
The Effect of the Oligofructose Supplementation on Body Weight in Overweight and Obese Children...
ObesityThis study is designed to assess the effect of oligofructose administration for 12 weeks on Body Mass Index (BMI) of overweight and obese children.

Endoscopic Suturing for Primary Obesity Treatment
ObesityBody Weight1 moreGastric restriction is an important principle of both roux-en-Y gastric bypass and laparoscopic adjustable gastric banding. The FDA cleared OverStitch Endoscopic Suturing System (Apollo Endosurgery, Austin, TX) offers the physician the ability to restrict gastric size by approximating tissue endoluminally via an incisionless/per-oral approach. The use of this system has the potential to reduce the complications associated with current surgical approaches while effecting the desired gastric restriction. The primary objective is to collect data on the use of the OverStitch Endoscopic Suturing System (Apollo Endosurgery, Inc. Austin, Texas) for gastric tissue approximation during primary gastric restrictive procedures.

Method-of-Use Study Assessing the Effect of Naltrexone Sustained Release (SR)/ Bupropion SR on Body...
ObesityOverweightThe purpose of this Phase 3b study is to assess the effects of combination therapy with naltrexone SR/bupropion SR (NB) used in conjunction with a comprehensive lifestyle intervention (CLI) and in a manner consistent with its intended use after marketing approval, on body weight and cardiovascular risk factors compared to the effects of Usual Care in subjects who are overweight with dyslipidemia and/or controlled hypertension or obese. Subjects in the NB and CLI group are required to undergo an evaluation to continue treatment at Week 16. Subjects are to be discontinued from full participation if they do not lose at least 5% of their body weight relative to baseline and/or are experiencing sustained increases in blood pressure (systolic or diastolic) of ≥10 mmHg above baseline. At Week 26, subjects originally assigned to Usual Care switch to treatment with NB and CLI, and subjects assigned to NB and CLI continue treatment for the duration of the study (78-weeks treatment period).

Families Improving Together (FIT) for Weight Loss
OverweightObeseThe increasing rate of obesity has become a major public health concern with national reports indicating 40% of African American adolescents are now overweight/obese. Little is known about effective weight loss interventions in ethnic minority adolescents. However, research has shown that ethnic minorities attend fewer intervention sessions, have higher attrition rates and lose less weight compared to Caucasians. Two fundamental problems related to this lack of progress are 1) lack of appropriate content of weight loss interventions for African American adolescents that integrate cultural issues, parenting skills, and motivational strategies for long-term change and, 2) poor dose of weight loss interventions because of participant fatigue and drop out. While previous weight loss studies for adolescents have been long lasting (12-25 weeks), our team developed a weight loss program that is a relatively brief (8-week) face-to-face intervention that integrates motivational (autonomy-support) and positive parenting skills (monitoring, social support, positive communication skills) for reducing z-BMI in overweight African American adolescents. Our team recently conducted a pilot study testing the feasibility of an 8-week on-line culturally tailored intervention, Thus, the goal of this project is to conduct a randomized controlled efficacy trial to address the problems with past studies by 1) making the face-to-face group intervention shorter, 2) using an on-line component to compliment the group-based intervention for increasing dose, and by 3) tailoring a motivational and parenting skills program directly to parents and adolescents skill levels and cultural background. 520 overweight African American adolescents and their parents will be recruited to participate. Phase I of the trial will test the efficacy of an 8-week face-to-face group randomized trial comparing motivational plus family-based weight loss (M+FWL) to a basic health (BH) education program on reducing z-BMI and improving diet and physical activity (PA) in overweight African American adolescents. In phase II of the trial participants will be re-randomized to either an 8-week on-line intervention or a control on-line program resulting in a 2 (M+FWL vs. BH group) x 2 (intervention vs. control on-line program) factorial design. A 6-month follow-up will examine whether adolescents in the 8-week M+FWL group plus 8-week on-line intervention program will show the greatest maintenance in reducing z-BMI.

