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Weight Gain clinical trials

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NCT ID: NCT00191828 Completed - Weight Gain Clinical Trials

A Study on Induced Weight Gain During Atypical Antipsychotic Treatment and Its Management With Psychoeducational Programme

Start date: March 2003
Phase: Phase 4
Study type: Interventional

Olanzapine is an atypical antipsychotic agent indicated for the treatment of schizophrenia and moderate to severe manic episode. Olanzapine is among the many antipsychotic agents associated with weight gain . The mechanism for antipsychotic drug-related weight gain is not known, although antagonism of serotonin receptors, especially the 5HT2C , and histamine receptors has been hypothesized. The purpose of this study is to observe the efficacy of a psychoeducational programme in managing the increased weight as a side effect of the olanzapine treatment. Interventions to prevent weight gain associated with olanzapine should at least include periodic monitoring and recommendations for changes in diet and physical activity. This is a phase IV, randomised, parallel study of subjects previously treated with olanzapine as antipsychotic monotherapy, which have shown an increase of B.M.I. >7% from the beginning of antipsychotic treatment (assessed during the routine visits). For the first 12 weeks of the trial approximately 60 outpatients, enrolled in one site during a period of one year, will be randomised in a 1:1 ratio into 2 treatment groups: olanzapine + psychoeducational programme or olanzapine alone. In the following 12 weeks of the study all patients undergo the psychoeducational programme. The efficacy of this programme will be assessed monitoring the mean difference from baseline to endpoint in total body weight and BMI.

NCT ID: NCT00177502 Completed - Weight Loss Clinical Trials

Effect of Exercise on Prevention of Weight Gain

Start date: January 2003
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to examine the dose-response of exercise on prevention of weight gain in overweight adults.

NCT ID: NCT00137280 Completed - Schizophrenia Clinical Trials

Implementing Effective, Collaborative Care for Schizophrenia (EQUIP-2)

EQUIP-2
Start date: June 13, 2007
Phase: N/A
Study type: Interventional

This project evaluates the implementation and effectiveness of a care model to improve treatment for schizophrenia within the context of diverse VA practices and priorities. The project provides information to VA clinicians and managers about Veterans with schizophrenia or schizoaffective disorder who are overweight and/or who would like to return to competitive work. The project facilitates reorganization of care practices in order to get veterans needed and desired services around wellness and work. The project creates a platform that other clinical and research interventions can build upon to improve care, and is designed to inform a national strategy for implementing evidence-based care in schizophrenia.

NCT ID: NCT00129246 Completed - Smoking Clinical Trials

Low-Dose Naltrexone Combined With Bupropion to Stop Smoking With Less Weight Gain

Start date: December 2004
Phase: Phase 1/Phase 2
Study type: Interventional

This study will test a combination of the drugs naltrexone and bupropion with weight-concerned smokers to investigate whether or not this combination of drugs improves smoking cessation quit rates and minimizes post quit weight gain.

NCT ID: NCT00122213 Completed - Weight Gain Clinical Trials

A Physical Activity and Diet Program to Prevent Accumulation of Abdominal Fat Mass in Recently Retired Men and Women

Start date: September 2003
Phase: Phase 2
Study type: Interventional

Advancing age in itself is associated with changes in body composition. However, during transitional life stages, such as retirement, detrimental changes on diet and physical activity may occur. This might lead to weight gain and accumulation of abdominal fat. To prevent these changes, participants receive a low-intensity intervention on energy balance and related behaviours. After six months, one and two years, the effects will be studied by comparing the intervention group with the control group.

NCT ID: NCT00119821 Completed - Obesity Clinical Trials

Strategies to Reduce Weight Gain in Hypertensive Smokers

Start date: September 2004
Phase: N/A
Study type: Interventional

To evaluate the effectiveness of lifestyle modification following a smoking cessation program in preventing weight gain among hypertensive smokers placed at medical risk by the post-cessation weight gain.

