124 Clinical Trials for Various Conditions
Children with cerebral palsy (CP), Gross Motor Functional Classification Scale (GMFCS) I-II will be recruited to participate in a home based physical activity intervention for 4 weeks. Demographic data will be collected, and validated surveys assessing baseline physical activity level and mobility will be completed. Participants will have an exercise program assigned and will be given a logbook to record their exercise adherence. They will be assigned to the Augment Reality (AR) app group. The AR app group will have exercises administered through the AR app. At the end of the program, participants will complete final surveys and an exit interview.
The goal of this pilot study is to test the feasibility and participant adherence (pediatric patients diagnosed with childhood cancer) to a virtual, 12-week physical activity program. The aims of this project are to: 1. Determine the feasibility of administering the program and patient acceptability. 2. Report program adherence and completion rates. 3. Explore trends on the impact of a virtual PA intervention on psychosocial health and physical fitness. Participants will undergo pre- and post-assessments including measurements of fitness, self-reported fatigue and depression symptoms, social support, and current amount of physical activity. Patients will then be invited to participate in two consecutive, 12-week virtual physical activity interventions with similar-aged peers (2x/week, 60 minutes/session) over 2 rounds.
The purpose of this study is to develop an implementation strategy to improve the use and sustainment of active learning in elementary schools and to conduct a feasibility study to evaluate the impact of the developed implementation strategy on the implementation and effectiveness of active learning.
'The PACT trial' is randomized pilot trial to demonstrate the feasibility and potential effectiveness of a personal "fitness tracker" to improve adherence to an activity regimen following an initial acute DVT in children.
This study is designed to determine if parents can deliver an intervention that will help increase physical activity in their children. The parents will be given the intervention through their mobile phones.
Hypothesis #1: Most children with CKD stages 2-4, ESRD and kidney transplantation will report participation in physical activity that falls short of recommended levels of physical activity; Children on dialysis will be less active. Hypothesis #2: Patients will endorse many barriers to physical activity, some of which will be related to their disease or its treatment; those who are less active will endorse more barriers. Hypothesis #3: Patients will increase their participation in physical activity in response to a pedometer-based 12 week intervention. Baseline level of physical activity and magnitude of increase in physical activity will be more closely associated with change in physical functioning and performance than stage of kidney disease or type of renal replacement therapy. Exercise capacity of the child will be measured by the six minute walk test whereby the subject will asked to walk as far as possible in 6 minutes in a straight corridor. Body fat or body composition will then be measured by Bioelectric Impedance Spectroscopy. Physical functioning or Health Related Quality of Life will be assessed self reported/ parent proxy reliable and validated questionnaire specifically designed for child with chronic kidney disease called Pediatric Quality of Life Inventory (Peds QL 4.0). Subjects (teens) or parents will also be asked to fill out a questionnaire on barriers to physical activity on their first visit. Physical activity will be measured in the form of daily steps. The child will wear the pedometer for the first week to assess his/her baseline level of activity. Then the child will continue to wear the pedometer for another 12 weeks during which time he or she will be asked to gradually increase steps walked per day above baseline physical activity. The patient will be called once a week in order to monitor progress, set new weekly step goals (usually 500-1000 steps/day greater than the previous week), and motivate the participant. After 12 weeks of the pedometer-based intervention to increase physical activity, physical performance, body composition and physical functioning (as described above) will be measured once again to assess the effect of increased physical activity on a second visit.
The purpose of this study is to conduct a two-arm randomized controlled trial and evaluate the feasibility, acceptability, and effects on the physical and psychosocial outcomes of children in response to a web-based physical activity intervention. 80 participants aged 8-11 will be enrolled in the Madison, WI area and can expect to be on study for up to 12 weeks.
Currently, 10 million children participate in afterschool programs (ASPs) each day, and ASPs provide a great opportunity to enhance children's health outside of the regular school environment, particularly given the decline in physical education. This proposed, randomized cluster, controlled trial will examine the immediate (pre- to post-test) and sustained (1-year post-intervention follow-up) effects of CHAMP-ASP on physical activity (primary outcome), motor performance, perceived motor competence, health-related physical fitness, and weight status. CHAMP-ASP will be implemented by ASP staff and will be conducted in ASPs located in Ypsilanti/Ann Arbor, Michigan. Children (N = 264; CHAMP-ASP=132 and control=132) K-2 graders (typically ages 5-8 years) will participate 35 minutes/day X 3-4 days/week for 19 weeks (dose of 1995 - 2240 minutes). The aims are to: a) examine the immediate and sustained effects of CHAMP-ASP on physical activity, motor performance, and perceived motor competence relative to the control ASP, b) examine the immediate and sustained effects of CHAMP-ASP on secondary health outcomes - health-related physical fitness (cardiorespiratory fitness, muscular strength), and weight status compared to children in schools randomized to control ASP, and c) determine if perceived motor competence mediates the effect of CHAMP-ASP on moderate-to-vigorous physical activity.
