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

Obesity Clinical Trial

— INSIGHT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01167270
• Other study ID #: 34493
• Secondary ID: 1R01DK088244-01
• Status: Completed
• Phase: N/A
• Start date: January 2012
• Est. completion date: December 31, 2023

Study information

• Verified date: January 2024
• Source: Milton S. Hershey Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 316
• Est. completion date: December 31, 2023
• Est. primary completion date: April 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Day and older

Eligibility

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

Related Conditions & MeSH terms

• Infant
• Obesity

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Penn State Hershey Medical Center	Hershey	Pennsylvania
United States	Penn State University	State College	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Ian M. Paul, MD	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

References & Publications (14)

Adams EL, Marini ME, Stokes J, Birch LL, Paul IM, Savage JS. INSIGHT responsive parenting intervention reduces infant's screen time and television exposure. Int J Behav Nutr Phys Act. 2018 Mar 15;15(1):24. doi: 10.1186/s12966-018-0657-5. — View Citation

Anzman-Frasca S, Paul IM, Moding KJ, Savage JS, Hohman EE, Birch LL. Effects of the INSIGHT Obesity Preventive Intervention on Reported and Observed Infant Temperament. J Dev Behav Pediatr. 2018 Dec;39(9):736-743. doi: 10.1097/DBP.0000000000000597. — View Citation

Carney MC, Tarasiuk A, DiAngelo SL, Silveyra P, Podany A, Birch LL, Paul IM, Kelleher S, Hicks SD. Metabolism-related microRNAs in maternal breast milk are influenced by premature delivery. Pediatr Res. 2017 Aug;82(2):226-236. doi: 10.1038/pr.2017.54. Epu — View Citation

Craig SJC, Blankenberg D, Parodi ACL, Paul IM, Birch LL, Savage JS, Marini ME, Stokes JL, Nekrutenko A, Reimherr M, Chiaromonte F, Makova KD. Child Weight Gain Trajectories Linked To Oral Microbiota Composition. Sci Rep. 2018 Sep 19;8(1):14030. doi: 10.10 — View Citation

Eagleton SG, Hohman EE, Verdiglione N, Birch LL, Paul IM, Savage JS. INSIGHT Study Maternal Return to Work and Infant Weight Outcomes. Acad Pediatr. 2019 Jan-Feb;19(1):67-73. doi: 10.1016/j.acap.2018.08.008. Epub 2018 Aug 23. — View Citation

Hohman EE, Paul IM, Birch LL, Savage JS. INSIGHT responsive parenting intervention is associated with healthier patterns of dietary exposures in infants. Obesity (Silver Spring). 2017 Jan;25(1):185-191. doi: 10.1002/oby.21705. — View Citation

Hohman EE, Savage JS, Birch LL, Beiler JS, Paul IM. Pacifier Use and Early Life Weight Outcomes in the Intervention Nurses Start Infants Growing on Healthy Trajectories Study. Child Obes. 2018 Jan;14(1):58-66. doi: 10.1089/chi.2017.0177. Epub 2017 Oct 4. — View Citation

Paul IM, Hohman EE, Birch LL, Shelly A, Vallotton CD, Savage JS. Exploring infant signing to enhance responsive parenting: Findings from the INSIGHT study. Matern Child Nutr. 2019 Jul;15(3):e12800. doi: 10.1111/mcn.12800. Epub 2019 Mar 19. — View Citation

Paul IM, Hohman EE, Loken E, Savage JS, Anzman-Frasca S, Carper P, Marini ME, Birch LL. Mother-Infant Room-Sharing and Sleep Outcomes in the INSIGHT Study. Pediatrics. 2017 Jul;140(1):e20170122. doi: 10.1542/peds.2017-0122. Epub 2017 Jun 5. — View Citation

Paul IM, Savage JS, Anzman-Frasca S, Marini ME, Beiler JS, Hess LB, Loken E, Birch LL. Effect of a Responsive Parenting Educational Intervention on Childhood Weight Outcomes at 3 Years of Age: The INSIGHT Randomized Clinical Trial. JAMA. 2018 Aug 7;320(5) — View Citation

Paul IM, Savage JS, Anzman-Frasca S, Marini ME, Mindell JA, Birch LL. INSIGHT Responsive Parenting Intervention and Infant Sleep. Pediatrics. 2016 Jul;138(1):e20160762. doi: 10.1542/peds.2016-0762. — View Citation

Paul IM, Williams JS, Anzman-Frasca S, Beiler JS, Makova KD, Marini ME, Hess LB, Rzucidlo SE, Verdiglione N, Mindell JA, Birch LL. The Intervention Nurses Start Infants Growing on Healthy Trajectories (INSIGHT) study. BMC Pediatr. 2014 Jul 18;14:184. doi: 10.1186/1471-2431-14-184. — View Citation

Savage JS, Birch LL, Marini M, Anzman-Frasca S, Paul IM. Effect of the INSIGHT Responsive Parenting Intervention on Rapid Infant Weight Gain and Overweight Status at Age 1 Year: A Randomized Clinical Trial. JAMA Pediatr. 2016 Aug 1;170(8):742-9. doi: 10.1 — View Citation

Savage JS, Hohman EE, Marini ME, Shelly A, Paul IM, Birch LL. INSIGHT responsive parenting intervention and infant feeding practices: randomized clinical trial. Int J Behav Nutr Phys Act. 2018 Jul 9;15(1):64. doi: 10.1186/s12966-018-0700-6. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Factors that influence the succession of the oral and gut microbiomes.	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	birth to 1 year of age
Primary	BMI percentile at 3 years	BMI percentile at 3 years	3 years
Secondary	Weight-for-length percentile at several intervals in the first 12 months after birth	Weight-for-length percentile at several intervals in the first 12 months after birth	12 months of age
Secondary	BMI percentile at age 2 years	BMI percentile at age 2 years	2 years of age
Secondary	Proportion of infants with BMI > 85th and 95th percentiles at ages 2 and 3 years	Proportion of infants with BMI > 85th and 95th percentiles at ages 2 and 3	aged 2 and 3 years
Secondary	Proportion of infants with accelerated weight gain between numerous study intervals	Proportion of infants with accelerated weight gain between numerous study	birth to 4 months, birth to 1 year, birth to 3 years, 1 year to 3 years