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Weight Gain clinical trials

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NCT ID: NCT01293825 Completed - Bipolar Disorder Clinical Trials

Ziprasidone Switching in Response to Adherence and Psychotropic-Related Weight Gain Concerns Among Patients With Bipolar Disorder (Zip Ad)

Zip Ad
Start date: January 2011
Phase: Phase 4
Study type: Interventional

Psychotropic-related weight gain is a common concern among patients with bipolar disorder (BD). This concern affects an individual's satisfaction with treatment and may lead to reduced adherence and illness relapse. Patient-focused care is attentive to patient concerns while at the same time utilizing evidence-based treatments. Ziprasidone is currently FDA approved for the maintenance treatment of BD. Ziprasidone may be associated with less weight gain compared to some alternative BD maintenance treatments. The proposed project will evaluate how switching to ziprasidone may affect patient adherence, drug attitudes, satisfaction with care and clinical outcomes (psychiatric symptoms, functional status, weight) among BD patients concerned with weight gain.

NCT ID: NCT01270451 Completed - Obesity Clinical Trials

Guidance in Diet and Physical Activity for Prevention of Weight Gain After Gastric Bypass Surgery

Start date: September 2008
Phase: N/A
Study type: Interventional

Primary Outcomes: 1. To study cross-sectional associations between diet, physical activity, T2DM and weight in subjects 2 yrs after surgery. 2. To study if subjects receiving extra guidance in diet and physical activity experience less weight gain compared to a control group. Secondary Outcomes: 3. To study the association between vit.D levels and T2DM. 4. To study the association between weight change and QOL. 5. To validate the new guidance strategy by recording food intake, energy expenditure and physical activity level. 6. To study if subjects receiving extra guidance in diet and physical activity experience other health effects compared to a control group. 7. To search for biomarkers that can identify people at risk of increasing weight post surgery

NCT ID: NCT01251887 Completed - Obesity Clinical Trials

Dietary Essential Fatty Acid Regulation of Omega-3 HUFA Metabolism; Satiety and Body Composition

Start date: November 12, 2010
Phase: N/A
Study type: Interventional

Background: - Rates of obesity have increased dramatically in recent decades, and researchers are investigating how changes in diets and physical activity have contributed to this increase. To understand how weight might be controlled, it is important to learn what kinds of dietary changes can affect hunger and might lower body weight. Essential fatty acids, for instance, are an important part of a healthy diet, but researchers have not yet determined the ideal amount of essential fatty acids that people should eat. By studying how different diets affect body chemistry and hormone levels in women who are overweight or obese, researchers hope to be able to determine better diets or treatments to help people reach and maintain an optimum healthy weight. Objectives: - To examine how certain fats in the diet affect body metabolism, hormones, and weight regulation. Eligibility: - Healthy women between 18 and 50 years of age who are overweight or obese (body mass index between 25 and 35). Design: - This study has an initial screening visit and three phases. All participants will be involved in the first two phases of the study, and some participants will be involved in the third phase. - Participants will be screened with a physical examination and medical history, in addition to blood and urine tests and questionnaires about eating habits and other diet factors. - Phase 1: Participants will have three visits to the National Institutes of Health over a 4-week period. At the visits, participants will have blood and urine tests, complete questionnaires, and have other tests including brain and body imaging studies. Participants will then be assigned to one of three study diets. - Phase 2: Participants will have a 12-week diet phase, with all foods supplied by the study researchers. Participants will keep a daily log of food and beverage intake, and will have three testing sessions with procedures similar to those performed in Phase 1. - Phase 3: Participants assigned to a particular study diet (one-third of all participants) will be given the option of continuing the diet for an additional 36 weeks (9 months), with food consumption, monitoring, and testing procedures similar to those performed in Phase 2....

NCT ID: NCT01231074 Completed - Obesity Clinical Trials

Reducing Antipsychotic-Induced Weight Gain in Children With Metformin

GFMS
Start date: February 2010
Phase: Phase 1
Study type: Interventional

Recent but limited short term studies have shown that Metformin can slow down weight gain in obese children and in children with psychotropic-induced weight gain, two distinct pediatric populations that are at risk for obesity related co-morbid conditions. The purpose of this study is to conduct a long term prospective pilot cohort study to investigate the use of Metformin to prevent or decrease weight gain in two cohorts of children: 1) children with psychotropic induced weight gain on Metformin and 2) children with BMI above the 95th percentile on Metformin. Both study populations will be enrolled in a lifestyle weight management program