The CHEER study takes advantage of a natural experiment happening in South Carolina (SC). The South Carolina Department of Social Services implemented new healthy eating and physical activity standards through a state-wide policy for family child care homes that participate in the ABC Grow Healthy program. Thus, CHEER is a quasi-experimental, two-group, pre-test/post-test design study.
Wellness Enhancing Physical Activity for Young Children (WE PLAY) is a teacher training that is based online and was designed to support early childhood educators' efforts to promote physical activity (PA) through structured and unstructured active play with preschoolers. WE PLAY includes six components: (1) online training; (2) video library; (3) game sheets; (4) teacher self-assessment; (5) supervisor support; and (6) activity packs that are designed to work synergistically. The purpose of this study was to examine the impact of WE PLAY on children's levels of moderate to vigorous physical activity (MVPA) during school hours. We hypothesized that children whose teachers received WE PLAY would have higher levels of MVPA during school hours at post-intervention relative to pre-intervention and relative to children whose teachers did not receive WE PLAY. A second purpose was to examine the impact of WE PLAY on teacher outcomes (i.e., knowledge, intentions, perceived behavior control, subjective norms, perceived power beliefs, normative beliefs, and moral norms). We hypothesized that teachers who participated in WE PLAY would demonstrate higher scores on each of these variables at post-intervention relative to pre-intervention and to teachers in the control group. A cluster randomized controlled trial was used in this study. Six Head Start preschools were pair matched and randomized to the intervention (WE PLAY) or control groups. Preschool children (N=57) and their teachers (N=25) participated. Child MVPA was measured using accelerometers for 5-day periods at pre- and post-intervention. Teacher variables were measured using online surveys.
The specific aims of this study are to: 1) evaluate the impact of a novel intervention delivered via school-based physical education (PE) on adolescents who have a high sensitivity to exercise-induced negative affect; 2) determine whether adolescents' tendency to feel uncomfortable during exercise is a stable trait that persists even in the face of an intervention; and 3) compare and contrast three alternative methods of measuring adolescents' sensitivity to exercise-induced affect. Healthy middle-school students who do not participate in team or individual competitive sports will be recruited and assessed to determine their existing predisposition toward exercise (i.e., "reluctant exercisers" and "latent exercisers"). The assessment will be conducted using three methods that have been used to measure individuals' propensity to experience positive affect in the face of a stimulus: 1) a pencil-and-paper assessment that measures tendency to respond to a challenge with positive affect; 2) electroencephalogram (EEG) to ascertain frontal cortical asymmetry; and 3) empirically assessed affective response to a standardized exercise task. Reluctant and latent exercisers will be assigned in equal numbers to one of two conditions. One condition will implement a PE-based intervention that differs from the traditional approach in that students will be instructed to exercise at an intensity that has been determined to elicit positive affect in that individual (based on baseline testing). In the other condition, students will be instructed to exercise at an intensity derived from standard formulas typically used in exercise prescriptions. It is hypothesized that the non-traditional approach will increase reluctant exercisers' enjoyment of PE and also their level of participation in physical activity outside of PE. The latter will be determined using portable monitors (accelerometers) worn at baseline, after the intervention, and again 1 year after the end of the intervention.
The purpose of this trial is to examine whether adding greater physical activity to standard family-based behavioral pediatric obesity treatment decreases the amount of visceral fat among treated overweight children.
The purpose of this study is to design and conduct research to tailor out of school time evaluation materials so they are applicable to various settings in Boston, are efficient in that minimal resources and time are used, and are useful to participants.
This study is a randomized controlled trial to evaluate ParkRx, a clinic-based counseling intervention in which health care providers prescribe park visits at a specific frequency, duration, and includes instructions for physical activity in the parks. We will assess whether prescribing visits to specific parks changes physical activity levels and improves health and mental health outcomes among low-income pediatric patients.
The aim of the 6-month randomized controlled trial, with 6-month no treatment follow-up, is to examine the effects of low-magnitude vibration on muscle, physical activity, and balance in children with spastic cerebral palsy.
