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Obesity, Childhood clinical trials

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NCT ID: NCT04620057 Completed - Obesity, Childhood Clinical Trials

Effects of Butyrate Against Pediatric Obesity

BAPO
Start date: November 1, 2020
Phase: N/A
Study type: Interventional

Worldwide obesity is a public health concern that is defined by the World Health Organization as abnormal or excessive fat accumulation that may impair health. The main drivers of obesity pathogenesis seem to be a long-term of energy discrepancy between too many calories consumed and an increase of sedentary behavior. A growing body of evidence suggests that the set of microbes that live within the digestive tract, making up the gut microbiota (GM), play a metabolic role in energy regulation and substrate metabolism. Various factors can impact GM, one of these are dietary compounds that deeply affect the growth and metabolism of gut bacteria, since fermentation of nutrients is one core function of the intestinal microbes. Among fermentation products an array of small organic metabolites are short-chain fatty acids (SCFAs) acetate, propionate and butyrate. Among SCFAs, the C-4 fatty acid butyrate, the main fuel for the colonocytes, might have a potential in alleviating obesity and related metabolic complications. Butyrate could act as a regulator of body weight: a reasonable speculation is that butyrate acts on components of the energy balance, promoting energy expenditure and/or reducing energy intake. Preclinical studies have shown that butyrate supplementation prevent high-fat diet-induced obesity and it is able to treat obesity. With the sharp increase of obesity prevalence seen in the pediatric population, novel insights are necessary to counteract this epidemic disease, the outcome of the study is to see whether oral butyrate supplementation could exert similar effect in obese children.

NCT ID: NCT04618458 Completed - Obesity Clinical Trials

Telehealth Diabetes Prevention Intervention for African American Youth

TELE-GEN
Start date: December 1, 2020
Phase: N/A
Study type: Interventional

The Telehealth Diabetes Prevention Intervention for the Next Generation of African American Youth (TELE-GEN) pilot study will evaluate the implementation and early efficacy of a telehealth diabetes prevention intervention for African American (AA) children (8- to 11-years) and their parents. Power to Prevent is a lifestyle diabetes prevention intervention from the Centers for Disease Control and Prevention that is based on the Diabetes Prevention Program and tailored for AA families. To investigators knowledge, this intervention has not been evaluated in a clinical trial with AA families with children at risk for type 2 diabetes mellitus (T2DM), nor been delivered via telehealth. Employing an effectiveness-implementation hybrid study design, investigators aim to concurrently (1) conduct a single arm pilot trial to assess the early efficacy of Power to Prevent delivered via telehealth to treat overweight/obesity in AA children and their parent, while (2) evaluating an implementation strategy for the uptake of the intervention by the pediatric weight management clinic at the University of Mississippi Medical Center. The primary outcome will be stabilization or reduction in BMI z-score in children (index participant) and reduction in parent BMI (co-participant). Parents (n=20) will receive the same telehealth diabetes prevention intervention, which will be delivered by a racially concordant, trained Lifestyle Coach using small-group videoconferencing (5 parents per group). Sessions will consist of nutrition and physical activity behavior change strategies (20 min), problem solving and decision-making skills to circumvent barriers to behavioral change (20 min), and family goal setting and action planning (20 min). Child and parent measures will be assessed at baseline, 12-weeks (post-intervention), and 30-weeks (follow-up). The implementation strategy has two targets: (1) the pediatric weight management clinical and clinical care team; and (2) overweight/obese pediatric patients and their overweight/obese parents. The multifaceted implementation plan includes four discrete strategies: (1) creating a new clinical team; (2) changing the service site; (3) intervening with families; and (4) assessing organizational readiness. Preliminary findings will provide data to design a full-scale study that will include a powered pilot randomized controlled trial to test the interventions effectiveness for preventing T2DM, while evaluating a refined implementation protocol.

NCT ID: NCT04552678 Completed - Obesity, Childhood Clinical Trials

Healthy Bodies Project to Prevent Childhood Obesity

Healthy Bodies
Start date: August 2015
Phase: N/A
Study type: Interventional

The goal of this study is to evaluate components of a preschool-based intervention designed to (1) increase children's nutrition knowledge, (2) increase physical activity in childcare settings, (3) increase emotional, behavioral and eating-related regulation, and (4) provide guidance to parents/caregivers about appropriate parenting and child-feeding strategies that promote healthy eating behaviors, dietary patterns and physical activity in preschool-aged children. The long-term goal is to help children develop healthy habits that reduce risk for obesity.

NCT ID: NCT04477577 Completed - Physical Activity Clinical Trials

First Heroes: Engaging Fathers in the First 1000 Days

First Heroes
Start date: August 4, 2020
Phase: N/A
Study type: Interventional

The First Heroes study plans to influence weight and health trajectories, modify disease risk, and improve health care services for mother-father-infant triads from racial/ethnic minority and health disparity populations. This study is a two-arm, randomized controlled trial recruiting from Massachusetts General Hospital (MGH) obstetrics practices. This study will enroll 250 father-mother dyads in the second trimester of pregnancy and intervene through their offspring's 1-year birthday. Each mother-father dyad participating will be randomly assigned to one of two arms: 1. Obstetric and Pediatric Standard of Care + New Parent Engagement Intervention Arm or; 2. Obstetric and Pediatric Standard of Care + Safety Control Arm.

