
Efficacy of Increasing Physical Activity to Reduce Children's Visceral Fat
ObesityThe purpose of this trial is to examine whether adding greater physical activity to standard family-based behavioral pediatric obesity treatment decreases the amount of visceral fat among treated overweight children.

Growth Hormone, Cardiovascular Risk, and Visceral Adiposity
ObesityThis study will compare growth hormone levels and cardiovascular risk markers in normal weight and overweight women and men. In women and men with increased abdominal weight, growth hormone (GH) versus placebo will be administered and effects on cardiovascular risk, insulin resistance and body composition will be measured.

Evaluation of the Shape Up Rhode Island Campaign
ObesityObesity is a major health problem that has reached epidemic levels. Efforts are needed to develop cost-effective public health approaches for weight loss and maintenance. One such approach is to develop team-based programs that may motivate people to lose weight and/or increase their physical activity. One such program is entitled Shape-up Rhode Island (SURI). The purpose of this project is to evaluate the overall effectiveness of SURI and to test if a behavioral intervention can enhance the effectiveness of the original program. The current trial is investigating whether adding a behavioral intervention delivered online would enhance the outcomes of SURI participants.

Open-Label Extension (OLE) Study for Safety and Efficacy of Velneperit (S-2367) in Obese Subjects...
ObesityThe purpose of this open-label extension study is to evaluate the safety and efficacy of velneperit (S-2367) in obese subjects.

Growth Hormone Treatment in Men With High Risk of Developing Type 2 Diabetes Mellitus
Abdominal ObesityMetabolic Syndrome1 moreThe overall aim of this study is to investigate the effects of GH treatment in men with the Metabolic Syndrome and a high risk of developing type 2 DM. Forty men with abdominal obesity and impaired glucose tolerance will be randomized to two parallel treatment groups with GH and placebo for 12 months. The subjects will receive treatment with recombinant human GH (Genotropin®) or placebo administered by a daily s.c. injection before bedtime. The initial dose of GH will be 0.4 IU per day increased to 0.8 IU after 2 weeks and to 1.2 IU after 4 weeks of treatment. Thus, the target dose is 1.2 IU per day which resembles approximately 0.015 IU/kg/day. The GH dose will be reduced by half in the event of side-effects. Oral and written instructions in terms of administration and dosage will be given. The treatment can be discontinued by the patient. The treatment should be discontinued if malignancy is discovered, DM developes, if the subject experience a cerebrovascular disease and in the event of any other side-effects that is considered as serious. The treatment code for each subject included in the trial will be kept at the Sahlgrenska University Hospital Pharmacy. This code can be broken on the request of the investigator. Compliance will be assessed by collecting empty vials from the study subjects. The treatment is discontinued at the end of the study.

Safety Study of the Inhibition of Agouti-related Protein (AgRP) for the Management of Obesity and...
ObesityMultiple pathways including peripheral and central hormones and neurotransmitters are involved in the regulation of food intake and body weight. One of the most studied pathways involves the melanocortin receptor. Agouti-related protein (AgRP) and alpha-melanocyte stimulating hormone (alphaMSH)have been shown to play an integral role in food intake and body weight. It is reasonable to speculate that if there is an imbalance of alphaMSH and AgRP exist in obese individuals and inhibiting the activity of AgRP may be of therapeutic benefit in treating obesity.

Improving the Management of Obesity in Primary Care Practice (The Power-UP Trial)
ObesityHypercholesterolemia3 moreThe purpose of the study is to compare three methods of achieving weight loss in primary care medical practice. The study will be conducted in six primary care practices. Weight management will be provided to a total of 390 obese patients (who have 2 or more components of the metabolic syndrome) by their own primary care providers, in conjunction with the practices' auxiliary health professionals, including medical assistants.

The Impact of the PACE Program Implementation on Health Services Utilization by Obese Arab Women...
ObesityScientific background: Obesity is a known risk factor for cardiovascular disease, metabolic syndrome, and diabetes. In Israel, the prevalence of obesity and diabetes among Arab females is 2 and 2.8 times higher than Jewish females, respectively. The economic impact of obesity and overweight in terms of illness, disease and lost productivity is estimated to amount to 2-9% of the national health budget in countries with high GDP. Diabetics have medical expenditure that is 2.4 times higher than non diabetics per capita. Lifestyle modification is an effective tool in reducing morbidity and health care expenditure but despite that most family practitioners usually treat the complications of obesity rather than preventing it. PACE is a comprehensive health promotion guide in counseling patients to an active healthy lifestyle. PACE is designed to assist the primary health care providers to promote physical activity and dietary changes during routine office visits. Objectives: To asses the impact of PACE program on increasing the amount of physical activity, improving clinical and metabolic indices, increasing the documentation of lifestyle indices in the medical records and reducing health care expenditure and utilization. Working hypothesis: Implementing a modified PACE protocol can achieve this objectives in Arab women. Methodology: The investigators will conduct a structured, multidisciplinary and continuous primary care based intervention, assisted by trained health promoters and applying a locally adjusted PACE protocol.

A First-Time-in-Human Study to Assess the Safety and Tolerability of PP 1420 in Healthy Subjects...
ObesityWhen humans eat, the bowels naturally secrete chemicals into the bloodstream which make people feel full and which stop eating. One of these chemicals is known as "Pancreatic Polypeptide" (PP). We have previously shown that injections of human PP reduces appetite and food intake. We have now developed a very similar chemical, PP 1420, as a treatment for obesity. PP 1420 has been tested in animals and has been shown to be safe, and to reduce their appetite. This study will test PP 1420 for its safety and tolerability in humans.

Childhood Obesity Treatment Targeting Specific Behaviors
Childhood ObesityThe US is in the midst of an obesity epidemic, affecting young children. The pediatric primary care setting is an ideal place to address this problem since most families have frequent contact with their pediatrician and a child's health status is regularly assessed in this setting. Recommendations for treating children with a body mass index (BMI) over the 85th percentile in the primary care setting have been developed by an Expert Committee on childhood. Programs are needed that meet the recommendations from the Committee, which include: 1) beginning treatment as young as possible; 2) focusing on the family, with the parent being the primary change agent for treatment; 3) using behavior modification techniques to change eating and activity behaviors; and 4) making 2 or 3 very specific changes in diet and activity at one time. Thus, the aim of this R21 application is to develop, implement, and evaluate a 6-month behavioral childhood obesity intervention that meets the Committee's recommendations and can be implemented in a primary care setting. A second aim of this project is to determine which eating and activity behaviors should be targeted in the intervention. One hundred thirty-five children, aged 4 to 9 years with a BMI > 85th percentile, assessed and referred by their pediatricians, will be randomized to one of three conditions: 1) a newsletter condition; 2) a Behavioral Parenting Program that increases physical activity (60 min/day) and decreases sweetened drink consumption (< 3 servings/week) (Traditional); or 3) a Behavioral Parenting Program that reduces TV watching (< 2 hours/day) and increases low-fat milk consumption (2 servings/day) (Substitutes). Follow-up assessments on weight, height, and standardized BMI (z-BMI), the primary dependent variable, will be conducted at 3, 6, 9, and 12 months. Pediatricians will provide follow-up letters to families, regarding weight and height status, following the assessments. This pilot study allows us to determine the feasibility and efficacy of a pediatric obesity intervention that optimizes the role of the pediatrician and meets the Committee's recommendations for treatment in a primary care setting. Moreover, by comparing the effects of targeting the traditional or substitute behaviors, data will be obtained for a power analysis for a full-scale trial of the effects of these two approaches on long-term weight loss.