Active clinical trials for "Pediatric Obesity"

This study will test the use of phentermine and topiramate compared with placebo in helping adolescents who are at high risk for developing obesity to lose weight

In this study, doctors want to find out more about why people who lose weight often regain the weight that they have lost once they resume a regular diet and whether hormones might play a role in weight regain. The study is divided into two parts, called the meal replacement period and the follow-up period. The meal replacement period will consist of drinking a shake for breakfast and lunch and eating a frozen meal for dinner that is calorie controlled. Individuals will also be asked to eat two servings of fruit and three servings of vegetables each day. The study will provide the shakes and the frozen entrees, participants are asked to supply the fruits and vegetables. Participation in this study will last for up to 35 weeks. There will be 10 in-person visits and 13 visits by phone or over Zoom over the 35 weeks.

This project aims to move what is currently a specialty-care model for the management of obesity of children and adolescents into the primary care setting.

Consumption of sweetened beverages, media-viewing, and physical activity patterns are often established during early childhood, and family-based obesity interventions show effectiveness in shaping healthy behaviors and weight outcomes for young children, including Latino children. Missing from these interventions, however, are methods to increase accessibility and dissemination to multiple family caregivers. The proposed work will use a randomized study design to evaluate the impact a family-based early childhood obesity intervention for Latino families that incorporates evidence-based strategies of in-person childhood obesity interventions, mobile phones, and leverages important determinants of Latino health (e.g. familism, language) in order to decrease ethnic disparities in childhood obesity and cardiovascular risk.

Obesity is a significant cause of cancer and cardiovascular disease incidence and mortality, and diabetes incidence among rural communities. Arkansas has the sixth-highest proportion of rural population (~41%),and has the third-highest obesity prevalence (37.4%) in the nation. Arkansas has the third-highest prevalence of obesity for high school students (22.1%) and the fifth-highest prevalence for children ages 10-17 (20.2%). In Arkansas, children in rural areas have very high rates of both food insecurity (26%) and free and reduced lunch eligibility (72.9%). In the study's 6 participating school districts, free and reduced lunch eligibility ranges from 51.4% to 79.3%. School meals are an important opportunity to influence students' nutritional intake and long-term food preferences, which can reduce obesity. A multidisciplinary team has partnered with 6 rural Arkansas school districts which have agreed to participate in a study to evaluate the effects of an evidence-based population-level policy intervention designed to improve the nutritional quality of food served in schools. The study team will conduct a matched-pairs cluster-randomized trial with pre-test and repeated post-tests in 6 rural Arkansas school districts, 3 implementing CSNEI, and 3 matched comparison school districts following their existing nutritional practices. Baseline data collection will take place prior to implementation (Year 1), and follow-up data will be collected annually thereafter (Years 2-5). The study will compare individual-level change in relative body mass index (adjusted for age and sex) and district-level changes in the nutritional quality of food served, amount of food consumed per diner, and fruit and vegetable intake in school districts implementing the intervention compared to matched comparison districts.

Pilot test the health system-based intervention to improve family beverage choices and promote water consumption, engaging WIC nutritionists to augment the intervention with follow-up and counseling of families at regularly-scheduled WIC appointments in a small randomized trial among 30 WIC-enrolled families.

A randomized controlled trial enrolling 900 parent-infant dyads (English and Spanish speaking) comparing Greenlight (control), a behavioral intervention focusing on nutrition, physical activity, media use, and sleep as compared to Greenlight Plus (intervention) which includes the above materials plus a health information technology (HIT) intervention aimed at supporting family goal-setting and behavior change during well-child checks throughout the first 2 years of life.