In this research project, the investigators addressed if incorporating physical movements with preschoolers will help increase their ability to retain concepts learned in preschool such as letter, sound and number recognition. Movement plays an important role in the brain. Exercise shows many benefits for the brain to help maintain clearer thought, improve memory, and increase activity in the brain, especially the areas involved in memory, attention, and language. The following research includes an eight week study of the implementation of movement breaks with one preschool class, while using another class as a control group. During the two weeks of baseline data, data was collected from every student in both groups on their letter recognition with both upper and lower case, letter sound identification, and number recognition for numbers 0-10. The group that implemented movement breaks had three-five minute scheduled times to stop for movement. Data was collected and compared between the two groups to find differences in their academic performance.
This study will evaluate the efficacy of a six-month-long intervention in improving the nutrition and physical activity environments of child care centers serving racially and ethnically diverse children from birth to two years of age and the family home. The focus of the intervention will be on center policies, provider and parent practices, and children's home environments that influence dietary intake and physical activity. Outcomes for this study include child dietary intake, physical activity, and two adiposity measures: weight-for-length and skinfold thicknesses. Child care centers and children's home environments will also be measured to evaluate how well they support healthy behaviors.
The purpose of this study is to develop and pilot test a new type of patient-centered, family-based treatment for children aged 8-12 with obesity and their caregivers. The treatment will focus specifically on improving children's self-regulation (SR) skills to help them better manage their feelings, behaviors, and thoughts to help them live a healthier lifestyle.
1. Compare physical activity and cognitive functions between children having cardiac surgery with an age-matched group of children undergoing non-cardiac surgery, as well as otherwise healthy siblings or best buddies (or age and gender-matched children if no siblings or best buddies available) before surgery and after surgery or six months following initial assessment. 2. Determine the effects of a structured physical activity program for 6 months following surgery on cognitive functions and adaptive behavior in children following congenital cardiac surgery. 3. Determine the effects of a structured physical activity program for 12 months following surgery on cognitive functions and adaptive behavior in children following congenital cardiac surgery. 4. We will perform exploratory analysis to determine whether any effects of a 12-months structured physical activity program on cognitive functions and adaptive behavior persist beyond 12 months after cessation of the program.
Drs. Patricia Risica (Brown University) and Kim Gans (University of Connecticut) are Dual Principal Investigators for this project. The research team will first conduct formative research using focus groups and key-informant interviews of Family Child Care Home (FCCH) providers. This formative work will inform our adaptation of components of previous evidence-based interventions to create a new innovative intervention in both English and Spanish to improve food and PA environments of Family Child Care Homes (FCCH). The intervention will integrate: a) support from peer counselors with child care experience who will serve as team leaders for groups of FCCPs; b) tailored print and video materials; and c) a set of portable active toys. A cluster-randomized trial with 132 FCCH will evaluate the effectiveness of the intervention with a Steering Committee and Community Advisory Board guiding all aspects. The Specific Aims of the study are to: 1) Conduct formative research to inform the development and adaptation of the FCCH intervention. 2) Conduct a cluster-randomized trial of the intervention's efficacy with 66 FCCH providers and a control intervention with 66 demographically-matched FCCH providers to evaluate its impact on: a) Children's overall dietary quality at FCCHs; b) Children's PA and sedentary behaviors at FCCHs; and c) the physical and social food and PA environments of FCCHs. Evaluation methods will include survey data collection of the FCCH Providers; observation of children's' dietary intake and physical activity in FCCHs; recruitment of children within the FCCH for physical and survey measurement with permission from their parents.
The main aim of the study would be to examine the effect of using a health behavior screening tool and a brief patient centered conversation on health behavior goal setting during well-child visits.
Children in the U.S. exhibit low levels of physical activity. In addition to the overall physical health and fitness benefits with increasing levels of physical activity, improvements in academic performance, mental cognition, and behavior may occur. Despite these benefits, opportunities for children to participate in physical activity are being reduced, particularly in schools. The proposed study is a pilot program with approximately 100 children ages 7-11 years expected to participate. All study participants will partake in a testing and measures session which will include body composition measures, nutrition and physical activity questionnaires, and curriculum-based measures. Following the first testing and measures session, 50 of the 100 children will participate in a 10-12 week, before-school, moderate to vigorous physical activity (MVPA) program. This program will consist of non-competitive, MVPA and occur 3 days/week at their school. Subsequent to the physical activity program, all 100 children will then participate in a follow-up testing and measures session. The objective of this proposed pilot study is to determine the feasibility of implementing a before-school, physical activity program as well as explore the effect the program may have on academic performance and health measures.
The purpose of this study was twofold: 1) to assess awareness of and adherence to Texas SB42 among a representative sample of public middle schools in Texas; and 2) to assess the impact of SB42 on the frequency of school PE class, the quality of school PE, and prevalence of child self-reported physical activity behaviors and child overweight along the Texas-Mexico border.
