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Pediatric Obesity clinical trials

View clinical trials related to Pediatric Obesity.

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NCT ID: NCT03629119 Not yet recruiting - Obesity Clinical Trials

Dietary Fiber in Severely Obese Children - Pilot

Start date: September 2018
Phase: N/A
Study type: Interventional

The purpose of this pilot study is to assess the feasibility of a 3-month dietary fiber intervention: 1) engaging adolescents in regularly consuming a dietary fiber preparation (psyllium powder) and obtaining their parents' support, 2) recruit into a clinical pilot trial with liquid meal challenge test to study the metabolic effects of the dietary fiber preparation. A study modification will be submitted to add additional study arms for feasibility (strength training, coaching).

NCT ID: NCT03628937 Not yet recruiting - Pediatric Obesity Clinical Trials

The Effect of Decaffeinated Green Tea Polyphenol Intake on the Risk of Precocious Puberty Among Obese Girls

Start date: August 30, 2018
Phase: N/A
Study type: Interventional

In this study, 7-10 years old obese girls will be recruited to test the preventive effect of decaffeinated green tea polyphenols on the risk of precocious puberty by the random, placebo-control and single blind design. The intervention group will be given decaffeinated green tea polyphenols capsule (400mg/d) and the control group will be given placebo. The oral treatment will be lasted for 12 weeks.Then all the subjects will be followed up every 3 months until three months after menstruation. At the baseline and after the 12 week intervention, the clinical manifestations of secondary sexual characters, the serum levels of sex hormones will be determined as the outcome variables. After controlling confounding factors, the preventive effect of the green tea polyphenols on precocious puberty or early puberty among obese girls will be analyzed.

NCT ID: NCT03624582 Recruiting - Childhood Obesity Clinical Trials

Shape Up Kids Fitness Ancillary

Start date: July 2, 2018
Phase:
Study type: Observational

The overall objective of this study is to quantify the decision-making process and underlying biases around leisure activity behaviors using the Activity Preference Assessment (APA), a novel psychological task. The investigators plan to validate the APA against objectively measured sedentary and physical activity time, and examine its potential to predict health-related outcomes in children and adolescents. The Shape Up Kids Fitness Ancillary protocol will add exercise testing, cognitive and behavioral measures, accelerometry, and questionnaires to the existing Shape Up Kids primary study dataset.

NCT ID: NCT03622086 Enrolling by invitation - Health Behavior Clinical Trials

Foundations of Fitness Program Pilot

Start date: July 12, 2018
Phase: N/A
Study type: Interventional

Approximately 17% of US children have obesity resulting in significant childhood co-morbidities and increased lifetime risk of adult obesity, diabetes, cardiovascular disease and cancer. Guidelines recommend intensive lifestyle programs as first-line treatment, yet few pediatric practices are equipped to provide this. Clinical-community partnerships are well-positioned to address this care gap. This proposal aims to assess whether a community-delivered lifestyle program offered in adjunct to primary care obesity management is feasible, acceptable, effective, and easily implemented in a rural care setting. In this study, approximately 40 children aged 7-13 years old and their caregiver pairs will be recruited from a primary care pediatric clinic. Child-adult dyads will participate in a 24-week program that includes 2 phases, a 12-week usual care phase and a 12-week intervention phase. The intervention phase will include bi-weekly meetings of a community intensive lifestyle program which focuses on healthy diet, daily physical activity, self-esteem and support for individual and family behavior change. A mixed-methods approach using qualitative interviews and study questionnaires, combined with objective measures of adiposity and fitness will assess study outcomes.

NCT ID: NCT03620773 Not yet recruiting - Obesity Clinical Trials

Impact of Metabolic Surgery on Pancreatic, Renal and Cardiovascular Health in Youth With Type 2 Diabetes

IMPROVE-T2D
Start date: September 2018
Phase: Phase 1/Phase 2
Study type: Interventional

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. Early DKD is characterized by changes in intrarenal hemodynamic function, including increased renal plasma flow (RPF) and glomerular pressure with resultant hyperfiltration, is common in Y-T2D, and predicts progressive DKD. Studies evaluating the two currently approved medications for treating T2D in youth (metformin and insulin) have shown these medications are not able to improve β-cell function over time in the youth. However, recent evidence suggests that bariatric surgery in adults is associated with improvements in diabetes outcomes, and even T2D remission in many patients. Limited data in youth also supports the benefits of bariatric surgery, regarding weight loss, glycemic control in T2D, and cardio-renal health. While weight loss is important, the acute effect of bariatric surgery on factors such as insulin resistance likely includes weight loss-independent mechanisms. A better understanding of the effects of bariatric surgery on pancreatic function, intrarenal hemodynamics, renal O2 and cardiovascular function is critical to help define mechanisms of surgical benefits, to help identify potential novel future non-surgical approaches to prevent pancreatic failure, DKD and cardiovascular disease. The investigators' overarching hypotheses are that: 1) Y-T2D is associated with IR, pancreatic dysfunction, intrarenal hemodynamic dysfunction, elevated renal O2 consumption and cardiovascular dysfunction which improve with bariatric surgery, 2) The early effect of bariatric surgery on intrarenal hemodynamics is mediated by improvement in IR and weight loss. To address these hypotheses, the investigators will measure GFR, RPF, glomerular pressure and renal O2, in addition to aortic stiffness, β-cell function and insulin sensitivity in youth ages 12-21 with T2D (n=15) before and after vertical sleeve gastrectomy (VSG).

