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Obesity, Childhood clinical trials

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NCT ID: NCT05700409 Recruiting - Obesity, Childhood Clinical Trials

Evaluating a Telemedicine-based Intensive Treatment Program for Children and Adolescents With Obesity

Start date: January 1, 2023
Phase: N/A
Study type: Interventional

The study objective is to evaluate whether a novel telemedicine-based intensive treatment program for children with obesity is superior to standard on-site care. This will be a randomized, non-blinded (due to the nature of the intervention) study, where 100 children and adolescents aged 10-18 years with obesity will be divided in a 1:1 ratio to either telemedicine or on-site treatments for 6 months. The telemedicine arm will include 30, mostly video, consultations for each participant: 3 physician appointments, 7 exercise consultations by our exercise physiologist, 10 dietary consultations by our pediatric dietitian, and 10 psychologist consultations to assist with goal setting and overall well-being. Three visits will be conducted in-office, for physician assessment, smartphone technical assistance and physical measurements (baseline, at 3 months and at the end of the 6-month period). Participants randomized to the telemedicine arm will have a step-counting rewarding app installed on their smartphone by our staff. The in-office arm will have 6 monthly visits during the study period, with two consultations performed in each visit - one by the physician or exercise physiologist, and one by our pediatric dietitian. The main outcome of the study is BMI standard deviation (z-score) changes, which will be evaluated after 3 and 6 months of treatment during physical office visits in both study arms. Secondary outcomes will be: - Body-fat percent changes, assessed by bioimpedance analysis in physical clinic visits. - Daily step counts, measured by smartphone data/ wearable activity tracker, if available. - Weight-related quality of life - Retention and visit cancellation rates. - Satisfaction of both parent and child from their allocated treatment.

NCT ID: NCT05665621 Recruiting - Obesity, Childhood Clinical Trials

The Effects of Strength and Balance Training on Physical Function in Overweight Children

Start date: March 13, 2023
Phase: N/A
Study type: Interventional

This intervention study aims to examine the efficacy of a school-based exercise programme to improve strength and balance in overweight and obese 7-11-year-olds in the United Kingdom. The main question[s] it aims to answer are: - Is the school-based exercise programme effective in improving lower limb muscular strength and balance control? - How do increases in strength and balance skills impact physical function, the risk to musculoskeletal health, and physical activity? Participants will attend baseline, post-intervention, and follow-up testing that includes assessment of strength, balance, 3D gait, plantar pressure, physical function and physical activity. The intervention group will take part in physical activity sessions in their school for 1 hour twice a week for a total of 8 weeks. Researchers will compare the intervention group to a control group that will take part in no-activity sessions and carry out their normal school and seasonal activities.

NCT ID: NCT05627011 Recruiting - Obesity, Childhood Clinical Trials

Dissemination and Implementation of Improving Pediatric Obesity Practice Using Prompts

iPOP-UP
Start date: February 9, 2023
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the dissemination and implementation of electronic health record-based clinical decision support tools for the management of pediatric overweight and obesity in primary care.

NCT ID: NCT05595161 Recruiting - Obesity, Childhood Clinical Trials

Dissemination and Implementation of the Bright Bodies Intervention for Childhood Obesity

Start date: October 11, 2022
Phase: N/A
Study type: Interventional

This study will evaluate the effectiveness of the Bright Bodies intervention in improving body mass index (BMI) among 7-13 year-old children with obesity simultaneously with the impact of the implementation strategy on adoption, reach, fidelity, cost, and maintenance of the intervention in three heterogenous settings serving patients disproportionately affected by obesity.

