STRONG Kids 2: A Cells-to-Society Approach to Nutrition in Early Childhood

NCT03341858 | Active Not Recruiting

• 3 other identifiers: IRB24-1825R01DK107561R01DK138032
• Study Type: observational
• Target: 450
• Locations: 0 countries
• Sites: N/A

Brief Summary

STRONG Kids 2: A Cells to Society Approach to Nutrition Overview Using a cells-to-society approach to nutrition, this transdisciplinary project will provide unique insights into how individual biology interacts with the family environment to promote healthy eating habits in young children. It is one of the first studies to take a longitudinal look at the habits, including milk and dairy consumption, from birth. STRONG Kids 2 is built upon previous research from STRONG Kids 1 with preschool-aged children, documenting the relationship among genetic, child, and family factors in predicting BMI and dietary habits. The study sample includes 450 infants and their families located in small urban communities in central Illinois. Biological samples and height and weight measurements from infants and toddlers are collected at 6 weeks, 3, 12, 18 months and annually from ages 2 through 12 years of age. Mothers are surveyed about weaning, dietary habits, household routines, children's emotions, feeding styles, and milk and dairy consumption. Additional measures such as maternal height and weight are also being collected.

Conditions

Child Obesity; Child, Only

Outcome Measures

Primary Outcomes (3)

• SK2 recruitment

  Recruit 440 families (increased by 10% to retain cohort of 400 over time should budget permit)

  Years 1-12

• Identify relationship between gut microbiota, weaning practices, and early milk consumption patterns

  Identify relationship between gut microbiota, weaning practices, and early milk consumption patterns

  Years 1-12

• Identify relationship between individual biology, family factors, and toddler food and dairy consumption

  Identify relationship between individual biology, family factors, and toddler food and dairy consumption

  Years 1-12

Interventions

no intervention-strictly observational OTHER

Eligibility Criteria

• Age: 0 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

We will enroll pregnant women recruited through three area hospitals and two clinics in the Champaign County region. Participants will be recruited in their last trimester of pregnancy in cooperation with OB/GYN and Family Practice Physicians at at Francis Nelson and Carle Foundation Hospital (Champaign), Christie Clinic (Champaign), Decatur Memorial Hospital (Decatur, IL), Provena United Samaritans Medical Center and Danville Polyclinic(Danville, IL). These recruitment sites will provide an adequate sample base to recruit 440 families.

You may not qualify if:

• Preterm delivery
• Non-singleton birth
• Down Syndrome
• Cleft palate
• Cystic Fibrosis
• Phenylketonuria or other inborn errors of metabolism,
• A congenital heart condition that affects feeding,
• Genetic defects or hormone deficiencies that would affect growth.
• If an infant is born with any other rare defect not listed there, they will also be excluded from participation.

Sponsors & Collaborators

• National Dairy Council: collaborator
• The Gerber Foundation: collaborator
• United States Department of Agriculture (USDA): collaborator
• University of Illinois at Urbana-Champaign: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Related Publications (17)

• Cai T, Sutter C, Donovan SM, Fiese BH. The Relationship Between Maternal and Infant Sleep Duration Across the First Two Years. J Dev Behav Pediatr. 2023 Aug 1;44(6):e421-e428. doi: 10.1097/DBP.0000000000001195. Epub 2023 Jun 2.

  PMID: 37276363 RESULT

• Fan Y, Vinjamuri A, Tu D, Lebrilla CB, Donovan SM. Determinants of human milk oligosaccharides profiles of participants in the STRONG kids 2 cohort. Front Nutr. 2023 Mar 28;10:1105668. doi: 10.3389/fnut.2023.1105668. eCollection 2023.

  PMID: 37057069 RESULT

• McMath AL, Iwinski S, Shen S, Bost KF, Donovan SM, Khan NA. Adherence to Screen Time and Physical Activity Guidelines is Associated with Executive Function in US Toddlers Participating in the STRONG Kids 2 Birth Cohort Study. J Pediatr. 2023 Jan;252:22-30.e6. doi: 10.1016/j.jpeds.2022.08.026. Epub 2022 Aug 24.

  PMID: 36027980 RESULT

• Ellis JL, Wang M, Fu X, Fields CJ, Donovan SM, Booth SL. Feeding Practice and Delivery Mode Are Determinants of Vitamin K in the Infant Gut: An Exploratory Analysis. Curr Dev Nutr. 2022 Feb 12;6(3):nzac019. doi: 10.1093/cdn/nzac019. eCollection 2022 Mar.

  PMID: 35295713 RESULT

• Iwinski S, Donovan SM, Fiese B, Bost K. The Impact of Household Chaos and Dietary Intake on Executive Function in Young Children. Nutrients. 2021 Dec 12;13(12):4442. doi: 10.3390/nu13124442.

  PMID: 34959994 RESULT

• Lundquist A, McBride BA, Donovan SM, Wszalek M. Father support for breastfeeding mothers who plan to utilize childcare: A qualitative look at Mothers' perspectives. Appetite. 2022 Feb 1;169:105854. doi: 10.1016/j.appet.2021.105854. Epub 2021 Dec 8.

