CONCEPTT Kids Childhood Adiposity and Neurodevelopmental Outcomes Among Offspring of Women With Type 1 Diabetes: A Follow up Study of the CONCEPTT Randomized Control Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University of Calgary
- Enrollment
- 174
- Locations
- 4
- Primary Endpoint
- IQ
Study Overview
Brief Summary
This is a follow-up study of children born to mothers who participated in the CONCEPTT Trial. CONCEPTT (a multicentre randomized controlled trial of continuous glucose monitoring (CGM) in women with Type 1 diabetes during pregnancy).
The purpose of this study is to examine the association of maternal glycemic measures on childhood intelligence quotient (IQ), behavioural outcomes, language scores and weight measures. The children of the women who participated in CONCEPTT will be assessed.
Detailed Description
The assessments will occur between the children's ages of 3-7 years. The assessment will include obtaining consent and child measurements including weight, height, waist circumference and skinfold thickness (at the triceps, subscapular, flank and quadriceps). Body mass index (BMI) and Waist-Height ratio will be calculated.
The other procedures will include:
- the Wechsler Preschool and Primary Scale of Intelligence-Fourth Edition (1);
- ADHD Rating Scale IV (2) and ADHD Rating Scale-IV Preschool Version (3);
- Social Responsiveness Scale-2 for ASD behaviours (4);
- Children's performance on the Speed Naming and Phonological Processing subscales of the NEPSY-II (5)
- Parent reported language development on the Children's Communication Checklist-2 for children over four years of age (6) or the Language Use Inventory (LUI) for children 36 to 47 months of age (7).
Basic demographic questions will be asked regarding the child's mother and father including age, ethnicity, education, occupation, family arrangement, presence of major illnesses, and diabetes complications. Questions regarding maternal diabetes, maternal and paternal family history of diabetes and risk factors for heart disease will be collected at the clinic visit.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 3 Years to 7 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Children of women who participated in the CONCEPTT trial at selected recruiting sites.
Exclusion Criteria
- •Children (of women who participated in the CONCEPTT trial) with major congenital anomalies will be assessed on a case by case basis to determine eligibility.
Outcomes
Primary Outcomes
IQ
Time Frame: 2 years
IQ assessed by the Wechsler Preschool and Primary Scale of Intelligence - Fourth Edition (WPPSI-IV)
Secondary Outcomes
- ASD(2 years)
- NEPSY-II(2 years)
- Adiposity(2 years)
- CCC-2/LUI(2 years)
- Demographics(2 years)
- ADHD(2 years)