NCT02031978

Brief Summary

The goal of the study is to be a current examination of infant and toddler feeding practices among families receiving WIC services. It has been more than 10 years since the last study of such feeding practices, and in the interim important changes have taken place in the WIC program, in society, and in the science of nutrition. The study will include exploration of breastfeeding practices and support, more general feeding practices, nutritional intake of infants and toddlers, transitions in infant and toddler feeding practices, early precursors of obesity, and family factors that may influence all of these nutrition-related issues. It will also explore characteristics of the WIC program in selected sites, and how these relate to infant and toddler feeding decisions and practices. This study is important both to update knowledge about the WIC population, and to uncover possible new avenues of inquiry regarding early childhood obesity. Update on November 25, 2020: The WIC ITFPS-2 will now follow participants through child age 9 years. This unprecedented opportunity will provide FNS with a better understanding of the impact of WIC participation on health and nutrition outcomes in childhood.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
4,367

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2013

Longer than P75 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 7, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 9, 2014

Completed
7.4 years until next milestone

Results Posted

Study results publicly available

June 10, 2021

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

June 9, 2022

Status Verified

May 1, 2022

Enrollment Period

10 years

First QC Date

January 7, 2014

Results QC Date

December 7, 2020

Last Update Submit

May 20, 2022

Conditions

Keywords

Breast FeedingInfant NutritionChildhood ObesityInfant feeding patternsWICDiet qualityFood security

Outcome Measures

Primary Outcomes (1)

  • Breastfeeding Initiation

    Whether the mother initiated breastfeeding after child was born

    first month after birth of child

Study Arms (1)

WIC Program Participants

The cohort is made up of infants. Pregnant women enrolling in WIC for the first time for that pregnancy and mothers/caregivers of infants younger than 2.5 months of age enrolling in WIC for the first time are recruited to participate.

Eligibility Criteria

AgeUp to 3 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

The target study participant is the infant. Mothers will be recruited prenatally and mothers/primary caregivers of infants will be recruited postnatally at 80 WIC clinic service locations.

You may qualify if:

  • Enrolling in WIC for the first time for that pregnancy or infant
  • Able to complete interviews in either English or Spanish

You may not qualify if:

  • Having enrolled in WIC previously for that pregnancy or child
  • The child being older than 2.5 months old at the time of recruitment
  • Adolescent mothers under age 16 were not eligible to participate.\\
  • Adolescents who were in foster care at the time of enrollment were not eligible to participate, as foster parents cannot typically provide consent for research participation.
  • Foster parents who were enrolling foster infants in WIC also were not eligible, as they cannot provide consent for the child's records.
  • As defined by HHS regulations at 45 CFR part 46.303(c), prisoners were excluded from this research.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (22)

  • Au LE, Gurzo K, Paolicelli C, Whaley SE, Weinfield NS, Ritchie LD. Diet Quality of US Infants and Toddlers 7-24 Months Old in the WIC Infant and Toddler Feeding Practices Study-2. J Nutr. 2018 Nov 1;148(11):1786-1793. doi: 10.1093/jn/nxy192.

  • Au LE, Paolicelli C, Gurzo K, Ritchie LD, Weinfield NS, Plank KR, Whaley SE. Contribution of WIC-Eligible Foods to the Overall Diet of 13- and 24-Month-Old Toddlers in the WIC Infant and Toddler Feeding Practices Study-2. J Acad Nutr Diet. 2019 Mar;119(3):435-448. doi: 10.1016/j.jand.2018.11.001. Epub 2019 Jan 9.

  • Whaley SE, Martinez CE, Paolicelli C, Ritchie LD, Weinfield NS. Predictors of WIC Participation Through 2 Years of Age. J Nutr Educ Behav. 2020 Jul;52(7):672-679. doi: 10.1016/j.jneb.2019.12.015. Epub 2020 Feb 14.

  • Gleason S, Wilkin MK, Sallack L, Whaley SE, Martinez C, Paolicelli C. Breastfeeding Duration Is Associated With WIC Site-Level Breastfeeding Support Practices. J Nutr Educ Behav. 2020 Jul;52(7):680-687. doi: 10.1016/j.jneb.2020.01.014. Epub 2020 Mar 11.

  • Weinfield NS, Borger C, Gola AA. Breastfeeding Duration in a Low-Income Sample Is Associated With Child Diet Quality at Age Three. J Hum Lact. 2021 Feb;37(1):183-193. doi: 10.1177/0890334420903029. Epub 2020 Feb 24.

  • Weinfield NS, Borger C, Au LE, Whaley SE, Berman D, Ritchie LD. Longer Participation in WIC Is Associated with Better Diet Quality in 24-Month-Old Children. J Acad Nutr Diet. 2020 Jun;120(6):963-971. doi: 10.1016/j.jand.2019.12.012. Epub 2020 Feb 14.

  • Hamner HC, Beauregard JL, Li R, Nelson JM, Perrine CG. Meeting breastfeeding intentions differ by race/ethnicity, Infant and Toddler Feeding Practices Study-2. Matern Child Nutr. 2021 Apr;17(2):e13093. doi: 10.1111/mcn.13093. Epub 2020 Oct 1.

  • Anderson CE, Martinez CE, Ventura AK, Whaley SE. Potential overfeeding among formula fed Special Supplemental Nutrition Program for Women, Infants and Children participants and associated factors. Pediatr Obes. 2020 Dec;15(12):e12687. doi: 10.1111/ijpo.12687. Epub 2020 Jun 18.