NCT ID: NCT03615274 Recruiting - Obesity Clinical Trials

Executive Function Training in Childhood Obesity: Food Choice, Quality of Life and Brain Connectivity

TOuCH
Start date: February 2, 2018
Phase: N/A
Study type: Interventional

This study evaluates if executive function training in obese children can improve food-related choices and produce cognitive and neuroimaging changes, but also improve psychological and physical status and quality of life measures.

NCT ID: NCT03612479 Enrolling by invitation - Pediatric Obesity Clinical Trials

Response of the Gut Microbiome and Circulating Metabolome to Diet in Children: Ancillary Study to KIDFIT (NCT03405246)

Start date: July 10, 2018
Phase: N/A
Study type: Interventional

This is an ancillary study to KIDFIT (NCT03405246). KIDFIT tests whether preschool-age children, born to overweight or obese mothers, respond to a healthy DASH diet intervention with better cardiovascular health. This ancillary study to KIDFIT investigates how the children's gut microbiomes (bacteria in the intestines) and blood metabolomes (small molecules in the blood) are affected by the DASH diet intervention, and how the microbiome and metabolome relate to the children's cardiovascular health over time. The investigators hypothesize that (1) the DASH diet will modify the gut microbiome and blood metabolome, (2) the gut microbiome and blood metabolome will be related to each other, and (3) the microbiome and metabolome will be associated with the children's cardiovascular health profiles (things like weight, body fat, blood pressure, and cholesterol).

NCT ID: NCT03611660 Recruiting - Pediatric Obesity Clinical Trials

Does Mindfulness Enhance BMI in Obese Adolescents Enrolled in the Bright Bodies Weight Management Program?

Start date: January 11, 2018
Phase: N/A
Study type: Interventional

Participants will be randomized to an evidence-based healthy lifestyle program alone or a healthy lifestyle program with mindfulness meditation added. The purpose of the study will be to determine if mindfulness improves BMI outcomes more than the program alone due to the stress-reduction benefits of mindfulness.

NCT ID: NCT03611296 Active, not recruiting - Childhood Obesity Clinical Trials

Translational Investigation of Growth and Everyday Routines in Kids (TIGER Kids) Fitness Ancillary

Start date: June 6, 2017
Phase:
Study type: Observational

The purpose of this ancillary study is to examine cardiorespiratory fitness, cognitive factors related to appetite, and objectively-measured food intake in a subsample of children and adolescents with overweight to severe obesity enrolled in the TIGER Kids prospective cohort. The primary study also collects data on habitual physical and sedentary activity, body weight and body composition, and cardiometabolic health markers.

NCT ID: NCT03601299 Recruiting - Obesity Clinical Trials

Back to Basics: Addressing Childhood Obesity Through Traditional Foods in Alaska

Start date: May 14, 2018
Phase: N/A
Study type: Interventional

Back to Basics is a mixed-methods intervention trial to reduce the prevalence of obese Alaska Native children by increasing the proportion of nutrient-dense traditional and non-traditional foods consumed, and decreasing consumption of sugar-sweetened beverages (SSBs). This 5-year intervention trial targeting 0-5 year olds is conducted in partnership with Rural Community Action Program, Inc. (RCAP) Head Start (HS), Early Head Start (EHS), and Parents as Teachers (PAT) programs in 12 rural Alaskan communities in the Yukon-Kuskokwim (YK) region, where each site is assigned to either a 9-month nutritional education and meal program intervention or a standard education and meal program repeating annually. This intervention trial aims to increase consumption of local traditional foods and nutrient-dense non-traditional foods, decrease SSB consumption, and decrease prevalence of obesity in children 3-5 years old by: (1) adjusting the nutritional content of existing meal services provided by RCAP to children ages 3-5 years; (2) providing culturally relevant nutrition education to families of children 0-5 years; (3) developing local and community driven initiatives that provide knowledge and skills and engage families in the gathering and preparing of local traditional foods; and (4) incorporating available and emerging resources (e.g. Fish/Farm-to- Schools) to increase integration of traditional foods into the diet. Phase 1 involves the collection and analysis of formative and baseline data to help guide the intervention in Phase 2. Phase 1 includes: 1. Gathering baseline height/weight and food/SSB consumption data previously collected on children ages 0-5 years enrolled in YK RCAP programs. 2. Conducting formative studies in the 12 YK communities to better understand attitudes towards childhood obesity and barriers/enablers to traditional foods consumption 3. Creating/integrating a traditional foods-focused nutrition curriculum into RCAP menu programs in YK communities. 5. Work to expand the "Fish to Schools" and "Farm to Preschool" programs into YK RCAP HS programs. Phase 2 includes implementing: 1. A physical activity curriculum in HS programs in all communities 2. A traditional food in HS menu program in intervention communities 3. A home-based nutrition program in intervention communities 4. A mechanism to document traditional foods important to each community