STRONG Kids 2: A Cells-to-Society Approach to Nutrition in Early Childhood (SK2)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03341858 |
Recruitment Status :
Active, not recruiting
First Posted : November 14, 2017
Last Update Posted : May 27, 2022
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 2, 3, 4, 5, 6, 7 and 8 years. 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.
Condition or disease | Intervention/treatment |
---|---|
Child Obesity Child, Only | Other: no intervention-strictly observational |
Study Type : | Observational |
Actual Enrollment : | 450 participants |
Observational Model: | Family-Based |
Time Perspective: | Prospective |
Official Title: | STRONG Kids 2: A Cells-to-Society Approach to Nutrition in Early Childhood |
Actual Study Start Date : | May 10, 2013 |
Estimated Primary Completion Date : | August 20, 2027 |
Estimated Study Completion Date : | August 20, 2027 |
- SK2 recruitment [ Time Frame: Years 1-3 ]Recruit 440 families (increased by 10% to retain cohort of 400 over time should budget permit)
- Identify relationship between gut microbiota, weaning practices, and early milk consumption patterns [ Time Frame: Years 1-12 ]Identify relationship between gut microbiota, weaning practices, and early milk consumption patterns
- Identify relationship between individual biology, family factors, and toddler food and dairy consumption [ Time Frame: Years 1-12 ]Identify relationship between individual biology, family factors, and toddler food and dairy consumption
Biospecimen Retention: Samples With DNA
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 0 Years to 15 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
Exclusion Criteria:
- preterm delivery
- non-singleton birth
- Down Syndrome
- Cleft palate
- Cystic Fibrosis
- Phenylketonuria [PKU]or other inborn errors of metabolism,
- a congenital heart condition that affects feeding,
- gene 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.
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): NCT03341858
Principal Investigator: | Sharon M Donovan, PhD | University of Illinois Urbana Champaign | |
Principal Investigator: | Barbara H Fiese, PhD | University of Illinois Urbana Champaign |
Responsible Party: | University of Illinois at Urbana-Champaign |
ClinicalTrials.gov Identifier: | NCT03341858 |
Other Study ID Numbers: |
13448 |
First Posted: | November 14, 2017 Key Record Dates |
Last Update Posted: | May 27, 2022 |
Last Verified: | May 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Pediatric Obesity Obesity Overweight |
Overnutrition Nutrition Disorders Body Weight |