iAmHealthy Feasibility Trial Adverse Event data (comma separated value) in Feasibility Trial of the iAMHealthy Intervention for Healthy Weight in Rural Children Recruited From Primary Care Clinics

iAmHealthy Feasibility Trial Adverse Event data including MedDRA coded data elements (comma separated value)
Study Description
The iAmHealthy Trial was a 6-month feasibility trial comparing the iAmHealthy behavioral intervention versus newsletter intervention. The trial was conducted in four clinics affiliated with the IDeA States Pediatric Clinical Trial Network and assessed: participant recruitment, participant retention, intervention dose, and blinding. The iAmHealthy behavioral intervention included group and individual sessions for caregivers and children delivered via video conference on study-supplied tablets. These sessions focused on nutrition, physical activity, and behavior change. The iAmHealthy behavioral intervention also included a monthly newsletter that focused on general child health. The newsletter intervention used only the same monthly newsletter. The objectives of the study were to determine which of 2 recruitment methods works best to get rural participants to join a research study about children who weigh more than is considered healthy and to determine what works to keep participants in the study. The study involved a total of 104 children between 6 to 11 years of age who live in a rural area and one of their caregivers. Key outcomes include the determination that the traditional recruitment method produced a higher percent success rate (21.7%) but a 23 times lower number of candidates (23 vs. 535 for the consecutive recruitment strategy) and a 20 percent lower number of enrolled participants (5 vs. 99). Each intervention had a high retention rate, 86.5% for the iAmHealthy intervention and 96.2% for the News Letter only intervention. This study involved children and one of their caregivers (parent/guardian) living in a rural area. The children were 6 to 11 years old and considered to have an unhealthy weight (high Body Mass Index).