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Obesity clinical trials

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NCT ID: NCT03196791 Not yet recruiting - Obesity Clinical Trials

Compare the Oncological Benefit of Deep Neuromuscular Block in Gastric Cancer Obesity Patient

Start date: June 30, 2017
Phase: N/A
Study type: Interventional

This study is designed to evaluate the impact of muscle relaxation during laparoscopic gastrectomy on oncological benefit, especially with obese patients over BMI 25. The primary endpoint is number of harvested lymph node that is critical point regarding quality of surgery in gastric cancer treatment. The secondary endpoint is intraoperative bleeding, surgeons' satisfaction. The patients were randomly assigned to two groups using a computer-generated randomization table : 196 persons - Deep neuromuscular block group (98persons) - Moderate neuromuscular group (98persons)

NCT ID: NCT03195790 Not yet recruiting - Childhood Obesity Clinical Trials

Creating Healthy Environments for Chicago Kids

CHECK
Start date: July 2017
Phase: N/A
Study type: Interventional

Pediatric obesity interventions for low-income populations are increasingly delivered in children's homes, which may make treatment more accessible to families and enhance the potency of the intervention in several ways. This randomized trial will directly test whether delivering family-based behavioral interventions for pediatric overweight/obesity in the home setting improves weight loss outcomes in low-income children relative to medical center-based treatment. The trial will also quantify the cost-effectiveness of home visitation, and explore the mechanisms accounting for observed treatment effects

NCT ID: NCT03190993 Not yet recruiting - Obesity Clinical Trials

The DEB Pilot Study

DEB Pilot
Start date: June 26, 2017
Phase: N/A
Study type: Interventional

The purpose of the current study is to test if weight change is differentially affected by consumption of foods that are identical in carbohydrate (i.e. sugar) but vary in food form over 1 month.

NCT ID: NCT03186885 Not yet recruiting - Obesity Clinical Trials

Healthy Frio: A Rural Community Partnership to Advance Latino Obesity Research

Start date: October 16, 2017
Phase: N/A
Study type: Interventional

Much has been learned about the efficacy and effectiveness of comprehensive healthy lifestyle interventions to reduce obesity. Few studies have been translated into rural settings or among Latinos. Y Living is an evidence-based family-focused intervention (FI) designed for urban Latino families. The FI is a 12-week behavioral modification program grounded in social cognitive theory, designed to engage the whole family in lifestyle changes by developing knowledge and skills in physical activity and healthy eating, building skills in goal-setting and self-monitoring, and creating a supportive home environment. Researchers will engage community partners in formative research to adapt the current FI for rural Latino families. Two parallel delivery methods of the FI will be developed and tested: 1) in-person group setting at a community center (FI-IP) and 2) home-based delivered remotely with technology (FI-RT). Both will be designed to address the unique social, cultural and environmental factors facing rural Latino families. The FI-RT will take advantage of innovative modern technology and e-Learning to increase program availability, accessibility and participation in rural settings. Researchers will conduct a 3-arm randomized controlled trial (RCT) to compare effectiveness of the two delivery approaches on weight loss (primary outcome) and energy balance behaviors (secondary outcomes) among obese Latino parent-child pairs versus control. The researchers will recruit 270 obese Latino adults (ages 21-65) with a child (ages 8-17) from three primary care practices in rural South Texas. These parent-child pairs will be randomized to one of three arms stratified by clinic: 1) FI-IP (n=90); 2) FI-RT (n=90); or 3) control group (n=90). Primary specific aims are to: 1) Conduct community-engaged formative studies to transform the existing FI into two unique delivery methods (FI-IP and FI-RT) for use in a subsequent RCT in a rural Latino community; and 2) Conduct a RCT to evaluate the comparative effectiveness of FI-IP and FI-RT to address weight loss (primary outcome) and energy balance behaviors (secondary outcomes) among obese rural Latino adults compared with adult participants in control group at immediate post intervention (3 months), after a 3-month maintenance program (6 months post randomization) and a 6-month follow-up (12 months post randomization). A secondary aim is to examine the impact of FI-IP and FI-RT children's weight and energy balance behaviors.

NCT ID: NCT03186508 Not yet recruiting - Obesity Clinical Trials

Enhancing Sleep Duration: Effects on Children's Eating and Activity Behaviors-Renewal

Start date: July 1, 2017
Phase: N/A
Study type: Interventional

Enhancing children's sleep may be a novel approach for prevention of obesity and cardiovascular (CV) disturbance. Observational studies with children demonstrate that short sleep increases risk of obesity and other CV risk factors. Randomized controlled trials with children 8-11 years old demonstrate that enhancing sleep duration leads to positive changes in eating and activity behaviors and weight status, particularly for children who enhance their sleep the most. Enhancing sleep may be particularly important for racial minority children and those from lower socioeconomic backgrounds given their increased risk for short sleep, obesity and CV risk factors. In this study two active obesity preventive interventions will be evaluated: a) enhancing sleep alone (Optimize Sleep [OS]), and b) enhancing sleep along with eating and activity behaviors that have demonstrated efficacy for obesity prevention and are implicated in self-regulatory pathways related to sleep (i.e., energy dense snack foods and beverages, TV viewing, and physical activity) (OS-Plus). Two hundred four children 8-11 years old who are African American/black, primarily from low socioeconomic backgrounds, and who sleep < 9.5 hours/night into a 12-month study will be enrolled. Children will be randomly assigned to either OS or OS-Plus. Over the 6-month treatment phase, all children will attend an 8-session treatment; monthly phone contacts will occur during maintenance (6-12 months). Primary aim is to determine the efficacy of OS-Plus relative to OS on change in body mass index z-score (BMIz) at end of treatment. Secondary aims will assess efficacy of OS-Plus relative to OS on additional cardiometabolic risk factors, eating and activity behaviors. Exploratory aims will assess maintenance of effects at 12 months.

