NCT01167270Completed
The Intervention Nurses Start Infants Growing on Healthy Trajectories (INSIGHT) Study
Source: ClinicalTrials.gov · Last updated 31 Jan 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 316 (actual)
- First submitted
- 21 Jul 2010
- Start date
- Jan 2012
- Primary completion date
- Apr 2017
- Lead sponsor
- Ian M. Paul, MD
- Diseases
- Obesity
- NCT number
- NCT01167270
What you commit to
- Study type: Interventional
- Participants enrolled: 316
- From Jan 2012 to the primary completion date, Apr 2017
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- presence of a congenital anomaly or neonatal condition that significantly affects a newborn's feeding (e.g. cleft lip, cleft palate, metabolic disease
- any major maternal morbidities and/or pre-existing condition that would affect postpartum care such as cancer, multiple sclerosis, lupus, etc.
Age
- maternal age \<=20 years
Other
- prenatal ultrasound presence of intrauterine growth retardation (IUGR)
- infant birth weight \<2500 grams plan for newborn to be adopted
- plan to move from Central Pennsylvania within 3 years
- inability to complete contact form with name, address, phone numbers, etc.
- Practicing pediatrician or pediatric resident
Who the study is looking for
- full-term infant(\> 37 0/7 weeks gestational age)discharged from hospital without significant morbidity
- singleton infant
- nursery/NICU/maternity stay of 7 days or less
- primiparous mother
- English speaking mother
Age in the registry: 1 day to - · Sex: All · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Penn State Hershey Medical Center Coordinator of this site? Confirm its status | Hershey | United States | Unknown status |
| Penn State University Coordinator of this site? Confirm its status | State College | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.