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Child ObesitySK2NCT03341858

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

An observational study of Child Obesity and Child, Only, run by University of Illinois at Urbana-Champaign.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 0 to 12 yearsHealthy volunteers can take part
Conditions the study is for
Child Obesity, Child, Only
How many people
450 participants
Where
No sites listed yet
Study dates
10 May 2013to 20 Aug 2029
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 0 to 12 years
  • All sexes
  • Healthy volunteers accepted
  • Child

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.

Who may be able to join

None listed.

Who cannot join

  • Preterm delivery
  • Non-singleton birth
  • Down Syndrome
  • Cleft palate
  • Cystic Fibrosis
  • Phenylketonuria or other inborn errors of metabolism,
Show all 9Show fewer
  • 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.

About this study

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.

Read the detailed description

Despite increased public awareness, there has been little progress over the past 2 decades in stemming the tide of childhood obesity in the U.S. Recent projections indicate that by 2030, at least 42% of American adults will be obese and 11% will be categorized as severely obese.Unfortunately, high rates of obesity begin in early childhood. According to the most recent estimates of obesity prevalence in U.S. children, 26.7% of 2-5 year-olds were overweight (>85th BMI percentile) and 12.1% were considered obese (>95th BMI percentile). Epidemiological data show that overweight and obesity during early childhood tracks into later childhood, adolescence, and adulthood.The persistence of unhealthy weight from early childhood into later years is multi factorial involving biological and behavioral facets, which may explain, in part, the relatively poor success of weight loss programs for children and adolescents.

The Synergistic Theory and Research on Obesity and Nutrition Group (STRONG) Kids Program (SKP) at the University of Illinois Urbana-Champaign is a well-established interdisciplinary research and education program aimed at identifying the multiple factors that contribute to unhealthy weight gain in preschool age (2-5 year-old) children. The team incorporates a "cells-to-society" approach, recognizing that biological and socio-environmental factors interact to affect eating and physical activity behaviors. The purpose of this project is to expand the STRONG Kids Program and launch a birth cohort study to examine the impact of food, milk, and dairy product consumption on weight trajectory from birth to twelve years of age. Due to the multidisciplinary expertise of our research team we will also examine the contributions of biological and environmental factors to the development of dietary habits, diet quality and the child's growth trajectory. The research team capitalize on emerging scientific findings that demonstrate that variability in individual biology(genetics), child self-regulation (e.g., inhibitory control), and family household characteristics (e.g., routines) make significant contributions to the development of satiety and food preferences during early childhood. This innovative longitudinal study will be the first of its kind to evaluate the composition of the gut microbiota over time and its potential impact on the self-regulatory personality characteristics in young children known to affect food preferences. Further, the research team will use well-established protocols to assess maternal and household characteristics known to promote healthy eating patterns to determine the intersection of child biological functioning and the introduction of solid foods, including milk and dairy foods, during the weaning period and their effects on weight trajectory up to three years of age.

The STRONG Kids Program 2 (SKP2), will recruit a cohort sample of 400 infants and their families into a comprehensive twelve-year longitudinal study that will be unique by its theory-driven integration of genetics, nutrition, child development and family science. This comprehensive approach will allow for a greater understanding of how dietary habits are established during the first five years of life and contribute to healthy weight. The team will collect biological samples (saliva and stool specimens) and height,weight from infants and toddlers at 1 and 6 weeks and 3 months, after the introduction of solid foods, 12, 18 months and annually from 2 through 12 years postpartum.

Concordantly we will survey mothers about weaning, dietary habits, household routines, child self-regulation, feeding practices and styles, and maternal height and weight. This comprehensive approach is based on our first phase of STRONG Kids research (SKP1) with preschool age children, which has documented the relationship among child and family factors in predicting BMI and dietary habits. To date, there is scant evidence-based information on how parents make decisions to introduce new foods during the weaning period and the effects of different food types on child weight from birth to the early years. Specifically, there is a glaring absence of scientific information on the contribution that individual biology plays in positively interacting with milk and cultured dairy products (e.g, cheese, yogurt) as initial foods introduced during the weaning period and their contribution to sustaining healthy weight during the preschool years. This is likely to be a complex interaction among the child's biological make-up, temperament and response to satiety, the parent's feeding practices and styles, availability of food resources, and the feeding policies in place once the child is enrolled in child care. The STRONG Kids team has the expertise to address these multiple influences and can provide a fresh comprehensive approach to the study of food consumption and weight gain during the early years.

Being tested
no intervention-strictly observational
Medical subject headings
Pediatric Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • no intervention-strictly observationalOther

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. SK2 recruitment

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

    Measured: Years 1-12

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

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

    Measured: Years 1-12

  3. 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

    Measured: Years 1-12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Nov 2017
  2. Study start10 May 2013
  3. Primary completion20 Aug 2029 (estimated)
  4. Study completion20 Aug 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Family based
Time perspective
Prospective
Enrolment
450 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03341858
Sponsor's protocol ID
IRB24-1825
Other IDs
R01DK107561, R01DK138032
Acronym
SK2
Status last verified
Apr 2026
First submitted
12 Oct 2017
Last updated
5 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 37276363
  • 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.

    PubMed 37057069
  • 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.

    PubMed 36027980
  • 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.

    PubMed 35295713
  • 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.

    PubMed 34959994
  • 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.

    PubMed 34890723
  • 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.

    PubMed 33310487
  • 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.

    PubMed 30896256
  • 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.

    PubMed 30882062
  • 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.

    PubMed 30307320
  • 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.

    PubMed 37841403
  • 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.

    PubMed 35780936
  • 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.

    PubMed 35231179
  • 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.

    PubMed 33624804
  • 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.

    PubMed 31318779

Questions about this trial

What is this clinical trial studying?

An observational study of Child Obesity and Child, Only, run by University of Illinois at Urbana-Champaign.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

SK2 recruitment (time frame: Years 1-12). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03341858, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.

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