NCT ID: NCT04414553 Completed - Obesity, Childhood Clinical Trials

Community Active and Healthy Families

CommunityAHF
Start date: March 10, 2023
Phase: N/A
Study type: Interventional

To address childhood overweight disparities among Latino children in immigrant families a pilot trial of a community-based obesity treatment program, Community Active and Healthy Families (AHF), among 5-12 year old overweight and obese Latino children in immigrant families using pre/post design will be conducted. The hypothesis is that children participating in Community-AHF will demonstrate a reduction in child body mass index as measured by %BMIp95 (primary outcome) and improved diet physical activity behaviors (secondary outcomes) at intervention completion compared with pre-intervention

NCT ID: NCT04381481 Completed - Obesity, Childhood Clinical Trials

Studying the Impact of Product Packaging in a Virtual Store Environment

Start date: May 14, 2020
Phase: N/A
Study type: Interventional

Purpose: Examine the impact of nutrition claims on parents' decisions to purchase fruit drinks in a randomized controlled trial in an online virtual convenience store (task 1) and examine the impact of added sugar warnings on parents' snack purchasing decisions in a randomized controlled trial in an online virtual convenience store. Participants: Participants will consist of approximately 2,500 individuals 18 and older with at least one child ages 1-5. The child 1-5 who had their birthday most recently must have consumed at least one fruit drink in the previous week. Additionally, they will live in the United States and identify as non-Hispanic black, non-Hispanic white, or Hispanic. The panel research company Kantar will recruit individuals from its pool of potential individuals. Procedures (methods): The investigators will randomize participants to one of 12 versions of a virtual convenience store (iShoppe) and then the participants will complete two shopping tasks in the store. They will select two beverages (task 1) for their child 1-5 who had their birthday most recently, and they will select a snack (task 2) for that same child. After completing the shopping tasks, the participant will complete a survey in Qualtrics. The survey will ask a series of questions about the beverages and snacks (e.g., perceived healthfulness, perceived appeal, intentions to consume products). Questions will also include standard demographic and health related variables.

NCT ID: NCT04346433 Completed - Obesity, Childhood Clinical Trials

Sleep and Stigma: Novel Moderators in the Relationship Between Weight Status and Cognitive Function

Start date: September 1, 2020
Phase: N/A
Study type: Interventional

The investigators aim to assess the relationship between overweight/obesity and decreased cognitive function in adolescents. While this relationship has been seen in past literature, the causal mechanisms are still unclear. Thus, the present study will assess sleep and stigma as possible moderators. As sleep is related to both weight and cognitive abilities it may be an important factor in the relationship between these two variables. Further, people with overweight/obesity have higher risk for stigma experiences which may increase inflammation through chronic stress and elevated cortisol. Because inflammation is theorized to play a role in the relationship between elevated BMI and decreased cognitive function, stigma may be an important moderator. 60 adolescent participants will complete two sleep conditions (adequate and restricted) in a randomized order, each followed by a lab visit during which participants will complete a short cognitive battery. At these visits, participants will also be given a self serve breakfast with a variety of whole and processed food options to further evaluate the relationship between overweight/obesity, sleep, nutritional intake, and cognitive function.

NCT ID: NCT04319419 Completed - Obesity, Childhood Clinical Trials

Milk Proteins and Micronutrient Supplementation in Obese Children

Start date: December 5, 2011
Phase: N/A
Study type: Interventional

Milk proteins and micronutrients could be beneficial in the prevention and treatment of obesity. The objective was to evaluate a supplement with milk proteins and multivitamins and minerals with nutrition education on anthropometry, body composition, micronutrient status, blood pressure, lipid profile, systemic inflammation, leptin and insulin resistance in obese children at baseline and after 6 months.

NCT ID: NCT04312919 Completed - Obesity, Childhood Clinical Trials

Cleveland Clinic Families Get Fit (CCFit) : A Family-based Activity-Monitor Intervention in Pediatric Obesity

CCFit
Start date: February 3, 2020
Phase: N/A
Study type: Interventional

This is a randomized prospective study to evaluate the effectiveness of a family-based intervention using activity-monitors (I.e. Fitbits) in children and adolescents aged 8-18 years with a BMI greater than or equal to 95%ile who attend the Cleveland Clinic multidisciplinary "Be Well" pediatric obesity clinic.

NCT ID: NCT04297722 Completed - Clinical trials for Overweight and Obesity

Dairy Consumption and Overweight and Obesity in Children and Adolescents: a Meta-analysis.

Start date: January 13, 2020
Phase:
Study type: Observational

According to statistics from the European Association for the Study of Obesity (EASO), taking into account the definition of overweight and obesity recommended by the International Obesity Task Fort (IOTF), the prevalence of overweight (including obesity) in European children aged 7 to 17 years is 16-22% and the prevalence of obesity is 4-6%. Some review studies3 and meta-analysis4,5 have reported an inverse relationship between dairy products consumption and the prevalence or incidence of overweight and obesity. However, some methodological issues arise from these analyses. For instance, the combination of studies with different exposures (e.g. full fat milk, total milk) in the total dairy product analysis. Moreover, since the publication of the lasts meta-analysis in 2016, new epidemiological studies evaluating the association between dairy product consumption and overweight or obesity risk have been published. Objective The aim of this work is to systematically review and assess the associations between total dairy consumption and its different subtypes with the prevalence and incidence of overweight and obesity in children and adolescents.