NCT ID: NCT00119574 Completed - Clinical trials for Schizoaffective Disorder

Evaluating a Collaborative Care Model for the Treatment of Schizophrenia (EQUIP)

Start date: January 2002
Phase: N/A
Study type: Interventional

Policy makers and consumers are increasingly concerned about the quality and efficiency of care provided to individuals with severe, chronic illnesses such as schizophrenia. These illnesses are expensive to treat and present significant challenges to organizations that are responsible for providing effective care. Occurring in 1% of the United States population, schizophrenia accounts for 10% of permanently disabled people, and 2.5% of all healthcare expenditures. Clinical practice guidelines have been promulgated. Schizophrenia is treatable and outcomes can be substantially improved with the appropriate use of antipsychotic medication, caregiver education and counseling, vocational rehabilitation, and assertive treatment. However, in the VA and other mental health systems, many patients with schizophrenia receive substandard care. Methods are needed that improve the quality of usual care for this disorder while being feasible to implement at typical clinics. To date, most efforts to improve care for schizophrenia have focused on educating clinicians or changing the financing of care, and have had limited success. We believe a more fundamental approach should be tried. While there are many potential strategies, experience in chronic medical illness and mental health support the efficacy of specific approaches. Collaborative care models are one such approach. They are a blueprint for reorganizing practice, and involve changes in division of labor and responsibility, adoption of new care protocols, and increased attention to patients' needs. Although collaborative care models have been successful in other chronic medical conditions, they have not yet been studied in the treatment of schizophrenia. We have developed a collaborative care model for schizophrenia that builds on work in other disorders, and includes service delivery approaches that are known to be effective in schizophrenia. The model focuses on improving treatment through assertive care management, caregiver education and support, and standardized patient assessment with feedback of information to psychiatrists. This project, "EQUIP" (Enhancing Quality Utilization In Psychosis) is implementing collaborative care and evaluating its effectiveness in schizophrenia.

NCT ID: NCT00072917 Completed - Obesity Clinical Trials

The Effects of Overfeeding on Obesity-Prone (OP) and Obesity-Resistant (OR) Women

Start date: October 2003
Phase: N/A
Study type: Observational

This is a longitudinal cohort study of how the responses to a 3 day period of controlled overfeeding relate to subsequent weight gain. We hypothesize that thin individuals are resistant to weight gain because they respond to periods of overfeeding by increasing fat oxidation, reducing food intake, and increasing physical activity relative to those who gain weight over time.

NCT ID: NCT00044187 Completed - Schizophrenia Clinical Trials

The Assessment of a Weight-Gain Agent for the Treatment of Olanzapine-Associated Anti-Obesity Agent in Patients With Schizophrenia, Schizophreniform Disorder, Schizoaffective Disorder, and Bipolar I Disorder

Start date: April 2001
Phase: Phase 4
Study type: Interventional

Olanzapine is currently marketed for the treatment of schizophrenia and acute manic episodes with bipolar 1 disorder. This Anti-obesity Agent is currently marketed for the management of obesity. In this study, the Anti-obesity Agent is being tested to see if it can treat weight gain that may be associated with taking olanzapine. The purposes of this study are to determine the safety of olanzapine when given in combination with the Anti-obesity Agent and any side effects that might be associated with it and whether weight-gain agent can help treat weight gain that may be associated with taking olanzapine.

NCT ID: NCT00029198 Completed - Premature Birth Clinical Trials

Preterm Infants' Weight Gain Following Massage Therapy

Start date: April 2003
Phase: Phase 3
Study type: Interventional

The specific aims of this study are: 1) to replicate the data that following ten days of massage therapy, preterm infants show greater daily weight gain and are discharged from the hospital earlier than the controls, thus demonstrating the cost-effectiveness of the intervention; 2) to test a model on two potential underlying mechanisms for weight gain including a) enhanced vagal activity leading to greater gastric motility, higher levels of insulin, IGF-1, and oxytocin and lower cortisol levels in the massage versus the control infants at the end of the study; and/or b) increased physical activity and its associated increase in heart rate oxygen consumption and temperature leading to greater weight gain. These pathways (vagal activity and physical activity) will be tested by path analyses. Determining underlying mechanisms for the massage therapy/weight gain relationship is a critical process required by the neonatology community for massage therapy to be adopted as a standard neonatal intensive care unit.