hormone (FSH) and, as a consequence, of testosterone by the testis. Testosterone administration could increase estradiol production, further promoting the inhibitory feedback to the hypothalamic-pituitary-gonadal axis. Although weight loss from lifestyle modification has been shown to reduce estradiol and increase testosterone levels, the effect is at best modest and weight regain results in recurrence of hypogonadism. The use of aromatase inhibitors, in combination with weight loss, could be an effective alternative strategy due to its action at the pathophysiology of the disease. Intervention Subjects (body mass index of ≥35, testosterone <300 ng/dl) will be randomized to the active (anastrozole) or control (placebo) group. Anastrozole 1 mg tablet / day will be self-administered with or without food, at around the same time every day (active group); placebo 1 tablet/day with or without food to take at around the same time every day (control group). The study duration will be 12 months. Both groups will undergo lifestyle intervention consisting of diet and supervised exercise program. Target weight loss will be at least 10% of baseline body weight during the intervention. Subjects will attend weekly group behavior modification sessions which will last ~75-90 min for the first 3 months and decreased to every two weeks from 3 to 12 months. Subjects will attend supervised research center-based exercise sessions during the first 6 months followed by community fitness center-based sessions during the next 6 months for at least 2 d/wk, with recording of home-based exercises for the other 2-4 days/week.