The Intervention Nurses Start Infants Growing on Healthy Trajectories (INSIGHT) Study (INSIGHT)
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| ClinicalTrials.gov Identifier: NCT01167270 |
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Recruitment Status :
Active, not recruiting
First Posted : July 22, 2010
Last Update Posted : August 1, 2017
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Infant Obesity | Behavioral: Child Safety Insights Behavioral: Parenting Insights | Not Applicable |
Principal Hypotheses: An intervention program designed to provide developmentally appropriate guidance to parents of infants on responsive parenting and healthy lifestyle will prevent rapid weight gain in infancy and overweight at age 3 years. Further, compared with control infants, intervention infants will have lower BMI percentiles at age 3. We also hypothesize that control infants will gain weight more rapidly over time, adjusting for trait-stable and time-varying covariates (e.g., maternal pre-pregnancy BMI, percent of feedings that are breast milk vs. formula, sleep duration, and feeding frequency).
The Intervention Nurses Start Infants Growing on Healthy Trajectories (INSIGHT) Study, will test these hypotheses in a two arm randomized trial where participants in a program to prevent childhood obesity will be compared with those in a child safety control program. Nurses will deliver interventions to first-time parents and their infants in both study groups at four home visits in the first year after birth followed by annual clinical research center visits until age 3. Blood samples for genetic testing on appetite, growth, and temperament will be collected from mother, child, and father. The obesity prevention program focuses on messages of responsive parenting and healthy lifestyle, extending from infancy through age 3 years. The intervention will teach first-time parents to interact with their infants in a way that is prompt, emotionally supportive, contingent, and developmentally appropriate. This information is especially important during the first year after birth as infants make a dramatic dietary transition from the initial exclusive milk diet to one with many foods of the adult diet of their culture. During this transition, as foods are being introduced to children, there are numerous opportunities to address dietary content as well as parent feeding style. In addition to these messages, intervention parents will be given education on growth charts, the meaning of growth chart percentiles, and healthy growth patterns during early life. The intervention program is hypothesized to show efficacy in both breast and formula fed infants as measured by the primary outcome, body mass index (BMI) percentile at age 3 years. Additionally, participants will be followed to collect anthropometric measurements at 4,5,6,10,14,and 17 years of age to provide significant insight into long-term obesity risk.
The proposed research adds two major pieces by enrolling second born siblings and collecting genetic specimens from both siblings and their parents. Specifically, this translational research will a) prospectively evaluate obesity-related parenting similarities and differences as well as weight-related outcomes between first and second-born siblings, b) explore how genetic differences among siblings that are associated with appetite, temperament, and obesity susceptibility affect parent-child interactions, degree of responsive parenting, and weight status, and c) determine whether INSIGHT study intervention carryover effects occur among families participating in the observation-only second-born child evaluation.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 316 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Prevention |
| Official Title: | The Intervention Nurses Start Infants Growing on Healthy Trajectories (INSIGHT) Study |
| Study Start Date : | January 2012 |
| Actual Primary Completion Date : | April 2017 |
| Estimated Study Completion Date : | June 2019 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Parenting Insight
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.
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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. |
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Placebo Comparator: 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 AAP guidelines and the Academy's guide for health supervision, Bright Futures
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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. |
- BMI percentile at 3 years [ Time Frame: 3 years ]BMI percentile at 3 years
- Weight-for-length percentile at several intervals in the first 12 months after birth [ Time Frame: 12 months of age ]Weight-for-length percentile at several intervals in the first 12 months after birth
- BMI percentile at age 2 years [ Time Frame: 2 years of age ]BMI percentile at age 2 years
- Proportion of infants with BMI > 85th and 95th percentiles at ages 2 and 3 years [ Time Frame: aged 2 and 3 years ]Proportion of infants with BMI > 85th and 95th percentiles at ages 2 and 3
- Proportion of infants with accelerated weight gain between numerous study intervals [ Time Frame: birth to 4 months, birth to 1 year, birth to 3 years, 1 year to 3 years ]Proportion of infants with accelerated weight gain between numerous study
- Factors that influence the succession of the oral and gut microbiomes. [ Time Frame: birth to 1 year of age ]Microbiome samples collected from mother and baby throughout the first year of life (including stool and buccal swabs) are collected for analyses. Outcome only for the sibling study not the first born study
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| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
- maternal age <=20 years
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01167270
| United States, Pennsylvania | |
| Penn State Hershey Medical Center | |
| Hershey, Pennsylvania, United States, 17033 | |
| Penn State University | |
| State College, Pennsylvania, United States, 16802 | |
| Principal Investigator: | Leann L Birch, PhD | Penn State University | |
| Principal Investigator: | Ian M Paul, MD, MSc | Penn State College of Medicine and Children's Hospital |
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Ian M. Paul, MD, Professor of Pediatrics and Public Health Sciences, Milton S. Hershey Medical Center |
| ClinicalTrials.gov Identifier: | NCT01167270 History of Changes |
| Other Study ID Numbers: |
34493 1R01DK088244-01 ( U.S. NIH Grant/Contract ) |
| First Posted: | July 22, 2010 Key Record Dates |
| Last Update Posted: | August 1, 2017 |
| Last Verified: | July 2017 |
Keywords provided by Ian M. Paul, MD, Milton S. Hershey Medical Center:
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Infant Diet Toddler Diet Responsive Feeding Infant Temperament |
Parent competency Childhood Obesity prevention Rapid infant weight gain |