  • Borger C, Paolicelli C, Ritchie L, Whaley SE, DeMatteis J, Sun B, Zimmerman TP, Reat A, Dixit-Joshi S. Shifts in Sources of Food but Stable Nutritional Outcomes among Children in the Early Months of the COVID-19 Pandemic. Int J Environ Res Public Health. 2021 Nov 30;18(23):12626. doi: 10.3390/ijerph182312626.

  • Weinfield NS, Anderson CE. Postpartum Symptoms of Depression are Related to Infant Feeding Practices in a National WIC Sample. J Nutr Educ Behav. 2022 Feb;54(2):118-124. doi: 10.1016/j.jneb.2021.09.002. Epub 2021 Dec 18.

  • Thompson HR, Borger C, Paolicelli C, Whaley SE, Reat A, Ritchie L. The Relationship between Breastfeeding and Initial Vegetable Introduction with Vegetable Consumption in a National Cohort of Children Ages 1-5 Years from Low-Income Households. Nutrients. 2022 Apr 22;14(9):1740. doi: 10.3390/nu14091740.

  • Borger C, Paolicelli CP, Sun B. Duration of Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) Participation is Associated With Children's Diet Quality at Age 3 Years. Am J Prev Med. 2022 Jun;62(6):e343-e350. doi: 10.1016/j.amepre.2021.12.019. Epub 2022 Mar 8.

  • Bably MB, Paul R, Laditka SB, Racine EF. Factors Associated with the Initiation of Added Sugar among Low-Income Young Children Participating in the Special Supplemental Nutrition Program for Women, Infants, and Children in the US. Nutrients. 2021 Oct 29;13(11):3888. doi: 10.3390/nu13113888.

  • Chaparro MP, Anderson CE. Differences in Early Childhood Dietary Behaviors by Infant Feeding Type and Sex. J Nutr. 2021 Jul 1;151(7):2001-2009. doi: 10.1093/jn/nxab076.

  • Bably MB, Laditka SB, Paul R, Racine EF. Age of Bottle Cessation and BMI-for-Age Percentile among Children Aged Thirty-Six Months Participating in WIC. Child Obes. 2022 Apr;18(3):197-205. doi: 10.1089/chi.2021.0119. Epub 2021 Sep 22.

  • Beauregard JL, Nelson JM, Li R, Perrine CG, Hamner HC. Maternity Care Practices and Breastfeeding Intentions at One Month Among Low-Income Women. Pediatrics. 2022 Apr 1;149(4):e2021052561. doi: 10.1542/peds.2021-052561.

  • Hamner HC, Chiang KV, Li R. Returning to Work and Breastfeeding Duration at 12 Months, WIC Infant and Toddler Feeding Practices Study-2. Breastfeed Med. 2021 Dec;16(12):956-964. doi: 10.1089/bfm.2021.0081. Epub 2021 Jul 28.

  • Thompson IJB, Ritchie LD, Bradshaw PT, Mujahid MS, Au LE. Earlier Introduction to Sugar-Sweetened Beverages Associated With Lower Diet Quality Among WIC Children at Age 3 Years. J Nutr Educ Behav. 2021 Nov;53(11):912-920. doi: 10.1016/j.jneb.2021.04.468. Epub 2021 Jul 3.

  • Paolicelli C, Berman D, Owens T, Magness A, Scanlon KS. Breastfeeding and Complementary Feeding Patterns Among Women Enrolled in WIC: WIC Infant and Toddler Feeding Practices Study-2. Breastfeed Med. 2017 Oct;12(8):482-486. doi: 10.1089/bfm.2017.0118. Epub 2017 Aug 22. No abstract available.

  • Chaney AM, Arnold CD, Frongillo EA, Ritchie LD, Steele EM, Au LE. Infant diet quality index predicts nutrients of concern and ultra-processed food intake in low-income children in the United States. Curr Dev Nutr. 2024 Oct 18;8(11):104483. doi: 10.1016/j.cdnut.2024.104483. eCollection 2024 Nov.

  • Borger C, Weinfield NS, Paolicelli C, Sun B, May L. Prenatal and Postnatal Experiences Predict Breastfeeding Patterns in the WIC Infant and Toddler Feeding Practices Study-2. Breastfeed Med. 2021 Nov;16(11):869-877. doi: 10.1089/bfm.2021.0054. Epub 2021 Jul 15.

  • Harrison GG, Hirschman JD, Owens TA, McNutt SW, Sallack LE. WIC Infant and Toddler Feeding Practices Study: protocol design and implementation. Am J Clin Nutr. 2014 Mar;99(3):742S-6S. doi: 10.3945/ajcn.113.073585. Epub 2014 Jan 29.

Related Links

MeSH Terms

Conditions

Breast FeedingPediatric ObesityFeeding Behavior

Condition Hierarchy (Ancestors)

BehaviorObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior, Animal

Results Point of Contact

Title
Courtney Paolicelli
Organization
USDA Food and Nutrition Service

Study Officials

  • Courtney Paolicelli, DrPH

    USDA Food and Nutrition Service

    STUDY DIRECTOR
  • Christine Borger, PhD

    Westat

    PRINCIPAL INVESTIGATOR
  • Amanda Reat, PhD

    USDA Food and Nutrition Service

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2014

First Posted

January 9, 2014

Study Start

July 1, 2013

Primary Completion

July 1, 2023

Study Completion

September 1, 2024

Last Updated

June 9, 2022

Results First Posted

June 10, 2021

Record last verified: 2022-05