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The Intervention Nurses Start Infants Growing on Healthy Trajectories (INSIGHT) Study

NCT01167270 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 316

Last updated 2024-01-31

No results posted yet for this study

Summary

This study will test an intervention program designed to provide developmentally appropriate guidance to parents of infants on responsive parenting and healthy lifestyle to see if that intervention will prevent rapid weight gain in infancy and overweight at age 3 years. Further, compared with control infants, intervention infants will have lower body mass index (BMI) percentiles at age 3. The investigators also hypothesize that control infants will gain weight more rapidly over time.

Conditions

Interventions

BEHAVIORAL

Child Safety Insights

A child safety intervention with messages focused on the infant's environment and interactions with parents. They will be guided by the American Academy of Pediatrics as well as the Academy's guide for health supervision, Bright Futures.

BEHAVIORAL

Parenting Insights

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.

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • Ian M. Paul, MD

    lead OTHER

Principal Investigators

  • Leann L Birch, PhD · Penn State University

  • Ian M Paul, MD, MSc · Penn State College of Medicine and Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Day
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2017-04-30
Completion
2023-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01167270 on ClinicalTrials.gov