Doctors recommend that young children participate in daily physical activity to promote bone health. However, studies in adults show that physical activity and increased calcium intake cause noticeable benefits for bone health only when both factors occur together. The goal of this study is to find out whether calcium intake changes the response of bone to activity in children 3 to 4 years old. Children will participate in one of two programs conducted in childcare centers 5 days a week for 1 year. One program will involve activities that use large muscles (gross motor activity). The other will involve activities using small muscles (fine motor activity). We will give a calcium supplement (1 gram per day) to half of the children in each program and give the other half an inactive pill. We will measure bone mass and bone mineral density at the beginning and end of the study. We will take measurements 12 months after the program's completion to see if physical activity and/or calcium supplements have long-term effects on bone mineral density and physical activity.
The intervention aims to increase physical activity, an important health behavior, in a high-risk sample (i.e., Black and Hispanic/Latino mothers). The study builds on the investigators' previous work by adapting an evidence-based theory guided physical activity intervention to be implemented in a community setting mothers regularly spend time for their children's extracurricular activities, circumventing barriers commonly cited by racial/ethnic minority mothers (e.g., other responsibilities, time barriers, transportation, and childcare). The investigators will partner with a local youth sports organization to adapt and deliver a physical activity intervention to mothers during practice. They aim to convene a community advisory board of coaches and parents to enhance participant acceptability and work through any feasibility issues with implementation. The investigators will then conduct an open pilot trial of the physical activity intervention administered to mothers during their children's sports practices. They will assess feasibility, acceptability, and examine the effects of the intervention on mothers' physical activity. The investigators hypothesize that mothers in the intervention will increase their physical activity.
The incidence of type 1 diabetes (T1D) in young children (age \<5 years) is rising. The burden of responsibility for disease management rests on parents and caregivers to check blood sugar, administer insulin, and monitor diet and physical activity to maintain tight glycemic control. This occurs at a vulnerable time in life when children's behavior is unpredictable, their T1D is difficult to control, and parenting stress is elevated. Despite behavioral interventions that have demonstrated success in reducing rates of parent stress and improving child behavior, improvements in young children's glycemic control has not been sufficiently achieved. The investigators' research will attempt to achieve this goal through the development and pilot of an innovative behavioral intervention for T1D in parents of young children. The focus of the intervention is on improving young children's nutrition and physical activity through the use of parent consultants and delivery of intervention through phone and text messaging. The study will be conducted in two phases. In Phase 1, 10 primary caregivers of young children (\<5 years) diagnosed with T1D for at least 6 months will receive the intervention and then be assessed at 3- and 6- months post baseline on indices of behavior and glycemic control (including continuous glucose monitoring). Participants will also complete in-depth surveys to provide qualitative as well as quantitative data. At the end of Phase 1, the data will be analyzed and used to develop the intervention further for Phase 2. During Phase 2, 60 participants and their children will be randomized to either the revised intervention (treatment) or usual care (control) condition. Intervention components include: T1D management support delivered by trained lay parent consultants, and T1D parenting strategies specific to improving eating and physical activity behaviors delivered by bachelor's level behavioral assistants via telephone and text messaging. Biomedical and psychosocial measurements (including HbA1c, physical activity, nutrition, mealtime behavior, parenting stress, quality of life) will occur at baseline and 3- and 6-months post baseline. The results of this work will ultimately lead to a program which can improve young children's T1D management and glycemic control that can be translated into a variety of clinical practice settings.
This is a pilot community-based research study to examine the effects of specific environmental and social factors on physical activity, fitness, and health of middle school Hispanic children living in an inner-city community.
The purpose of this study is to compare the effect of two after-school programs on children's physical activity, fitness, body composition, and academic performance.
The goal of this study will be to examine the implementation and preliminary efficacy of a teacher taught gross motor skill-based physical activity (PA) intervention on cognitive variables in low low socio-economic (SES) preschoolers. The movement and cognition intervention will be implemented for 4 days per week for 6 months. Primary outcome variables will be processed evaluation data. Secondary outcome variables will be changes in children's cognitive function (executive functions and memory), gross motor skills, and PA levels at baseline, 3- and 6-month.
The goal of this 15-month cluster clinical trial is to compare a resilience and stress management program to a physical activity program for early childhood education (ECE) staff on change in well-being. It will also look to see if changes in well-being continue over time. The study sample will include 80 child care centers. Including 80 ECE center directors and approximately 560 ECE center staff. Some ECE centers will receive only the remotely delivered Resilience program. This program works with ECE staff and helps them recognize and strengthen their resilience assets and resources. Other ECE centers will receive only the remotely delivered Physical Activity program that will focus on staff physical activity habits and strength training. There will be 3 months of active program participation and 12 months of a maintenance period where participants will only have access to program materials.