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Responsive Parenting Education for Infant Obesity (INSIGHT Trial)
N/A
Waitlist Available
Led By Ian M Paul, MD, MSc
Research Sponsored by Ian M. Paul, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up aged 2 and 3 years
Awards & highlights
INSIGHT Trial Summary
This trial will test if an intervention program teaching responsive parenting and healthy lifestyle habits to parents of infants can help prevent those infants from becoming overweight at age 3.
Who is the study for?
The INSIGHT study is for first-time English-speaking mothers with healthy, full-term single babies. The infants must be discharged from the hospital within a week without significant health issues. Mothers under 21 or those planning to move away from Central Pennsylvania in the next three years cannot participate.Check my eligibility
What is being tested?
This trial tests a program that teaches new parents about responsive parenting and promoting a healthy lifestyle for their infant. It aims to see if this guidance can prevent rapid weight gain in babies and reduce the risk of obesity by age three.See study design
What are the potential side effects?
Since this trial involves educational interventions rather than medications, there are no direct medical side effects expected. However, any changes in behavior or stress related to parenting practices could potentially affect both mother and child.
INSIGHT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ aged 2 and 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~aged 2 and 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
BMI percentile at 3 years
Secondary outcome measures
BMI percentile at age 2 years
Proportion of infants with BMI > 85th and 95th percentiles at ages 2 and 3 years
Proportion of infants with accelerated weight gain between numerous study intervals
+1 moreOther outcome measures
Gastrointestinal tract structure
INSIGHT Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Parenting InsightActive Control1 Intervention
Educational program contains messages to provide developmentally appropriate guidance to parents of infants on responsive parenting and healthy lifestyle that will prevent rapid weight gain in infancy and overweight at age 3 years.
Group II: Child Safety InsightsPlacebo Group1 Intervention
A child safety intervention with messages focused on the infant's environment and interactions with parents. They will be guided by the AAP guidelines and the Academy's guide for health supervision, Bright Futures
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Who is running the clinical trial?
Ian M. Paul, MDLead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,357 Previous Clinical Trials
4,314,870 Total Patients Enrolled
Ian M Paul, MD, MScPrincipal InvestigatorPenn State College of Medicine and Children's Hospital
9 Previous Clinical Trials
2,088 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any vacancies left that patients can fill in this research endeavor?
"The clinical trial hosted on the website clinicialtrials.gov is not presently accepting participants; the information was initially posted in 2012 and was most recently updated two months ago. Nonetheless, there are 968 other medical trials that are looking for volunteers at present."
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