The proposed study is a randomized controlled trial to test the effectiveness of a primary care, family-centered child obesity prevention program beginning in pregnancy and continuing throughout the first three years of life compared to routine standard of care. The study aims to reduce the prevalence of obesity at age three, improve child diet composition and healthy lifestyle behaviors. Pregnant women will be enrolled from a large urban medical center serving primarily low-income immigrant Latino families. The intervention "Starting Early" will consist of three components. 1) Family Groups: interactive groups coordinated with the child's primary care visits and led by a Nutritionist/ Child Developmental Specialist. 2) Nutritional Video: a culturally-specific bilingual early nutrition video will be incorporated into family group discussions. 3) Plain Language Handouts: given to reinforce the curriculum from the family groups. The proposed research included in the funding continuation is titled: "Starting Early: Expansion of a Primary Care-Based Early Child Obesity Prevention Program". It adds three major components to the current project: 1) Following the original Starting Early cohort until age 5; 2) Developing and piloting an extended Starting Early preschool intervention for children aged 3-5 years.; 3) Developing and piloting an extended Starting Early prenatal intervention for women in the 1st trimester of pregnancy. A new cohort of 200 women in the first trimester of pregnancy will be recruited for the prenatal intervention; all women will receive the intervention in this feasibility trial. Hypothesis: Compared to controls, the intervention group will show reduced obesity and improved parent feeding knowledge and increased healthy feeding attitudes, styles and practices

Type 2 diabetes (T2D) in youth is increasing in prevalence in parallel with the obesity epidemic. In the US, almost half of patients with renal failure have DKD, and ≥80% have T2D. Compared to adult-onset T2D, youth with T2D have a more aggressive phenotype with greater insulin resistance (IR), more rapid β-cell decline and higher prevalence of diabetic kidney disease (DKD), arguing for separate and dedicated studies in youth-onset T2D. Hyperfiltration is common in youth with T2D, and predicts progressive DKD. Hyperfiltration may also be associated with early changes in intrarenal hemodynamic function, including increased renal plasma flow (RPF) and glomerular pressure. Despite the high prevalence and gravity of DKD in youth-onset T2D, widely effective therapeutic options are lacking. The investigators' preliminary data support a strong association between IR and hyperfiltration in youth-onset T2D, but the pathology contributing to this relationship remains unclear. A better understanding of the pathophysiology underlying hyperfiltration and its relationship with IR is critical to inform development of new therapeutics. The investigators' overarching hypotheses are that: 1) hyperfiltration in youth-onset T2D is associated with changes in intrarenal hemodynamics, resulting in increased renal oxygen demand, 2) the demand is unmet by the inefficient fuel profile associated with IR (decreased glucose oxidation and increase free fatty acid [FFA] oxidation), resulting in renal hypoxia and ultimately renal damage. To address these hypotheses, the investigators will measure peripheral insulin sensitivity, adipose insulin sensitivity (FFA suppression), glomerular filtration rate (GFR), RPF, and renal oxygenation in youth with T2D (n=60), obesity (n=20) and in lean (n=20) controls. To further investigate the mechanisms of renal damage in youth with T2D, two optional procedures are included in the study: 1) kidney biopsy procedure and 2) induction of induced pluripotent stem cells (iPSCs) to assess morphometrics and genetic expression of renal tissue.

Adverse influences starting in utero may predestine an individual's long- term risk for developing cardiometabolic diseases. The Keeping Ideal CVH (cardiovascular health) Family Intervention Trial (KIDFIT) will test whether preschool-age children, born to overweight/obese (OW/OB (mothers who did or did not experience a diet and lifestyle intervention to reduce GWG: 1) demonstrate more favorable adiposity (body fat %), body mass index percentiles (BMI%), diet quality (DASH diet score), physical activity, and other CVH metrics at baseline according to antenatal intervention status; and 2) respond to an early childhood intervention targeting diet and lifestyle behaviors with improvement in these same adiposity and CVH metrics. We hypothesize children randomized to the KIDFIT diet and lifestyle intervention group at age 3-5 years, regardless of initial maternal antenatal group assignment, will demonstrate more favorable adiposity changes assessed by anthropometry (body fat %/sum of skinfolds) and a lower cumulative incidence of obesity after the 12-month intervention, as compared with the control group. Additionally, after 12 months of the KIDFIT Intervention, children will have more favorable blood pressure and blood lipids, better diet quality (as measured by the DASH-style diet score), increased physical activity levels, and more optimal sleep duration, without adverse effects on height, compared to the control group