NCT ID: NCT01217164 Completed - Weight Gain Preterm Clinical Trials

Strategy to Minimize In-hospital Malnutrition in Premature Babies

SPN
Start date: October 2008
Phase: Phase 0
Study type: Interventional

Adequate nutrition is important for preventing malnutrition in the postnatal period and thus optimize growth and development of children born prematurely. To avoid malnutrition is recommended to provide nutrients necessary for a growth rate similar to the intrauterine life. For nearly one decade studying how to minimize in-hospital malnutrition in children born prematurely, especially with gestational age less than 32 weeks or with birth weight below 1,500 g, called newborn very low birth weight (VLBW). Embleton et al.demonstrated that with the current nutritional recommendations (protein between 3.0 and 3.8 g / kg / day), the VLBW had malnutrition caused by protein and calorie cumulative deficit. Poor nutrition in the neonatal period can impair growth and neuromotor and cognitive development after hospital discharge. The investigators hypothesis is that VLBW subjected to aggressive nutrition with protein-calorie high from birth until discharge, would present higher weight gain than the VLBW infants who received routine diet of service, without producing adverse effects.

NCT ID: NCT01183689 Completed - Weight Gain Clinical Trials

Study of Novel Approaches for Prevention

SNAP
Start date: August 2010
Phase: N/A
Study type: Interventional

The Study of Novel Approaches for Prevention (SNAP) is randomized trial designed to test whether behavioral interventions based on self-regulation can prevent weight gain in young adults (18-35 years; body mass index (BMI) 21-30 kg/m2). Two different self-regulation interventions for weight gain prevention will be compared in this trial; one intervention will focus on making small, consistent, changes in eating and exercise behavior to prevent weight gain or reverse weight gain if it occurs, whereas the other will emphasize larger changes in eating and exercise that occur periodically, with a goal of producing weight loss and thereby providing a buffer against anticipated weight gains. The primary aim of the trial is to test whether the magnitude of weight gain from baseline across an average three-year follow-up differs across the three groups, with the hypotheses that weight gain will be greater in the Control group than in either intervention and greater in the Small Changes than Large Changes group. SNAP-E (Extension) will determine whether the effects of the intervention can be maintained over an additional 3 years (i.e. through a total of 6 years).

NCT ID: NCT01168947 Completed - Clinical trials for Fluid Overload and Hypertension in Hemodialysis Patients

Effect of Sodium Concentration of Priming and Rinsing Fluids on Weight Gain

Start date: July 2010
Phase: N/A
Study type: Interventional

Sodium loading during hemodialysis treatment is common and may contribute to increased interdialytic weight gain and hypertension. Excessive use of isotonic saline (containing 0.9% sodium chloride) is one of the factors that may cause sodium loading. During each hemodialysis session, approximately 400 mL of isotonic saline fluid, representing 1.4 grams of sodium, is used to prime and rinse the extracorporeal circuit, and is often administered to the patient. Switching to a non sodium-containing priming and rinsing fluid could allow for removal of the equivalent amount of sodium. Switching to a non sodium-containing solution for the priming and rinsing of the extracorporeal circuit can contribute to increased sodium removal during the dialysis treatment and allow for reduced interdialytic weight gain, reduced thirst, and improved blood pressure control.

NCT ID: NCT01158352 Completed - Growth Clinical Trials

Study to Evaluate the Effect of Short Treatment With Nutritional Supplementation Standardized Innovative Formula, on Growth and Weight Gain in Short and Lean Prepubertal Children

