Active clinical trials for "Pediatric Obesity"

Obesity is a multi-dimensional problem that has roots in infancy and tracks into adulthood. Obesity is represented disproportionately among children and families from low socioeconomic and minority backgrounds, particularly in rural areas that have limited access to food, activity, and health-related services. There is a need for culturally-tailored, effective interventions that can positively impact the environments (home, preschool, community) in which young children grow and develop their eating and activity behaviors. Developing family interventions, particularly for families with limited resources, requires improving caregivers' health literacy and home food/activity environments, and also requires tailoring to accommodate the realities of stressful and unpredictable family settings. The overall objective of this proposed HEROs Study (HEalthy EnviROnments Study) is to develop a companion, technology-based, interactive family intervention that will promote healthy lifestyles for young children in both Head Start and family settings.

There is a large body of literature regarding efficacious intervention strategies for treating childhood obesity. Unfortunately, the degree to which efficacious programs have been packaged for translation in micropolitan and surrounding rural areas is unclear-an important issue when considering the prevalence of obesity is higher in rural areas when compared to urban areas. Epstein's Traffic Light Diet (TLD) is likely the most studied pediatric weight management intervention (PWMI) and has demonstrated efficacy across a wide range of randomized controlled trials in children 6-12 years of age. Building Healthy Families (BHF) is an adaptation of the TLD and has been implemented in a micropolitan city and achieved clinically and statistically significant reductions in child BMI z-score (-0.27±0.22)-a similar magnitude of effect relative to previous efficacy trials. The investigators have created online resources for organizations interested in delivering PWMIs, training modules for related interventions, and participant-facing program materials that could be combined into a 'turn-key' approach for communities interested in reducing childhood obesity to adopt, adapt and sustain it in other micropolitan/rural communities. The primary aim is to collaboratively refine and develop an intervention package for the BHF that includes materials necessary for others to implement the intervention in new metropolitan/rural locations. The second aim is to perform a rigorous, mixed-methods pilot implementation study using an innovative community application process to identify 4 to 8 new communities to pilot test the utility of the packaged PWMI and training materials while determining factors that predict adoption, implementation and sustainability. The investigators will also use a learning collaborative implementation strategy to improve implementation fidelity and local context and facilitation capacity in communities interested in delivering BHF. The third aim is to use the pilot evaluation data and results of the sustainability action plan to refine program and training materials and develop a dissemination plan to move the program to other communities. The approach will use an implementation research explanatory process and outcome model to test hypotheses related to implementation and sustainability, engaging community/ clinical partners in the implementation and sustainability process, and evaluate outcomes at both the individual and organizational level.

Happy Family, Healthy Kids program, funded by the Michigan Health Endowment Fund, is a 14-week healthy eating program aimed to foster "Happy Family & Healthy Kids." The program will target parental emotional eating through a life stress management component, and parents will be coached on making happy and healthy eating behavioral changes at home that will support their children to establish lifelong healthy eating habits. At the end of this project, the investigators expect to have an effective, comprehensive, and sustainable healthy eating program ready to expand to any Head Start center in an urban or rural setting.

Background: The sending of text messages (short messaging service, SMS) has been proven as an effective strategy in behavior change. In Mexico, the Strategy of Comprehensive Care for the Nutrition (EsIAN for its acronym in Spanish ) focuses on improving access to information for the main caregivers of child beneficiaries on the practice of infant feeding and healthy physical activity. Objective: To assess whether the mHealth (or mobile health) strategy or the sending of SMS has an effect on knowledge, attitudes, intentionality, perceived control and practices to prevent childhood malnutrition in a population living in poverty. Design: Randomized effectiveness trial by conglomerates. Participants: 400 primary caregivers of children <59 months and health personnel working in the health units included in the study. Control group: Healthy child care in standard health units plus exposure to EsIAN. Intervention group: In addition to the control group, the SMS are sent through a cell pone through the RapidPro platform on practices related to prevention of child malnutrition (in primary caregivers) and the reinforcement of counseling for the prevention of infant malnutrition (with health personnel). Randomization: The first level health units were stratified by state (Morelos or Yucatan); rural and urban area and affiliation institution (Secretary of Health or Mexican Institute of Social Security); and randomized to be assigned to the control or intervention group; 400 primary caregivers of children <59 months in total will be included for the study. Main measures of interest: State of nutrition and knowledge, attitudes or practices on breastfeeding, physical activity, adoption and preparation of healthy foods and beverages in primary caregivers of children<5 years old; and advice on the key messages of EsIAN by health providers.

This pilot trial is designed to test the acceptability and preliminary efficacy of offering the BOKS program, an evidence-based physical activity curriculum that engages school-age children in moderate to vigorous physical activity for one hour daily, alongside the USDA's Summer Food Service Program (SFSP) during the summer. Eighty children, ages 6-12 years and from low-income households, will be randomized to participate in the BOKS + SFSP program or to the SFSP alone. We anticipate that the BOKS program will not only provide increased physical activity for the participants, but that it will help to promote participation in the SFSP given that it will be offered in the same location directly before the SFSP lunches are served.

Pilot randomized trial of a technology-based intervention to reduce sugary drink consumption and promote water intake in families with young children.

Childhood obesity is a major global public health problem. Several strategies have been implemented to reduce the high prevalence, the most cost-effective of which were those that focused on the school environment. Although there is vast research that focus on interventions that address obesity through interventions to improve schoolchildren diets and physical activity level in many countries of the Latin American region, there is lack of evidence of the effectiveness of multicomponent interventions that aim to reduce the prevalence of obesity among schoolchildren in the Paraguayan context.

Obesity has been reported to impair regulation of appetite and lead uncontrollably hunger and satiety response. Ghrelin is orexigenic hormone from the stomach meanwhile, leptin is anorexigenic from adipose. Interestingly, obesity is associated with acylated ghrelin and leptin resistance. Study about the impact of high protein and fiber with combined exercise (HPFE) to suppress hunger among young obese still unclear. The hypothesis was that high protein-fiber would result in decreased in acylated ghrelin and leptin in HPFE group. Thus, the investigator examined the effect of an 8 weeks HPFE on acylated ghrelin and leptin. Subjects were randomized into four groups: High Protein-Fiber (HPF; n=15). High Protein-Fiber and exercise (HPFE; n=15), Exercise (E; n=15) and control (C; n=15). The diet prescribed 1200 kcal/day, based on basic energy requirement minus 300kcal, consisted high protein (25%) and fiber (30g/day). The exercise is combination aerobic and resistance training, with target 75% heart rate maximum. Plasma acylated ghrelin and leptin were analyzed with enzyme immunoassay.

This study will assess the feasibility to assess practicality of early weight loss medication usage in adolescent patients post-VSG with inadequate weight loss. Participants who enroll in the study will be prescribed off-label use of weight loss medications for a period of up to 1 year.

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.