NCT ID: NCT05456516 Recruiting - Obesity, Childhood Clinical Trials

Study of Brain, Reward, and Kids' Eating

BRAKE
Start date: January 10, 2023
Phase: N/A
Study type: Interventional

Children from rural communities are at greater risk for obesity than children from more urban communities. However, some children are resilient to obesity despite greater exposure to obesogenic influences in rural communities (e.g., fewer community-level physical activity or healthy eating resources). Identifying factors that promote this resiliency could inform obesity prevention. Eating habits are learned through reinforcement (e.g., hedonic, familial environment), the process through which environmental food cues become valued and influence behavior. Therefore, understanding individual differences in reinforcement learning is essential to uncovering the causes of obesity. Preclinical models have identified two reinforcement learning phenotypes that may have translational importance for understanding excess consumption in humans: 1) goal-tracking-environmental cues have predictive value; and 2) sign-tracking-environmental cues have predictive and hedonic value (i.e., incentive salience). Sign-tracking is associated with poorer attentional control, greater impulsivity, and lower prefrontal cortex (PFC) engagement in response to reward cues. This parallels neurocognitive deficits observed in pediatric obesity (i.e., worse impulsivity, lower PFC food cue reactivity). The proposed research aims to determine if reinforcement learning phenotype (i.e., sign- and goal-tracking) is 1) associated with adiposity due to its influence on neural food cue reactivity and 2) associated with reward-driven overconsumption and meal intake due to its influence on eating behaviors. The investigators hypothesize that goal-tracking will promote resiliency to obesity due to: 1) reduced attribution of incentive salience and greater PFC engagement to food cues; and 2) reduced reward-driven overconsumption. Finally, the investigators hypothesize reinforcement learning phenotype will be associated due to its influence on eating behaviors associated with overconsumption (e.g., larger bites, faster bite rat and eating sped). To test this hypothesis, the investigators will enroll 76, 8-9-year-old children, half with healthy weight and half with obesity based on Centers for Disease Control definitions. Methods will include computer tasks to assess reinforcement learning, dual x-ray absorptiometry to assess adiposity, and neural food cue reactivity from functional near-infrared spectroscopy (fNIRS).

NCT ID: NCT05416125 Recruiting - Obesity, Childhood Clinical Trials

Vyvanse in Children Aged 6 to 12 Years

Start date: December 20, 2023
Phase: Early Phase 1
Study type: Interventional

This study will randomize children who have difficulty maintaining a healthy weight to one of two treatment groups: lifestyle therapy plus lisdexamfetamine or lifestyle therapy plus placebo.

NCT ID: NCT05396443 Recruiting - Obesity, Childhood Clinical Trials

Telehealth Lifestyle Program for Black Adolescent Girls at Risk for Type 2 Diabetes

Start date: August 15, 2022
Phase: N/A
Study type: Interventional

The aim of this study is to look at changes in diabetes-related risk factors in Black adolescent girls who are at risk for type 2 diabetes after participating in a 12-wk telehealth lifestyle program.

NCT ID: NCT05350267 Recruiting - Obesity, Childhood Clinical Trials

Changing Health and Lifestyle Behaviors of Offspring Following Maternal Bariatric Surgery

HALO-2
Start date: March 14, 2022
Phase: N/A
Study type: Interventional

This is the Phase 2 pilot/feasibility randomized controlled trial of HALO (Health And Lifestyle Behaviors In Offspring), a parent-led behavioral intervention targeting a high-risk pediatric population (i.e., residing offspring ages 6-12; body mass index > the 70th and < 120% of the 95th percentiles of mothers with severe obesity) that is uniquely well-timed, when mothers are highly engaged in behavior change and losing weight during the first year following bariatric surgery.

NCT ID: NCT05334420 Recruiting - Obesity Clinical Trials

Efficacy Trial Healthy Dads, Healthy Kids for Hispanic Fathers and Children

HDHK
Start date: April 28, 2022
Phase: N/A
Study type: Interventional

Hispanic men and children experience health disparities for overweight and obesity-related medical conditions, and therefore family level obesity prevention programs for Hispanic populations are needed. 'Healthy Dads Healthy Kids' is the first program to primarily target fathers for obesity prevention for themselves and their children, with significant and clinically relevant treatment effects. This is an efficacy trial to assess a culturally adapted 'Healthy Dads Healthy Kids' for Hispanic families.

NCT ID: NCT05294601 Recruiting - Obesity, Childhood Clinical Trials

Effect of High Intensity Children's Games Compared With Medium Intensityregulation, Obesity Biomarkers and Body Composition in Boys and Girls

Start date: April 25, 2022
Phase: N/A
Study type: Interventional

To evaluate the effect of high intensity children's games compared with those of medium intensity on cardiac autonomic regulation, obesity biomarkers and body composition in Boys and Girls from 6 to 9 years old with Obesity or Overweight