Formula
Start date: November 2010
Phase: N/A
Study type: Interventional

Study design: Double blind, randomized, placebo controlled study.The proposed study will consist of two main segments: 1. Segment 1 is aimed to assess the effect of 6-12 months treatment with nutritional supplementation standardized formula, in short and lean prepubertal children on weight SDS, height SDS, BMI SDS and growth velocity 2. Segment 2 is aimed to explore the eating behavior of idiopathic short stature and lean prepubertal children against their sibling who have a normal height and body weight and to find out whether there is a difference in eating patterns and quality of life between idiopathic short stature and lean prepubertal children and children with normal height and body weight Segment 1 Population: 200 subjects and controls will be recruited to segment 1 of the proposed study, 100 at each group. Participants will be recruited from healthy children who will be referred to either the institute for endocrinology or the gastroenterology unit, at Schneider Children's Medical Center for growth assessment, due to low height and weight, in whom, no gastrointestinal morbidity or other underlying cause was found. Methods: Randomization & Blinding: Participants will be randomly assigned either to the intervention group or the placebo control group. Randomization for the two study groups will be made in a ratio of 1:1. Both participants and study team will be blinded to the type of treatment that each patient will receive during the first 6 months of the study. Treatment: Participants in the intervention group will be treated with a nutritional supplementation standardized formula.Participants in the control group will be instructed to consume the same volume of formula as was calculated if they were in the intervention group. Treatment duration: The study will be divided into two treatment periods: 6 months of intervention versus active placebo followed with additional 6 months (an extension period), in which participants at the intervention group will be offered to extend the intervention period and participants at the control arm will be offered to switch to the intervention group. Study Schedule: Follow up visits will take place at 0, 3, 6, 9 and 12 months and will include: 1. Demographic data, medical history and growth data (month 0): Demographic parameters, including birth date, gender, birth weight and length for gestational age, medical history and growth data, including height velocity, parent's and sibling's weight and height will be documented from patient's file. 2. Nutritional assessment 3. Anthropometric assessment (months 0, 3, 6, 9 12): 1. Height without shoes 2. Length 3. Weight with light cloths and without shoes 4. MAC 5. Body mass index (BMI) will be calculated from children's weight and height and age and gender specific BMI SDS will be calculated 6. Body composition assessment using the method of bioelectrical impedance 4. Laboratory parameters (months 0, 6 and 12): 5. Sleeping Questionaire Segment 2: 86 subjects and controls will be recruited to segment 2 of the proposed study Population: Short and lean prepubertal children participating at segment 1 of the study and who are at study entry under 10th percentile in height, when the weight percentile is equal or smaller to the height percentile. Only participants from segment 1 who have siblings with normal height and body weight for age and gender, will be able to participate in segment 2 of the study Control group 1: Sibling of participants in segment 1 of the study, who have a normal height- above 25th percentile and normal BMI for age and gender- above 5th percentile and under 85th percentile. Control group 2: Healthy children from the community who have a normal height above 25th percentile and normal BMI for age and gender above 5th percentile and under 85th percentile Segment 2 of the study will be designed as a case- control study and will focus on the eating patterns, sleeping patterns and quality of life of participants at segment 1 at time 0 month of the study, before the beginning of the nutrition intervention. These findings will be compared to data of a control group, which will be comprised of siblings of participants in segment 1, with normal height and body weight which are matched in age.

NCT ID: NCT01129505 Completed - Childhood Obesity Clinical Trials

Preventing Childhood Obesity: A Two-pronged Approach Starting in Pregnancy and the First Year Postpartum

Start date: March 2009
Phase: N/A
Study type: Interventional

Our longitudinal aim is to reduce childhood obesity using our two-pronged intervention program, which includes healthy food choices and increased physical activity initiated during pregnancy and re-instated in the early period after delivery for overweight and obese women. We will accomplish this with our family-based Nutrition and Exercise Lifestyle Intervention Program (NELIP) to promote healthy family living. An intervention targeting school-aged children on the importance of healthy lifestyles occurs too late to prevent childhood obesity and establish lifelong healthy body weights. To break this spiraling cycle of generations of unhealthy body weights in Canadian children, and to reduce the risk of future obesity-related health problems, it is necessary to prevent excessive pregnancy weight gain, high blood sugars in the mother and to promote a healthy lifestyle during pregnancy and early post delivery. With our NELIP team as a cornerstone, and our pilot data already collected with promising results, we foresee an opportunity over the next 3 years to contribute to changing patient care with emphasis on disease prevention and healthy family lifestyle initiation early in life to reverse the trend of childhood obesity. With a solid research-based initiative from the lab to the community by educating health care providers, future health care can be improved by putting prevention-based programs into practice. Healthy women = healthy babies = healthy families = healthy futures!!

NCT ID: NCT01117961 Completed - Weight Gain Clinical Trials

Promoting Healthy Weight Gain During Pregnancy

Start date: March 2007
Phase: Phase 3
Study type: Interventional

Study goal is to determine whether behavioral lifestyle intervention during pregnancy can reduce the number of women who exceed the Institute of Medicine recommendations for weight gain during pregnancy. It is hypothesized that the intervention will reduce the number of women who exceed weight gain guidelines relative to standard care. The investigators also expect the intervention to reduce the proportion of women exceeding weight gain guidelines in both normal weight and overweight groups.