  PMID: 34890723 RESULT

• Iwinski S, Cole NC, Saltzman JA, Donovan SM, Lee SY, Fiese BH, Bost KK. Child attachment behavior as a moderator of the relation between feeding responsiveness and picky eating behavior. Eat Behav. 2021 Jan;40:101465. doi: 10.1016/j.eatbeh.2020.101465. Epub 2020 Nov 27.

  PMID: 33310487 RESULT

• Lundquist A, McBride BA, Donovan SM, Kieffer A. An Exploratory Look at the Role of Childcare Providers as a Support and Resource for Breastfeeding Mothers. Breastfeed Med. 2019 Jun;14(5):313-319. doi: 10.1089/bfm.2018.0091. Epub 2019 Mar 21.

  PMID: 30896256 RESULT

• Fiese BH, Musaad S, Bost KK, McBride BA, Lee SY, Teran-Garcia M, Donovan SM. The STRONG Kids 2 Birth Cohort Study: A Cell-to-Society Approach to Dietary Habits and Weight Trajectories across the First 5 Years of Life. Curr Dev Nutr. 2019 Jan 18;3(3):nzz007. doi: 10.1093/cdn/nzz007. eCollection 2019 Mar.

  PMID: 30882062 RESULT

• Sutter C, Fiese BH, Lundquist A, Davis EC, McBride BA, Donovan SM. Sources of Information and Support for Breastfeeding: Alignment with Centers for Disease Control and Prevention Strategies. Breastfeed Med. 2018 Nov;13(9):598-606. doi: 10.1089/bfm.2018.0056. Epub 2018 Oct 9.

  PMID: 30307320 RESULT

• Fiese BH, Barton JM, Sahin E. Longitudinal changes in home food availability across the first 3 years of life and associations with family context predictors. Front Nutr. 2023 Sep 28;10:1215894. doi: 10.3389/fnut.2023.1215894. eCollection 2023.

  PMID: 37841403 RESULT

• Ju S, Iwinski S, Fiese BH, McBride BA, Bost KK. Infant temperament and mealtime distractions as predictors of preschool Children's bite speed during family mealtime. Appetite. 2022 Oct 1;177:106157. doi: 10.1016/j.appet.2022.106157. Epub 2022 Jun 30.

  PMID: 35780936 RESULT

• Ju S, Iwinski S, Fiese BH, McBride BA, Bost KK. Influences of Child Temperament and Household Chaos on Preschoolers' Emotional Eating. Child Obes. 2022 Dec;18(8):523-532. doi: 10.1089/chi.2021.0237. Epub 2022 Feb 28.

  PMID: 35231179 RESULT

• Fiese BH, Cai T, Sutter C, Bost KK. Bedtimes, bedtime routines, and children's sleep across the first 2 years of life. Sleep. 2021 Aug 13;44(8):zsab045. doi: 10.1093/sleep/zsab045.

  PMID: 33624804 RESULT

• Saltzman JA, Bost KK, McBride BA, Fiese BH. Household Chaos, Maternal Emotional Responsiveness, and Child Eating Behavior: A Moderation Analysis. J Dev Behav Pediatr. 2019 Oct/Nov;40(8):622-632. doi: 10.1097/DBP.0000000000000701.

  PMID: 31318779 RESULT

• Dolcos F, Katsumi Y, Shen C, Bogdan PC, Jun S, Larsen R, Heller W, Bost KF, Dolcos S. The Impact of Focused Attention on Emotional Experience: A Functional MRI Investigation. Cogn Affect Behav Neurosci. 2020 Oct;20(5):1011-1026. doi: 10.3758/s13415-020-00816-2.

  PMID: 32770316 RESULT

• Dolcos F, Katsumi Y, Bogdan PC, Shen C, Jun S, Buetti S, Lleras A, Bost KF, Weymar M, Dolcos S. The impact of focused attention on subsequent emotional recollection: A functional MRI investigation. Neuropsychologia. 2020 Feb 17;138:107338. doi: 10.1016/j.neuropsychologia.2020.107338. Epub 2020 Jan 8.

  PMID: 31926178 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Biological and genetic sampling: STOOL SAMPLE: A stool sample will be collected from the infant/child at 1week, 6 week, 3 months, 1 month after the introduction of solids (ITS), 12 months, 18 months, and annually from ages 2-12. A stool samples will be collected from the mother at 6weeks postpartum. SALIVA SAMPLE: A saliva sample will be collected at the 6 week home visit from both the mother and infant and again from the child at 4 years of age. A trained researcher will swab each participant's mouth and collect a small sample using a non-invasive technique. BREASTMILK SAMPLE: Breastfeeding mothers will be asked to provide a breast milk sample representative of the milk provided in the 24 hours prior to the fecal sample collection at 6 weeks postpartum.

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sharon M Donovan, PhD

  University of Illinois Urbana Champaign

  PRINCIPAL INVESTIGATOR

• Barbara H Fiese, PhD

  University of Illinois Urbana Champaign

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: FAMILY BASED
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2017
• First Posted: November 14, 2017
• Study Start: May 10, 2013
• Primary Completion (Estimated): August 20, 2029
• Study Completion (Estimated): August 20, 2029
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share