Physical Activity Referrals to the Community
OverweightObesityThe purpose of this study is to determine the impact of primary care referrals to community physical activity programs for overweight and obese youth aged 6-18 years on objectively measured physical activity and cardiorespiratory fitness, as well as other cardiovascular health indicators. We hypothesize that physical activity referrals will result in higher levels of physical activity and fitness.

Timing of Meals for Weight Loss
OverweightObesity1 moreWhile eating the majority of energy earlier in the day appears to have a positive effect on weight and cardiometabolic outcomes, it is not clear how eating earlier in the day influences other behaviors that have a circadian rhythm (sleep), other energy balance behaviors important for weight loss (physical activity), and self-reported feelings of appetite control (hunger and fullness). Thus the purpose of this study is to examine the influence of timing of eating on sleep patterns, physical activity, and self-reported feelings of appetite control. It is hypothesized that those who eat the majority of their calories earlier in the day will have greater weight loss than those who eat the majority later in the day.

A Technology-Based Intervention for the Reduction of Overweight and Obesity Among College Students...
Overweight and ObesityThe purpose of this study is to determine the feasibility and acceptability and efficacy of a two month technology-based weight loss program for overweight and obese college students.

A Study to Assess the Effect of Diets With Different Protein Composition - Mainly Coming From Lean...
Weight LossObesity4 moreThe objective of the study is to assess the effect of diets with different protein composition (20%, 27% and 35%), mainly coming from animal proteins such as lean red meat, on body weight and lipid profile in overweight and obese women. A dietary intervention is carried out during 3 months in 90 women who are individually randomized to an hypocaloric diet with three types of macronutrient composition: 1) 35% proteins, 30% fat and 35% carbohydrates; 2) 27% proteins, 30% fat and 43% carbohydrates and 3) 20% proteins, 30% fat and 50% carbohydrates. Around 50% of total proteins in diet come from lean red meat (leg or shoulder of lamb) by providing up to 15 different recipes to participants to use them as part of the diet. At the beginning of the study, after 6 weeks and at the end of the intervention, the following parameters are determined: anthropometric (weight, waist circumference, body mass index and body composition), blood pressure, dietary (72-hours dietary registry) and exercise assessments and biochemical analysis (total cholesterol, triglycerides, HDL cholesterol, LDL cholesterol, apolipoprotein A1, apolipoprotein B, iron, transferrin, ferritin, uric acid, glucose, HbA1c, insulin and adipokines). In 3-months visit, participants will be advised to follow the prescribed diets during the next 3 months. Monitoring visits with the nutritionist will not be performed. A follow-up visit will be done after 3-months of end of intervention (at 6-months after beginning the study) to assess the long-time efficacy on main endpoint of each diet. In this visit only anthropometric parameters (weight, waist circumference, body mass index and body composition) will be determined.

Effects of Obex in Overweight and Obese Patients
OverweightObesityObesity is an important and growing public health worldwide Obesity is highly related to the development of metabolic syndrome, diabetes, cardiovascular diseases and cancer An extensive body of evidence from efficacy trials has shown that weight loss is achievable, however, a modest weight loss is achieved in a small proportion of patients Important adverse events have been reported with the use of antiobesity drugs. The use of natural products with potential effects inducing weight loss is an alternative strategy for treating patients with overweight and obesity. However, efficacy and safety should be evaluated in RCT. Obex combines different molecules with potential effects inducing weight loss and control on metabolic parameters such as fasting glucose, cholesterol and triglycerides. Therefore, the administration of Obex in overweight and obese patients with impaired fasting glucose could be an excellent strategy to induce weight loss and ameliorate the metabolic disturbances related to obesity and overweight.

Effects of a Health-At-Every-Size Approach on Weight Management in Premenopausal Overweight Women...
OverweightThe purpose of this study is to measure the effects of a Health-At-Every-Size (HAES) approach on global health status of premenopausal overweight women preoccupied about their weight and who have been unsuccessful in previous weight loss attempts.