NCT ID: NCT03177148 Not yet recruiting - Pediatric Obesity Clinical Trials

Population Effects of MI on Pediatric Obesity in Primary Care

BMi2+
Start date: July 21, 2017
Phase: N/A
Study type: Interventional

In this cluster randomized effectiveness trial, pediatric primary care practices will be recruited from the American Academy of Pediatrics' national Pediatric Research in Office Settings (PROS) practice-based research network, as well as the client database of the Physician's Computer Company (PCC) - an Electronic Health Record (EHR) vendor. We will recruit 18 practices. 9 practices will be randomized to the Intervention arm and 9 practices to Usual Care. Intervention arm practices will select 1-2 pediatric clinicians to receive in-person training in Motivational Interviewing (MI), behavioral therapy, billing and coding, and study procedures. Usual Care practices will select 1-2 pediatric clinicians to receive billing / coding and study protocol training only, via telephone and webinar; they will be offered in-person MI training at the close of the trial. Around 316 parents of overweight or obese children (BMI > 85th percentile for age and gender) between 3 and 8 years of age at baseline that are patients of participating Intervention arm clinicians will be enrolled. Over 24 months, these parents may receive up to 4 in-person, MI-based counseling sessions with a trained pediatric clinician and up to 6 telephone counseling sessions with an MI-trained Registered Dietician (RD). There will be no study-specific contact with parents or their children in Usual Care practices during the trial - they will continue to receive usual care. EHR and billing data for all 3-8 year old children within all participating practices will be extracted by PCC to permit determination of the effectiveness of the intervention versus usual care on change in BMI z-score among 3 groups: 1) all eligible children in the Intervention arm), 2) all eligible children whose parent actively participates in the trial , and 3) all 3-8 year old children in all participating practices.

NCT ID: NCT03175601 Not yet recruiting - Sarcopenic Obesity Clinical Trials

Sleep Disturbances and Biomarkers of Sarcopenic OBesity

SleSOB
Start date: June 2017
Phase: N/A
Study type: Observational

The general objective of this study is to identify biomarkers of sleep quality, sarcopenia, insulin resistance, oxidative stress and inflammation associated with prefrailty in middle-aged and elderly obese subjects through the integrated study of sleep patterns, functional cardiovascular testing, olfactory function and circulating molecules. Results from the SleSOB study will contribute to identify molecular and functional determinants of prefrailty, to allow early targeted interventions and will have important implications for empowerment of elderly citizens to self-management of preventive measures and healthy lifestyle.

NCT ID: NCT03171415 Not yet recruiting - Obesity Clinical Trials

Evaluation of Safety, Efficacy and Thermogenesis-induction of RZL-012 in Overweight and Obese Volunteers

Start date: June 2017
Phase: Phase 2
Study type: Interventional

Obesity is a direct result of food-intake in excess of body energy expenditure. Thus, induction of increased energy expenditure via the activation of thermogenesis at targeted anatomical sites can counterbalance obesity. This trial aims to study RZL-012, a novel compound, in treating obesity by activating thermogenesis in subcutaneous fat.

NCT ID: NCT03170700 Not yet recruiting - Obesity, Childhood Clinical Trials

Online Videos and New Feeding Content to Enhance a Current EFNEP Program

Start date: September 2017
Phase: N/A
Study type: Interventional

The goal of this study is to further increase the impact of a validated and widely-used Eating Smart • Being Active EFNEP curriculum by teaching parents responsive feeding practices resulting in the development of healthier patterns of child eating behavior and food intake. Additionally, the effectiveness of two delivery strategies for adding feeding video-based content will be examined (in-person versus online lessons).

NCT ID: NCT03163264 Not yet recruiting - Obesity Clinical Trials

The Move Toward Your Goals Intervention

MTG
Start date: October 1, 2017
Phase: N/A
Study type: Interventional

The MTG intervention uses a new MTG software tool delivered on tablets to facilitate 5As-based weight management counseling with a health coach and the VA PACT healthcare team to promote goal-setting, behavior change, and weight loss in the primary care (PC) setting. The MTG intervention also includes 10-15 health-coaching calls to the patient over 12 months. As part of a cluster-randomized controlled study, the investigators will randomize 10 PACT teams at the Brooklyn VA to receive either the MTG Intervention or an Enhanced Usual Care control. The primary aim of the study is to explore differences in feasibility, acceptability, and intermediate, behavioral, and weight loss outcomes at 3, 6 and 12 months of 520 patients recruited from the randomized PACTs. Objective: 1) Explore the feasibility and impact of this intervention on intermediate, behavioral, and weight loss outcomes at 3, 6 and 12 months post-intervention when compared to enhanced usual care.