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Obesity clinical trials

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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: NCT03182621 Completed - Obesity Clinical Trials

Comprehensive Versus Traditional Lifestyle Program

Start date: January 2014
Phase: N/A
Study type: Interventional

Despite recommends that school-based interventions use a comprehensive approach for health promotions; most fitness programs exclusively emphasize physical activity. This study compared the comprehensive Translational Health in Nutrition and Kinesiology (THINK) program to a traditional YMCA program (The Sports, Play, and Active Recreation for Kids (SPARK) fitness curriculum) on measures of physical fitness, body composition, and executive cognitive function outcomes among 105 ethnic minority children (9±1.03 years old) following a 10-week intervention period.

NCT ID: NCT03181971 Recruiting - Obesity Clinical Trials

School Water Access, Food and Beverage Intake, and Obesity

Start date: August 1, 2016
Phase: N/A
Study type: Interventional

It is widely argued that the promotion of water consumption, as an alternative to sugar-sweetened beverages, can assist in childhood obesity prevention efforts. Yet no studies have tested this argument in real world schools where flavored milk or juices are available. This trial will fill gaps by examining how promoting fresh water intake-both in schools that do and do not provide access to caloric beverages -impacts children's consumption of food and beverages both during and outside of school, and obesity.

NCT ID: NCT03181555 Recruiting - Obesity Clinical Trials

Pilot Study: Identification of a Multi-omic Predictive Signature for Preterm Birth in Obese African American Women

Start date: August 2016
Phase: N/A
Study type: Interventional

1. Determine if the stool or vaginal microbiome and urinary metabolite profiles in a pregnant obese population of African American women differ from their pregnant non-obese counterparts 2. Determine if the stool or vaginal microbiome and urinary metabolite profiles vary by class of obesity and magnitude of excess weight gain in this population of pregnant African-American women. 3. Assess the ability of the stool, vaginal microbiome, or metabolites, or the combination of all biomarkers as predictors of preterm birth (PTB) and onset of labor. 4. Determine if any dietary or clinical variables are correlated with changes in the microbiome or urinary metabolites or modify their association with PTB

NCT ID: NCT03181321 Active, not recruiting - Obesity Clinical Trials

The First Twenty for Volunteer Firefighters

Start date: November 1, 2014
Phase: N/A
Study type: Interventional

The purpose of this study is to assess the efficacy of an internet-based firefighter health and wellness program for volunteer fire departments.

NCT ID: NCT03180580 Completed - Clinical trials for Overweight and Obesity

School Based Childhood Obesity Feasibility Study

Start date: July 2015
Phase: N/A
Study type: Interventional

In Bangladesh, the prevalence of overweight and obesity among children varies from less than 1% to 17.9% based on different reference standard. In 2014 school based country wide study has been demonstrated that among children (6-15 years of age), 9.6% were overweight and 3.5% children were obese. Childhood obesity is getting increasing attention due to its association with adult obesity and increased risk of co morbidities in adulthood. Childhood obesity is known to be an independent risk factor for adult obesity and once a child is obese, it is difficult to reverse through interventions. This suggests an urgent need to address overweight and obesity levels in childhood. The increasing trend of childhood obesity suggests urgent solution of the problem. There is no evidence of intervention for childhood overweight and obesity exists in Bangladesh. This feasibility study will be able to generate evidence for overcoming this upcoming epidemic in resource poor setting. If the proposed study will be able to address its objective that will create a possibility for developing a large cluster randomized trial in low resource setting like Bangladesh. This study will also give opportunity to our policy makers for advocating to the government of Bangladesh for adopting an obesity control policy for children. The aim of the study is to develop a school based healthy eating and active lifestyles module and assess feasibility and acceptability of the guideline in school setting. Outcome measures/variables: Healthy Eating and Active Living intervention material (Guideline, Tiffin box) Perception of children, parents and policy makers regarding obesogenic behavior Acceptance of children, parents and policy makers regarding planned intervention. Facilitators and barriers of Healthy Eating and Active Living.

NCT ID: NCT03179852 Active, not recruiting - Obesity Clinical Trials

Effects of Nutrition Education on 3rd and 5th Grade Student's Fruit and Vegetable Consumption and Knowledge

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

The primary objective is to assess pre- and post-intervention nutrition education knowledge and preference. The secondary objective is to assess pre- and post-intervention fruit and vegetable consumption via a plate waste study.

NCT ID: NCT03179657 Active, not recruiting - Obesity Clinical Trials

Guangzhou Nutrition and Health Study (GNHS)

GNHS
Start date: July 1, 2008
Phase: N/A
Study type: Observational

Purpose: The Guangzhou Nutrition and Health Study (GNHS) aims to assess the determinants of risk of osteoporosis and cardio-metabolic diseases and changes in their relevant indices in nutritional aspects, as well as other environmental and genetic factors. Study design: GNHS is a community-based prospective cohort study. Participants: About 4540 apparently healthy residents, living in Guangzhou city (South China) for >5 years, aged 40-80 years, recruited between 2008 and 2013. Visits and Data Collection: Participants were/will be visited every three years by invited to the School of Public Health, Sun Yat-sen University. At each visit, face-to-face interviews, specimen collection, anthropometric measurements, DXA scanning, ultrasonography evaluation were/will be conducted. Up to May 2017, 3400 and 2380 subjects completed the 2nd and 3rd visits. Key variables: 1. Questionnaire interviews: Structured questionnaires were/will be used to collect the participants' socio-demographic characteristics, lifestyle factors, menstruation and reproductive history (women only), sleep quality, family history, psychological health, social support and participation, cognitive function, habitual dietary intake, use of supplements and history of chronic diseases. 2. Physical examinations: Anthropometric measurements, blood pressure tests, handgrip strength, and usual gait speed. 3. DXA scanning: A dual-energy x-ray absorptiometry (DXA) was/will be used to determine bone density and bone mineral content, bone geometry information, fat mass and muscle mass. 4. Ultrasonography evaluations: Ultrasonography evaluation was/will be performed to determine carotid artery intima-media thickness and plaque, and fatty liver. 5. Specimen collections: Overnight fasting blood sample and early morning first-void urine sample and faces samples were/will be collected, separated and stored at −80°C till tests. 6. Laboratory tests: 1. Blood tests: Metabolic syndrome-related indices; inflammatory markers; sexual hormones and SHBG; genetic markers; nutritional indices (e.g., carotenoids; fatty acids; minerals, folate, betaine, choline, and vitamin D, etc.) 2. Urinary tests: Flavonoids and flavones; minerals; creatinine and renal function related markers 3. Fecal test: Gut microbiota and related metabolites. 7. Morbidity and mortality: Relevant data were/will be also retrieved via local multiple health information systems.

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.